Boston Scientific Corp. executives said Wednesday that they expect to weather multiple regulatory challenges facing the industry and still meet 2019 profit goals, helped by faster growth in the second half of the year.
"We're essentially in line with our plans, reiterating our full-year 7% to 8% organic outlook [for revenue growth], which does imply, obviously, acceleration in the third quarter fourth quarter," Boston Scientific Chief Executive Mike Mahoney told stock analysts Wednesday morning in a conference call. "With the exception of [electrophysiology] all of our businesses continue to grow faster than their peer group. We have a lot of momentum."
Boston Scientific on Wednesday posted a sharp drop in profit, with adjusted earnings for the second quarter edging analysts' expectations by a penny. It reported a 5.6% increase in revenue that was just shy of estimates.
The medical device company, which employs thousands of people in the Twin Cities to design and make products ranging from vascular stents to defibrillator batteries, is navigating obstacles in several key lines of business.
Executives said they expect the Food and Drug Administration to announce next month whether it will update safety disclosures for paclitaxel-coated devices used in the legs to treat peripheral artery disease (PAD), following reports of higher long-term mortality in competitors' devices.
Cuts in the sales forecast for the Minnesota-designed Eluvia stent for PAD have already been added to company guidance. But Mahoney said the Eluvia is expected to be a growth driver in Japan, where the device to open blocked blood vessels in the legs just had a market launch. Also, executives noted that a recent panel of FDA experts looked deeply at industry data and was unable to find a "class effect" — meaning there was not evidence to prove that all devices with paclitaxel are linked to long-term mortality.
"We believe Eluvia remains well-positioned if the [FDA's] guidance continues to recommend drug-eluting technologies only for patients with a high risk of restenosis [reclosure of target vessels], which does represent 40% to 60% of the market. And Eluvia has potential to achieve higher share in this segment given its performance in these patient types," Mahoney said.
The company also announced a delay in seeking approvals for a second-generation transcatheter aortic heart valve in Europe called the Acurate neo 2 because of uncertainty stemming from ongoing systemic changes to the medical device testing and evaluation system there. However, the U.S. clinical trial for the device has begun, CEO Mahoney said.
He also highlighted growing sales effects from several "structural heart" devices, including the Watchman device, which is used to plug up a cul-de-sac in the heart called the left atrial appendage where stroke-causing clots sometimes form; the Lotus Edge transcatheter aortic heart valve; and the Sentinel embolic protection device, which works like a tiny net to capture debris that come loose from the heart and travel through the blood stream during a procedure to implant a new heart valve.
"We're in very good position with supply across the company, momentum across our businesses, new product launches that impact the second half more greatly," Mahoney said.
The stock closed Wednesday essentially unchanged at $42.87 per share.
Boston Scientific on Wednesday reported net income of $154 million, down 73% from $555 million a year ago chiefly due to acquisition-related expenses.
Adjusted for those expenses and other one-time items, the company's latest profit amounted to $550 million, or 39 cents a share. That's down 2 cents from a year ago and was 1 cent above the consensus estimate of Wall Street analysts.
Revenue was $2.63 billion, up 5.6% and slightly below analysts' consensus.
Sales of surgical and general medical products were up 7%, and cardiovascular device sales climbed 8%, while overall sales of devices to monitor the heartbeat were up 2.8% in the quarter.
Mahoney noted that sales of heart-rhythm devices grew faster than the overall market for the devices.
Analysts with SVB Leerink noted that the company reiterated its organic-sales growth, and EPS guidance of $1.54-$1.58: "To us, this guidance likely baked in the potential negative impact" of several ongoing challenges, "and despite the lowered sales guidance, management seemingly remains confident in continued margin expansion."