Boston Scientific beats earnings estimates, touts patent ruling

Brisk sales of devices that alter the diseased heart anatomy and neurostimulators to treat pain drove organic revenue growth of more than 8 percent in the third quarter for medical device maker Boston Scientific, helping it post better than expected earnings.

Chief Executive Mike Mahoney said the company was "very pleased" with a German patent-infringement ruling on Tuesday that allows Boston Scientific to strike a significant settlement with competitor Edwards Lifesciences or to block sales of Edwards' next-generation Sapien Ultra 3 transcatheter aortic valve in Germany.

Edwards can still appeal the patent-infringement ruling, but Mahoney counted it among the signs of positive momentum in Boston Scientific's structural heart business, which includes minimally invasive heart valves and the Watchman left-atrial appendage closure device.

"Our structural heart program continues to build strong momentum, and we are excited about our overall performance in this significant category — which includes the defense of our intellectual property — so that we may continue to sustain our cycle of innovation," Mahoney told investors Wednesday.

Revenue guidance for structural heart devices was raised Wednesday by $25 million, to $475 million for the year, driven by sales of devices like the Watchman heart valve. Mahoney reiterated Boston Scientific's commitment to selling two different types of transcatheter aortic valve replacements (TAVR), including a much-anticipated launch of the Lotus Edge valve in the United States in mid-2019.

Shares of the Massachusetts-based company, which has major offices in Maple Grove and Arden Hills, closed down nearly 1 percent Wednesday, to $35.68.

If approved, the Lotus Edge would become the third such valve on the U.S. market, competing with similar devices from Edwards and Medtronic. Abbott Laboratories is also working on a TAVR valve intended for the U.S. market as well.

Meanwhile, Boston Scientific received permission from the Food and Drug Administration for a clinical trial to support an application for its second minimally invasive aortic valve, the Acurate. And the company announced an "add on" bonus payment from Medicare for its Sentinel device for embolic protection, which is a net that can catch stroke-causing debris released during TAVR implants.

"We see a significant opportunity for embolic protection," Mahoney said. "We believe the unique value of this technology is evidenced by the technology add-on payment for Sentinal in the U.S., which went into effect Oct. 1."

Meanwhile, sales of devices that administer electricity to the nervous system to disrupt pain jumped by 23 percent in the quarter to $189 million, driven by new adoption of the WaveWriter Spinal Cord Stimulator in the U.S. and increasing demand in Europe. Such devices have seen far more marketing emphasis in the past year, as device makers tout their nonopioid treatments for chronic pain.

Sales of heart-rhythm devices grew 3 percent, as increases in high-voltage implantable defibrillators like the Emblem subcutaneous implantable defibrillator made up for a double-digit percentage decline in low-voltage pacemaker sales. Overall, cardiac rhythm management is still one of Boston Scientific's largest product categories by revenue, with $475 million in sales in the third quarter.

Chief Financial Officer Dan Brennan said Boston Scientific is getting closer to settling the nearly 50,000 lawsuits pending against the company over allegedly defective pelvic mesh products. On Wednesday he said the company's current "balance of restricted cash," which is primarily related to the mesh settlements, stood at $781 million.

"As a result, we have approximately $300 million left to fund and the remaining balance sheet liability will be released as the funds are released out of the qualifying settlement fund to plaintiffs, which should occur in Q4, with a small portion in the first half of 2019, to complete the process," Brennan said.

Stock analysts with Leerink Partners noted that with huge liabilities like the mesh settlements in the past, Boston Scientific will have greater flexibility to stay "nimble" in mergers-and-acquisition activity and "cash deployment."

"To us, BSX remains one of the strongest and safest 'growth' stories in large-cap MedTech," Leerink's note to investors Wednesday morning said.

Across all product categories, companywide adjusted net income in the third quarter rose 12 percent. Boston Scientific reported $485 million in adjusted net income on $2.39 billion in revenue during the quarter. Revenue was $8 million under Wall Street consensus expectations. Adjusted diluted earnings per share came in at 35 cents, a penny better than estimates.

The company now expects to book about $9.8 billion in 2018 revenue and projects $1.38 to $1.40 per share in adjusted diluted earnings.

Joe Carlson • 612-673-4779