Integer gains on Q3 sales, earnings beats, raises outlook

Integer Holdings (NYSE:ITGR) share prices rose today after the contract manufacturer posted third-quarter results that handily beat the consensus forecast, powered by a whopping 733.3% bottom-line gain.

Plano, Texas-based Integer reported profits of $114.1 million, or $3.54 per share, on sales of $305.1 million for the three months ended Sept. 28, for top-line growth of 6.6% compared with Q3 2017.

Get the full story on our sister site, Medical Design & Outsourcing.

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Intuitive doesn’t expect any Chinese expanded quota da Vinci Sales this year

Intuitive Surgical (NSDQ:ISRG) said yesterday that despite the Chinese National Health Commission publishing a new quota expansion looking to add more surgical robots over the next two years, it does not expect to sell any systems under the new quota this year.

Sunnyvale, Calif.-based Intuitive Surgical saw shares rise over 5% yesterday on the news that the Chinese Government was calling for a total of 197 endoscopic surgical instrument control systems, or surgical robots, by the end of 2020.

That number includes 154 new systems, according to the government release.

Shortly after the announcement, the robotic surgical giant said in an SEC filing that the process to fill the quota could take time, and that it doesn’t see any transactions in it’s immediate future.

“Da Vinci Surgical systems sales under the quota are uncertain, as they are dependent on hospitals completing a tender process and receiving associated approvals. The tender process could be lengthy, and the company does not expect to sell any systems under this quota in 2018,” the company wrote in the filing.

Shares in Intuitive Surgical have dropped 2.8% so far today, at $506.47 as of 9:50 a.m. EDT.

Last month, shares of Intuitive got a pre-market bump after the robot-assisted surgery pioneer posted third-quarter results that beat the consensus forecast, despite lower profits, and upped its outlook on procedure growth for the year.

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Abiomed shreds fiscal Q2 forecasts

Abiomed (NSDQ:ABMD) today posted fiscal second-quarter numbers that shredded the consensus forecast and raised its outlook on the rest of the year, sending share prices up sharply today.

The Danvers, Mass.-based cardiac assist device maker more than doubled its profits to $50.1 million, or $1.09 per share, on sales of $181.8 million, for a 104.6% bottom-line gain on revenue growth of 36.9%.

Analysts on Wall Street were looking for EPS of 74¢ on sales of $175.2 million.

“We have established a strong foundation with our innovation and technology, balance sheet and intellectual property portfolio,” chairman, president & CEO Michael Minogue said in prepared remarks. “We are executing our plan for sustainable growth while helping to improve patient outcomes focused on native heart recovery.”

Abiomed boosted the low end of its full-year revenue guidance for the second quarter in a row, saying it now expects to log revenues of $765 million to $770 million, compared with $755 million to $770 million previously. The company stood pat on its GAAP operating margin guidance of 28% to 30%.

ABMD shares were up 6.2% to $362.35 apiece today in early trading.

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OsteoRemedies wins FDA nod for Remedy Spectrum GV hip spacer and bone cement

OsteoRemedies recently announced that it has received FDA clearance for its Remedy Spectrum GV hip spacer system and Spectrum GV bone cement.

The system is designed to give surgeons a broad spectrum of treatment options with both Gentamicin and Vancomycin.

Get the full story on our sister site, Drug Delivery Business.

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Reva launches Fantom Encore bioresorbable scaffold

Reva Medical (ASX:RVA) said this week that it launched its Fantom Encore bioresorbable, drug-eluting scaffold and that the first person was treated in a post-market trial of the device.

The Fantom Encore product is a third-gen coronary bioresorbable scaffold featuring a thin strut profile and Reva’s Tyrocore polymer.

Get the full story at our sister site, Drug Delivery Business News.

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Smith & Nephew up on Q3 sales gain

Investors pushed share prices for Smith & Nephew (NYSE:SNN) up in London and New York today after the medical device giant posted a third-quarter revenue gain and confirmed its outlook for the rest of the year.

The British orthopedics and wound care firm reported that sales grew 1.5% to $1.15 billion during the three months ended Sept. 29, powered by a 4.4% gain to $569 million for its U.S. business.

Sales in established markets outside the U.S. were off -3.4% to $393 million; emerging-market sales were $207 million, up 3.5%.

“Improved underlying revenue growth in the third quarter was led by growth in the U.S. and emerging markets. We are on-track to deliver our full year guidance,” CEO Namal Nawana said in prepared remarks. “These results were achieved whilst successfully redesigning how we will run the company. There is still more to do, and I am pleased with the pace of progress and engagement across the organization.”

Although it affirmed its forecast for underlying revenue growth of 2% to 3% this year, Smith & Nephew said it expects sales to come in at the lower half of the range.

The company also unveiled a new structural model involving its three main segments: orthopedics, sports medicine/ENT, and wound, each led by a president. Smith & Nephew downplayed the impact of the U.K.’s exit from the European Union, saying Brexit won’t have “a significant impact on our long-term ability to conduct business into and out of the EU or UK.”

“We are making good progress with our preparations for the various scenarios,” the company said.

The news sent SNN shares up 7.7% to $35.40 apiece today in pre-market trading in New York. In London, SN shares were up 6.3% to £13.54 each as of about 1 pm local time.

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Staar Surgical shares jump on Q3 Beat

Shares in Staar Surgical (NSDQ:STAA) have risen in after-hours trading today after the medical device maker beat expectations on Wall Street with its third quarter results.

The Monrovia, Calif.-based company posted profits of approximately $1.5 million, or 3¢ per share, on sales of approximately $31.8 million for the three months ended September 28, for bottom-line growth of 24.4% on sales growth of 35.3% compared with the same period during the previous year.

Adjusted to exclude one time items, earnings per share were 7¢, well ahead of the 3¢ loss-per-share expectation on Wall Street, where analysts expected to see sales of $29 million, which it handily topped.

“STAAR’s operating momentum continued during the third quarter resulting in an increase in sales of 35% over the prior year driven by the growth of our EVO Visian ICL family of lenses. ICL unit growth highlights for the quarter included China up 100%, Japan up 95%, India up 27% and Germany up 20%. We continue to see strengthening in our key international markets as we prepare for Europe’s and Korea’s high implant season beginning this quarter and extending into Q1 2019 with strong trends continuing in our Asian markets as well. In addition, we believe our full year fiscal 2018 sales growth should exceed 30% over 2017, based on current market conditions, and we fully expect to maintain GAAP profitability for the year. We are also pleased to report that implants have begun and the staged rollout of our Toric ICL lens in the U.S. with certified surgeons is in progress and ahead of schedule. Based upon the enthusiastic reception from prominent surgeons to the Toric ICL, we anticipate that this product introduction represents a positive re-entry point for STAAR in the U.S., the world’s second largest market for refractive vision correction procedures. Finally, outside the U.S. our multi-site EVO with Aspheric Optic clinical trial for presbyopia is ongoing. Our principal investigator from the initial first-in-person clinical trial of the EVO with Aspheric Optic lens for presbyopia presented his study data during our invitation only Experts Summit for surgeons held immediately ahead of the European Society of Cataract and Refractive Surgeons meeting in Vienna last month. We are very pleased with the enthusiastic reception his presentation received,” prez & CEO Caren Mason said in a press release.

Shares in Staar Surgical closed up 4.2% today, closing at $40.11. Shares have jumped another 7.1% in after-hours trading, at $42.95 as of 4:46 p.m. EDT.

In September, Staar Surgical said that it won FDA approval for its Visian toric implantable collamer lens designed for correcting myopia with astigmatism.

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