Teleflex updates on Q2 earnings, FDA clearances, acquisitions, deals & study data.

Teleflex (NYSE:TFX) yesterday released a slew of new information on the company, including its fiscal 2nd quarter results, new FDA clearances, the acquisition of Australian distributor assets, details on a new group purchase agreement and data from a set of new studies.

 

Teleflex shares slide on Q2 report

Teleflex’s shares dropped nearly 5% today after the medical device company released fiscal 2nd quarter results that just squeaked by expectations.

The company reported profits of $44.5 million, or 93¢ per share, on sales of $452.1 million for the 3 months ended June 29.

That amounts to a 7.9% decline in profits and a 3.4% slide in sales compared to 2014. Adjusted to include 1-time items, earnings per share were $1.42, down 9¢ from last year and directly inline with analyst expectations.

In light of the news, shares have fallen roughly 5% today as of 4:00 p.m. EST.

“During the 2nd quarter of 2015, Teleflex continued its solid operating performance, building upon the results realized earlier this year. Once again, we generated mid-single digit constant currency revenue growth and achieved adjusted earnings per share ahead of our previous expectations. In fact, adjusted earnings per share would have been higher during the second quarter of 2015 had it not been for foreign exchange, which impacted results negatively by approximately 20% as compared to the second quarter of 2014,” CEO Benson Smith said in a prepared statement.

Teleflex wins 510(k) for Arrow Endurance catheter system

Teleflex said it won FDA 510(k) clearance for its Arrow Endurance extended dwell peripheral catheter system, according to a release published yesterday.

The Arrow Endurance device is cleared to dwell up to 29 days, which allows hospitals to avoid using multiple peripheral IVs or peripherally inserted central catheters.

“The Arrow Endurance extended dwell peripheral catheter system is yet another offering from Teleflex that helps vascular access professionals provide the right line for the right patient at the right time. This is the ideal solution when patients need IV therapy for more than the few days that a traditional PIV allows but don’t require a PICC,” vascular access division prez Jay White said in a press release.

The company said it plans to launch the catheter system in the U.S. later this year.

Teleflex acquires Australian distributor assets

Teleflex said yesterday it acquired certain assets of its Australian distribution partner N. Stenning & Co.

Included in the deal are N. Stenning’s surgical customer relationships and a surgical sales team who are now direct employees of Teleflex, the company said. N. Stenning has been distributing for Teleflex for 35 years.

“Combining the experienced N. Stenning team with our existing direct distribution organization in Australia will strengthen and leverage the Teleflex sales platform to support new surgical product growth. At the same time, this accretive acquisition allows us to capture additional margin and to better understand the needs of our customers, enabling us to grow our surgical products business more effectively,” CEO Benson Smith said in a press release.

Teleflex said it continues to execute a strategy of converting select diestributors to direct sales models, which enables the company to sell on a direct basis with its end-customers.

Teleflex inks new group purchase agreement

Teleflex said yesterday it signed a group purchasing agreement with HealthTrust for its Weck EFx portfolio of port closure products, slated to begin August 1 this year.

The company’s Weck EFx products are designed for closing laparoscopic port sites and provide a range of options for different procedures, the company said. The portfolio includes Teleflex’s Weck EFx Shield fascial closure system, which it says is the only shielded port closure device on the market.

“Teleflex has built a comprehensive port-site closure portfolio created around the need for increased patient safety, procedural efficiency and reduced cost. Teleflex’s latest innovation, the Weck EFx Shield fascial closure system, introduces the industry’s 1st and only shielded device for enhanced patient safety. We are pleased to sign an agreement with HealthTrust and have the opportunity to bring these solutions to its members,” Teleflex surgical prez John Tushar said in prepared remarks.

Teleflex touts data from 2 new studies

Teleflex released the results of 2 new studies yesterday, involving its Arrow system Central Venous Catheter and its Arrow EZ-IO intrasosseous vascular access system.

The peer-reviewed, retrospective study of its Arrow CVC compared the company’s antimicrobial catheter with unprotected CVCs, and was published in the American Journal of Infection Control.

The study examined 871 catheters over 6,040 days of use and found a zero infection rate with the Arrow catheter, lower than the 1.4% infection rate with unprotected catheters.

The study also reported the Arrow catheter provided longer catheter-related bloodstream infections-free periods than unprotected catheters, with dwell times up to 30 days without infections occurring.

“This study, when combined with the 2 earlier independent studies by the same team, shows that using an Arrow CVC with antimicrobial protection from Teleflex makes sense from many perspectives. This study is further evidence that using an unprotected catheter may put both patients and a hospital’s bottom line at unnecessary risk. The Arrow CVC with Arrow+ard Technology has been repeatedly shown to improve patient safety even when the risk of infection is low, and it more than pays for itself in the process,” vascular access division prez Jay White said in a prepared statement.

The Arrow catheter also displayed lower CVC related costs compared to unprotected catheters, Teleflex said, with the cost being significantly lower per-day in comparison.

“Our research had previously established that the antimicrobial catheter justified itself both clinically and in cost-effectiveness when inserted in sites associated with higher CRBSI rates. Would the same thing be true if the catheter was used in sites with a low risk of infection? The answer is ‘yes’ according to our data, making the protected catheter a prudent choice in many circumstances – especially for hospitals that have an above-benchmark rate of CRBSIs,” study head Dr. Leonardo Lorente of Tenerife, Spain’s Hospital Universitario de Canarias said in a press release.

Another study, involving the company’s Arrow EZ-IO intraosseous vascular access sytem, compared the system against central venous catheterization during medical emergencies involving adult patients.

Intraossesous vascular access refers to administering medications or fluids into bone marrow.

A peer-reviewed article on the study, published in the Critical Care Medicine journal, involved 79 adults, 31 of which received intraosseous access and 48 who received a CVC. First-pass success rates with the Arrow EZ-IO were at 90.3%, significantly higher than the 37.5% rate associated with CVC.

Overall success rates were also higher, at 96.8% for the Arrow and 81.3% for CVC. The time spent during the procedure was faster with the Arrow EZ-IO, taking on average 1.2 minutes compared to 10.7 minutes with CVC.

“As the market leader in vascular access, we continue to partner with clinicians to expand their options for vascular access. Our full line of vascular access solutions provides clinicians with the ability to select the right line for the right patient at the right time, optimizing patient outcomes. This study has done an excellent job demonstrating the benefits of the ARROW EZ-IO System during inpatient medical emergencies,” White said in prepared remarks.

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