Vascular Solutions, Inc. Receives 510(K) Clearance for R350 Guidewire
Nov 24 15
Vascular Solutions Inc. announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for a new and enhanced version of the R350 guidewire, an extra-long guidewire designed for use in complex interventional procedures. The company will begin U.S. sales of the device immediately. The new version of the R350 will replace the original R350 guidewire that was launched in 2012 and will now be discontinued. The design of the new version has been enhanced by the use of a nitinol core, which provides superior flexibility and kink-resistance in even the most extreme tortuosity, and a hydrophilic coating on the distal 200cm for excellent deliverability. Initial clinical evaluations of the new version of the R350 guidewire were performed in Canada, where Vascular Solutions received regulatory clearance earlier in 2015. The Vascular Solutions’ R350 guidewire is indicated for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature. It is designed for use in procedures that are performed with a retrograde (against blood flow) approach to the targeted lesion.
Vascular Solutions Inc. Presents at Stifel Healthcare Conference 2015, Nov-17-2015 01:30 PM
Nov 3 15
Vascular Solutions Inc. Presents at Stifel Healthcare Conference 2015, Nov-17-2015 01:30 PM. Venue: The New York Palace Hotel, Hubbard Room, New York, New York, United States. Speakers: James Hennen, Chief Financial Officer and Senior Vice President of Finance.
Vascular Solutions Inc. Presents at Canaccord Genuity 2015 Medical Technology & Diagnostics Forum, Nov-19-2015 02:30 PM
Oct 31 15
Vascular Solutions Inc. Presents at Canaccord Genuity 2015 Medical Technology & Diagnostics Forum, Nov-19-2015 02:30 PM. Venue: Westin Grand Central, New York, New York, United States. Speakers: Howard C. Root, Co-Founder, Chief Executive Officer and Director.
Vascular Solutions Inc. Reports Unaudited Earnings Results for the Third Quarter and Nine Months Ended September 30, 2015; Provides Earnings Guidance for the Fourth Quarter of 2015 and Full Year of 2016; Revised Earnings Guidance for the Full Year of 2015
Oct 20 15
Vascular Solutions Inc. reported unaudited earnings results for the third quarter and nine months ended September 30, 2015. For the quarter, the company's total revenue was $36,954,000 compared to $31,929,000 a year ago. Operating earnings was $4,368,000 compared to $5,213,000 a year ago. Earnings before income taxes was $4,414,000 compared to $5,204,000 a year ago. Net earnings was $2,973,000 compared to $2,570,000 a year ago. Net earnings per share - diluted was $0.16 compared to $0.15 a year ago. Non-GAAP adjusted operating earnings was $7,131,000 compared to $6,761,000 a year ago. Non-GAAP adjusted net earnings per share - diluted was $0.27 compared to $0.20 a year ago. During the third quarter, the company generated $6.9 million in cash from operations and used $2.8 million for capital expenditures related to building improvements and the purchase of manufacturing, operations, and research and development equipment.
For the nine months, the company's total revenue was $109,115,000 compared to $92,513,000 a year ago. Operating earnings was $13,440,000 compared to $14,615,000 a year ago. Earnings before income taxes was $13,527,000 compared to $14,607,000 a year ago. Net earnings was $8,907,000 compared to $8,574,000 a year ago. Net earnings per share - diluted was $0.49 compared to $0.49 a year ago. Non-GAAP adjusted operating earnings was $20,906,000 compared to $17,364,000 a year ago. Non-GAAP adjusted net earnings per share - diluted was $0.77 compared to $0.59 a year ago.
For the fourth quarter of 2015, the company is providing guidance for net revenue of between $37.0 million and $38.0 million, which at the mid-point represents growth of approximately 12% from $33.6 million in the fourth quarter of 2014. The company is providing adjusted net earnings guidance for the fourth quarter of 2015 of between $0.26 and $0.28 per fully diluted share. The company’s adjusted net earnings guidance for the fourth quarter of 2015 includes $1.0 million in non-cash stock-based compensation, $400,000 in amortization of intangibles, $400,000 for the U.S. medical device excise tax, and an assumed 36% effective income tax rate. The company expects gross margin to be in the range of 67.5% to 68%.
For the full year 2015, the company is raising its guidance for net revenue to a range of $146 million to $147 million. The mid-point of this range represents an increase of more than 16% from net revenue of $126 million in 2014. The company’s previous net revenue guidance range for 2015 was $145 million to $147 million. The company is also raising its adjusted earnings guidance for the full year 2015 to a range of $1.03 to $1.05 per share. Previously, the company’s 2015 adjusted EPS guidance was $1.00 to $1.04. Included in the company’s revised 2015 earnings guidance are $4.1 million in non-cash stock-based compensation, $1.6 million in amortization of intangibles, between $1.6 million and $1.7 million for the U.S. medical device excise tax, and an assumed 35% tax rate. As previously disclosed, Vascular Solutions is providing 2015 earnings guidance on an adjusted basis excluding the expenses to be incurred in connection with the Short Kit litigation. The company expects gross margin to be approximately 67%.
For now, however, based on the company's preliminary analysis and currently projected product launches, the company expects to sustain double-digit pace of revenue growth throughout 2016 and are most comfortable with expectations in the 10% to 12% range for the year. Regarding the adjusted earnings per share for 2016, the company currently expects percentage growth and adjusted earnings to be consistent with percentage growth in revenue for the year. These preliminary expectations are obviously subject to increase if the company is successful in concluding distribution agreements or tuck-in acquisitions.
Vascular Solutions Inc. Presents at Barclays Select Series: MedTech SMID Cap Day, Nov-16-2015
Oct 7 15
Vascular Solutions Inc. Presents at Barclays Select Series: MedTech SMID Cap Day, Nov-16-2015 . Venue: Barclays - New York, 745 Seventh Avenue, New York, NY 10019, United States.