Review of srdx update#

The continuing debate surrounding paclitaxel-coated devices created external headwinds many of which will be under our control.Īs we look ahead to 2020, we are acutely aware that the paclitaxel debate will continue to influence the future of the therapeutic modality including our own drug-coated balloon applications. While fiscal year 2019 was a terrific year within Surmodics it was not without its challenges. We also reported diluted GAAP earnings of $0.26 per share and non-GAAP earnings of $0.37 per share in the fourth quarter. Total revenue for the quarter grew 34% to $30.8 million as compared with $23 million in the fourth quarter of 2018. These businesses continue to provide investment funding to fuel our strategic growth initiatives.Īs a result of these advancements, we delivered another excellent quarter of solid topline growth and operational performance. We have begun to fill initial orders from our partner and expect the commercial launch to occur later in calendar 2019.įinally we saw substantial revenue growth from our Medical Device in coatings offerings, while our IVD business continued to generate strong operating margins in fiscal 2019. We also signed an agreement with a leading multinational medical device partner to commercialize our Telemark coronary support catheter in the United States and Europe. Turning to our non-drug delivery pipeline, we received I think a clearance for our Sublime radial guide sheath and have completed development of our Telemark XP coronary device. We both started and recently completed enrollment for the first in-human study of AVess, our arteriovenous access drug-coated balloon and we also filed for regulatory approval to begin the first in-human study for Sundance our sirolimus-coated balloon for below-the-knee treatment. We also made significant advancements to our drug-coated balloon product pipeline. Starting with SurVeil we completed enrollment in the TRANSCEND study on schedule despite the headwinds from the paclitaxel debate and submitted our application for CE Mark approval on schedule as well. During the year we made important progress on all the key initiatives we laid out at the beginning of the year. Fiscal 2019 was a great year of accomplishment for Surmodics. Good afternoon and thank you for joining us. I will now turn the call over to Gary Maharaj. A press release disclosing our quarterly results was issued earlier this morning - or afternoon excuse me and is available on our website at. This conference call is being webcast and is accessible through the Investor Relations section of the Surmodics website where the audio recording of the webcast will also be archived for future reference. Today's news release contains a reconciliation table to GAAP results. We'll also refer to non-GAAP measures because we believe they provide useful information for our investors.

Review of srdx update#

Surmodics disclaims any duty to update or revise our forward-looking statements as a result of new information, future events, developments or otherwise.

Please be advised that actual results could differ materially from those stated or implied by our forward-looking statements resulting from certain risks and uncertainties including those described in our SEC filings. These forward-looking statements are covered under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements regarding Surmodics future financial and operating results or other statements that are not historical facts. Before we begin I would like to remind you that during this call, we will make forward-looking statements.

Good afternoon and welcome to Surmodics Fiscal 2019 Fourth Quarter Earnings Call. At this time, I would like to turn the conference over to Tim Arens, Vice President of Finance and Chief Financial Officer.

Good day and welcome to the Surmodics Fourth Quarter Fiscal 2019 Earnings Conference Call. Gary Maharaj - President & Chief Executive Officerīrooks O'Neil - Lake Street Capital Markets Tim Arens - Vice President of Finance & Chief Financial Officer ( NASDAQ: SRDX) Q4 2019 Earnings Conference Call Octo5:00 PM ET