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Surmodics shares drop on Q3 earnings, Sundance DCB wins breakthrough FDA nod

November 1, 2019 By Sean Whooley

SurModicsSurmodics (NSDQ:SRDX) shares plummeted today despite third-quarter results that topped Wall Street projections.

Eden Prairie, Minn.-based Surmodics posted profits of $3.55 million, or 26¢ per share, on sales of $30.8 million for the three months ended Sept. 30, moving from red to black on revenue growth of 33.8% compared with Q3 2018.

Adjusted to exclude one-time items, earnings per share were 37¢, 2¢ ahead of Wall Street, where analysts were looking for sales of $28.5 million.

“During fiscal 2019, we made important progress across our key strategic objectives while delivering strong organic revenue and solid operational results,” president & CEO Gary Maharaj said in prepared remarks. “In the face of unpredictability related to the paclitaxel debate, our team has demonstrated impressive execution which included completing enrollment for our Transcend clinical trial. I am excited by our achievements to date and look forward to continued progress in 2020.”

Surmodics widened its outlook on the rest of the year, saying it now expects to put up adjusted EPS of 14¢ to 44¢, compared with between 26¢ and 36¢ previously, on sales of $87 million to $91 million (compared to prior guidance for between $88.5 million and $91.5 million).

SRDX shares dropped -14.6% to $40.56 per share in midday trading today.

In a separate release earlier this week, Surmodics said its Sundance drug-coated balloon won breakthrough device designation from the FDA. The sirolimus-coated device is designed to enhance endovascular revascularization options for below-the-knee arterial lesions in patients with critical limb ischemia and infrapopliteal arterial disease.

“The Sundance SCB is intended to address the unmet clinical need in patients with CLI and infrapopliteal arterial disease by providing a revascularization option with a proprietary sirolimus coating,” Maharaj said. “This second platform adds to our stable of drug-coated balloon devices and furthers our effort to provide treatment solutions for the entire peripheral anatomy. The Sundance SCB has the potential for improved outcomes in CLI patients over other available treatment options, and its availability is in the best interest of patients.”

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), MassDevice Earnings Roundup, Regulatory/Compliance, Wall Street Beat Tagged With: Surmodics, SurModics Inc.

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at swhooley@wtwhmedia.com.

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