Silk Road Medical sinks despite Street-beating Q1, raised guidance

Silk Road Medical (NSDQ:SILK) shares took a big hit today despite first-quarter results that beat the consensus forecast.

SILK shares were down -10% at $55.30 per share in early-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was down -0.9%.

The Sunnyvale, Calif.-based company posted losses of -$10.7 million, or -31¢ per share, on sales of $22.1 million for the three months ended March 31, 2021, for a -12.9% bottom-line slide despite sales growth of 16.5%.

Silk Road’s EPS of -31¢ came in 9¢ ahead of Wall Street projections, while sales numbers topped analysts’ estimates by 3.1%.

“Our first-quarter results were characterized by meaningful progress on several commercial and operational initiatives and strong financial performance,” Silk Road president & CEO Erica Rogers said in a news release. “Procedure trends are improving, and we are workin…

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Silk Road Medical reports losses in Q4, sales up 13%

Silk Road Medical (NSDQ:SILK) posted fourth-quarter results that missed the consensus forecast on Wall Street, citing a second wave of COVID-19 in the last quarter of 2020.

The Sunnyvale, Calif.-based company reported losses of -$16.8 million, or -49¢ per share, on sales of $21.1 million for the three months ended Dec. 31, 2020, for a sales growth of 13.41% compared with Q4 2019.

Earnings per share were -49¢, 21¢ behind The Street, where analysts were looking for sales of $21.4 million.

“Throughout 2020, we made meaningful progress on our strategic, market development, and commercial goals which is a testament to the tenacity of our team and the underlying demand for TCAR,” president and CEO Erica Rogers said in a news release. “We are well-positioned for growth and success in 2021 and beyond, as we work to drive deeper physician adoption and further expand our total addressable market.”

Rogers said the resurgence of COVID-19 in Q4 contributed to …

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Silk Road Medical touts results of large TCAR study

Silk Road Medical (NSDQ:SILK) touted results from a comparative effectiveness study of transcarotid artery revascularization (TCAR).

Results, published in JAMA Network Open, found that the availability of TCAR at a hospital was associated with a significant decrease in the likelihood of major adverse cardiovascular events, which are a composite of in-hospital stroke, myocardial infarction or death at 30 days after carotid revascularization through either TCAR or carotid endarterectomy (CEA), according to a news release.

Sunnyvale, Calif.-based Sil Road Medical’s analysis observed 86,037 patients who underwent carotid procedures between 2015 and 2019, using retrospective data from the Vascular Quality Initiative registry. In total, 7,664 patients (8.9%) underwent TCAR and 78,363 patients (91.1%) underwent CEA.

The analysis revealed that, among the more than 400 North American centers participating, 15 used both TCAR and CEA at the beginning of the a…

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Silk Road Medical issues voluntary recall of Enroute transcarotid stent system

Silk Road Medical (NSDQ:SILK) announced today that it is voluntarily recalling additional lots of its Enroute transcarotid stent system.

Enroute, which is manufactured by Cardinal Health (NYSE:CAH) subsidiary Cordis, has received a total of six product complaints between September 2020 and January 2021 involving an issue in which a tip detaches from the stent delivery system.

Additionally, test results from lots manufactured in the same time frame as those subject to the recall contributed to the decision to recall an added 48 lots with approximately 1,800 units of the system. The initial recall of five lots was initiated on Jan. 13, with the sixth complaint leading to a total of 53 lots comprising approximately 2,100 units.

The recalled units were manufactured between October 2019 and July 2020. The recall is limited to 6French crossing profile stent systems (9mm-10mm stent diameter sizes), while testing has determined that the 5French crossing profile …

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Silk Road Medical appoints chief commercial officer

Stroke treatment developer Silk Road Medical (NSDQ:SILK) announced that it promoted Andrew Davis as its new chief commercial officer.

In the newly created role at the Sunnyvale, Calif.-based company, Davis is slated to oversee Silk Road Medical’s global commercialization efforts by establishing near-term priorities and setting the long-term strategic direction for the organization, according to a news release.

“Andy and his team have had a monumental role in our commercial success driving the safe adoption of [transcarotid artery revascularization] across the U.S.,” Silk Road Medical CEO Erica Rogers said in the release. “His contributions to the development of our sales team and commercial strategy have been vital to our organization. In his new role, we are confident that Andy will provide additional strategic direction and value and deliver meaningful and lasting results for Silk Road Medical.”

Davis joined the company as its first commercial le…

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Silk Road Medical closes allotment option

Silk Road Medical (NSDQ:SILK) announced that underwriters fully exercised and closed on additional options to purchase shares in a stock offering.

The offering of more than 6.8 million shares included the exercise of the option to purchase more than 1 million additional shares at the public offering price of $39 per share. Silk Road Medical did not receive any proceeds from the sale, as securityholders were the sellers.

J.P. Morgan and BofA Securities acted as joint book-running managers of the offering. Citigroup also acted as book-running manager. Stifel acted as co-manager.

Sunnyvale, Calif.-based Silk Road Medical develops transcarotid artery revascularization (TCAR) technology as a potential treatment for stroke.

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