SUNNYVALE, Calif., Nov. 09, 2021 (GLOBE NEWSWIRE) -- Silk Road Medical, Inc. (NASDAQ:SILK), a company focused on reducing the risk of stroke and its devastating impact, today reported financial results for the quarter ended September 30, 2021.

"I am incredibly proud of our team for continuing to drive TCAR adoption forward against the headwinds of the pandemic," said Erica Rogers, President and Chief Executive Officer of Silk Road Medical. "We are investing confidently in the people and programs that will drive our growth in 2022 and beyond. We remain as committed as ever to establishing TCAR as the new standard of care in carotid artery disease."

Third Quarter 2021 Financial Results

Revenue for the third quarter of 2021 was $24.7 million, an increase of $4.6 million or 23%, compared to the third quarter of 2020.

Gross profit for the third quarter of 2021 was $18.6 million compared to $14.6 million for the third quarter of 2020. Gross margin for the third quarter of 2021 increased to 75% compared to 73% in the third quarter of 2020. Gross margin in the prior year period included unfavorable production variances as a result of temporarily idled manufacturing operations and lower than anticipated demand due to COVID-19.

Operating expenses were $31.9 million for the third quarter of 2021, compared to $23.9 million in the corresponding prior year period, which represents an increase of 33%. The increase was driven by investment in new and ongoing R&D programs, as well as continued expansion of our sales team and commercial efforts, and general corporate and other costs.

Net loss was $13.9 million in the third quarter of 2021, or a loss of $0.40 per share, as compared to a loss of $10.3 million, or $0.31 per share, in the corresponding period of the prior year.

Cash, cash equivalents, and short-term investments were $122.8 million as of September 30, 2021.

2021 Financial Guidance

Based on unforeseen impacts from the COVID-19 delta variant, Silk Road Medical now projects revenue for the full year 2021 to range from $99 million to $102 million, which represents 32% to 36% growth over the company's prior year revenue.

Conference Call

Silk Road Medical will host a conference call at 1:30 p.m. PT / 4:30 p.m. ET on Tuesday, November 9, 2021 to discuss its third quarter 2021 financial results. The call may be accessed through an operator by dialing (844) 883-3861 for domestic callers or (574) 990-9820 for international callers, using conference ID: 3998078. A live and archived webcast of the event will be available at https://investors.silkroadmed.com/.

About Silk Road Medical

Silk Road Medical, Inc. (NASDAQ:SILK), is a medical device company located in Sunnyvale, California, that is focused on reducing the risk of stroke and its devastating impact. The company has pioneered a new approach for the treatment of carotid artery disease called TransCarotid Artery Revascularization (TCAR). TCAR is a clinically proven procedure combining surgical principles of neuroprotection with minimally invasive endovascular techniques to treat blockages in the carotid artery at risk of causing a stroke. For more information on how Silk Road Medical is delivering brighter patient outcomes through brighter clinical thinking, visit www.silkroadmed.com and connect on Twitter, LinkedIn and Facebook.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These statements include statements regarding the impact of COVID-19 on our business, financial guidance, progress made on achieving our corporate goals, and the overall strength of our business and culture. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties, many of which are beyond our control, include risks described in the section entitled Risk Factors and elsewhere in our filing made with the Securities and Exchange Commission in Silk Road's Quarterly Report on Form 10-Q filing made with the Securities and Exchange Commission on August 6, 2021. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Silk Road Medical disclaims any obligation to update these forward-looking statements.

Investor Contact:

Lynn Lewis or Marissa Bych

Gilmartin Group

investors@silkroadmed.com

Media:

Michael Fanucchi

Silk Road Medical

mfanucchi@silkroadmed.com


SILK ROAD MEDICAL, INC. Statements of Operations Data (Unaudited, in thousands, except share and per share data)

			Three Months Ended September 30,						Nine Months Ended September 30,
				2021			2020			2021			2020


Revenue			$	24,701		$	20,067		$	73,210		$	54,093
Cost of goods sold				6,076			5,488			18,213			16,074
		Gross profit		18,625			14,579			54,997			38,019
Operating expenses:
	Research and development			6,867			4,711			19,611			11,232
	Selling, general and administrative			25,049			19,202			68,792			54,652
		Total operating expenses		31,916			23,913			88,403			65,884
		Loss from operations		(13,291	)		(9,334	)		(33,406	)		(27,865	)
Interest income				42			249			183			951
Interest expense				(633	)		(1,215	)		(1,884	)		(3,620	)
Other income (expense), net				(3	)		(15	)		(11	)		(74	)
		Net loss		(13,885	)		(10,315	)		(35,118	)		(30,608	)

Other comprehensive loss:
	Unrealized gain (loss) on investments, net			(2	)		(164	)		(38	)		150
Net change in other comprehensive loss				(2	)		(164	)		(38	)		150

Net loss and comprehensive loss			$	(13,887	)	$	(10,479	)	$	(35,156	)	$	(30,458	)


Net loss per share, basic and diluted			$	(0.40	)	$	(0.31	)	$	(1.02	)	$	(0.94	)

Weighted average common shares used to compute net loss per share, basic and diluted				34,736,015			33,757,599			34,536,980			32,597,007

SILK ROAD MEDICAL, INC. Balance Sheets Data (Unaudited, in thousands)

			September 30, 2021			December 31, 2020

Assets
Current assets
	Cash and cash equivalents		$	105,642		$	69,466
	Short-term investments			17,127			78,016
	Accounts receivable, net			10,976			9,070
	Inventories			16,049			9,989
	Prepaid expenses and other current assets			4,662			6,787
		Total current assets		154,456			173,328
	Property and equipment, net			5,132			2,844
	Restricted cash			232			310
	Other non-current assets			5,711			2,832
		Total assets	$	165,531		$	179,314
Liabilities and stockholders' equity
Current liabilities
	Accounts payable		$	4,908		$	2,598
	Accrued liabilities			16,011			16,957
		Total current liabilities		20,919			19,555
	Long-term debt			48,652			48,533
	Other liabilities			7,781			3,726
		Total liabilities		77,352			71,814

Stockholders' equity
	Preferred stock, $0.001 par value			-			-
	Common stock, $0.001 par value			35			34
Additional paid-in capital				362,152			346,318
Accumulated other comprehensive income				1			39
Accumulated deficit				(274,009	)		(238,891	)
		Total stockholders' equity		88,179			107,500
		Total liabilities and stockholders' equity	$	165,531		$	179,314

Silk Road Medical Reports Third Quarter 2021 Financial Results