EX-99.1 2 silk-20230228xex99_1.htm EX-99.1 Exhibit 99.1_2.28.2023

Exhibit 99.1

Image 2049



Silk Road Medical Reports Fourth Quarter and Full Year 2022 Financial Results and

Provides 2023 Financial Outlook



SUNNYVALE, Calif., Feb. 28, 2023 (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 three months and full year ended December 31, 2022.



“Our fourth quarter closes the books on a remarkable year for Silk Road Medical,” said Erica Rogers, President and Chief Executive Officer. “We are well positioned to drive strong growth and category leadership while building upon the operating leverage we began to see in 2022.”



Fourth Quarter 2022 Financial Results
Revenue for the fourth quarter of 2022 was $40.1 million, an increase of $11.8 million or 42%, compared to the fourth quarter of 2021. Growth was driven primarily by increased TCAR adoption.



Gross profit for the fourth quarter of 2022 was $29.1 million compared to $21.0 million for the fourth quarter of 2021. Gross margin for the fourth quarter of 2022 declined to 73% compared to 74% for the fourth quarter of 2021, due to higher manufacturing costs associated with labor and materials and maintaining two manufacturing facilities.



Operating expenses were $41.7 million for the fourth quarter of 2022, compared to $35.1 million in the comparable prior year period, which represents an increase of 19% compared to the fourth quarter of 2021.  The increase was primarily driven by increased headcount in the company’s commercial and R&D organizations, along with continued investments in new and ongoing R&D programs.



Net loss was $12.6 million in the fourth quarter of 2022, or a loss of $0.34 per share, as compared to a loss of $14.7 million, or $0.42 per share, in the corresponding period of the prior year.



Full Year 2022 Financial Results
Revenue for the full year 2022 was $138.6 million, an increase of $37.2 million or 37%, compared to 2021. The increase was driven primarily by increased TCAR adoption.



Gross profit for the full year 2022 was $100.8 million compared to $76.0 million for 2021. Gross margin for the full year 2022 decreased to 73% compared to 75% in 2021. The decrease in gross margin was driven primarily by increased manufacturing and overhead costs associated with bringing online a second manufacturing facility, as well as unfavorable production variances due to impacts from COVID-19 in the first quarter of 2022.



Operating expenses were $152.8 million for the full year 2022, compared to $123.5 million in the corresponding prior year period, which represents an increase of 24%. The increase was primarily driven by new and ongoing R&D programs, growth in personnel and continued commercialization initiatives, as well as the resumption of travel, tradeshow, and other expenses.



Net loss was $55.0 million in the full year 2022, or a loss of $1.54 per share, as compared to a loss of $49.8 million, or $1.44 per share, in the prior year.



Cash, cash equivalents and short-term investments were $213.7 million as of December 31, 2022.

1

 


 

 

 

2023 Financial Guidance
Silk Road Medical projects revenue for the full year 2023 to range from $176 million to $184 million.



Conference Call
Silk Road Medical will host a conference call at 1:30 p.m. PT / 4:30 p.m. ET on Tuesday, February 28, 2023, to discuss its fourth quarter and full year 2022 financial results. Those interested in listening to the conference call should register online using this link. Participants are encouraged to register more than 15 minutes before the start of the call. A live and replay version of the webcast 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, and Plymouth, Minnesota, 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
Statements contained in this release that relate to future, not past, events are forward-looking statements under the Private Securities Litigation Reform Act of 1995, including Silk Road Medical’s financial guidance and statements related to the strength of its business and ability to achieve growth. Forward-looking statements are based on current expectations of future events and often can be identified by words such as “expect,” “should,” “project,” “anticipate,” “intend,” “will,” “can,” “may,” “believe,” “could,” “continue,” “outlook,” “guidance,” “future,” other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Risks and uncertainties may cause Silk Road Medical’s actual results to be materially different than those expressed in or implied by Silk Road Medical’s forward-looking statements. For Silk Road Medical, such risks and uncertainties include, among others, future operating results and financial performance; the ability to obtain an adequate supply of materials and components from its third-party suppliers; product development plans and the ability to commercialize new products in a timely manner; plans to conduct further clinical trials; the ability to obtain additional indications or new regulatory approvals or clearances for its products; use of its products by physicians; the ability to grow its commercialization infrastructure; the effect of economic conditions and COVID-19 or similar pandemics on its business; government and third-party payer coverage and reimbursement; success in retaining and recruiting key personnel; and the ability to obtain and maintain intellectual property protection for its products. More detailed information on these and other factors that could affect Silk Road Medical’s actual results are described in its filings with the U.S. Securities and Exchange Commission, including its most recent quarterly report on Form 10-Q filed with the Securities and Exchange Commission on November 9, 2022. Silk Road Medical undertakes no obligation to update its forward-looking statements.





Investor Contact:

Lynn Lewis or Marissa Bych

Gilmartin Group

investors@silkroadmed.com



Media:

Michael Fanucchi

Silk Road Medical

mfanucchi@silkroadmed.com



2

 


 

 

 

SILK ROAD MEDICAL, INC.

Statements of Operations Data

(Unaudited, in thousands, except share and per share data)







 

 

 

 

 

 

 

 

 

 

 

 



 

Three Months Ended December 31,

 

Year Ended December 31,



 

2022

 

2021

 

2022

 

2021

Revenue

 

$

40,070 

 

$

28,265 

 

$

138,638 

 

$

101,475 

Cost of goods sold

 

 

10,979 

 

 

7,233 

 

 

37,876 

 

 

25,446 

Gross profit

 

 

29,091 

 

 

21,032 

 

 

100,762 

 

 

76,029 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 Research and development

 

 

9,200 

 

 

7,499 

 

 

36,449 

 

 

27,110 

 Selling, general and administrative

 

 

32,521 

 

 

27,595 

 

 

116,317 

 

 

96,387 

Total operating expenses

 

 

41,721 

 

 

35,094 

 

 

152,766 

 

 

123,497 

Loss from operations

 

 

(12,630)

 

 

(14,062)

 

 

(52,004)

 

 

(47,468)

Interest income

 

 

1,776 

 

 

15 

 

 

2,527 

 

 

198 

Interest expense

 

 

(1,732)

 

 

(634)

 

 

(5,098)

 

 

(2,518)

Loss on debt extinguishment

 

 

 —

 

 

 —

 

 

(245)

 

 

 —

Other income (expense), net

 

 

(28)

 

 

(12)

 

 

(190)

 

 

(23)



 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

(12,614)

 

 

(14,693)

 

 

(55,010)

 

 

(49,811)



 

 

 

 

 

 

 

 

 

 

 

 

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

 Change in unrealized gain (loss) on investments, net

 

 

25 

 

 

(1)

 

 

(166)

 

 

(39)

Net change in other comprehensive income (loss)

 

 

25 

 

 

(1)

 

 

(166)

 

 

(39)



 

 

 

 

 

 

 

 

 

 

 

 

Net loss and comprehensive loss

 

$

(12,589)

 

$

(14,694)

 

$

(55,176)

 

$

(49,850)



 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share, basic and diluted

 

$

(0.34)

 

$

(0.42)

 

$

(1.54)

 

$

(1.44)



 

 

 

 

 

 

 

 

 

 

 

 

Weighted average common shares used to compute net loss per share, basic and diluted

 

 

37,609,019 

 

 

34,927,283 

 

 

35,775,672 

 

 

34,635,358 



3

 


 

 

 

SILK ROAD MEDICAL, INC.

Balance Sheets Data

(Unaudited, in thousands)





 

 

 

 

 

 



 

December 31, 2022

 

December 31, 2021

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

55,358 

 

$

110,231 

Short-term investments

 

 

158,316 

 

 

 —

Accounts receivable, net

 

 

18,007 

 

 

11,832 

Inventories

 

 

19,293 

 

 

17,851 

Prepaid expenses and other current assets

 

 

3,924 

 

 

3,412 

Total current assets

 

 

254,898 

 

 

143,326 

Property and equipment, net

 

 

9,372 

 

 

7,697 

Restricted cash

 

 

155 

 

 

232 

Other non-current assets

 

 

5,260 

 

 

5,370 

Total assets

 

$

269,685 

 

$

156,625 

Liabilities and stockholders' equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

2,523 

 

$

2,379 

Accrued liabilities

 

 

21,965 

 

 

19,802 

Short-term debt

 

 

 —

 

 

3,905 

Total current liabilities

 

 

24,488 

 

 

26,086 

Long-term debt

 

 

74,596 

 

 

44,786 

Other liabilities

 

 

6,726 

 

 

6,513 

Total liabilities

 

 

105,810 

 

 

77,385 



 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

Preferred stock, $0.001 par value

 

 

 —

 

 

 —

Common stock, $0.001 par value

 

 

38 

 

 

35 

Additional paid-in capital

 

 

507,715 

 

 

367,907 

Accumulated other comprehensive income (loss)

 

 

(166)

 

 

 —

Accumulated deficit

 

 

(343,712)

 

 

(288,702)

Total stockholders' equity

 

 

163,875 

 

 

79,240 

Total liabilities and stockholders' equity

 

$

269,685 

 

$

156,625 



4