silk-20240807x8k
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

____________________________

FORM 8-K

____________________________

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 7, 2024

____________________________

SILK ROAD MEDICAL, INC.

(Exact name of registrant as specified in its charter)

____________________________

Delaware

001-38847

20-8777622

(State or other jurisdiction

of incorporation)

(Commission
File Number)

(IRS Employer
Identification No.)

1213 Innsbruck Drive

Sunnyvale, California

94089

(Address of principal executive offices)

(Zip Code)

(408) 720-9002

(Registrant’s telephone number, including area code)

Not Applicable

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, Par Value $0.001 Per Share

SILK

Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐


Item 2.02.      Results of Operations and Financial Condition.

On August 7, 2024, Silk Road Medical, Inc. issued a press release regarding its financial results for the quarter ended June 30, 2024. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K.

 

This information is intended to be furnished under Item 2.02 of Form 8-K and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item 9.01.Financial Statements and Exhibits.

(d)Exhibits.

Exhibit No.

Description

99.1

Press Release of Silk Road Medical, Inc. issued on August 7, 2024.

104

Cover Page Interactive Data File (formatted as inline XBRL)


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

SILK ROAD MEDICAL, INC.

Date: August 7, 2024

By:

/s/ Mhairi L. Jones

Name:

Mhairi L. Jones

Title:

Vice President, Finance and Chief Accounting Officer

Exhibit 991_872024

Exhibit 99.1

Image 2049



Silk Road Medical Reports Second Quarter 2024 Financial Results



SUNNYVALE, Calif., August 7, 2024 (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 ended June 30, 2024.



“Our solid second quarter performance demonstrates continued TCAR adoption and growth driven by the unwavering dedication of our team,” said Chas McKhann, CEO of Silk Road Medical. “We look forward to continuing our mission as part of Boston Scientific and, together, expanding patient access to our minimally invasive approach to stroke prevention.”



Second Quarter 2024 Financial Results
Revenue for the second quarter of 2024 was $51.2 million, an increase of $5.9 million or 13%, compared to the second quarter of 2023.



Gross profit for the second quarter of 2024 was $38.5 million compared to $32.3 million for the second quarter of 2023. Gross margin was 75% for the second quarter of 2024 compared to 71% in the second quarter of 2023.



Operating expenses were $55.7 million for the second quarter of 2024, compared to $46.6 million in the comparable prior year period, an increase of 20%. 



Net loss was $16.6 million in the second quarter of 2024, or $0.42 per share, as compared to a loss of $13.5 million, or $0.35 per share, in the corresponding period of the prior year.



Adjusted EBITDA was a loss of $1.1 million for the second quarter of 2024 compared to a loss of $3.4 million for the second quarter of 2023. For additional information regarding non-GAAP financial measures see “Use of Non-GAAP Financial Measures” and “Reconciliation of GAAP Net Loss to Adjusted EBITDA” below.



Cash, cash equivalents and investments were $186.2 million as of June 30, 2024.



2024 Financial Guidance
Given the proposed acquisition of Silk Road Medical by Boston Scientific Corporation (NYSE: BSX), the Company is withdrawing its prior full year 2024 financial guidance.



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 X, LinkedIn and Facebook.



Forward-Looking Statements
Statements contained in this press 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 future opportunity of its business. 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, risks and uncertainties relating to the Company’s proposed merger with Boston Scientific Corporation, including without limitation the risk that the merger may not be completed on the anticipated timeline or at all or the effect of the announcement or pendency of the merger on the Company’s business relationships, operating results and business generally and ability to retain and hire key personnel and maintain relationships with key business partners, customers and others with whom it does business; future operating results and financial performance; the Company’s success in retaining and recruiting key personnel; the ability to continue to grow the business and expand the use of TCAR; 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; the success of current clinical trials; plans to conduct further clinical trials; the ability to obtain additional indications or new regulatory approvals or clearances for its products; market acceptance and use of its products by physicians; the ability to grow and leverage its commercialization infrastructure; the effect of increased competition; the effect of economic conditions and COVID-19 or similar pandemics on its business; government and third-party payer coverage and reimbursement 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 quarterly report on Form 10-Q filed with the Securities and Exchange Commission on August 7, 2024. Silk Road Medical undertakes no obligation to update its forward-looking statements.



Use of Non-GAAP Financial Measures

To supplement its financial statements prepared in accordance with U.S. generally accepted accounting principles (GAAP), Silk Road Medical uses adjusted EBITDA, which is a non-GAAP financial measure, in this press release. A reconciliation of non-GAAP adjusted EBITDA to GAAP net loss, which is the most directly comparable GAAP financial measure, is provided in the financial statement tables included in this press release, and investors are encouraged to review the reconciliation.  Non-GAAP adjusted EBITDA is calculated by adding back to net loss or excluding, as appropriate, interest income and expense, provision for income taxes, and charges for depreciation and amortization and is further adjusted by adding back in or excluding, as appropriate, other income and expense, stock-based compensation and acquisition-related costs.  Silk Road Medical believes the presentation of adjusted EBITDA provides useful information to investors as it provides visibility to its underlying continuing operating performance from period to period by excluding the impact of certain items that are non-cash or non-recurring in nature or not related to its core business operations. Adjusted EBITDA is also frequently used by analysts, investors and other interested parties to evaluate companies in the same industry. Management uses adjusted EBITDA internally for evaluation of the performance of its business, including the allocation of resources.



Silk Road Medical’s definition of adjusted EBITDA may differ from similarly titled measures used by others. Adjusted EBITDA should be considered only as a supplement to, and not as a substitute for, or superior to, net income or loss prepared in accordance with GAAP. Because adjusted EBITDA excludes the effect of items that increase or decrease Silk Road Medical’s reported results of operations, management strongly encourages investors to review, when they become available, its financial statements and publicly filed SEC reports in their entirety.









 

 


 

 

 

Investor Contact:

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

 

Six Months Ended



June 30,

 

June 30,



2024

 

2023

 

2024

 

2023

Revenue

$

51,242 

 

$

45,298 

 

$

99,726 

 

$

85,429 

Cost of goods sold

 

12,736 

 

 

13,004 

 

 

24,719 

 

 

25,530 

Gross profit

 

38,506 

 

 

32,294 

 

 

75,007 

 

 

59,899 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

11,883 

 

 

10,780 

 

 

22,543 

 

 

21,213 

Selling, general and administrative

 

43,818 

 

 

35,830 

 

 

84,593 

 

 

69,913 

Total operating expenses

 

55,701 

 

 

46,610 

 

 

107,136 

 

 

91,126 

Loss from operations

 

(17,195)

 

 

(14,316)

 

 

(32,129)

 

 

(31,227)

Interest income

 

2,321 

 

 

2,434 

 

 

4,792 

 

 

4,721 

Interest expense

 

(1,725)

 

 

(1,712)

 

 

(3,445)

 

 

(3,405)

Other income (expense), net

 

(4)

 

 

110 

 

 

43 

 

 

(33)

Net loss

 

(16,603)

 

 

(13,484)

 

 

(30,739)

 

 

(29,944)

Other comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

Unrealized loss on investments, net

 

(105)

 

 

(414)

 

 

(194)

 

 

(165)

Other comprehensive income loss

 

(105)

 

 

(414)

 

 

(194)

 

 

(165)



 

 

 

 

 

 

 

 

 

 

 

Comprehensive loss

$

(16,708)

 

$

(13,898)

 

$

(30,933)

 

$

(30,109)



 

 

 

 

 

 

 

 

 

 

 

Net loss per share, basic and diluted

$

(0.42)

 

$

(0.35)

 

$

(0.78)

 

$

(0.77)



 

 

 

 

 

 

 

 

 

 

 

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

 

39,620,888 

 

 

38,765,166 

 

 

39,441,192 

 

 

38,649,327 



 

 


 

 

 

SILK ROAD MEDICAL, INC.

Balance Sheets Data

(Unaudited, in thousands)





 

 

 

 

 



June 30, 2024

 

December 31, 2023

Assets

 

 

 

 

 

Current assets

 

 

 

 

 

Cash and cash equivalents

$

22,639 

 

$

20,210 

Short-term investments

 

149,344 

 

 

161,264 

Accounts receivable, net

 

26,252 

 

 

23,573 

Inventories

 

29,682 

 

 

29,876 

Prepaid expenses and other current assets

 

13,104 

 

 

5,912 

Total current assets

 

241,021 

 

 

240,835 

Long-term investments

 

14,178 

 

 

9,456 

Property and equipment, net

 

8,381 

 

 

8,114 

Other non-current assets

 

6,227 

 

 

6,904 

Total assets

$

269,807 

 

$

265,309 

Liabilities and stockholders' equity

 

 

 

 

 

Current liabilities

 

 

 

 

 

Accounts payable

$

3,693 

 

$

5,676 

Accrued liabilities

 

27,879 

 

 

24,607 

Total current liabilities

 

31,572 

 

 

30,283 

Long-term debt

 

76,147 

 

 

75,626 

Other liabilities

 

7,404 

 

 

8,249 

Total liabilities

 

115,123 

 

 

114,158 

Stockholders' equity

 

 

 

 

 

Preferred stock, $0.001 par value

 

 —

 

 

 —

Common stock, $0.001 par value

 

41 

 

 

39 

Additional paid-in capital

 

584,959 

 

 

550,495 

Accumulated other comprehensive income (loss)

 

(122)

 

 

72 

Accumulated deficit

 

(430,194)

 

 

(399,455)

Total stockholders' equity

 

154,684 

 

 

151,151 

Total liabilities and stockholders' equity

$

269,807 

 

$

265,309 





 

 


 

 

 

SILK ROAD MEDICAL, INC.

Reconciliation of GAAP Net Loss to Adjusted EBITDA

(Unaudited, in thousands)





 

 

 

 

 

 

 

 

 

 

 

 



Three Months Ended
June 30,

 

Six Months Ended
June 30,

 



2024

 

2023

 

2024

 

2023

 

GAAP Net Loss

S

(16,603)

 

$

(13,484)

 

$

(30,739)

 

$

(29,944)

 

Non-GAAP Adjustments:

 

 

 

 

 

 

 

 

 

 

 

 

Interest (income) expense, net

 

(596)

 

 

(722)

 

 

(1,347)

 

 

(1,316)

 

Depreciation and amortization

 

665 

 

 

685 

 

 

1,309 

 

 

1,384 

 

Other (income) expense, net

 

 

 

(110)

 

 

(43)

 

 

33 

 

Stock-based compensation expense

 

11,040 

 

 

10,198 

 

 

21,399 

 

 

19,037 

 

Acquisition-related costs

 

4,382 

 

 

 -

 

 

4,382 

 

 

 -

 

Adjusted EBITDA

$

(1,108)

 

$

(3,433)

 

$

(5,039)

 

$

(10,806)