8-K

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): February 28, 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 February 28, 2024, Silk Road Medical, Inc. issued a press release regarding its financial results for the quarter and full year ended December 31, 2023. 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 February 28, 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: February 28, 2024	By:	/s/ Mhairi L. Jones
	Name:	Mhairi L. Jones
	Title:	Vice President, Finance and Chief Accounting Officer

EX-99.1

Exhibit 99.1

Silk Road Medical Reports Fourth Quarter and Full Year 2023 Financial Results and

Provides 2024 Financial Outlook

SUNNYVALE, Calif., Feb. 28, 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 and full year ended December 31, 2023.

“With the right team in place, broad reimbursement, and extensive evidence in support of TCAR, we are laser focused on deepening adoption in physicians who perform TCAR,” said Chas McKhann, CEO of Silk Road Medical. “My experience thus far at Silk Road has only served to further validate the vast opportunity that we see for TCAR to benefit many more patients with carotid artery disease, and I’m excited by the underlying progress we are already making towards that end.”

Recent Business Highlights

· Completed more than 25,000 TCAR procedures in 2023, bringing the cumulative total to over 85,000

· Received expanded coverage for TCAR under a revised national coverage decision issued by CMS, further expanding access to TCAR and reducing administrative barriers

· Initiated the limited market release of new tapered configurations for the Company’s ENROUTE Transcarotid Stent System

· Executed distribution agreements with Medico’s Hirata in Japan and Genesis MedTech Group in China following clearance for the Company’s ENROUTE Stent and ENROUTE Neuroprotection System in both countries

Fourth Quarter 2023 Financial Results
Revenue for the fourth quarter of 2023 was $47.3 million, an increase of $7.2 million or 18%, as compared to the fourth quarter of 2022. Growth was driven primarily by increased TCAR adoption.

Gross profit for the fourth quarter of 2023 was $34.8 million compared to $29.1 million for the fourth quarter of 2022. Gross margin for the fourth quarter of 2023 increased to 74% compared to 73% for the fourth quarter of 2022, primarily due to an increase in production volumes.

Operating expenses were $49.2 million for the fourth quarter of 2023 compared to $41.7 million in the fourth quarter of 2022, which represents an increase of 18%. The increase was primarily driven by increased headcount.

Net loss was $13.0 million for the fourth quarter of 2023, or a loss of $0.33 per share, as compared to a loss of $12.6 million, or $0.34 per share, for the fourth quarter of 2022.

Adjusted EBITDA was a loss of $4.1 million for the fourth quarter of 2023 compared to a loss of $4.4 million for the fourth quarter of 2022.

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.

Full Year 2023 Financial Results
Revenue for the full year 2023 was $177.1 million, an increase of $38.5 million or 28%, as compared to 2022. The increase was driven primarily by increased TCAR adoption.

Gross profit for the full year 2023 was $127.1 million compared to $100.8 million for 2022. Gross margin for the full year 2023 decreased to 72% compared to 73% in 2022. The decrease in gross margin was driven primarily by unfavorable production variances.

Operating expenses were $186.4 million for the full year 2023, compared to $152.8 million for 2022, which represents an increase of 22%. The increase was primarily driven by increased headcount.

Net loss was $55.7 million in the full year 2023, or a loss of $1.44 per share, as compared to a loss of $55.0 million, or $1.54 per share, for 2022.

Adjusted EBITDA was a loss of $17.7 million for the full year 2023, compared to a loss of $25.1 million for 2022.

Cash, cash equivalents and investments were $190.9 million as of December 31, 2023.

2024 Financial Guidance
Silk Road Medical projects revenue for the full year 2024 to range from $194 million to $198 million.

Conference Call
Silk Road Medical will host a conference call at 1:30 p.m. PT / 4:30 p.m. ET on Wednesday, February 28, 2024, to discuss its fourth quarter and full year 2023 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 and will remain available for at least 12 months.

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, 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 most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission today, February 28, 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), the Company 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 and stock-based compensation.  The Company believes the presentation of adjusted EBITDA provides useful information to investors as it provides visibility to the Company’s 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 the Company’s 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 the Company’s business, including the allocation of resources.

The Company’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 the Company’s reported results of operations, management strongly encourages investors to review, when they become available, the Company’s 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 December 31,				Year Ended December 31,
	2023		2022		2023		2022
Revenue	$	47,270	$	40,070	$	177,134	$	138,638
Cost of goods sold		12,468		10,979		50,048		37,876
Gross profit		34,802		29,091		127,086		100,762
Operating expenses:
Research and development		10,064		9,200		41,324		36,449
Selling, general and administrative		39,110		32,521		145,033		116,317
Total operating expenses		49,174		41,721		186,357		152,766
Loss from operations		(14,372)		(12,630)		(59,271)		(52,004)
Interest income		2,618		1,776		9,957		2,527
Interest expense		(1,734)		(1,732)		(6,871)		(5,098)
Loss on debt extinguishment		—		—		—		(245)
Other income (expense), net		477		(28)		442		(190)
Net loss		(13,011)		(12,614)		(55,743)		(55,010)
Other comprehensive income (loss):
Unrealized gain (loss) on investments, net		356		25		238		(166)
Other comprehensive income (loss)		356		25		238		(166)
Comprehensive loss	$	(12,655)	$	(12,589)	$	(55,505)	$	(55,176)
Net loss per share, basic and diluted	$	(0.33)	$	(0.34)	$	(1.44)	$	(1.54)
Weighted average common shares used to compute net loss per share, basic and diluted		39,048,656		37,609,019		38,804,343		35,775,672

SILK ROAD MEDICAL, INC.

Balance Sheets Data

(Unaudited, in thousands)

	December 31, 2023		December 31, 2022
Assets
Current assets:
Cash and cash equivalents	$	20,210	$	55,358
Short-term investments		161,264		158,316
Accounts receivable, net		23,573		18,007
Inventories		29,876		19,293
Prepaid expenses and other current assets		5,912		3,924
Total current assets		240,835		254,898
Long-term investments		9,456		—
Property and equipment, net		8,114		9,372
Restricted cash		—		155
Other non-current assets		6,904		5,260
Total assets	$	265,309	$	269,685
Liabilities and stockholders' equity
Current liabilities:
Accounts payable	$	5,676	$	2,523
Accrued liabilities		24,607		21,965
Total current liabilities		30,283		24,488
Long-term debt		75,626		74,596
Other liabilities		8,249		6,726
Total liabilities		114,158		105,810
Stockholders' equity:
Preferred stock, $0.001 par value		—		—
Common stock, $0.001 par value		39		38
Additional paid-in capital		550,495		507,715
Accumulated other comprehensive income (loss)		72		(166)
Accumulated deficit		(399,455)		(343,712)
Total stockholders' equity		151,151		163,875
Total liabilities and stockholders' equity	$	265,309	$	269,685

SILK ROAD MEDICAL, INC.

Reconciliation of GAAP Net Loss to Adjusted EBITDA

(Unaudited, in thousands)

	Three Months Ended December 31,				Year Ended December 31,
	2023		2022		2023		2022
GAAP Net Loss	$	(13,011)	$	(12,614)	$	(55,743)	$	(55,010)
Non-GAAP Adjustments:
Interest (income) expense, net		(884)		(44)		(3,086)		2,571
Depreciation and amortization		656		661		2,696		2,127
Other (income) expense, net		(477)		28		(442)		190
Stock-based compensation expense		9,609		7,546		38,893		25,023
Adjusted EBITDA	$	(4,107)	$	(4,423)	$	(17,682)	$	(25,099)

XML

Cover Page	Feb. 28, 2024
Cover Abstract
Document Type	8-K
Document Period End Date	Feb. 28, 2024
Entity Registrant Name	SILK ROAD MEDICAL, INC.
Entity Incorporation, State or Country Code	DE
Entity File Number	001-38847
Entity Tax Identification Number	20-8777622
Entity Address, Address Line One	1213 Innsbruck Drive
Entity Address, City or Town	Sunnyvale
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	94089
City Area Code	408
Local Phone Number	720-9002
Written Communications	false
Soliciting Material	false
Pre-Commencement Tender Offer	false
Pre-Commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, Par Value $0.001 Per Share
Trading Symbol	SILK
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false
Entity Central Index Key	0001397702
Amendment Flag	false