0001397702-24-000029.txt : 20240430 0001397702-24-000029.hdr.sgml : 20240430 20240430160647 ACCESSION NUMBER: 0001397702-24-000029 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20240430 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20240430 DATE AS OF CHANGE: 20240430 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Silk Road Medical Inc CENTRAL INDEX KEY: 0001397702 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] ORGANIZATION NAME: 08 Industrial Applications and Services IRS NUMBER: 208777622 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-38847 FILM NUMBER: 24897155 BUSINESS ADDRESS: STREET 1: 1213 INNSBRUCK DR. CITY: SUNNYVALE STATE: CA ZIP: 94089-2918 BUSINESS PHONE: 6505669060 MAIL ADDRESS: STREET 1: 1213 INNSBRUCK DR. CITY: SUNNYVALE STATE: CA ZIP: 94089-2918 8-K 1 silk-20240430x8k.htm 8-K silk-20240430x8k
false000139770200013977022024-04-302024-04-30

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): April 30, 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 April 30, 2024, Silk Road Medical, Inc. issued a press release regarding its financial results for the quarter ended March 31, 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 April 30, 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: April 30, 2024

By:

/s/ Mhairi L. Jones

Name:

Mhairi L. Jones

Title:

Vice President, Finance and Chief Accounting Officer

 EX-99.1 2 silk-20240430xex99_1.htm EX-99.1 Exhibit 991_4302024

Exhibit 99.1

Image 2049



Silk Road Medical Reports First Quarter 2024 Financial Results



SUNNYVALE, Calif., April 30, 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 March 31, 2024.



“Our team delivered a strong start to 2024 as we deepened relationships with the physicians we serve and continued broadening our patient impact,” said Chas McKhann, CEO of Silk Road Medical. “In the first quarter, we made meaningful commercial progress while also taking steps toward sustainable profitability. We enter the second quarter feeling energized by TCAR’s outstanding value proposition for physicians and patients and in our opportunity to drive strong, sustainable growth as a business.”



First Quarter 2024 Financial Results


Revenue for the first quarter of 2024 was $48.5 million, an increase of $8.4 million or 21%, compared to the first quarter of 2023. Growth was driven primarily by increased TCAR adoption.



Gross profit for the first quarter of 2024 was $36.5 million compared to $27.6 million for the first quarter of 2023. Gross margin was 75% for the first quarter of 2024 compared to 69% in the first quarter of 2023. The increase in gross margin was driven by unfavorable production variances in the prior year period as well as favorable purchase price variances in the first quarter of 2024.



Operating expenses were $51.4 million for the first quarter of 2024, compared to $44.5 million in the comparable prior year period, which represents an increase of 16%.  The increase was primarily driven by increased headcount and related expense in our commercial organization.



Net loss was $14.1 million in the first quarter of 2024, or $0.36 per share, as compared to a loss of $16.5 million, or $0.43 per share, in the corresponding period of the prior year.



Adjusted EBITDA was a loss of $3.9 million for the first quarter of 2024 compared to a loss of $7.4 million for the first 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 $176.5 million as of March 31, 2024.



2024 Financial Guidance
Silk Road Medical projects revenue for the full year 2024 to range from $194 million to $198 million, which represents 10% to 12% 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, April 30, 2024, to discuss its first quarter 2024 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 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 on 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), 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 and stock-based compensation.  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



March 31,



2024

 

2023

Revenue

$

 48,484 

 

$

 40,131 

Cost of goods sold

 

 11,983 

 

 

 12,526 

Gross profit

 

 36,501 

 

 

 27,605 

Operating expenses:

 

 

 

 

 

Research and development

 

 10,660 

 

 

 10,433 

Selling, general and administrative

 

 40,775 

 

 

 34,082 

Total operating expenses

 

 51,435 

 

 

 44,515 

Loss from operations

 

 (14,934)

 

 

 (16,910)

Interest income

 

 2,471 

 

 

 2,287 

Interest expense

 

 (1,721)

 

 

 (1,693)

Other income (expense), net

 

 48 

 

 

 (144)

Net loss

 

 (14,136)

 

 

 (16,460)

Other comprehensive income (loss):

 

 

 

 

 

Unrealized gain (loss) on investments, net

 

 (89)

 

 

 249 

Other comprehensive income (loss)

 

 (89)

 

 

 249 



 

 

 

 

 

Comprehensive loss

$

 (14,225)

 

$

 (16,211)



 

 

 

 

 

Net loss per share, basic and diluted

$

 (0.36)

 

$

 (0.43)



 

 

 

 

 

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

 

 39,261,496 

 

 

 38,532,202 



 

 

 

 

 

SILK ROAD MEDICAL, INC.

Balance Sheets Data

(Unaudited, in thousands)





 

 

 

 

 



March 31, 2024

 

December 31, 2023

Assets

 

 

 

 

 

Current assets

 

 

 

 

 

Cash and cash equivalents

$

 22,629 

 

$

 20,210 

Short-term investments

 

 151,833 

 

 

 161,264 

Accounts receivable, net

 

 27,203 

 

 

 23,573 

Inventories

 

 30,486 

 

 

 29,876 

Prepaid expenses and other current assets

 

 3,543 

 

 

 5,912 

Total current assets

 

 235,694 

 

 

 240,835 

Long-term investments

 

 2,027 

 

 

 9,456 

Property and equipment, net

 

 8,085 

 

 

 8,114 

Other non-current assets

 

 6,508 

 

 

 6,904 

Total assets

$

 252,314 

 

$

 265,309 

Liabilities and stockholders' equity

 

 

 

 

 

Current liabilities

 

 

 

 

 

Accounts payable

$

 2,966 

 

$

 5,676 

Accrued liabilities

 

 18,371 

 

 

 24,607 

Total current liabilities

 

 21,337 

 

 

 30,283 

Long-term debt

 

 75,886 

 

 

 75,626 

Other liabilities

 

 7,806 

 

 

 8,249 

Total liabilities

 

 105,029 

 

 

 114,158 

Stockholders' equity

 

 

 

 

 

Preferred stock, $0.001 par value

 

 —

 

 

 —

Common stock, $0.001 par value

 

 39 

 

 

 39 

Additional paid-in capital

 

 560,854 

 

 

 550,495 

Accumulated other comprehensive income (loss)

 

 (17)

 

 

 72 

Accumulated deficit

 

 (413,591)

 

 

 (399,455)

Total stockholders' equity

 

 147,285 

 

 

 151,151 

Total liabilities and stockholders' equity

$

 252,314 

 

$

 265,309 





 

 

 

 

 

SILK ROAD MEDICAL, INC.

Reconciliation of GAAP Net Loss to Adjusted EBITDA

(Unaudited, in thousands)





 

 

 

 

 



 

Three Months Ended March 31,



 

2024

 

2023

GAAP Net Loss

 

$                   (14,136)

 

 

$                  (16,460)

Non-GAAP Adjustments:

 

 

 

 

 

Interest (income) expense, net

 

 (750)

 

 

 (594)

Depreciation and amortization

 

 644 

 

 

 699 

Other (income) expense, net

 

 (48)

 

 

 144 

Stock-based compensation expense

 

 10,359 

 

 

 8,838 

Adjusted EBITDA

 

$                     (3,931)

 

 

$                    (7,373)



 

 

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Cover Page
Apr. 30, 2024
Cover Abstract  
Document Type 8-K
Document Period End Date Apr. 30, 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
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