0001397702-20-000004.txt : 20200226 0001397702-20-000004.hdr.sgml : 20200226 20200226160655 ACCESSION NUMBER: 0001397702-20-000004 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 16 CONFORMED PERIOD OF REPORT: 20200226 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20200226 DATE AS OF CHANGE: 20200226 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Silk Road Medical Inc CENTRAL INDEX KEY: 0001397702 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] 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: 20655683 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-20200226.htm 8-K silk-20200226
0001397702false00013977022020-02-262020-02-26


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 26, 2020

SILK ROAD MEDICAL, INC.
(Exact name of Registrant as specified in its charter)

Delaware001-3884720-8777622
(State or other jurisdiction of
incorporation or organization)
(Commission
File Number)
(I.R.S. Employer
Identification Number)
1213 Innsbruck Drive
Sunnyvale, California 94089
(Address of principal executive office) (Zip Code)
(408) 720-9002
(Registrant’s telephone number, including area code)
N/A
(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))
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 26, 2020, Silk Road Medical, Inc. issued a press release regarding its consolidated financial results for the quarter and full year ended December 31, 2019. 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




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, thereunto duly authorized.
SILK ROAD MEDICAL, INC.
Date: February 26, 2020By:/s/ Erica J. Rogers
Erica J. Rogers
Chief Executive Officer


EX-99.1 2 silkq42019earningspres.htm EX-99.1 Document
silkq42019earningsprei.jpg


Silk Road Medical Reports Fourth Quarter and Full Year 2019 Financial Results and Provides Full Year 2020 Outlook

SUNNYVALE, Calif. – February 26, 2020 – 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, 2019.

Recent Highlights
Revenue of $18.6 million for the fourth quarter and $63.4 million for the full year of 2019, representing 62% and 83% increases, respectively, over the corresponding periods of 2018
Positive results from the ongoing TransCarotid Artery Revascularization (TCAR) Surveillance Project comparing TCAR and transfemoral carotid artery stenting (TF-CAS) published in The Journal of the American Medical Association (JAMA)
Completed over 8,400 TCAR procedures in the U.S. in 2019 growing the cumulative number of procedures performed to over 16,000 globally

“Throughout 2019, we made important headway on our key initiatives of commercial execution and clinical evidence which continued to drive TCAR interest and adoption leading to revenue growth of more than 80% in 2019,” said Erica Rogers, Chief Executive Officer of Silk Road Medical. “As we look to 2020, we expect continued adoption among physicians as well as further development on our label expansion and pipeline strategies. We have built a strong foundation to support our mission of becoming standard of care and to positively impact patient lives.”

Fourth Quarter 2019 Financial Results
Revenue for the fourth quarter of 2019 was $18.6 million, an increase of $7.2 million or 62%, compared to the fourth quarter of 2018. The increase was driven primarily by growing adoption of TCAR across an expanded base of hospital accounts, trained physicians and sales territories.

Gross profit for the fourth quarter of 2019 was $13.9 million compared to $7.8 million for the fourth quarter of 2018. Gross margin for the fourth quarter of 2019 increased to 75% compared to 68% in the fourth quarter of 2018, driven primarily by leveraging manufacturing overhead costs across a greater number of products sold and higher revenue.

Operating expenses were $21.4 million for the fourth quarter of 2019, compared to $15.1 million in the corresponding prior year period, which represents an increase of 42%. The increase was driven primarily by selling, general and administrative expenses related to growth in our commercial team and marketing efforts as well as costs related to being a public company.

Net loss was $8.3 million in the fourth quarter of 2019, or a loss of $0.27 per share, as compared to $15.6 million, or a loss of $14.12 per share, in the corresponding period of the prior year.





Full Year 2019 Financial Results
Revenue for the full year 2019 was $63.4 million, an increase of $28.8 million or 83%, compared to 2018. The increase was driven primarily by growing adoption of TCAR across an expanded base of hospital accounts, trained physicians, and sales territories.

Gross profit for the full year 2019 was $47.4 million compared to $23.7 million for 2018. Gross margin for full year 2019 increased to 75% compared to 69% in 2018, driven primarily by leveraging manufacturing overhead costs across a greater number of products sold and higher revenue.

Operating expenses were $75.5 million for the full year 2019, compared to $45.1 million in 2018, which represents an increase of 67%. The increase was driven primarily by selling, general and administrative expenses related to growth in our commercial team and marketing efforts as well as costs related to being a public company.

Net loss was $52.4 million for the full year 2019, or a loss of $2.28 per share, as compared to $37.6 million, or a loss of $39.16 per share, in 2018.

Cash, cash equivalents and short-term investments were $90.7 million as of December 31, 2019.

2020 Financial Guidance
Silk Road Medical projects revenue for the full year 2020 to range from $92 million to $95 million, which represents 45% to 50% 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 Wednesday, February 26, 2020 to discuss its fourth quarter and full year 2019 financial results. The call may be accessed through an operator by calling (844) 883-3861 for domestic callers and (574) 990-9820 for international callers using conference ID: 5078571. 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’s flagship procedure, TransCarotid Artery Revascularization (TCAR), is clinically proven 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 financial guidance, market




adoption and expectations for growth. 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 Form 10-Q filing made with the Securities and Exchange Commission on November 13, 2019. 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.

Investors:
Lynn Lewis
Gilmartin Group
investors@silkroadmed.com


Media:
Joni Ramirez
Merryman Communications
joni@merrymancommunications.com






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


Three Months Ended
December 31,
Year Ended
December 31,
2019201820192018
Revenue$18,634  $11,470  $63,354  $34,557  
Cost of goods sold4,721  3,667  15,927  10,874  
Gross profit13,913  7,803  47,427  23,683  
Operating expenses:
Research and development
3,264  3,390  12,272  10,258  
Selling, general and administrative
18,156  11,712  63,220  34,820  
Total operating expenses
21,420  15,102  75,492  45,078  
Loss from operations(7,507) (7,299) (28,065) (21,395) 
Interest income441  124  1,656  189  
Interest expense(1,217) (1,296) (4,952) (4,361) 
Remeasurement of warrant liability and other income (expense), net(8) (7,147) (21,054) (12,063) 
Net loss(8,291) (15,618) (52,415) (37,630) 
Other comprehensive loss:
Unrealized gains on investments, net —   —  
Net change in other comprehensive loss —   —  
Net loss and comprehensive loss$(8,289) $(15,618) $(52,413) $(37,630) 
Net loss per share, basic and diluted$(0.27) $(14.12) $(2.28) $(39.16) 
Weighted average common shares used to compute net loss per share, basic and diluted30,989,705  1,106,311  22,956,679  960,882  






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


December 31,
2019
2018 (1)
Assets
Current assets
Cash and cash equivalents
$39,181  $24,990  
Short-term investments
51,508  —  
Accounts receivable, net
8,601  6,382  
Inventories
10,322  5,744  
Prepaid expenses and other current assets
2,878  1,408  
Total current assets
112,490  38,524  
Long-term investments18,224  —  
Property and equipment, net2,734  2,880  
Restricted cash310  310  
Other non-current assets3,644  1,029  
Total assets
$137,402  $42,743  
Liabilities, convertible preferred stock and stockholders' equity (deficit)
Current liabilities
Accounts payable
$1,898  $1,252  
Accrued liabilities
15,034  9,448  
Total current liabilities
16,932  10,700  
Long-term debt44,879  44,201  
Redeemable convertible preferred stock warrant liability—  16,091  
Other liabilities3,700  1,069  
Total liabilities
65,511  72,061  
Convertible preferred stock—  105,235  
Stockholders’ equity (deficit)
Preferred stock, $0.001 par value
—  —  
Common stock, $0.001 par value
31   
Additional paid-in capital263,384  4,557  
Accumulated other comprehensive income —  
Accumulated deficit(191,526) (139,111) 
Total stockholders’ equity (deficit)71,891  (134,553) 
Total liabilities, convertible preferred stock and
stockholders' equity (deficit)$137,402  $42,743  


(1)We have adjusted the December 31, 2018 consolidated balance sheet to increase each of the accounts receivable and accrued liabilities balances to correct for an immaterial prior year error in the classification of provisions for returns from customers.

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Cover Page
Feb. 26, 2020
Cover page.  
Document Type 8-K
Document Period End Date Feb. 26, 2020
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
Entity Emerging Growth Company true
Entity Ex Transition Period true
Entity Central Index Key 0001397702
Amendment Flag false
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