Document


 
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): July 29, 2019
 
 
 

SILK ROAD MEDICAL, INC.
(Exact name of Registrant as specified in its charter)
 
 
 
Delaware
001-38847
20-8777622
(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 x
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. x
 




Item 2.02.      Results of Operations and Financial Condition.
 
On July 29, 2019, Silk Road Medical, Inc. issued a press release regarding its consolidated financial results for the quarter ended June 30, 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
Exhibit No.
 
Description
 




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: July 29, 2019
By:
/s/ Erica J. Rogers
 
 
Erica J. Rogers
 
 
Chief Executive Officer

Exhibit
http://api.tenkwizard.com/cgi/image?quest=1&rid=23&ipage=13027491&doc=3


Silk Road Medical Reports Second Quarter 2019 Financial Results and Raises 2019 Outlook

SUNNYVALE, Calif. - July 29, 2019 - 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, 2019.

Recent Highlights
Revenue of $14.9 million for the second quarter of 2019, representing a 92% increase over the second quarter of 2018
Results from ROADSTER 2 study demonstrated compelling safety profile with 30-day rates of stroke and combined stroke and death of 0.6% and 0.8%, respectively
Updated results from the TCAR Surveillance Project demonstrated, for the first time, significantly lower odds of composite in-hospital stroke, death and myocardial infarction for TCAR compared to carotid endarterectomy (CEA), the current standard of care

“Our second quarter results demonstrate strong performance as we expand our footprint with TCAR to reduce the risk of stroke and its devastating impact,” said Erica Rogers, Chief Executive Officer. “The recently presented data from ROADSTER-2, taken together with the updated results from the TCAR Surveillance Project, mark a major milestone in our journey demonstrating successful patient outcomes. We are challenging the standard of care with mounting clinical evidence in support of TCAR.”
Second Quarter 2019 Financial Results
Revenue for the second quarter of 2019 was $14.9 million, an increase of $7.2 million or 92%, compared to the second quarter of 2018. The increase was driven primarily by growing adoption of the TCAR procedure across an expanded base of hospital accounts, trained physicians, and active sales territories.

Gross profit for the second quarter of 2019 was $11.2 million compared to $5.4 million for the second quarter of 2018. Gross margin for the second quarter of 2019 increased to 75% compared to 69% in the second quarter of 2018, driven primarily by leveraging manufacturing overhead costs across higher revenue, as well as manufacturing efficiencies and the delayed timing of certain manufacturing engineering projects.

Operating expenses were $17.2 million for the second quarter of 2019, as compared to $10.1 million in the corresponding prior year period, which represents an increase of 70%. 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 of being a public company.

Net loss was $12.0 million in the second quarter of 2019, or a loss of $0.42 per share, as compared to $7.7 million, or a loss of $8.16 per share, in the corresponding period of the prior year. This metric for the second quarter of 2019 and 2018 included a $5.3 and $1.9 million noncash charge, respectively, resulting from the remeasurement of the fair value of our convertible preferred stock warrant liability at each balance sheet date. We continued to record adjustments to the estimated fair value of the convertible preferred stock warrants until they were exercised in connection with our IPO in April 2019.

Cash and cash equivalents were $118.2 million as of June 30, 2019.

2019 Financial Guidance





Silk Road Medical projects revenue for the full year 2019 to range from $60 million to $62 million, which represents 74% to 79% growth over the company’s prior year revenue. This compares to previous revenue guidance of $59 million to $61 million.

Conference Call
Silk Road Medical will host a conference call at 1:30 p.m. PT / 4:30 p.m. ET on Monday, July 29, 2019 to discuss its second quarter 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: 4657248. A live and archived webcast of the event will be available at https://investors.silkroadmed.com/.

About Silk Road Medical
Silk Road Medical, Inc. is a medical device company located in Sunnyvale, California, 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.     

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 and ability to penetrate the market 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 May 15, 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 or Carrie Mendivil
Gilmartin Group
investors@silkroadmed.com

Media:
Joni Ramirez
Merryman Communications
joni@merrymancommunications.com







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


 
Three Months Ended
June 30,
 
Six Months Ended
June 30,
 
2019
 
2018
 
2019
 
2018
Revenue
$
14,928

 
$
7,767

 
$
27,694

 
$
13,473

Cost of goods sold
3,697

 
2,391

 
7,035

 
4,325

Gross profit
11,231

 
5,376

 
20,659

 
9,148

Operating expenses:
 
 
 
 
 
 
 
Research and development
3,114

 
2,326

 
5,820

 
4,426

Selling, general and administrative
14,135

 
7,816

 
28,001

 
14,135

Total operating expenses
17,249

 
10,142

 
33,821

 
18,561

Loss from operations
(6,018
)
 
(4,766
)
 
(13,162
)
 
(9,413
)
Interest income
598

 
24

 
650

 
37

Interest expense
(1,207
)
 
(1,011
)
 
(2,560
)
 
(2,000
)
Remeasurement of warrant liability and other income (expense), net
(5,332
)
 
(1,898
)
 
(21,045
)
 
(1,682
)
Net loss and comprehensive loss
$
(11,959
)
 
$
(7,651
)
 
$
(36,117
)
 
$
(13,058
)
Net loss per common share, basic and diluted
$
(0.42
)
 
$
(8.16
)
 
$
(2.42
)
 
$
(15.56
)
Weighted-average shares used to compute net loss per common share, basic and diluted
28,458,793

 
938,052

 
14,905,052

 
839,229







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


 
June 30,
 2019
 
December 31,
2018
Assets
 
 
 
Current assets
 
 
 
Cash and cash equivalents
$
118,247

 
$
24,990

Accounts receivable, net
5,417

 
4,520

Inventories
8,963

 
5,744

Prepaid expenses and other current assets
3,249

 
1,408

Total current assets
135,876

 
36,662

Property and equipment, net
2,743

 
2,880

Restricted cash
310

 
310

Other non-current assets
3,723

 
1,029

Total assets
$
142,652

 
$
40,881

Liabilities, convertible preferred stock and stockholders' equity (deficit)
 
 
 
Current liabilities
 
 
 
Accounts payable
$
1,189

 
$
1,252

Accrued liabilities
8,299

 
7,586

Total current liabilities
9,488

 
8,838

Long-term debt
44,690

 
44,201

Redeemable convertible preferred stock warrant liability

 
16,091

Other liabilities
4,097

 
1,069

Total liabilities
58,275

 
70,199

Convertible preferred stock

 
105,235

Stockholders’ equity (deficit)
 
 
 
Preferred stock, $0.001 par value

 

Common stock, $0.001 par value
31

 
1

Additional paid-in capital
259,574

 
4,557

Accumulated deficit
(175,228
)
 
(139,111
)
Total stockholders’ equity (deficit)
84,377

 
(134,553
)
Total liabilities, convertible preferred stock and stockholders' equity (deficit)
$
142,652

 
$
40,881