UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM
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CURRENT REPORT
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of the Securities Exchange Act of 1934
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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
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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 May 4, 2021, Silk Road Medical, Inc. issued a press release regarding its financial results for the quarter ended March 31, 2021. 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
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Exhibit No. |
| Description |
| Press Release of Silk Road Medical, Inc. issued on May 4, 2021. |
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.
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| SILK ROAD MEDICAL, INC. | |
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Date: May 4, 2021 | By: | /s/ Erica J. Rogers |
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| Erica J. Rogers |
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| President, Chief Executive Officer and Director |
Silk Road Medical Reports First Quarter 2021 Financial Results
SUNNYVALE, Calif. – May 4, 2021 – 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 quarter ended March 31, 2021.
“Our first quarter results were characterized by meaningful progress on several commercial and operational initiatives and strong financial performance,” said Erica Rogers, President and Chief Executive Officer of Silk Road Medical. “Procedure trends are improving, and we are working closely with our trained physicians to drive adoption of TCAR as the environment normalizes. Simultaneously, we are driving forward development efforts aimed at new indications, therapies, and market opportunities.”
The company also announced that the FDA has approved an IDE for its feasibility study in acute ischemic stroke, Neuroprotection in Transcarotid Embolectomy (NITE-1).
First Quarter 2021 Financial Results
Revenue for the first quarter of 2021 was $22.1 million, an increase of $3.1 million or 16%, compared to the first quarter of 2020.
Gross profit for the first quarter of 2021 was $16.5 million compared to $13.7 million for the first quarter of 2020. Gross margin for the first quarter of 2021 increased to 75% compared to 72% in the first quarter of 2020, primarily due to lower fixed costs per unit from increased production volume in comparison with prior period. Gross margin in the three months ended March 31, 2020 was impacted by unfavorable production variances as a result of temporarily idled manufacturing operations due to COVID-19.
Operating expenses were $26.7 million for the first quarter of 2021, compared to $22.8 million in the corresponding prior year period, which represents an increase of 17%. The increase was driven by growth in personnel and continued commercialization initiatives as well as the timing of certain research and development expenses, partially offset by the reduction in travel, tradeshow and other expenses due to COVID-19 compared to the first quarter of 2020.
Net loss was $10.7 million in the first quarter of 2021, or a loss of $0.31 per share, as compared to a loss of $9.9 million, or $0.32 per share, in the corresponding period of the prior year.
Cash, cash equivalents, and short-term investments were $136.1 million as of March 31, 2021.
2021 Financial Guidance
Silk Road Medical projects revenue for the full year 2021 to range from $103 million to $108 million. This compares to previous revenue guidance of $102 million to $108 million.
Conference Call
Silk Road Medical will host a conference call at 1:30 p.m. PT / 4:30 p.m. ET on Tuesday, May 4, 2021 to discuss its first quarter 2021 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: 9973707. 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 the impact of COVID-19 on our business, financial guidance, progress made on achieving our corporate goals, and the overall strength of our business and culture. 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 Annual Report on Form 10-K filing made with the Securities and Exchange Commission on March 1, 2021. 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 Caroline Paul
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)
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Three Months Ended |
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March 31, |
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2021 |
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2020 |
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Revenue |
$ |
22,053 |
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$ |
18,933 |
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Cost of goods sold |
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5,538 |
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5,250 |
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Gross profit |
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16,515 |
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13,683 |
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Operating expenses: |
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Research and development |
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5,484 |
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3,131 |
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Selling, general and administrative |
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21,194 |
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19,692 |
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Total operating expenses |
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26,678 |
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22,823 |
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Loss from operations |
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(10,163) |
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(9,140) |
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Interest income |
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95 |
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404 |
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Interest expense |
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(623) |
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(1,202) |
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Other income (expense), net |
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(3) |
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(3) |
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Net loss |
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(10,694) |
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(9,941) |
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Other comprehensive loss: |
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Unrealized gain (loss) on investments, net |
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(34) |
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440 |
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Net change in other comprehensive loss |
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(34) |
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440 |
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Net loss and comprehensive loss |
$ |
(10,728) |
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$ |
(9,501) |
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Net loss per share, basic and diluted |
$ |
(0.31) |
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$ |
(0.32) |
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Weighted average common shares used to compute net loss per share, basic and diluted |
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34,336,433 |
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31,338,310 |
SILK ROAD MEDICAL, INC.
Balance Sheets Data
(Unaudited, in thousands)
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March 31, 2021 |
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December 31, 2020 |
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Assets |
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Current assets |
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Cash and cash equivalents |
$ |
94,575 |
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$ |
69,466 |
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Short-term investments |
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41,497 |
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78,016 |
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Accounts receivable, net |
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11,106 |
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9,070 |
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Inventories |
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11,960 |
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9,989 |
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Prepaid expenses and other current assets |
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4,757 |
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6,787 |
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Total current assets |
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163,895 |
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173,328 |
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Property and equipment, net |
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2,777 |
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2,844 |
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Restricted cash |
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310 |
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310 |
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Other non-current assets |
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2,680 |
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2,832 |
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Total assets |
$ |
169,662 |
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$ |
179,314 |
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Liabilities and stockholders' equity |
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Current liabilities |
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Accounts payable |
$ |
2,923 |
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$ |
2,598 |
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Accrued liabilities |
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13,291 |
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16,957 |
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Total current liabilities |
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16,214 |
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19,555 |
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Long-term debt |
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48,574 |
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48,533 |
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Other liabilities |
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3,720 |
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3,726 |
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Total liabilities |
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68,508 |
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71,814 |
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Stockholders' equity |
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Preferred stock, $0.001 par value |
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— |
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— |
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Common stock, $0.001 par value |
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34 |
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34 |
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Additional paid-in capital |
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350,699 |
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346,318 |
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Accumulated other comprehensive income |
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6 |
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39 |
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Accumulated deficit |
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(249,585) |
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(238,891) |
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Total stockholders' equity |
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101,154 |
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107,500 |
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Total liabilities and stockholders' equity |
$ |
169,662 |
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$ |
179,314 |