silk-20230930x10q
false--12-31Q320230001397702YesYes0001397702us-gaap:EmployeeStockOptionMembersilk:TwoThousandNineteenStockOptionPlanMember2023-01-012023-09-300001397702us-gaap:CommonStockMember2023-07-012023-09-300001397702us-gaap:CommonStockMember2023-04-012023-06-300001397702us-gaap:CommonStockMember2023-01-012023-03-310001397702us-gaap:CommonStockMember2022-07-012022-09-300001397702us-gaap:CommonStockMember2022-04-012022-06-300001397702us-gaap:CommonStockMember2022-01-012022-03-310001397702us-gaap:RetainedEarningsMember2023-09-300001397702us-gaap:AdditionalPaidInCapitalMember2023-09-300001397702us-gaap:AccumulatedOtherComprehensiveIncomeMember2023-09-300001397702us-gaap:RetainedEarningsMember2023-06-300001397702us-gaap:AdditionalPaidInCapitalMember2023-06-300001397702us-gaap:AccumulatedOtherComprehensiveIncomeMember2023-06-3000013977022023-06-300001397702us-gaap:RetainedEarningsMember2023-03-310001397702us-gaap:AdditionalPaidInCapitalMember2023-03-310001397702us-gaap:AccumulatedOtherComprehensiveIncomeMember2023-03-3100013977022023-03-310001397702us-gaap:RetainedEarningsMember2022-12-310001397702us-gaap:AdditionalPaidInCapitalMember2022-12-310001397702us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-12-310001397702us-gaap:RetainedEarningsMember2022-09-300001397702us-gaap:AdditionalPaidInCapitalMember2022-09-300001397702us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-09-300001397702us-gaap:RetainedEarningsMember2022-06-300001397702us-gaap:AdditionalPaidInCapitalMember2022-06-300001397702us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-06-3000013977022022-06-300001397702us-gaap:RetainedEarningsMember2022-03-310001397702us-gaap:AdditionalPaidInCapitalMember2022-03-3100013977022022-03-310001397702us-gaap:RetainedEarningsMember2021-12-310001397702us-gaap:AdditionalPaidInCapitalMember2021-12-310001397702us-gaap:CommonStockMember2023-09-300001397702us-gaap:CommonStockMember2023-06-300001397702us-gaap:CommonStockMember2023-03-310001397702us-gaap:CommonStockMember2022-12-310001397702us-gaap:CommonStockMember2022-09-300001397702us-gaap:CommonStockMember2022-06-300001397702us-gaap:CommonStockMember2022-03-310001397702us-gaap:CommonStockMember2021-12-3100013977022022-01-012022-12-310001397702silk:BenchmarkMemberus-gaap:PerformanceSharesMember2023-01-012023-09-300001397702us-gaap:RestrictedStockUnitsRSUMember2022-12-310001397702us-gaap:PerformanceSharesMember2022-12-310001397702us-gaap:PerformanceSharesMember2023-03-012023-03-310001397702us-gaap:RestrictedStockUnitsRSUMembersilk:TwoThousandNineteenStockOptionPlanMember2023-01-012023-09-300001397702us-gaap:PerformanceSharesMembersilk:TwoThousandNineteenStockOptionPlanMember2023-01-012023-09-300001397702silk:IncentiveandNonqualifiedStockOptionMember2023-01-012023-09-300001397702us-gaap:RestrictedStockUnitsRSUMember2023-01-012023-09-300001397702us-gaap:PerformanceSharesMember2023-01-012023-09-3000013977022023-05-012023-05-310001397702us-gaap:RetainedEarningsMember2023-07-012023-09-300001397702us-gaap:RetainedEarningsMember2023-04-012023-06-300001397702us-gaap:RetainedEarningsMember2023-01-012023-03-310001397702us-gaap:RetainedEarningsMember2022-07-012022-09-300001397702us-gaap:RetainedEarningsMember2022-04-012022-06-300001397702us-gaap:RetainedEarningsMember2022-01-012022-03-310001397702us-gaap:AccumulatedOtherComprehensiveIncomeMember2023-07-012023-09-300001397702us-gaap:AccumulatedOtherComprehensiveIncomeMember2023-04-012023-06-300001397702us-gaap:AccumulatedOtherComprehensiveIncomeMember2023-01-012023-03-310001397702us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-07-012022-09-300001397702us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-04-012022-06-300001397702us-gaap:RevolvingCreditFacilityMembersilk:OxfordFinanceMembersilk:TermLoanMember2023-09-300001397702us-gaap:RevolvingCreditFacilityMembersilk:OxfordFinanceMemberus-gaap:SecuredDebtMember2022-05-310001397702us-gaap:RevolvingCreditFacilityMembersilk:OxfordFinanceMembersilk:TermLoanMember2022-05-310001397702silk:StifelBankMemberus-gaap:SecuredDebtMember2022-05-310001397702silk:LoanAndSecurityAgreementMembersilk:OxfordFinanceMember2022-05-310001397702us-gaap:LetterOfCreditMembersilk:OxfordFinanceMember2023-01-012023-09-300001397702us-gaap:LetterOfCreditMembersilk:OxfordFinanceMember2023-09-300001397702silk:HeadquartersMember2023-09-300001397702silk:AdditionalOfficeLaboratoryAndManufacturingSpaceMember2023-09-3000013977022023-05-310001397702silk:StifelBankMembersilk:TermLoanMember2022-05-012022-05-310001397702us-gaap:EmployeeStockOptionMember2023-01-012023-09-300001397702us-gaap:EmployeeStockMember2023-01-012023-09-300001397702silk:LoanFacilityMembersilk:StifelBankMember2022-05-310001397702silk:TermLoanTrancheCMembersilk:TermLoanMember2022-05-310001397702silk:TermLoanTrancheBMembersilk:TermLoanMember2022-05-310001397702silk:TermLoanTrancheAMembersilk:TermLoanMember2022-05-310001397702us-gaap:RevolvingCreditFacilityMembersilk:OxfordFinanceMembersilk:IndexRateMember2022-05-012022-05-3100013977022022-09-3000013977022021-12-310001397702us-gaap:USTreasurySecuritiesMember2023-09-300001397702us-gaap:MoneyMarketFundsMember2023-09-300001397702us-gaap:CommercialPaperMember2023-09-300001397702us-gaap:MoneyMarketFundsMember2022-12-310001397702us-gaap:CommercialPaperMember2022-12-310001397702us-gaap:USGovernmentAgenciesDebtSecuritiesMember2023-09-300001397702us-gaap:CorporateDebtSecuritiesMember2023-09-300001397702us-gaap:CorporateDebtSecuritiesMember2022-12-310001397702us-gaap:AssetBackedSecuritiesMember2022-12-310001397702silk:AgencyNotesMember2023-09-300001397702us-gaap:USTreasurySecuritiesMember2022-12-310001397702us-gaap:USGovernmentAgenciesDebtSecuritiesMember2022-12-310001397702silk:AgencyNotesMember2022-12-310001397702us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMemberus-gaap:USGovernmentAgenciesDebtSecuritiesMember2023-09-300001397702us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMemberus-gaap:CorporateDebtSecuritiesMember2023-09-300001397702us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMemberus-gaap:CommercialPaperNotIncludedWithCashAndCashEquivalentsMember2023-09-300001397702us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMembersilk:AgencyNotesMember2023-09-300001397702us-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMemberus-gaap:USTreasurySecuritiesMember2023-09-300001397702us-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMemberus-gaap:MoneyMarketFundsMember2023-09-300001397702us-gaap:FairValueMeasurementsRecurringMemberus-gaap:USTreasurySecuritiesMember2023-09-300001397702us-gaap:FairValueMeasurementsRecurringMemberus-gaap:USGovernmentAgenciesDebtSecuritiesMember2023-09-300001397702us-gaap:FairValueMeasurementsRecurringMemberus-gaap:MoneyMarketFundsMember2023-09-300001397702us-gaap:FairValueMeasurementsRecurringMemberus-gaap:CorporateDebtSecuritiesMember2023-09-300001397702us-gaap:FairValueMeasurementsRecurringMemberus-gaap:CommercialPaperNotIncludedWithCashAndCashEquivalentsMember2023-09-300001397702us-gaap:FairValueMeasurementsRecurringMembersilk:AgencyNotesMember2023-09-300001397702us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMember2023-09-300001397702us-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMember2023-09-300001397702us-gaap:FairValueMeasurementsRecurringMember2023-09-300001397702us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMemberus-gaap:USGovernmentAgenciesDebtSecuritiesMember2022-12-310001397702us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMemberus-gaap:CorporateDebtSecuritiesMember2022-12-310001397702us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMemberus-gaap:CommercialPaperNotIncludedWithCashAndCashEquivalentsMember2022-12-310001397702us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMemberus-gaap:AssetBackedSecuritiesMember2022-12-310001397702us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMembersilk:AgencyNotesMember2022-12-310001397702us-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMemberus-gaap:USTreasurySecuritiesMember2022-12-310001397702us-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMemberus-gaap:MoneyMarketFundsMember2022-12-310001397702us-gaap:FairValueMeasurementsRecurringMemberus-gaap:USTreasurySecuritiesMember2022-12-310001397702us-gaap:FairValueMeasurementsRecurringMemberus-gaap:USGovernmentAgenciesDebtSecuritiesMember2022-12-310001397702us-gaap:FairValueMeasurementsRecurringMemberus-gaap:MoneyMarketFundsMember2022-12-310001397702us-gaap:FairValueMeasurementsRecurringMemberus-gaap:CorporateDebtSecuritiesMember2022-12-310001397702us-gaap:FairValueMeasurementsRecurringMemberus-gaap:CommercialPaperNotIncludedWithCashAndCashEquivalentsMember2022-12-310001397702us-gaap:FairValueMeasurementsRecurringMemberus-gaap:AssetBackedSecuritiesMember2022-12-310001397702us-gaap:FairValueMeasurementsRecurringMembersilk:AgencyNotesMember2022-12-310001397702us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMember2022-12-310001397702us-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMember2022-12-310001397702us-gaap:FairValueMeasurementsRecurringMember2022-12-310001397702us-gaap:EmployeeStockOptionMember2023-01-012023-09-300001397702silk:RestrictedStockUnitsAndPerformanceStockUnitsMember2023-01-012023-09-300001397702us-gaap:EmployeeStockOptionMember2022-01-012022-09-300001397702silk:RestrictedStockUnitsAndPerformanceStockUnitsMember2022-01-012022-09-300001397702us-gaap:SellingGeneralAndAdministrativeExpensesMember2023-07-012023-09-300001397702us-gaap:ResearchAndDevelopmentExpenseMember2023-07-012023-09-300001397702us-gaap:CostOfSalesMember2023-07-012023-09-300001397702us-gaap:SellingGeneralAndAdministrativeExpensesMember2023-01-012023-09-300001397702us-gaap:ResearchAndDevelopmentExpenseMember2023-01-012023-09-300001397702us-gaap:CostOfSalesMember2023-01-012023-09-300001397702us-gaap:SellingGeneralAndAdministrativeExpensesMember2022-07-012022-09-300001397702us-gaap:ResearchAndDevelopmentExpenseMember2022-07-012022-09-300001397702us-gaap:CostOfSalesMember2022-07-012022-09-300001397702us-gaap:SellingGeneralAndAdministrativeExpensesMember2022-01-012022-09-300001397702us-gaap:ResearchAndDevelopmentExpenseMember2022-01-012022-09-300001397702us-gaap:CostOfSalesMember2022-01-012022-09-300001397702us-gaap:AdditionalPaidInCapitalMember2023-07-012023-09-300001397702us-gaap:AdditionalPaidInCapitalMember2023-04-012023-06-3000013977022023-04-012023-06-300001397702us-gaap:AdditionalPaidInCapitalMember2023-01-012023-03-3100013977022023-01-012023-03-310001397702us-gaap:AdditionalPaidInCapitalMember2022-07-012022-09-3000013977022022-07-012022-09-300001397702us-gaap:AdditionalPaidInCapitalMember2022-04-012022-06-3000013977022022-04-012022-06-300001397702us-gaap:AdditionalPaidInCapitalMember2022-01-012022-03-3100013977022022-01-012022-03-310001397702us-gaap:RestrictedStockUnitsRSUMember2023-09-300001397702us-gaap:PerformanceSharesMember2023-09-300001397702srt:MaximumMembersilk:IncentiveandNonqualifiedStockOptionMember2023-09-300001397702silk:NonqualifiedStockOptionsMember2023-09-300001397702silk:IncentiveStockOptionMember2023-09-300001397702silk:IncentiveandNonqualifiedStockOptionMember2023-09-300001397702silk:TwoThousandNineteenStockOptionPlanMember2023-09-300001397702silk:TwoThousandNineteenStockOptionPlanMember2022-12-310001397702silk:TwoThousandNineteenStockOptionPlanMember2023-01-012023-09-300001397702srt:MaximumMemberus-gaap:PerformanceSharesMembersilk:TwoThousandNineteenStockOptionPlanMember2023-03-012023-03-310001397702silk:TermLoanMember2023-09-300001397702silk:LoanAndSecurityAgreementMembersilk:OxfordFinanceMembersilk:TermLoanMember2022-05-310001397702srt:MaximumMembersilk:SecuredTermLoanFacilityMembersilk:OxfordFinanceMember2023-01-012023-09-300001397702silk:LoanAndSecurityAgreementMembersilk:OxfordFinanceMembersilk:TermLoanMember2022-05-012022-05-310001397702silk:OxfordFinanceMembersilk:TermLoanMember2023-01-012023-09-3000013977022022-01-012022-09-300001397702us-gaap:RevolvingCreditFacilityMembersilk:OxfordFinanceMembersilk:IndexRateMember2023-01-012023-09-300001397702us-gaap:RevolvingCreditFacilityMembersilk:OxfordFinanceMember2022-05-012022-05-310001397702silk:OxfordFinanceMember2023-01-012023-09-300001397702us-gaap:EmployeeStockOptionMembersilk:TwoThousandNineteenStockOptionPlanMember2023-09-300001397702us-gaap:RevolvingCreditFacilityMembersilk:OxfordFinanceMember2023-01-012023-09-3000013977022022-12-3100013977022023-09-3000013977022023-07-012023-09-3000013977022023-10-3100013977022023-01-012023-09-30silk:segmentiso4217:USDxbrli:sharesxbrli:pureiso4217:USDxbrli:shares

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

____________________________

FORM 10-Q

______________________________

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2023

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from               to

Commission File Number:   001-38847     

______________________________

SILK ROAD MEDICAL, INC.

(Exact name of registrant as specified in its charter)

______________________________

Delaware

20-8777622

(State or other jurisdiction of
incorporation or organization)

(I.R.S. Employer
Identification No.)

1213 Innsbruck Dr., Sunnyvale, CA 94089

(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code: (408) 720-9002

_______________________________

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, $0.001 par value

SILK

Nasdaq Stock Market LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes     No 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).    Yes     No 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company”, and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large Accelerated Filer

 

Accelerated Filer

Non-accelerated Filer

Smaller Reporting Company

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.  ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule12b-2 of the Exchange Act).  Yes ☐    No 

As of October 31, 2023, the number of outstanding shares of the registrant’s common stock, par value $0.001 per share, was 38,945,496.


TABLE OF CONTENTS

Part I: Financial Information

Page

Item 1.

Condensed Financial Statements

4

Condensed Balance Sheets

4

Condensed Statements of Operations and Comprehensive Loss

5

Condensed Statements of Stockholders’ Equity

6

Condensed Statements of Cash Flows

7

Notes to Condensed Financial Statements

8

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations 

21

Item 3.

Quantitative and Qualitative Disclosure About Market Risk

29

Item 4.

Controls and Procedures

30

Part II: Other Information

Item 1.

Legal Proceedings

31

Item 1A.

Risk Factors

31

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

72

Item 3.

Defaults Upon Senior Securities

72

Item 4.

Mine Safety Disclosures

72

Item 5.

Other Information

72

Item 6.

Exhibits

74

Signatures

75

 

As used in this report, references to “Silk Road Medical,” the “Company,” “we,” “our” or “us,” unless the context otherwise requires, refer to Silk Road Medical, Inc.

“Silk Road Medical,” the “Silk Road Medical” logo, “TCAR,” “ENROUTE,” the “ENROUTE” logo, “ENHANCE,” “Enflate” and our other registered or common law trade names, trademarks or service marks appearing in this Quarterly Report on Form 10-Q are our property. Trade names, trademarks and service marks of other companies appearing in this Quarterly Report on Form 10-Q are the property of their respective owners. We do not intend our use or display of other companies’ trade names, trademarks or service marks to imply a relationship with, or endorsement or sponsorship of us by, these other companies unless otherwise stated. Solely for convenience, the trademarks and tradenames referred to in this Quarterly Report on Form 10-Q appear without the ® and ™ symbols, but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights, or the right of the applicable licensor to these trademarks and tradenames.

1


CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements concerning our business, operations and financial performance and condition, as well as our plans, objectives and expectations for our business, operations and financial performance and condition. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements within the meaning of the federal securities laws and are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology, or the use of future dates.

These forward-looking statements include, but are not limited to, statements about the following subjects:

our goal to establish transcarotid artery revascularization, or TCAR, as the standard of care for the treatment of carotid artery disease;

our 2023 strategic priorities to grow, strengthen and diversify our business;

our plans to conduct further clinical trials and anticipated enrollment, clinical sites, completion, results and timing thereof;

our plans and expected timeline related to our products, including timing of commercial launch, or developing new products, to address additional indications or to obtain regulatory approvals or clearances or otherwise;

the expected use of our products by physicians, including market awareness, acceptance and adoption of our products and anticipated increased utilization of our products and market penetration;

our expectations regarding the number of procedures that will be performed with our products, the number of physicians we expect to train, and the number of our sales territories;

our ability to obtain, maintain and expand regulatory clearances for our current products and any new products we create;

the expected growth of our business and our organization;

our expectations regarding government and third-party payer coverage and reimbursement and the anticipated effect of such decisions;

our ability to manage our recent CEO transition and retain and recruit key personnel, including the continued expansion of our sales and marketing infrastructure, and the anticipated timing and effect of such actions;

our ability to obtain an adequate supply of materials and components for our products from our third-party suppliers, most of whom are single-source suppliers;

our ability to manufacture sufficient quantities of our products with sufficient quality and the sufficiency of our current manufacturing capabilities;

our ability to obtain and maintain intellectual property protection for our products and our business;

our ability to expand our business into new geographic markets and the anticipated timing thereof, including in Japan and China;

our compliance with extensive Nasdaq and U.S. Securities and Exchange Commission, or SEC, requirements and government laws, rules and regulations both in the United States and internationally;

our expectations regarding operating trends, future financial performance and expense management and our estimates of our future expenses, ongoing losses, future revenue, including per procedure revenue and the effect thereon of new products, gross margins, operating leverage, capital requirements and our need for, or ability to obtain, additional financing;

2


our ability to identify and develop new and planned products and/or acquire new products; 

our expectations regarding operating in a more normal health care operating environment;

our experience with inflationary and price pressures and increased labor costs and labor and staffing shortages;

developments and projections relating to our market opportunity and penetration, competitors or our industry; and

our intended use of net proceeds from our public offerings.

We believe that it is important to communicate our future expectations to our investors. However, there may be events in the future that we are not able to accurately predict or control and that may cause our actual results to differ materially from the expectations we describe in our forward-looking statements. These forward-looking statements are based on management’s current expectations, estimates, forecasts and projections about our business and the industry in which we operate and management’s beliefs and assumptions and are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors that are in some cases beyond our control. As a result, any or all of our forward-looking statements in this Quarterly Report on Form 10-Q may turn out to be inaccurate. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q.

These forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q. We undertake no obligation to update publicly any forward-looking statements for any reason after the date of this Quarterly Report on Form 10-Q to conform these statements to actual results or changes in our expectations. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur.

You should read this Quarterly Report on Form 10-Q and the documents that we reference in this Quarterly Report on Form 10-Q and have filed with the SEC as exhibits to this Quarterly Report on Form 10-Q with the understanding that our actual future results, levels of activity, performance and events and circumstances may be materially different from what we expect.

 

3


Part I. Financial Information

Item 1: Condensed Financial Statements

 

Silk Road Medical, Inc.

Condensed Balance Sheets

(unaudited)

(in thousands, except share and per share data)

September 30,

December 31,

2023

2022

Assets

Current assets:

Cash and cash equivalents

$

29,188 

$

55,358 

Short-term investments

163,673 

158,316 

Accounts receivable, net

21,779 

18,007 

Inventories

22,066 

19,293 

Prepaid expenses and other current assets

4,277 

3,924 

Total current assets

240,983 

254,898 

Long-term investments

4,348 

Property and equipment, net

8,337 

9,372 

Restricted cash

155 

Other non-current assets

7,196 

5,260 

Total assets

$

260,864 

$

269,685 

Liabilities and stockholders' equity

Current liabilities:

Accounts payable

$

5,094 

$

2,523 

Accrued liabilities

18,928 

21,965 

Total current liabilities

24,022 

24,488 

Long-term debt

75,364 

74,596 

Other liabilities

8,336 

6,726 

Total liabilities

107,722 

105,810 

Commitments and contingencies (Note 7)

 

 

Stockholders' equity:

Preferred stock, $0.001 par value

Shares authorized: 5,000,000 at September 30, 2023 and December 31, 2022

Shares issued and outstanding: none at September 30, 2023 and December 31, 2022

Common stock, $0.001 par value

Shares authorized: 100,000,000 at September 30, 2023 and December 31, 2022

Shares issued and outstanding: 38,907,789 and 38,355,972 at September 30, 2023 and December 31, 2022, respectively

39 

38 

Additional paid-in capital

539,831 

507,715 

Accumulated other comprehensive loss

(284)

(166)

Accumulated deficit

(386,444)

(343,712)

Total stockholders' equity

153,142 

163,875 

Total liabilities and stockholders' equity

$

260,864 

$

269,685 

 

The accompanying notes are an integral part of these condensed financial statements.

4


Silk Road Medical, Inc.

Condensed Statements of Operations and Comprehensive Loss

(unaudited)

(in thousands, except share and per share data)

Three Months Ended

Nine Months Ended

September 30,

September 30,

2023

2022

2023

2022

Revenue

$

44,435 

$

37,374 

$

129,864 

$

98,567 

Cost of goods sold

12,050 

9,308 

37,580 

26,897 

Gross profit

32,385 

28,066 

92,284 

71,670 

Operating expenses:

Research and development

10,047 

8,471 

31,260 

27,249 

Selling, general and administrative

36,009 

28,821 

105,923 

83,795 

Total operating expenses

46,056 

37,292 

137,183 

111,044 

Loss from operations

(13,671)

(9,226)

(44,899)

(39,374)

Interest income

2,617 

617 

7,339 

751 

Interest expense

(1,732)

(1,714)

(5,137)

(3,366)

Loss on debt extinguishment

(245)

Other income (expense), net

(2)

4 

(35)

(162)

Net loss

(12,788)

(10,319)

(42,732)

(42,396)

Other comprehensive loss:

Unrealized gain (loss) on investments, net

47 

(189)

(118)

(191)

Other comprehensive loss

47 

(189)

(118)

(191)

Net loss and comprehensive loss

$

(12,741)

$

(10,508)

$

(42,850)

$

(42,587)

Net loss per share, basic and diluted

$

(0.33)

$

(0.29)

$

(1.10)

$

(1.21)

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

38,865,011 

35,303,958 

38,722,012 

35,157,840 

The accompanying notes are an integral part of these condensed financial statements.

5


Silk Road Medical, Inc.

Condensed Statements of Stockholders' Equity

(unaudited)

(in thousands, except share data)

Common Stock

Additional
Paid-in

Accumulated

Accumulated
Other Comprehensive

Shares

Amount

Capital

Deficit

Income (Loss)

Total

Balances at December 31, 2022

38,355,972 

$

38 

$

507,715 

$

(343,712)

$

(166)

$

163,875 

Exercise of stock options

144,474 

— 

1,110 

— 

— 

1,110 

Issuance of common stock upon vesting of restricted stock units

207,995 

1

— 

— 

1 

Stock-based compensation

— 

— 

8,838 

— 

— 

8,838 

Net loss

— 

— 

— 

(16,460)

— 

(16,460)

Unrealized gain on investments, net

— 

— 

— 

249

249 

Balances at March 31, 2023

38,708,441 

39 

517,663 

(360,172)

83 

157,613 

Exercise of stock options

32,483 

232 

232 

Issuance of common stock upon vesting of restricted stock units

19,400 

Issuance of common stock under employee purchase plan

51,956 

1,359 

1,359 

Stock-based compensation

10,199 

10,199 

Net loss

(13,484)

(13,484)

Unrealized loss on investments, net

(414)

(414)

Balances at June 30, 2023

38,812,280 

39 

529,453 

(373,656)

(331)

155,505 

Exercise of stock options

18,751 

131 

131 

Issuance of common stock upon vesting of restricted stock units

76,758 

Stock-based compensation

10,247 

10,247 

Net loss

(12,788)

(12,788)

Unrealized gain on investments, net

47 

47 

Balances at September 30, 2023

38,907,789 

$

39 

$

539,831 

$

(386,444)

$

(284)

$

153,142 

(in thousands, except share data)

Common Stock

Additional
Paid-in

Accumulated

Accumulated
Other Comprehensive

Shares

Amount

Capital

Deficit

Income (Loss)

Total

Balances at December 31, 2021

34,980,896 

$

35 

$

367,907 

$

(288,702)

$

— 

$

79,240 

Exercise of stock options

35,453 

— 

168 

— 

— 

168 

Issuance of common stock upon vesting of restricted stock units

57,253 

— 

— 

— 

Stock-based compensation

— 

— 

4,978 

— 

— 

4,978 

Net loss

— 

— 

— 

(16,679)

— 

(16,679)

Balances at March 31, 2022

35,073,602 

35 

373,053 

(305,381)

— 

67,707 

Exercise of stock options

55,941 

— 

322 

— 

— 

322 

Issuance of common stock upon release of restricted stock units

13,075 

— 

— 

— 

Issuance of common stock under employee stock purchase plan

50,551 

— 

1,239 

— 

— 

1,239 

Stock-based compensation

— 

— 

6,161 

— 

— 

6,161 

Net loss

— 

— 

(15,398)

— 

(15,398)

Unrealized loss on investments, net

— 

— 

— 

(2)

(2)

Balances at June 30, 2022

35,193,169 

35 

380,775 

(320,779)

(2)

60,029 

Exercise of stock options

161,924 

— 

1,338 

— 

—