lhdx-10q_20210630.htm
false Q2 0001652724 --12-31 0.2320 true 1 1 true true true P10Y 0.2320 1 P4Y 1 P9Y2M12D P9Y1M6D P8Y9M18D P8Y9M18D P8Y2M12D P6Y18D P5Y11M8D P6Y18D P6M 0001652724 2021-01-01 2021-06-30 xbrli:shares 0001652724 2021-08-10 iso4217:USD 0001652724 2021-06-30 0001652724 2020-12-31 iso4217:USD xbrli:shares 0001652724 2021-04-01 2021-06-30 0001652724 2020-04-01 2020-06-30 0001652724 2020-01-01 2020-06-30 0001652724 us-gaap:CommonStockMember 2021-03-31 0001652724 us-gaap:AdditionalPaidInCapitalMember 2021-03-31 0001652724 us-gaap:RetainedEarningsMember 2021-03-31 0001652724 2021-03-31 0001652724 us-gaap:CommonStockMember 2021-04-01 2021-06-30 0001652724 us-gaap:AdditionalPaidInCapitalMember 2021-04-01 2021-06-30 0001652724 us-gaap:RetainedEarningsMember 2021-04-01 2021-06-30 0001652724 us-gaap:CommonStockMember 2021-06-30 0001652724 us-gaap:AdditionalPaidInCapitalMember 2021-06-30 0001652724 us-gaap:RetainedEarningsMember 2021-06-30 0001652724 us-gaap:RedeemableConvertiblePreferredStockMember 2020-03-31 0001652724 us-gaap:CommonStockMember 2020-03-31 0001652724 us-gaap:AdditionalPaidInCapitalMember 2020-03-31 0001652724 us-gaap:RetainedEarningsMember 2020-03-31 0001652724 2020-03-31 0001652724 us-gaap:CommonStockMember 2020-04-01 2020-06-30 0001652724 us-gaap:AdditionalPaidInCapitalMember 2020-04-01 2020-06-30 0001652724 us-gaap:RetainedEarningsMember 2020-04-01 2020-06-30 0001652724 us-gaap:RedeemableConvertiblePreferredStockMember 2020-06-30 0001652724 us-gaap:CommonStockMember 2020-06-30 0001652724 us-gaap:AdditionalPaidInCapitalMember 2020-06-30 0001652724 us-gaap:RetainedEarningsMember 2020-06-30 0001652724 2020-06-30 0001652724 us-gaap:RedeemableConvertiblePreferredStockMember 2020-12-31 0001652724 us-gaap:CommonStockMember 2020-12-31 0001652724 us-gaap:AdditionalPaidInCapitalMember 2020-12-31 0001652724 us-gaap:RetainedEarningsMember 2020-12-31 0001652724 us-gaap:RedeemableConvertiblePreferredStockMember 2021-01-01 2021-06-30 0001652724 us-gaap:CommonStockMember 2021-01-01 2021-06-30 0001652724 us-gaap:AdditionalPaidInCapitalMember 2021-01-01 2021-06-30 0001652724 us-gaap:RetainedEarningsMember 2021-01-01 2021-06-30 0001652724 us-gaap:RedeemableConvertiblePreferredStockMember 2019-12-31 0001652724 us-gaap:CommonStockMember 2019-12-31 0001652724 us-gaap:AdditionalPaidInCapitalMember 2019-12-31 0001652724 us-gaap:RetainedEarningsMember 2019-12-31 0001652724 2019-12-31 0001652724 us-gaap:RedeemableConvertiblePreferredStockMember 2020-01-01 2020-06-30 0001652724 us-gaap:CommonStockMember 2020-01-01 2020-06-30 0001652724 us-gaap:AdditionalPaidInCapitalMember 2020-01-01 2020-06-30 0001652724 us-gaap:RetainedEarningsMember 2020-01-01 2020-06-30 xbrli:pure 0001652724 2021-01-28 2021-01-28 0001652724 us-gaap:IPOMember us-gaap:CommonStockMember 2021-02-09 2021-02-09 0001652724 us-gaap:OverAllotmentOptionMember us-gaap:CommonStockMember 2021-02-09 2021-02-09 0001652724 us-gaap:IPOMember us-gaap:CommonStockMember 2021-02-09 lhdx:Customer 0001652724 us-gaap:CreditConcentrationRiskMember us-gaap:AccountsReceivableMember 2021-01-01 2021-06-30 0001652724 us-gaap:CreditConcentrationRiskMember us-gaap:AccountsReceivableMember lhdx:CustomerOneMember 2021-01-01 2021-06-30 0001652724 us-gaap:CreditConcentrationRiskMember us-gaap:AccountsReceivableMember lhdx:CustomerTwoMember 2021-01-01 2021-06-30 0001652724 us-gaap:CreditConcentrationRiskMember 2021-06-30 0001652724 us-gaap:CreditConcentrationRiskMember 2020-12-31 0001652724 us-gaap:CustomerConcentrationRiskMember us-gaap:SalesRevenueNetMember lhdx:CustomerOneMember 2021-04-01 2021-06-30 0001652724 us-gaap:CustomerConcentrationRiskMember us-gaap:SalesRevenueNetMember lhdx:CustomerTwoMember 2021-04-01 2021-06-30 0001652724 us-gaap:CustomerConcentrationRiskMember us-gaap:SalesRevenueNetMember 2021-04-01 2021-06-30 0001652724 lhdx:PreapprovalInventoryForCOVID19TestKitMember 2020-11-17 2020-11-17 0001652724 lhdx:PreapprovalInventoryForCOVID19TestKitMember 2020-12-31 0001652724 us-gaap:CostOfSalesMember lhdx:PreapprovalInventoryForCOVID19TestKitMember srt:MaximumMember 2021-04-01 2021-06-30 0001652724 us-gaap:CostOfSalesMember lhdx:PreapprovalInventoryForCOVID19TestKitMember 2021-01-01 2021-06-30 0001652724 lhdx:SellingGeneralAndAdministrativeAndResearchAndDevelopmentActivitiesMember lhdx:PreapprovalInventoryForCOVID19TestKitMember 2021-01-01 2021-06-30 0001652724 srt:MinimumMember 2021-01-01 2021-06-30 0001652724 srt:MaximumMember 2021-01-01 2021-06-30 0001652724 us-gaap:IPOMember us-gaap:RedeemableConvertiblePreferredStockMember us-gaap:CommonStockMember 2021-02-09 0001652724 us-gaap:IPOMember us-gaap:OtherAssetsMember 2021-06-30 0001652724 us-gaap:IPOMember us-gaap:OtherAssetsMember 2020-12-31 0001652724 us-gaap:IPOMember 2021-01-01 2021-02-09 0001652724 country:US 2021-04-01 2021-06-30 0001652724 country:US 2021-01-01 2021-06-30 0001652724 us-gaap:NonUsMember 2021-04-01 2021-06-30 0001652724 us-gaap:NonUsMember 2021-01-01 2021-06-30 0001652724 lhdx:BiomedicalAdvancedResearchAndDevelopmentAuthorityMember 2018-07-01 2018-07-31 0001652724 lhdx:BiomedicalAdvancedResearchAndDevelopmentAuthorityMember 2019-09-01 2019-09-30 0001652724 lhdx:BiomedicalAdvancedResearchAndDevelopmentAuthorityMember 2021-04-01 2021-06-30 0001652724 lhdx:BiomedicalAdvancedResearchAndDevelopmentAuthorityMember 2021-01-01 2021-06-30 0001652724 lhdx:BiomedicalAdvancedResearchAndDevelopmentAuthorityMember 2020-04-01 2020-06-30 0001652724 lhdx:BiomedicalAdvancedResearchAndDevelopmentAuthorityMember 2020-01-01 2020-06-30 0001652724 srt:MaximumMember 2020-04-01 2020-06-30 0001652724 us-gaap:SellingGeneralAndAdministrativeExpensesMember 2021-04-01 2021-06-30 0001652724 us-gaap:SellingGeneralAndAdministrativeExpensesMember 2021-01-01 2021-06-30 0001652724 us-gaap:SellingGeneralAndAdministrativeExpensesMember 2020-04-01 2020-06-30 0001652724 us-gaap:SellingGeneralAndAdministrativeExpensesMember 2020-01-01 2020-06-30 0001652724 lhdx:TwoThousandTwentyOneEmployeeStockPurchasePlanMember 2021-02-01 2021-02-28 0001652724 us-gaap:EmployeeStockOptionMember 2021-01-01 2021-06-30 0001652724 us-gaap:EmployeeStockOptionMember 2020-01-01 2020-06-30 0001652724 lhdx:UnvestedRestrictedStockMember 2021-01-01 2021-06-30 lhdx:Segment 0001652724 us-gaap:AccountingStandardsUpdate201912Member 2021-06-30 0001652724 us-gaap:FairValueInputsLevel1Member us-gaap:FairValueMeasurementsRecurringMember 2021-06-30 0001652724 us-gaap:FairValueInputsLevel1Member us-gaap:FairValueMeasurementsRecurringMember 2020-12-31 0001652724 us-gaap:FairValueInputsLevel3Member us-gaap:FairValueMeasurementsRecurringMember 2020-12-31 0001652724 us-gaap:ConstructionInProgressMember 2021-06-30 0001652724 us-gaap:ConstructionInProgressMember 2020-12-31 0001652724 us-gaap:MachineryAndEquipmentMember 2021-06-30 0001652724 us-gaap:MachineryAndEquipmentMember 2020-12-31 0001652724 us-gaap:SoftwareAndSoftwareDevelopmentCostsMember 2021-06-30 0001652724 us-gaap:FurnitureAndFixturesMember 2021-06-30 0001652724 us-gaap:FurnitureAndFixturesMember 2020-12-31 0001652724 us-gaap:LeaseholdImprovementsMember 2021-06-30 0001652724 us-gaap:LeaseholdImprovementsMember 2020-12-31 0001652724 lhdx:EikenAgreementMember 2021-01-01 2021-06-30 0001652724 lhdx:EikenAgreementMember 2021-04-01 2021-04-30 0001652724 us-gaap:CostOfSalesMember lhdx:EikenAgreementMember 2021-04-01 2021-06-30 0001652724 us-gaap:CostOfSalesMember lhdx:EikenAgreementMember 2021-01-01 2021-06-30 0001652724 us-gaap:CostOfSalesMember lhdx:EikenAgreementMember 2020-04-01 2020-06-30 0001652724 us-gaap:CostOfSalesMember lhdx:EikenAgreementMember 2020-01-01 2020-06-30 0001652724 lhdx:TechnologyServicesAgreementWithJabilMember 2021-01-01 2021-06-30 0001652724 lhdx:ManufacturingServicesAgreementWithJabilMember 2021-01-01 2021-06-30 0001652724 srt:MinimumMember 2021-06-30 0001652724 srt:MaximumMember 2021-06-30 0001652724 lhdx:TwoThousandTwentyANotesMember 2020-06-01 2020-07-31 0001652724 lhdx:TwoThousandTwentyANotesMember 2020-07-31 0001652724 lhdx:TwoThousandTwentyANotesMember srt:MinimumMember lhdx:TwoThousandTwentyAQualifiedFinancingMember 2020-06-01 2020-07-31 0001652724 lhdx:TwoThousandTwentyANotesMember lhdx:TwoThousandTwentyAQualifiedFinancingMember 2020-06-01 2020-07-31 0001652724 lhdx:TwoThousandTwentyANotesMember lhdx:TwoThousandTwentyAQualifiedFinancingMember 2020-07-31 0001652724 lhdx:TwoThousandTwentyANotesMember 2021-01-01 2021-06-30 0001652724 lhdx:SeriesCRedeemableConvertiblePreferredStockMember lhdx:TwoThousandTwentyAQualifiedFinancingMember lhdx:TwoThousandTwentyANotesMember 2020-08-01 2020-08-31 0001652724 lhdx:TwoThousandTwentyAQualifiedFinancingMember lhdx:TwoThousandTwentyANotesMember 2020-08-31 0001652724 lhdx:SeriesCRedeemableConvertiblePreferredStockMember lhdx:TwoThousandTwentyAQualifiedFinancingMember lhdx:TwoThousandTwentyANotesMember 2020-08-31 0001652724 lhdx:SeriesCRedeemableConvertiblePreferredStockMember lhdx:TwoThousandTwentyANotesMember 2020-08-01 2020-08-31 0001652724 lhdx:SeriesCRedeemableConvertiblePreferredStockMember lhdx:TwoThousandTwentyANotesMember 2020-08-31 0001652724 lhdx:TwoThousandTwentyANotesMember 2020-08-31 0001652724 lhdx:TwoThousandTwentyBNotesMember 2020-12-01 2020-12-31 0001652724 lhdx:TwoThousandTwentyBNotesMember 2020-12-31 0001652724 lhdx:TwoThousandTwentyBNotesMember lhdx:TwoThousandTwentyBQualifiedFinancingMember srt:MaximumMember 2020-12-01 2020-12-31 0001652724 lhdx:TwoThousandTwentyBNotesMember lhdx:TwoThousandTwentyBQualifiedFinancingMember 2020-12-01 2020-12-31 0001652724 lhdx:TwoThousandTwentyBNotesMember lhdx:TwoThousandTwentyBNonQualifiedFinancingMember 2020-12-01 2020-12-31 0001652724 lhdx:TwoThousandTwentyBNotesMember lhdx:SeriesCRedeemableConvertiblePreferredStockMember 2020-12-01 2020-12-31 0001652724 lhdx:TwoThousandTwentyBNotesMember us-gaap:CommonStockMember 2020-12-01 2020-12-31 0001652724 lhdx:TwoThousandTwentyBNotesMember 2021-01-01 2021-06-30 0001652724 lhdx:TwoThousandTwentyANotesMember us-gaap:OtherNonoperatingIncomeExpenseMember 2020-07-01 2020-07-31 0001652724 lhdx:TwoThousandTwentyBNotesMember us-gaap:OtherNonoperatingIncomeExpenseMember 2020-01-01 2020-12-31 0001652724 lhdx:TwoThousandTwentyBNotesMember us-gaap:OtherNonoperatingIncomeExpenseMember 2021-01-01 2021-03-31 0001652724 lhdx:TwoThousandTwentyBNotesMember us-gaap:IPOMember 2021-02-09 2021-02-09 0001652724 lhdx:TwoThousandTwentyBNotesMember us-gaap:CommonStockMember 2021-02-09 2021-02-09 0001652724 lhdx:SeriesARedeemableConvertiblePreferredStockMember 2015-10-31 0001652724 us-gaap:RedeemableConvertiblePreferredStockMember 2019-03-06 0001652724 us-gaap:RedeemableConvertiblePreferredStockMember 2019-07-24 0001652724 us-gaap:RedeemableConvertiblePreferredStockMember 2019-11-04 0001652724 lhdx:SeriesBRedeemableConvertiblePreferredStockMember 2019-03-06 0001652724 lhdx:SeriesBRedeemableConvertiblePreferredStockMember 2019-07-24 0001652724 lhdx:SeriesBRedeemableConvertiblePreferredStockMember 2019-11-04 0001652724 lhdx:SeriesBRedeemableConvertiblePreferredStockMember 2019-03-31 0001652724 lhdx:SeriesBRedeemableConvertiblePreferredStockMember 2019-08-31 0001652724 lhdx:SeriesBRedeemableConvertiblePreferredStockMember 2019-03-01 2019-03-31 0001652724 lhdx:SeriesBRedeemableConvertiblePreferredStockMember 2019-06-01 2019-08-31 0001652724 2019-03-01 2019-03-31 0001652724 lhdx:SeriesBRedeemableConvertiblePreferredStockMember 2019-01-01 2019-12-31 0001652724 us-gaap:RedeemableConvertiblePreferredStockMember 2020-01-09 0001652724 us-gaap:RedeemableConvertiblePreferredStockMember 2020-08-06 0001652724 lhdx:SeriesBRedeemableConvertiblePreferredStockMember 2020-01-09 0001652724 lhdx:SeriesBRedeemableConvertiblePreferredStockMember 2020-08-06 0001652724 lhdx:SeriesCRedeemableConvertiblePreferredStockMember 2020-08-06 0001652724 lhdx:SeriesCRedeemableConvertiblePreferredStockMember 2020-08-31 0001652724 lhdx:SeriesCRedeemableConvertiblePreferredStockMember 2020-08-01 2020-08-31 0001652724 2021-02-09 2021-02-09 0001652724 2021-02-09 0001652724 us-gaap:PreferredStockMember 2021-06-30 0001652724 lhdx:SeriesARedeemableConvertiblePreferredStockMember 2020-12-31 0001652724 lhdx:SeriesBRedeemableConvertiblePreferredStockMember 2020-12-31 0001652724 lhdx:SeriesCRedeemableConvertiblePreferredStockMember 2020-12-31 0001652724 lhdx:SeriesARedeemableConvertiblePreferredStockMember 2020-01-01 2020-12-31 0001652724 lhdx:SeriesBRedeemableConvertiblePreferredStockMember 2020-01-01 2020-12-31 0001652724 lhdx:SeriesCRedeemableConvertiblePreferredStockMember 2020-01-01 2020-12-31 0001652724 2018-12-31 0001652724 2019-03-31 0001652724 2019-07-31 0001652724 2019-11-30 0001652724 2020-01-31 0001652724 2020-08-31 0001652724 lhdx:CommonStockOptionGrantsIssuedAndOutstandingUnderTwoThousandAndFourteenPlanMember 2021-06-30 0001652724 lhdx:CommonStockOptionGrantsIssuedAndOutstandingUnderTwoThousandAndFourteenPlanMember 2020-12-31 0001652724 lhdx:CommonSharesIssuableOnConversionOfConvertibleNotesPayableMember 2020-12-31 0001652724 lhdx:CommonStockReservedForIssuanceUnderTwoThousandTwentyOnePlanMember 2021-06-30 0001652724 lhdx:CommonStockReservedForIssuanceUnderTwoThousandTwentyOnePlanMember 2020-12-31 0001652724 lhdx:CommonStockOptionGrantsIssuedAndOutstandingUnderTwoThousandAndTwentyOnePlanMember 2021-06-30 0001652724 lhdx:RestrictedCommonStockUnitsIssuedAndOutstandingMember 2021-06-30 0001652724 lhdx:CommonStockReservedForIssuanceUnderEmployeeStockPurchasePlanMember 2021-06-30 0001652724 lhdx:TwoThousandFourteenEquityIncentivePlanMember 2021-01-01 2021-06-30 0001652724 us-gaap:ShareBasedCompensationAwardTrancheOneMember lhdx:TwoThousandFourteenEquityIncentivePlanMember 2021-01-01 2021-06-30 0001652724 lhdx:TwoThousandFourteenEquityIncentivePlanMember 2020-12-31 0001652724 lhdx:TwoThousandTwentyOneEquityIncentivePlanMember 2021-01-31 0001652724 lhdx:TwoThousandTwentyOneEquityIncentivePlanMember 2021-01-01 2021-01-31 0001652724 us-gaap:ShareBasedCompensationAwardTrancheOneMember us-gaap:RestrictedStockUnitsRSUMember 2021-01-01 2021-06-30 0001652724 us-gaap:RestrictedStockUnitsRSUMember 2021-01-01 2021-03-31 0001652724 us-gaap:RestrictedStockUnitsRSUMember 2021-03-31 0001652724 us-gaap:RestrictedStockUnitsRSUMember 2021-04-01 2021-06-30 0001652724 us-gaap:RestrictedStockUnitsRSUMember 2021-06-30 0001652724 2021-01-01 2021-03-31 0001652724 2020-01-01 2020-12-31 0001652724 us-gaap:EmployeeStockOptionMember 2020-06-30 0001652724 us-gaap:EmployeeStockOptionMember 2021-06-30 0001652724 us-gaap:EmployeeStockOptionMember 2020-04-01 2020-06-30 0001652724 us-gaap:EmployeeStockOptionMember 2021-01-01 2021-06-30 0001652724 us-gaap:EmployeeStockOptionMember 2020-01-01 2020-06-30 0001652724 us-gaap:EmployeeStockOptionMember 2021-04-01 2021-06-30 0001652724 us-gaap:CostOfSalesMember 2021-04-01 2021-06-30 0001652724 us-gaap:CostOfSalesMember 2021-01-01 2021-06-30 0001652724 us-gaap:ResearchAndDevelopmentExpenseMember 2021-04-01 2021-06-30 0001652724 us-gaap:ResearchAndDevelopmentExpenseMember 2020-04-01 2020-06-30 0001652724 us-gaap:ResearchAndDevelopmentExpenseMember 2021-01-01 2021-06-30 0001652724 us-gaap:ResearchAndDevelopmentExpenseMember 2020-01-01 2020-06-30 0001652724 us-gaap:EmployeeStockMember 2021-01-01 2021-06-30 0001652724 us-gaap:EmployeeStockMember 2021-04-01 2021-06-30 0001652724 us-gaap:EmployeeStockMember srt:MaximumMember 2021-06-30 0001652724 us-gaap:EmployeeStockMember 2021-06-30 0001652724 us-gaap:EmployeeStockMember 2020-04-01 2020-06-30 0001652724 us-gaap:EmployeeStockMember 2020-01-01 2020-06-30 0001652724 us-gaap:ConvertibleNotesPayableMember 2020-01-01 2020-12-31 0001652724 lhdx:ConvertibleNotes2020BMember 2020-12-31 0001652724 srt:MaximumMember 2020-01-01 2020-06-30

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 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 June 30, 2021

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: 001-39976

 

Lucira Health, Inc.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

27-2491037

( State or other jurisdiction of

incorporation or organization)

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

1412 62nd Street

Emeryville, California 94608

 

(Address of principal executive offices)

 

Registrant’s telephone number, including area code: (510) 350-8071

 

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

 

LHDX

 

Nasdaq Global Select Market

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, 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 Rule 12b-2 of the Exchange Act).     Yes      No  

As of August 10, 2021, the number of shares of registrant’s common stock, par value $0.001 per share, outstanding was 38,698,789.

 

 

 


 

 

Table of Contents

 

 

 

Page

PART I.

FINANCIAL INFORMATION

 

Item 1.

Financial Statements (Unaudited)

1

 

Condensed Balance Sheets

1

 

Condensed Statements of Operations

2

 

Condensed Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)

3

 

Condensed Statements of Cash Flows

4

 

Notes to Unaudited Condensed Financial Statements

5

Item 2.

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

27

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

34

Item 4.

Controls and Procedures

34

PART II.

OTHER INFORMATION

 

Item 1.

Legal Proceedings

36

Item 1A.

Risk Factors

36

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

87

Item 3.

Defaults Upon Senior Securities

88

Item 4.

Mine Safety Disclosures

88

Item 5.

Other Information

88

Item 6.

Exhibits

89

Signatures

90

 

 

Where You Can Find More Information

Investors and others should note that we announce material financial and other information using our investor relations website, press releases, SEC filings and public conference calls and webcasts. We also post supplemental materials on the Press Release section of our investor relations website at www. https://ir.lucirahealth.com/. Except as specifically noted herein, information on or accessible through our website is not, and will not be deemed to be, a part of this Quarterly Report on Form 10-Q or incorporated by reference into any other filings we may make with the U.S. Securities and Exchange Commission (the “SEC”).

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

i


 

 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, which statements involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q, including statements regarding our future results of operations or financial condition; business strategy and plans; and objectives of management for future operations, including our statements regarding the benefits and timing of the roll out of new technology, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. Forward-looking statements contained in this Quarterly Report on Form 10-Q include, but are not limited to, statements about:

 

 

the extent and duration of the COVID-19 pandemic and our expectations regarding customer and user demand for our COVID-19 test kit;

 

 

our expected future growth;

 

 

our ability to obtain and maintain regulatory approval for our test kits, including our existing Emergency Use Authorizations, or EUAs, for our COVID-19 test kits;

 

 

the size and growth potential of the markets for our test kits, including the COVID-19 diagnostic testing market, and our ability to serve those markets;

 

 

our ability to accurately forecast demand for our test kits;

 

 

the rate and degree of physician and market acceptance of our test kits;

 

 

the expected future growth of our sales and marketing organization;

 

 

coverage and reimbursement for our test kits;

 

 

the performance of, and our reliance on, third parties in connection with the commercialization of our test kits, including Jabil Inc., or Jabil, and our single-source suppliers;

 

 

our ability to accurately forecast, and Jabil’s ability to manufacture, appropriate quantities of our COVID-19 test kit to meet commercial demand;

 

 

regulatory developments in the United States and foreign countries;

 

 

our research and development for our influenza test kit and any future test kits;

 

 

the development, regulatory approval, and commercialization of competing products;

 

 

our ability to retain and hire senior management and key personnel;

 

 

our expectations regarding the period during which we qualify as an emerging growth company under the JOBS Act;

 

 

our ability to develop and maintain our corporate infrastructure, including our internal controls;

 

 

our financial performance and capital requirements; and

 

 

our expectations regarding our ability to obtain and maintain intellectual property protection for our test kits, as well as our ability to operate our business without infringing the intellectual property rights of others.

 

ii


 

 

You should not rely on forward-looking statements as predictions of future events. We have based the forward-looking statements contained in this Quarterly Report on Form 10-Q primarily on our current expectations and projections about future events and trends that we believe may affect our business, financial condition, and operating results. The outcome of the events described in these forward-looking statements is subject to risks, uncertainties, and other factors described in the section titled “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q. Moreover, we operate in a very competitive and rapidly changing environment. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this Quarterly Report on Form 10-Q. The results, events, and circumstances reflected in the forward-looking statements may not be achieved or occur, and actual results, events, or circumstances could differ materially from those described in the forward-looking statements.

 

In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based on information available to us as of the date of this Quarterly Report on Form 10-Q. While we believe that such information provides a reasonable basis for these statements, that information may be limited or incomplete. Our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely on these statements.

 

The forward-looking statements made in this Quarterly Report on Form 10-Q relate only to events as of the date on which the statements are made. We undertake no obligation to update any forward-looking statements made in this Quarterly Report on Form 10-Q to reflect events or circumstances after the date of this Quarterly Report on Form 10-Q or to reflect new information or the occurrence of unanticipated events, except as required by law. We may not actually achieve the plans, intentions, or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, or investments.

 

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 Securities and Exchange Commission 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.

 

“Lucira Health,” “Lucira,” the Lucira Health logo 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. 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.

 

 

iii


 

 

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

LUCIRA HEALTH, INC.

CONDENSED BALANCE SHEETS

(Unaudited)

(In thousands, except share and per share data)

 

 

 

June 30,

 

 

December 31,

 

 

 

2021

 

 

2020 (1)

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash

 

$

161,662

 

 

$

58,212

 

Accounts receivable, net

 

 

3,392

 

 

 

293

 

Inventory

 

 

36,182

 

 

 

4,865

 

Grant income receivable

 

 

92

 

 

 

183

 

Prepaid expenses

 

 

6,164

 

 

 

3,496

 

Other current assets

 

 

6,099

 

 

 

844

 

Restricted cash equivalents

 

 

2,338

 

 

 

2,338

 

Total current assets

 

 

215,929

 

 

 

70,231

 

Property and equipment, net

 

 

28,153

 

 

 

19,408

 

Operating lease right-of-use assets

 

 

576

 

 

 

748

 

Other assets

 

 

31

 

 

 

2,316

 

Total assets

 

$

244,689

 

 

$

92,703

 

Liabilities, Redeemable Convertible Preferred Stock, and Stockholders’ Equity (Deficit)

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

6,673

 

 

$

3,981

 

Accrued liabilities

 

 

18,672

 

 

 

4,445

 

Operating lease liabilities, current

 

 

374

 

 

 

431

 

Customer deposits

 

 

2,916

 

 

 

 

Total current liabilities

 

 

28,635

 

 

 

8,857

 

Convertible notes payable

 

 

 

 

 

24,694

 

Operating lease liabilities, net of current portion

 

 

254

 

 

 

380

 

Total liabilities

 

 

28,889

 

 

 

33,931

 

Commitments and contingencies (Note 5)

 

 

 

 

 

 

 

 

        Redeemable convertible preferred stock $0.001 par value; 0 and 103,355,827 shares

        authorized as of June 30, 2021 and December 31, 2020, respectively; 0 and 23,978,747

        shares issued and outstanding as of June 30, 2021 and December 31, 2020,

        respectively; aggregate liquidation preference of $0 as of June 30, 2021

 

 

 

 

 

121,080

 

Stockholders’ equity (deficit):

 

 

 

 

 

 

 

 

        Preferred stock $0.001 par value; 10,000,000 and 0 shares authorized as

        of June 30, 2021 and December 31, 2020, respectively; 0 shares issued

        and outstanding as of June 30, 2021 and December 31, 2020

 

 

 

 

 

 

  Common stock, $0.001 par value; 200,000,000 and 150,000,000 shares authorized as of

  June 30, 2021 and December 31, 2020, respectively; 38,684,546 and 2,712,694 shares

  issued and outstanding as of June 30, 2021 and December 31, 2020, respectively

 

 

39

 

 

 

3

 

Additional paid-in capital

 

 

308,991

 

 

 

1,403

 

Accumulated deficit

 

 

(93,230

)

 

 

(63,714

)

Total stockholders’ equity (deficit)

 

 

215,800

 

 

 

(62,308

)

Total liabilities, redeemable convertible preferred stock, and stockholders’ equity (deficit)

 

$

244,689

 

 

$

92,703

 

 

(1) The balance sheet as of December 31, 2020 is derived from the audited financial statements as of that date

 

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

1


 

LUCIRA HEALTH, INC.

CONDENSED STATEMENTS OF OPERATIONS

(Unaudited)

(In thousands, except share and per share data)

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Net sales

 

$

12,439

 

 

$

 

 

$

16,955

 

 

$

 

Cost of products sold

 

 

12,505

 

 

 

 

 

 

17,873

 

 

 

 

Gross loss

 

 

(66

)

 

 

 

 

 

(918

)

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

10,117

 

 

 

4,574

 

 

 

16,399

 

 

 

7,315

 

Selling, general and administrative

 

 

6,100

 

 

 

931

 

 

 

12,200

 

 

 

1,559

 

Total operating expenses

 

 

16,217

 

 

 

5,505

 

 

 

28,599

 

 

 

8,874

 

Loss from operations

 

 

(16,283

)

 

 

(5,505

)

 

 

(29,517

)

 

 

(8,874

)

Other income (expense), net:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Grant income

 

 

79

 

 

 

335

 

 

 

281

 

 

 

1,977

 

Interest income (expense)

 

 

4

 

 

 

(10

)

 

 

1

 

 

 

(10

)

Remeasurement of derivative liabilities and convertible notes

 

 

 

 

 

(1,444

)

 

 

(281

)

 

 

(1,444

)

Total other income (expense), net

 

 

83

 

 

 

(1,119

)

 

 

1

 

 

 

523

 

Net loss

 

$

(16,200

)

 

$

(6,624

)

 

$

(29,516

)

 

$

(8,351

)

Net loss per share of common stock, basic and diluted

 

$

(0.42

)

 

$

(2.90

)

 

$

(0.96

)

 

$

(3.68

)

Weighted-average number of shares used in net loss per share of common stock, basic and diluted

 

 

38,483,766

 

 

 

2,282,024

 

 

 

30,688,349

 

 

 

2,270,130

 

 

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

2


 

LUCIRA HEALTH, INC.

CONDENSED STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK

AND STOCKHOLDERS’ EQUITY (DEFICIT)

(Unaudited)

(In thousands, except share data)

 

 

 

 

Redeemable

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

 

 

 

 

Total

 

 

 

Convertible Preferred Stock

 

 

 

Common Stock

 

 

Paid-In

 

 

Accumulated

 

 

Stockholders'

 

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Equity

 

Balance as of March 31, 2021

 

 

-

 

 

 

-

 

 

 

 

38,550,148

 

 

 

39

 

 

 

307,903

 

 

$

(77,030

)

 

$

230,912

 

Issuance of common stock upon exercise of stock options

 

 

-

 

 

 

-

 

 

 

 

134,398

 

 

 

-

 

 

 

143

 

 

 

-

 

 

 

143

 

Stock-based compensation

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

945

 

 

 

-

 

 

 

945

 

Net loss

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(16,200

)

 

 

(16,200

)

Balance as of June 30, 2021

 

 

-

 

 

$

-

 

 

 

 

38,684,546

 

 

$

39

 

 

$

308,991

 

 

$

(93,230

)

 

$

215,800

 

 

 

 

 

Redeemable

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

 

 

 

 

Total

 

 

 

Convertible Preferred Stock

 

 

 

Common Stock

 

 

Paid-In

 

 

Accumulated

 

 

Stockholders'

 

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Deficit

 

Balance as of March 31, 2020

 

 

10,466,169

 

 

$

48,426

 

 

 

 

2,257,740

 

 

$

2

 

 

$

757

 

 

$

(28,093

)

 

$

(27,334

)

Issuance of common stock upon exercise of stock options

 

 

-

 

 

 

-

 

 

 

 

187,164

 

 

 

-

 

 

 

153

 

 

 

-

 

 

 

153

 

Stock-based compensation

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

59

 

 

 

-

 

 

 

59

 

Net loss

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(6,624

)

 

 

(6,624

)

Balance as of June 30, 2020

 

 

10,466,169

 

 

$

48,426

 

 

 

 

2,444,904

 

 

$

2

 

 

$

969

 

 

$

(34,717

)

 

$

(33,746

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Redeemable

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

 

 

 

 

Total

 

 

 

Convertible Preferred Stock

 

 

 

Common Stock

 

 

Paid-In

 

 

Accumulated

 

 

Stockholders'

 

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Equity (Deficit)

 

Balance as of December 31, 2020

 

 

23,978,747

 

 

$

121,080

 

 

 

 

2,712,694

 

 

 

3

 

 

 

1,403

 

 

$

(63,714

)

 

$

(62,308

)

Conversion of redeemable convertible preferred shares into

   common stock

 

 

(23,978,747

)

 

 

(121,080

)

 

 

 

23,978,747

 

 

 

24

 

 

 

121,056

 

 

 

-

 

 

 

121,080

 

Conversion of convertible notes into common stock

 

 

-

 

 

 

-

 

 

 

 

1,470,947

 

 

 

2

 

 

 

24,980

 

 

 

-

 

 

 

24,982

 

Issuance of common stock upon IPO, net of issuance costs

 

 

-

 

 

 

-

 

 

 

 

10,350,000

 

 

 

10

 

 

 

159,889

 

 

 

-

 

 

 

159,899

 

Issuance of common stock upon exercise of stock options

 

 

-

 

 

 

-

 

 

 

 

172,158

 

 

 

-

 

 

 

190

 

 

 

-

 

 

 

190

 

Stock-based compensation

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

1,473

 

 

 

-

 

 

 

1,473

 

Net loss

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(29,516

)

 

 

(29,516

)

Balance as of June 30, 2021

 

 

-

 

 

$

-

 

 

 

 

38,684,546

 

 

$

39

 

 

$

308,991

 

 

$

(93,230

)

 

$

215,800

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Redeemable

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

 

 

 

 

Total

 

 

Convertible Preferred Stock

 

 

 

Common Stock

 

 

Paid-In

 

 

Accumulated

 

 

Stockholders'

 

 

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Deficit

 

 

Balance as of December 31, 2019

 

 

6,712,085

 

 

$

30,960

 

 

 

 

2,257,740

 

 

$

2

 

 

$

699

 

 

$

(26,366

)

 

$

(25,665

)

 

Issuance of Series B redeemable convertible preferred stock, net of issuance costs

 

 

3,754,084

 

 

 

17,466

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

Issuance of common stock upon exercise of stock options

 

 

-

 

 

 

-

 

 

 

 

187,164

 

 

 

-

 

 

153

 

 

 

-

 

 

 

153

 

 

Stock-based compensation

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

117

 

 

 

-

 

 

 

117

 

 

Net loss

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(8,351

)

 

 

(8,351

)

 

Balance as of June 30, 2020

 

 

10,466,169

 

 

$

48,426

 

 

 

 

2,444,904

 

 

$

2

 

 

$

969

 

 

$

(34,717

)

 

$

(33,746

)

 

 

 

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

 

3


 

 

LUCIRA HEALTH, INC.

CONDENSED STATEMENTS OF CASH FLOWS

(Unaudited)

(In thousands)

 

 

 

Six Months Ended June 30,

 

 

 

2021

 

 

2020

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

Net loss

 

$

(29,516

)

 

$

(8,351

)

Adjustments to reconcile net loss to net cash used in operating

   activities:

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

1,473

 

 

 

117

 

Allowance for doubtful accounts

 

 

259

 

 

 

 

 

Depreciation and amortization

 

 

882

 

 

 

118

 

Remeasurement of derivative liabilities and convertible notes

 

 

281

 

 

 

1,444

 

Noncash interest expense

 

 

3

 

 

 

6

 

Noncash lease expense

 

 

172

 

 

 

150

 

Changes in assets and liabilities:

 

 

 

 

 

 

 

 

Inventory

 

 

(31,317

)

 

 

 

Accounts receivable

 

 

(3,358

)

 

 

 

Grant income receivable

 

 

91

 

 

 

1,639

 

Prepaid expenses and other current assets

 

 

(8,767

)

 

 

(800

)

Other assets

 

 

3,129

 

 

 

 

Accounts payable

 

 

2,678

 

 

 

527

 

Customer deposits

 

 

2,916