P6MP6MP6MP6Mfalse--12-31Q320230001267602YesYes0.010.01http://fasb.org/us-gaap/2023#OtherLiabilitiesNoncurrenthttp://fasb.org/us-gaap/2023#OtherLiabilitiesNoncurrenthttp://fasb.org/us-gaap/2023#OtherLiabilitiesNoncurrenthttp://fasb.org/us-gaap/2023#PropertyPlantAndEquipmentNethttp://fasb.org/us-gaap/2023#PropertyPlantAndEquipmentNetP1Yhttp://fasb.org/us-gaap/2023#AccruedLiabilitiesCurrenthttp://fasb.org/us-gaap/2023#AccruedLiabilitiesCurrenthttp://fasb.org/us-gaap/2023#OtherLiabilitiesNoncurrenthttp://fasb.org/us-gaap/2023#OtherLiabilitiesNoncurrent0.010.0100012676022023-03-242023-03-240001267602us-gaap:SeriesAPreferredStockMemberus-gaap:RetainedEarningsMember2023-01-012023-03-310001267602us-gaap:CommonClassAMemberus-gaap:AdditionalPaidInCapitalMember2023-01-012023-03-310001267602us-gaap:SeriesAPreferredStockMember2023-01-012023-03-310001267602us-gaap:CommonClassAMember2023-01-012023-03-310001267602us-gaap:SeriesAPreferredStockMember2023-03-242023-03-240001267602us-gaap:CommonStockMember2023-03-242023-03-240001267602us-gaap:SeriesAPreferredStockMemberus-gaap:PreferredStockMember2023-01-012023-03-310001267602us-gaap:CommonClassAMemberus-gaap:CommonStockMember2023-01-012023-03-310001267602us-gaap:SeriesBPreferredStockMemberus-gaap:AdditionalPaidInCapitalMember2023-04-012023-06-300001267602us-gaap:SeriesBPreferredStockMember2023-04-012023-06-300001267602us-gaap:SeriesBPreferredStockMember2023-01-012023-03-310001267602us-gaap:SeriesBPreferredStockMemberus-gaap:AdditionalPaidInCapitalMember2023-07-012023-09-300001267602us-gaap:SeriesBPreferredStockMember2023-07-012023-09-300001267602us-gaap:CommonStockMember2022-07-012022-09-300001267602us-gaap:CommonStockMember2023-07-012023-09-300001267602alim:PurchaseAgreementAmendmentMemberus-gaap:SeriesBPreferredStockMember2023-05-172023-05-170001267602us-gaap:SeriesBPreferredStockMemberus-gaap:PreferredStockMember2023-04-012023-06-300001267602srt:MaximumMemberalim:SecuritiesPurchaseAgreementMemberus-gaap:SeriesBPreferredStockMember2023-03-242023-03-240001267602us-gaap:SeriesBPreferredStockMemberus-gaap:PreferredStockMember2023-01-012023-03-310001267602us-gaap:CommonStockMember2023-08-152023-08-150001267602us-gaap:SeriesBPreferredStockMemberus-gaap:PreferredStockMember2023-07-012023-09-300001267602us-gaap:SeriesBPreferredStockMemberus-gaap:CommonStockMember2023-07-012023-09-300001267602srt:MaximumMemberalim:SecuritiesPurchaseAgreementMemberus-gaap:CommonStockMember2023-03-242023-03-240001267602us-gaap:RetainedEarningsMember2023-09-300001267602us-gaap:AdditionalPaidInCapitalMember2023-09-300001267602us-gaap:AccumulatedOtherComprehensiveIncomeMember2023-09-300001267602alim:CommonStockWarrantsMember2023-09-300001267602us-gaap:RetainedEarningsMember2023-06-300001267602us-gaap:AdditionalPaidInCapitalMember2023-06-300001267602us-gaap:AccumulatedOtherComprehensiveIncomeMember2023-06-300001267602us-gaap:RetainedEarningsMember2023-03-310001267602us-gaap:AdditionalPaidInCapitalMember2023-03-310001267602us-gaap:AccumulatedOtherComprehensiveIncomeMember2023-03-3100012676022023-03-310001267602us-gaap:RetainedEarningsMember2022-12-310001267602us-gaap:AdditionalPaidInCapitalMember2022-12-310001267602us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-12-310001267602us-gaap:RetainedEarningsMember2022-09-300001267602us-gaap:AdditionalPaidInCapitalMember2022-09-300001267602us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-09-300001267602us-gaap:RetainedEarningsMember2022-06-300001267602us-gaap:AdditionalPaidInCapitalMember2022-06-300001267602us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-06-300001267602us-gaap:RetainedEarningsMember2022-03-310001267602us-gaap:AdditionalPaidInCapitalMember2022-03-310001267602us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-03-3100012676022022-03-310001267602us-gaap:RetainedEarningsMember2021-12-310001267602us-gaap:AdditionalPaidInCapitalMember2021-12-310001267602us-gaap:AccumulatedOtherComprehensiveIncomeMember2021-12-310001267602us-gaap:CommonStockMember2023-09-300001267602us-gaap:SeriesBPreferredStockMemberus-gaap:PreferredStockMember2023-06-300001267602us-gaap:CommonStockMember2023-06-300001267602us-gaap:SeriesBPreferredStockMemberus-gaap:PreferredStockMember2023-03-310001267602us-gaap:CommonStockMember2023-03-310001267602us-gaap:SeriesAPreferredStockMemberus-gaap:PreferredStockMember2022-12-310001267602us-gaap:CommonStockMember2022-12-310001267602us-gaap:SeriesAPreferredStockMemberus-gaap:PreferredStockMember2022-09-300001267602us-gaap:CommonStockMember2022-09-300001267602us-gaap:SeriesAPreferredStockMemberus-gaap:PreferredStockMember2022-06-300001267602us-gaap:CommonStockMember2022-06-300001267602us-gaap:SeriesAPreferredStockMemberus-gaap:PreferredStockMember2022-03-310001267602us-gaap:CommonStockMember2022-03-310001267602us-gaap:SeriesAPreferredStockMemberus-gaap:PreferredStockMember2021-12-310001267602us-gaap:CommonStockMember2021-12-310001267602alim:EquityIncentivePlan2023Member2023-08-012023-08-0100012676022023-06-3000012676022022-06-3000012676022022-01-012022-12-310001267602alim:NewAwardsMemberalim:OmnibusIncentivePlanMember2023-09-300001267602alim:NewAwardsMemberalim:EquityIncentivePlanTwentyTenMember2023-09-300001267602alim:EquityIncentivePlan2023Member2023-09-300001267602alim:RestrictedStockAndRestrictedStockUnitsMember2023-09-300001267602alim:RestrictedStockAndRestrictedStockUnitsMember2023-06-300001267602alim:RestrictedStockAndRestrictedStockUnitsMember2022-12-310001267602alim:RestrictedStockAndRestrictedStockUnitsMember2022-09-300001267602alim:RestrictedStockAndRestrictedStockUnitsMember2022-06-300001267602alim:RestrictedStockAndRestrictedStockUnitsMember2021-12-310001267602alim:RestrictedStockAndRestrictedStockUnitsMember2023-07-012023-09-300001267602alim:RestrictedStockAndRestrictedStockUnitsMember2023-01-012023-09-300001267602alim:RestrictedStockAndRestrictedStockUnitsMember2022-07-012022-09-300001267602alim:RestrictedStockAndRestrictedStockUnitsMember2022-01-012022-09-300001267602us-gaap:ProductMemberalim:UnitedStatesSegmentMember2022-01-012022-09-300001267602us-gaap:ProductMemberalim:InternationalSegmentMember2022-01-012022-09-300001267602us-gaap:ProductMember2022-01-012022-09-300001267602alim:MilestoneOneMemberalim:OcumensionMember2023-01-012023-09-300001267602alim:TrancheOneMember2023-03-242023-03-240001267602alim:SecuritiesPurchaseAgreementMember2023-03-242023-03-240001267602us-gaap:SeriesAPreferredStockMember2012-10-012012-10-310001267602alim:TrancheTwoMemberus-gaap:CommonStockMember2023-05-172023-05-170001267602us-gaap:SeriesAPreferredStockMember2023-03-240001267602us-gaap:SeriesAPreferredStockMember2023-09-300001267602alim:SecuritiesPurchaseAgreementMemberus-gaap:SeriesBPreferredStockMember2023-03-240001267602us-gaap:SeriesAPreferredStockMember2022-12-310001267602alim:TrancheTwoMemberus-gaap:SeriesBPreferredStockMember2023-05-170001267602alim:TrancheOneMemberus-gaap:SeriesBPreferredStockMember2023-03-2400012676022012-10-012012-10-310001267602us-gaap:AccumulatedOtherComprehensiveIncomeMember2023-07-012023-09-300001267602us-gaap:AccumulatedOtherComprehensiveIncomeMember2023-01-012023-03-310001267602us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-07-012022-09-300001267602us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-04-012022-06-300001267602us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-01-012022-03-310001267602us-gaap:StateAndLocalJurisdictionMember2022-12-310001267602us-gaap:DomesticCountryMember2022-12-310001267602us-gaap:RetainedEarningsMember2022-07-012022-09-300001267602us-gaap:RetainedEarningsMember2022-04-012022-06-300001267602us-gaap:RetainedEarningsMember2022-01-012022-03-310001267602alim:LoanAgreement2019Memberalim:SLRInvestmentCorpMember2019-12-310001267602alim:LoanAgreement2018Memberalim:SLRInvestmentCorpMember2018-01-050001267602srt:MinimumMember2023-09-300001267602srt:MaximumMember2023-09-300001267602country:US2023-01-012023-09-300001267602alim:OperatingCostMember2023-07-012023-09-300001267602alim:OperatingCostMember2023-01-012023-09-300001267602alim:OperatingCostMember2022-07-012022-09-300001267602alim:OperatingCostMember2022-01-012022-09-3000012676022023-05-172023-05-170001267602srt:PartnershipInterestMember2021-04-090001267602alim:IluvienIntangibleAssetMember2022-12-310001267602alim:IluvienIntangibleAssetMember2023-09-300001267602alim:YutiqIntangibleAssetMember2023-09-300001267602alim:ProductRightsMemberus-gaap:CollaborativeArrangementTransactionWithPartyToCollaborativeArrangementMember2023-01-012023-09-300001267602us-gaap:EmployeeStockOptionMember2023-09-300001267602us-gaap:RestrictedStockMember2023-09-300001267602us-gaap:RetainedEarningsMember2023-07-012023-09-300001267602us-gaap:RetainedEarningsMember2023-04-012023-06-300001267602us-gaap:RetainedEarningsMember2023-01-012023-03-310001267602us-gaap:AllOtherSegmentsMember2023-07-012023-09-300001267602us-gaap:AllOtherSegmentsMember2023-01-012023-09-300001267602us-gaap:AllOtherSegmentsMember2022-07-012022-09-300001267602us-gaap:AllOtherSegmentsMember2022-01-012022-09-300001267602alim:Amendment5Memberalim:LoanAgreement2019Memberalim:SLRInvestmentCorpMember2023-09-300001267602alim:Amendment4Memberalim:LoanAgreement2019Memberalim:SLRInvestmentCorpMember2023-09-300001267602alim:Amendment6Memberalim:TermLoanMemberalim:SLRInvestmentCorpMember2023-05-170001267602alim:Amendment5Memberalim:TermLoanMemberalim:SLRInvestmentCorpMember2023-03-240001267602alim:Amendment5Memberalim:TermLoanMemberalim:SLRInvestmentCorpMemberus-gaap:SecuredOvernightFinancingRateSofrOvernightIndexSwapRateMember2023-03-242023-03-240001267602alim:UnitedStatesSegmentMember2023-07-012023-09-300001267602alim:InternationalSegmentMember2023-07-012023-09-300001267602alim:UnitedStatesSegmentMember2023-01-012023-09-300001267602alim:InternationalSegmentMember2023-01-012023-09-300001267602alim:UnitedStatesSegmentMember2022-07-012022-09-300001267602alim:InternationalSegmentMember2022-07-012022-09-300001267602alim:UnitedStatesSegmentMember2022-01-012022-09-300001267602alim:InternationalSegmentMember2022-01-012022-09-300001267602alim:LargePharmaceuticalDistributorsMemberus-gaap:SalesMemberus-gaap:CustomerConcentrationRiskMemberalim:UnitedStatesSegmentMember2023-07-012023-09-300001267602alim:LargePharmaceuticalDistributorsMemberus-gaap:SalesMemberus-gaap:CustomerConcentrationRiskMemberalim:UnitedStatesSegmentMember2023-01-012023-09-300001267602alim:LargePharmaceuticalDistributorsMemberus-gaap:AccountsReceivableMemberus-gaap:CustomerConcentrationRiskMemberalim:UnitedStatesSegmentMember2023-01-012023-09-300001267602alim:LargePharmaceuticalDistributorsMemberus-gaap:SalesMemberus-gaap:CustomerConcentrationRiskMemberalim:UnitedStatesSegmentMember2022-07-012022-09-300001267602alim:LargePharmaceuticalDistributorsMemberus-gaap:AccountsReceivableMemberus-gaap:CustomerConcentrationRiskMemberalim:UnitedStatesSegmentMember2022-01-012022-12-310001267602alim:LargePharmaceuticalDistributorsMemberus-gaap:SalesMemberus-gaap:CustomerConcentrationRiskMemberalim:UnitedStatesSegmentMember2022-01-012022-09-300001267602alim:EquityIncentivePlan2023Member2023-08-010001267602alim:PreFundedWarrantsMember2023-08-150001267602alim:PurchaseAgreementAmendmentMemberus-gaap:CommonStockMember2023-05-170001267602srt:MaximumMemberalim:SecuritiesPurchaseAgreementMemberus-gaap:CommonStockMember2023-03-2400012676022012-10-310001267602alim:PreFundedWarrantsMember2023-08-010001267602srt:PartnershipInterestMember2021-04-1400012676022022-09-3000012676022021-12-310001267602us-gaap:WarrantMember2023-01-012023-09-300001267602us-gaap:EmployeeStockOptionMember2023-01-012023-09-300001267602us-gaap:SeriesAPreferredStockMember2022-01-012022-09-300001267602us-gaap:EmployeeStockOptionMember2022-01-012022-09-300001267602alim:YutiqIntangibleAssetMember2023-07-012023-09-300001267602alim:IluvienIntangibleAssetMember2023-07-012023-09-300001267602alim:YutiqIntangibleAssetMember2023-01-012023-09-300001267602alim:IluvienIntangibleAssetMember2023-01-012023-09-300001267602alim:IluvienIntangibleAssetMember2022-07-012022-09-300001267602alim:IluvienIntangibleAssetMember2022-01-012022-09-300001267602us-gaap:RestrictedStockMember2023-07-012023-09-300001267602us-gaap:EmployeeStockOptionMember2023-07-012023-09-300001267602us-gaap:EmployeeStockMember2023-07-012023-09-300001267602us-gaap:RestrictedStockMember2023-01-012023-09-300001267602us-gaap:EmployeeStockOptionMember2023-01-012023-09-300001267602us-gaap:EmployeeStockMember2023-01-012023-09-300001267602us-gaap:RestrictedStockMember2022-07-012022-09-300001267602us-gaap:EmployeeStockOptionMember2022-07-012022-09-300001267602us-gaap:EmployeeStockMember2022-07-012022-09-300001267602us-gaap:RestrictedStockMember2022-01-012022-09-300001267602us-gaap:EmployeeStockOptionMember2022-01-012022-09-300001267602us-gaap:EmployeeStockMember2022-01-012022-09-300001267602us-gaap:AdditionalPaidInCapitalMember2023-07-012023-09-3000012676022023-01-012023-03-310001267602us-gaap:AdditionalPaidInCapitalMember2022-07-012022-09-300001267602us-gaap:AdditionalPaidInCapitalMember2022-01-012022-03-310001267602us-gaap:CollaborativeArrangementMember2023-09-3000012676022023-10-270001267602us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMember2023-09-300001267602us-gaap:FairValueMeasurementsRecurringMember2023-09-300001267602us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMember2022-12-310001267602us-gaap:FairValueMeasurementsRecurringMember2022-12-310001267602us-gaap:AdditionalPaidInCapitalMember2023-01-012023-03-310001267602us-gaap:AdditionalPaidInCapitalMember2022-04-012022-06-3000012676022022-04-012022-06-3000012676022022-01-012022-03-310001267602alim:CommonStockWarrantsMember2023-07-012023-09-300001267602us-gaap:CommonStockMember2023-04-012023-06-300001267602us-gaap:CommonStockMember2023-01-012023-03-310001267602us-gaap:CommonStockMember2022-04-012022-06-300001267602us-gaap:CommonStockMember2022-01-012022-03-310001267602us-gaap:AdditionalPaidInCapitalMember2023-04-012023-06-3000012676022023-04-012023-06-300001267602srt:MaximumMemberus-gaap:CollaborativeArrangementTransactionWithPartyToCollaborativeArrangementMember2023-09-300001267602srt:MaximumMemberus-gaap:CollaborativeArrangementTransactionWithPartyToCollaborativeArrangementMember2017-08-010001267602srt:PartnershipInterestMember2021-04-142021-04-140001267602alim:ProductRightsMemberus-gaap:CollaborativeArrangementTransactionWithPartyToCollaborativeArrangementMember2023-05-172023-05-170001267602alim:ProductRightsMemberus-gaap:CollaborativeArrangementTransactionWithPartyToCollaborativeArrangementMember2023-05-170001267602us-gaap:SalesMemberus-gaap:CustomerConcentrationRiskMemberalim:UnitedStatesSegmentMember2023-07-012023-09-300001267602us-gaap:SalesMemberus-gaap:CustomerConcentrationRiskMemberalim:UnitedStatesSegmentMember2023-01-012023-09-300001267602us-gaap:AccountsReceivableMemberus-gaap:CustomerConcentrationRiskMemberalim:UnitedStatesSegmentMember2023-01-012023-09-300001267602us-gaap:SalesMemberus-gaap:CustomerConcentrationRiskMemberalim:UnitedStatesSegmentMember2022-07-012022-09-300001267602us-gaap:AccountsReceivableMemberus-gaap:CustomerConcentrationRiskMemberalim:UnitedStatesSegmentMember2022-01-012022-12-310001267602us-gaap:SalesMemberus-gaap:CustomerConcentrationRiskMemberalim:UnitedStatesSegmentMember2022-01-012022-09-300001267602alim:IluvienMember2023-09-300001267602alim:Milestone2Memberalim:SLRInvestmentCorpMemberalim:ExitFeeAgreement1Member2023-01-012023-09-300001267602alim:Milestone1Memberalim:SLRInvestmentCorpMemberalim:ExitFeeAgreement1Member2023-01-012023-09-300001267602alim:YutiqIntangibleAssetMemberus-gaap:CollaborativeArrangementTransactionWithPartyToCollaborativeArrangementMember2023-01-012023-09-300001267602alim:Amendment6Memberalim:LoanAgreement2019Memberalim:SLRInvestmentCorpMember2023-05-172023-05-170001267602alim:Amendment4Memberalim:LoanAgreement2019Memberalim:SLRInvestmentCorpMember2023-01-012023-09-300001267602alim:Amendment3Memberalim:LoanAgreement2019Memberalim:SLRInvestmentCorpMember2023-01-012023-09-300001267602alim:Amendment5Memberalim:LoanAgreement2019Memberalim:SLRInvestmentCorpMember2023-03-242023-03-240001267602alim:Amendment5Memberalim:SLRInvestmentCorpMemberalim:ExitFeeAgreement2Member2023-03-240001267602alim:OcumensionMember2023-01-012023-09-3000012676022022-12-310001267602alim:OcumensionMember2023-09-300001267602alim:SLRInvestmentCorpMemberalim:ExitFeeAgreement3Member2023-03-242023-03-240001267602alim:Milestone2Memberalim:SLRInvestmentCorpMemberalim:ExitFeeAgreement2Member2023-01-012023-09-300001267602alim:AchievementOfMilestoneMemberalim:SLRInvestmentCorpMemberalim:ExitFeeAgreement1Member2023-01-012023-09-300001267602alim:SLRInvestmentCorpMemberalim:ExitFeeAgreement2Member2023-01-012023-09-300001267602alim:SLRInvestmentCorpMemberalim:ExitFeeAgreement1Member2023-01-012023-09-300001267602srt:MinimumMember2023-01-012023-09-300001267602srt:MaximumMember2023-01-012023-09-300001267602srt:MinimumMemberalim:AfterConversionMemberus-gaap:CommonStockMember2023-08-012023-08-010001267602srt:MinimumMemberalim:BeforeApprovalMemberus-gaap:CommonStockMember2023-03-242023-03-240001267602srt:MinimumMemberalim:AfterConversionMemberus-gaap:CommonStockMember2023-03-242023-03-240001267602srt:ScenarioForecastMemberalim:ProductRightsMemberus-gaap:CollaborativeArrangementTransactionWithPartyToCollaborativeArrangementMember2025-01-012025-12-310001267602us-gaap:CollaborativeArrangementMember2023-07-012023-09-300001267602us-gaap:CollaborativeArrangementMember2023-01-012023-09-300001267602us-gaap:CollaborativeArrangementMember2022-07-012022-09-300001267602us-gaap:CollaborativeArrangementMember2022-01-012022-09-300001267602us-gaap:CollaborativeArrangementTransactionWithPartyToCollaborativeArrangementMember2019-03-012019-03-310001267602alim:TrancheOneMemberus-gaap:SeriesBPreferredStockMember2023-03-242023-03-2400012676022023-07-012023-09-3000012676022022-07-012022-09-3000012676022022-01-012022-09-300001267602srt:ScenarioForecastMemberalim:ProductRightsMemberus-gaap:CollaborativeArrangementTransactionWithPartyToCollaborativeArrangementMember2024-01-012024-12-310001267602srt:ScenarioForecastMemberus-gaap:CollaborativeArrangementTransactionWithPartyToCollaborativeArrangementMember2024-01-012024-12-310001267602us-gaap:CollaborativeArrangementTransactionWithPartyToCollaborativeArrangementMember2014-10-312014-10-3100012676022023-01-012023-09-300001267602alim:ProductRightsMemberus-gaap:CollaborativeArrangementTransactionWithPartyToCollaborativeArrangementMember2023-09-3000012676022023-09-30iso4217:HKDxbrli:sharesiso4217:USDxbrli:sharesalim:segmentalim:customeralim:countryxbrli:sharesxbrli:pureiso4217:USD

UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549 

FORM 10-Q

(Mark One)

For the quarterly period ended September 30, 2023

or

For the transition period from                     to                    

Commission File Number: 001-34703

Alimera Sciences, Inc.

(Exact name of registrant as specified in its charter)

 

(678) 990-5740

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

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  x    No  o

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  x    No  o

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.

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. o

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes  o  No  x

As of October 27, 2023, there were 52,416,841 shares of the registrant’s Common Stock issued and outstanding.

---

ALIMERA SCIENCES, INC.

QUARTERLY REPORT ON FORM 10-Q

INDEX

‎

---

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS AND PROJECTIONS

Various statements in this report of Alimera Sciences, Inc. (we, our, Alimera or the Company) are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this report, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. These statements are subject to risks and uncertainties (some of which are beyond our control) and are based on information currently available to our management. Words such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “contemplates,” “predict,” “project,” “target,” “likely,” “potential,” “continue,” “ongoing,” “will,” “would,” “should,” “could,” or the negative of these terms and similar expressions or words, identify forward-looking statements. The events and circumstances reflected in our forward-looking statements may not occur and actual results could differ materially from those projected in our forward-looking statements.

All written and oral forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by the cautionary statements contained or referred to in this section. We caution investors not to rely on the forward-looking statements we make or that are made on our behalf as predictions of future events. We undertake no obligation and specifically decline any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

We encourage you to read management’s discussion and analysis of our financial condition and results of operations and our accompanying unaudited interim condensed consolidated financial statements and notes thereto (Interim Financial Statements) contained in this Quarterly Report on Form 10-Q and our audited financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2022. There can be no assurance that we will in fact achieve the actual results or developments we anticipate or, even if we do substantially realize them, that they will have the expected consequences to, or effects on, us. Therefore, we can give no assurances that we will achieve the outcomes stated in those forward-looking statements, projections and estimates.

 
‎

---

PART I. FINANCIAL INFORMATION

ITEM 1. Financial Statements (unaudited)

ALIMERA SCIENCES, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

 

See Notes to Unaudited Interim Condensed Consolidated Financial Statements (Interim Financial Statements).

‎

---

ALIMERA SCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

See Notes to Interim Financial Statements.

 
‎

---

ALIMERA SCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

See Notes to Interim Financial Statements.

‎

---

ALIMERA SCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

See Notes to Interim Financial Statements.

 

---

ALIMERA SCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)

---

See Notes to Interim Financial Statements.

---

1. NATURE OF OPERATIONS

Alimera Sciences, Inc., together with its wholly owned subsidiaries (the Company), is a pharmaceutical company that specializes in the commercialization and development of ophthalmic pharmaceuticals. The Company was formed on June 4, 2003 under the laws of the State of Delaware.

The Company presently focuses on diseases affecting the retina, because the Company believes these diseases are not well treated with current therapies and affect millions of people globally. The Company’s products are ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg, which has received marketing authorization and reimbursement in 24 countries for the treatment of diabetic macular edema (DME), and YUTIQ® (fluocinolone acetonide intravitreal implant) 0.18 mg, available in the United States for the treatment and prevention of non-infectious uveitis affecting the posterior segment of the eye (NIU-PS).

In the U.S. and certain other countries outside Europe, ILUVIEN is indicated for the treatment of DME in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. In 17 countries in Europe, ILUVIEN is indicated for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies. In addition, ILUVIEN has received marketing authorization in 17 European countries and reimbursement in ten countries for the prevention of relapse in recurrent NIU-PS.

The Company markets ILUVIEN directly in the U.S., Germany, the U.K., Portugal and Ireland. In addition, the Company has entered into various agreements under which distributors are providing or will provide regulatory, reimbursement and sales and marketing support for ILUVIEN in Austria, Belgium, the Czech Republic, Denmark, Finland, France, Italy, Luxembourg, the Netherlands, Norway, Spain, Sweden, Switzerland, Australia, New Zealand and several countries in the Middle East. In addition, the Company has granted an exclusive license to Ocumension Therapeutics for the development and commercialization of the Company’s 0.19 mg fluocinolone acetonide intravitreal injection in China, East Asia and the Western Pacific. As of September 30, 2023, the Company has recognized sales of ILUVIEN to its international distributors in the Middle East, China, Austria, Belgium, Czech Republic, France, Italy, Luxembourg, Spain, the Netherlands, and the Nordic Region.

In the U.S., YUTIQ is indicated for the treatment and prevention of chronic NIU-PS of the eye. The Company has the rights to commercialize YUTIQ under a product rights agreement dated May 17, 2023 (the Product Rights Agreement) with EyePoint Pharmaceuticals, Inc. (EyePoint Parent) in the entire world, except Europe, the Middle East and Africa as the Company had previously licensed from EyePoint Pharmaceuticals US, Inc. (EyePoint) rights in those territories to certain products, which included YUTIQ (known as ILUVIEN in Europe, the Middle East and Africa) for the prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment. (See Note 16) The Product Rights Agreement also excludes any rights to YUTIQ for the treatment and prevention of chronic NIU-PS in China and certain other countries and regions in Asia, which rights are subject to a pre-existing exclusive license between EyePoint Parent and Ocumension Therapeutics.

2. BASIS OF PRESENTATION

The Company has prepared the accompanying unaudited interim condensed consolidated financial statements and notes thereto (Interim Financial Statements) in accordance with accounting principles generally accepted in the U.S. (U.S. GAAP) for interim financial information and with the instructions to Form 10-Q and Article 8-03 of Regulation S-X of the Securities and Exchange Commission (SEC). Accordingly, these Interim Financial Statements do not include all of the information and disclosures required by U.S. GAAP for complete financial statements. In the opinion of the Company’s management, the accompanying Interim Financial Statements reflect all adjustments, which include normal recurring adjustments, necessary to present fairly the Company’s interim financial information.

The accompanying Interim Financial Statements and related notes should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2022, and related notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, which was filed with the SEC on March 31, 2023 (the 2022 Form 10-K). The financial results for any interim period are not necessarily indicative of the expected financial results for the full year.

As of September 30, 2023, the Company had approximately $8,316,000 in cash and cash equivalents. Based on the Company’s updated evaluation of its ability to continue as a going concern, the Company has concluded that the factors which previously raised substantial doubt about its ability to continue as a going concern no longer exist as of the issuance date of the accompanying unaudited interim condensed consolidated financial statements. The Company believes its commercial operations, including its rights under the Product Rights Agreement to commercialize YUTIQ, will generate sufficient cash flow, combined with its current financial assets, to fund all conditional and unconditional financial obligations for at least the next 12 months.

---

3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

The accounting policies followed for quarterly financial reporting are the same as those disclosed in the Notes to Financial Statements included in the 2022 Form 10-K. Certain of the Company’s more significant accounting policies adopted in the current year are as follows:

Acquisition of Intangible Assets

The Company accounts for the acquisition of pharmaceutical product licenses as an asset acquisition in accordance with FASB ASC 805 – Business Combinations (ASC 805). ASC 805 specifies that if substantially all of the fair value of the gross assets acquired in a transaction are concentrated in a single identifiable asset or group of similar identifiable assets, then the set is not a business and is recorded as an asset acquisition. Under this model, the Company assigns the cost of the transaction to the acquired tangible assets, to the identified intangible assets and liabilities, and to any above or below-market contracts. The purchase price, including the direct amounts paid for the net assets in the transaction and any acquisition costs incurred that relate directly to the acquisition, is assigned based on the relative fair values of the assets acquired and liabilities assumed. The fair value of any identified intangible assets is determined at the acquisition date based on inputs and other factors based on market participants.

Adoption of New Accounting Standard

In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (ASC 326): Measurement of Credit Losses on Financial Instruments. This ASU replaces the then current incurred loss impairment methodology for financial assets measured at amortized cost with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information, including forecasted information, to develop credit loss estimates. The standard became effective for the Company on January 1, 2023. The adoption of this ASU did not have a material impact on its financial statements.

In October 2021, the FASB issued ASU 2021-08, Business Combinations (Topic 805): Accounting for Contract Assets and Contract Liabilities from Contracts with Customers. The amendments in this ASU require that an acquirer recognize and measure contract assets and contract liabilities acquired in a business combination in accordance with ASC Topic 606, Revenue from Contracts with Customers (ASC 606). The amendments in this ASU are effective for fiscal years beginning after December 15, 2022, with early adoption permitted. The adoption of this ASU did not have a material impact on the Company’s financial statements.

Accounting Standards Issued but Not Yet Effective

In March 2020, the FASB issued ASU 2020-04, Reference Rate Reform (ASC 848) - Facilitation of the Effects of Reference Rate Reform on Financial Reporting. This standard provides optional expedients and exceptions for applying GAAP to contracts, hedging relationships, and other transactions affected by reference rate reform if certain criteria are met. The standard was available until December 31, 2022. In December 2022, the FASB issued ASU No. 2022-06 which extended the period of time preparers can utilize the reference-rate reform relief guidance in Topic 848. The guidance ensures the relief in Topic 848 covers the period of time during which a significant number of modifications may take place, and the ASU defers the sunset date of Topic 848 from December 31, 2022 to December 31, 2024. The Company does not anticipate the adoption of this ASU will have a material impact on its financial statements.

 

4. REVENUE RECOGNITION

Overview

The Company recognizes revenue when a customer obtains control of the related good or service. The amount recognized reflects the consideration the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606 Revenue from Contracts with Customers, the Company performs the following steps as outlined in the guidance: (1) identify the contract with the customer, (2) identify the performance obligations within the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in the contract, and (5) recognize revenue when the entity satisfies a performance obligation. At the inception of a contract, the contract is evaluated to determine if it falls within the scope of ASC 606, followed by the Company’s assessment of the goods or services promised within each contract, assessment of whether the promised good or service is distinct and determination of the performance obligations. The Company then recognizes revenue based on the transaction price that is allocated to the respective performance obligation when the performance obligation is satisfied.

---

If the contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation. Contracts that contain multiple performance obligations require an allocation of the transaction price based on the estimated relative standalone selling prices of the promised products or services underlying each performance obligation. The Company determines standalone selling prices based on the price at which the performance obligation is sold separately. If the standalone selling price is not observable through past transactions, the Company estimates the standalone selling price taking into account available information such as market conditions related to the performance obligations.

Net Product Sales

The Company sells its products to major pharmaceutical distributors, pharmacies, hospitals and wholesalers (collectively, its Customers). In addition to distribution agreements with Customers, the Company enters into arrangements with healthcare providers and payors that provide for government-mandated and/or privately negotiated rebates, chargebacks, and discounts with respect to the purchase of the Company’s products. The Company recognizes revenues from product sales at a point in time when the Customer obtains control, typically upon delivery. The Company accrues for fulfillment costs when the related revenue is recognized. Taxes collected from Customers relating to product sales and remitted to governmental authorities are excluded from revenues.

Estimates of Variable Consideration

Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for reserves related to statutory rebates to State Medicaid and other government agencies; commercial rebates and fees to Managed Care Organizations (MCOs), Group Purchasing Organizations (GPOs), distributors, and specialty pharmacies; product returns; sales discounts (including trade discounts); distributor costs; wholesaler chargebacks; and allowances for patient assistance programs relating to the Company’s sales of its products.

These reserves are based on estimates of the amounts earned or to be claimed on the related sales. Management’s estimates take into consideration historical experience, current contractual and statutory requirements, specific known market events and trends, industry data, and Customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the contract. The amount of variable consideration included in the net sales price is limited to the amount that is probable not to result in a significant reversal in the amount of the cumulative revenue recognized in a future period. If actual results vary, the Company may adjust these estimates, which could have an effect on earnings in the period of adjustment.

With respect to the Company’s international contracts with third-party distributors, certain contracts have elements of variable consideration, and management reviews those contracts on a regular basis and makes estimates of revenue based on historical ordering patterns and known market events and data. The amount of variable consideration included in net sales in each period could vary depending on the terms of these contracts and the probability of reversal in future periods.

Consideration Payable to Customers

Distribution service fees are payments issued to distributors for compliance with various contractually defined inventory management practices or services provided to support patient access to a product. Distribution service fees reserves are based on the terms of each individual contract and are classified within accrued expenses and are recorded as a reduction of revenue.

Product Returns

The Company’s policies provide for product returns in the following circumstances: (a) expiration of shelf life on certain products; (b) product damaged while in the Customer’s possession; and (c) following product recalls. Generally, returns for expired product are accepted three months before and up to one year after the expiration date of the related product, and the related product is destroyed after it is returned. The Company may, at its option, either refund the sales price paid by the Customer by issuing a credit or exchange of the returned product for replacement inventory. The Company typically does not provide cash refunds. The Company estimates the proportion of recorded revenue that will result in a return by considering relevant factors, including historical returns experience, the estimated level of inventory in the distribution channel, the shelf life of products, and product recalls, if any.

The estimation process for product returns involves, in each case, several interrelating assumptions, which vary for each Customer. The Company estimates the amount of its product sales that may be returned by its Customers and records this estimate as a reduction of revenue from product sales in the period the related revenue is recognized, and because this returned product cannot be resold, there is no corresponding asset for product returns. Through the date of this report, product returns have been minimal.

---

License Revenue

The Company enters into agreements in which it licenses certain rights to its products to partner companies that act as distributors. The terms of these agreements may include payment to the Company of one or more of the following: non-refundable up-front license fees, milestone payments if specified objectives are achieved, and/or royalties on product sales. The Company recognizes revenue from upfront payments at a point in time, typically upon fulfilling the delivery of the associated intellectual property to the customer.

Contracts that contain multiple performance obligations require an allocation of the transaction price based on the estimated relative standalone selling prices of the promised products or services underlying each performance obligation. The Company determines standalone selling prices based on the price at which the performance obligation is sold separately. If the standalone selling price is not observable through past transactions, the Company estimates the standalone selling price taking into account available information such as market conditions related to the performance obligations.

The Company will recognize sales-based milestone payments as revenue upon the achievement of the cumulative sales amount specified in the contract in accordance with ASC 606. For those milestone payments which are contingent on the occurrence of particular future events, the Company determines that these need to be considered for inclusion in the calculation of total consideration from the contract as a component of variable consideration using the expected value method. As such, the Company assesses each milestone to determine the probability of and substance behind achieving each milestone. Given the inherent uncertainty associated with these future events, the Company will not recognize revenue from such milestones until there is a high probability of occurrence, which typically occurs near or upon achievement of the event.

Customer Payment Obligations

The Company receives payments from its Customers based on billing schedules established in each contract, which vary across the Company’s locations, but generally range between 30 to 120 days. Occasionally, the Company offers extended payment terms or payment term discounts to certain Customers. Amounts are recorded as accounts receivable when the Company's right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation is that the Customer will pay for the product or services within one year or less of receiving those products or services.

 

5. LEASES

The Company evaluates all of its contracts to determine whether it is or contains a lease at inception. The Company reviews its contracts for options to extend, terminate or purchase any right-of-use assets and accounts for these, as applicable, at inception of the contract. Upon adoption of ASC 842, the Company elected the transition package of three practical expedients permitted within the standard. In accordance with the package of practical expedients, the Company did not reassess initial direct costs, lease classification or whether its contracts contain or are leases. The Company made an accounting policy election not to recognize right-of-use assets and liabilities for leases with a term of 12 months or less, or those that do not meet the Company’s capitalization threshold, unless the leases include options to renew or purchase the underlying asset that are reasonably certain to be exercised. Lease costs associated with those leases are recognized as incurred. The Company has also chosen the practical expedient that allows it to combine lease and non-lease components as a single lease component.

Lease renewal options are not recognized as part of the lease liability until the Company determines it is reasonably certain it will exercise any applicable renewal options. The Company has determined it is not reasonably certain it will exercise any applicable renewal options. The Company has not recorded any liability for renewal options in these Interim Financial Statements. The useful lives of leased assets as well as leasehold improvements, if any, are limited by the expected lease term.

Operating Leases

The Company’s operating lease activities primarily consist of leases for office space in the U.S., the U.K., Ireland, Portugal and Germany. Most of these leases include options to renew, with renewal terms generally ranging from one to eight years. The exercise of lease renewal options is at the Company’s sole discretion. Certain of the Company’s operating lease agreements include variable lease costs that are based on common area maintenance and property taxes. The Company expenses these payments as incurred. The Company’s operating lease agreements do not contain any material residual value guarantees or material restrictive covenants.

---

Supplemental balance sheet information as of September 30, 2023 and December 31, 2022 for the Company’s operating leases is as follows:

The Company’s operating lease cost for the three and nine months ended September 30, 2023 was $123,000 and $415,000, respectively, and is included in general and administrative expenses in its condensed consolidated statement of operations. The Company’s operating lease cost for the three and nine months ended September 30, 2022 was $136,000 and $408,000, respectively, and is included in general and administrative expenses in its condensed consolidated statement of operations.

As of September 30, 2023, a schedule of maturity of lease liabilities under all of the Company’s operating leases is as follows:

Cash paid for operating leases was $177,000 and $528,000 during the three and nine months ended September 30, 2023, respectively. No right-of-use assets were obtained in connection with operating leases for the three and nine months ended September 30, 2023. Cash paid for operating leases was $61,000 and $193,000 during the three and nine months ended September 30, 2022, respectively. No right-of-use assets were obtained in connection with operating leases for the three and nine months ended September 30, 2022.

As of September 30, 2023, the weighted average remaining lease terms of the Company’s operating leases was 5.9 years. The weighted average discount rate used to determine the lease liabilities was 9.5%.

Finance Leases

The Company’s finance lease activities primarily consist of leases for office equipment and automobiles. Property and equipment leases are capitalized at the lesser of fair market value or the present value of the minimum lease payments at the inception of the leases using the Company’s incremental borrowing rate. The Company’s finance lease agreements do not contain any material residual value guarantees or material restrictive covenants.