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MeiraGTx(MGTX) - 2024 Q4 - Annual Report
MGTXMeiraGTx(MGTX)2025-03-13 14:52

Financial Performance - Total revenue for 2024 was 33,279,000,asignificantincreasefrom33,279,000, a significant increase from 14,017,000 in 2023, representing a growth of 137%[714] - Operating expenses increased to 197,491,000in2024from197,491,000 in 2024 from 151,078,000 in 2023, marking a rise of 30.7%[714] - The net loss for 2024 was 147,791,000,comparedtoanetlossof147,791,000, compared to a net loss of 84,027,000 in 2023, indicating a 75.9% increase in losses[714] - Cash and cash equivalents decreased to 103,659,000in2024from103,659,000 in 2024 from 129,566,000 in 2023, reflecting a decline of 20%[713] - Total current assets fell to 123,518,000in2024,downfrom123,518,000 in 2024, down from 159,622,000 in 2023, a decrease of 22.6%[713] - Total liabilities increased to 201,924,000in2024from201,924,000 in 2024 from 188,567,000 in 2023, an increase of 7.1%[713] - Shareholders' equity decreased significantly to 67,827,000in2024from67,827,000 in 2024 from 138,177,000 in 2023, a decline of 50.9%[713] - The company reported a basic and diluted net loss per ordinary share of 2.12for2024,comparedto2.12 for 2024, compared to 1.49 for 2023[714] - The segment net loss for 2024 was 147,791,000,comparedtoanetlossof147,791,000, compared to a net loss of 84,027,000 in 2023, indicating a worsening financial performance[814] Capital and Funding - The company requires additional capital to fund operations, which may not be available on acceptable terms[14] - The Company’s capital resources have been primarily funded through collaboration agreements and equity offerings[727] - The Company raised gross proceeds of 8.4millionthroughthesaleof1,508,517ordinarysharesunderthe"at−the−market"equityofferingprogramduringtheyearendedDecember31,2024[842]−TheCompanycompletedapublicofferingof12,500,000ordinarysharesatapriceof8.4 million through the sale of 1,508,517 ordinary shares under the "at-the-market" equity offering program during the year ended December 31, 2024[842] - The Company completed a public offering of 12,500,000 ordinary shares at a price of 4.00 per share, resulting in gross proceeds of 50.0 million on August 12, 2024[843] Research and Development - The company is heavily dependent on the success of its product candidates, which are still in development, and if none receive regulatory approval, the business may be harmed[14] - Clinical trials are expensive and time-consuming, with uncertain outcomes, and the company may encounter substantial delays[14] - The Company incurred research and development costs with Johnson & Johnson Innovative Medicine responsible for up to 100% of the costs, depending on the type of services performed[795] - Research and development costs are charged to expense as incurred, including employee-related expenses and costs associated with clinical studies[800] - The Company recorded reductions to research and development expenses of 5.5 million and 5.1millionfortheyearsendedDecember31,2024and2023,respectively,relatedtotaxincentiveprograms[736]RegulatoryandCompliance−Thecompanyissubjecttosignificantregulationregardingthemanufacturingofitsproducts,anditsmanufacturingfacilitiesmaynotcontinuetomeetregulatoryrequirements[14]−TheCompanyhasnotrecognizedaprovisionforobsoleteandexcessinventoryasofDecember31,2024[734]CompetitionandMarketEnvironment−Thecompanyfacessignificantcompetitioninarapidlychangingtechnologicalenvironment,whichmayaffectitsfinancialconditionandabilitytomarketitsproductcandidates[21]−Thecompanydependsonproprietarytechnologylicensedfromothers,andlosingtheselicensescouldhinderitsabilitytodevelopproductcandidates[21]TaxandDeferredTax−TheCompanyrecordedunrecognizedtaxpositionsof5.1 million for the years ended December 31, 2024 and 2023, respectively, related to tax incentive programs[736] Regulatory and Compliance - The company is subject to significant regulation regarding the manufacturing of its products, and its manufacturing facilities may not continue to meet regulatory requirements[14] - The Company has not recognized a provision for obsolete and excess inventory as of December 31, 2024[734] Competition and Market Environment - The company faces significant competition in a rapidly changing technological environment, which may affect its financial condition and ability to market its product candidates[21] - The company depends on proprietary technology licensed from others, and losing these licenses could hinder its ability to develop product candidates[21] Tax and Deferred Tax - The Company recorded unrecognized tax positions of 2.2 million and 2.0millionasofDecember31,2024and2023,respectively[805]−TheCompanyhasrecordedafullvaluationallowanceagainstitsdeferredtaxassets,indicatingmanagement′sassessmentthatitismorelikelythannotthattheseassetswillnotbefullyrealized[852]−TheCompanyrecordedadeferredtaxassetof2.0 million as of December 31, 2024 and 2023, respectively[805] - The Company has recorded a full valuation allowance against its deferred tax assets, indicating management's assessment that it is more likely than not that these assets will not be fully realized[852] - The Company recorded a deferred tax asset of 155.2 million as of December 31, 2024, compared to 130.3millionin2023,primarilyduetonetoperatinglosscarryforwardsincreasingfrom130.3 million in 2023, primarily due to net operating loss carryforwards increasing from 70.7 million to 85.3million[852]−ThetotaldeferredtaxexpensefortheCompanywas85.3 million[852] - The total deferred tax expense for the Company was 24.0 million in 2024, compared to 9.7millionin2023,reflectingasignificantincreaseindeferredtaxliabilities[852]CollaborationAgreements−TheCompanyreceivedanon−refundableupfrontcashpaymentof9.7 million in 2023, reflecting a significant increase in deferred tax liabilities[852] Collaboration Agreements - The Company received a non-refundable upfront cash payment of 65.0 million from Janssen in December 2023 under the Asset Purchase Agreement[720] - Janssen agreed to pay future contingent consideration of up to 350.0million,includingmilestonepaymentsof350.0 million, including milestone payments of 50.0 million for initiating a Phase 3 clinical trial and 175.0 million upon the first commercial sale of the RPGR Product in the U.S.[720] - Under the Collaboration Agreement with Johnson & Johnson Innovative Medicine, the Company received a non-refundable upfront fee of 100.0 million and a milestone payment of 30.0millioninDecember2021[856]AssetManagement−Long−livedassetsdecreasedfrom30.0 million in December 2021[856] Asset Management - Long-lived assets decreased from 157,356,000 in 2023 to 136,473,000in2024,withnotabledeclinesinassetslocatedintheUnitedStatesandtheEuropeanUnion[816]−Thebalanceofassetretirementobligationsincreasedfrom136,473,000 in 2024, with notable declines in assets located in the United States and the European Union[816] - The balance of asset retirement obligations increased from 2,401,000 in 2023 to 2,821,000in2024,reflectingachangeinestimateof2,821,000 in 2024, reflecting a change in estimate of 345,000[763] Share-Based Compensation - The total share-based compensation expense for the year ended December 31, 2024, was 25.2million,adecreasefrom25.2 million, a decrease from 27.7 million in 2023[841] - The total compensation expense related to unvested options as of December 31, 2024, was 8.5million,expectedtoberecognizedover3.2years[836]−ThetotalcompensationexpenserelatedtounvestedRSUsasofDecember31,2024,was8.5 million, expected to be recognized over 3.2 years[836] - The total compensation expense related to unvested RSUs as of December 31, 2024, was 21.9 million, expected to be recognized over 3.3 years[839] - The Company recorded share-based compensation expense of 15.2millionforRSUsin2024,comparedto15.2 million for RSUs in 2024, compared to 14.1 million in 2023[838] Revenue Recognition - The Company recognizes revenue based on the control of promised goods or services, following ASC 606, and evaluates performance obligations to determine revenue recognition[782] - The Company recognizes revenues from nonrefundable, up-front fees allocated to licenses when the license is transferred and the licensee can benefit from it[792] - The Company’s collaboration revenue is recognized using the cost-to-cost input method under ASC 606, reflecting the progress towards completion of performance obligations[864] - The company recognized 33.3millionofservicerevenueduringtheyearendedDecember31,2024,whichincluded33.3 million of service revenue during the year ended December 31, 2024, which included 14.0 million of deferred revenue recognized as service revenue[876]