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Legend Biotech(LEGN) - 2024 Q3 - Quarterly Report
LEGNLegend Biotech(LEGN)2024-11-12 12:03
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Revenue Performance - Total revenue for the nine months ended September 30, 2024, was 440.72million,a114440.72 million, a 114% increase from 205.68 million in the same period of 2023[14] - License revenue reached 120.12million,upfrom120.12 million, up from 35.17 million year-over-year, representing a 241% increase[14] - Collaboration revenue increased to 314.56million,comparedto314.56 million, compared to 170.37 million in the prior year, marking an 84% growth[14] - Total revenue for the nine months ended September 30, 2024, was 440.7million,asignificantincreaseof440.7 million, a significant increase of 235.0 million compared to 205.7millionforthesameperiodin2023[69]−Licenserevenueincreasedto205.7 million for the same period in 2023[69] - License revenue increased to 120.1 million for the nine months ended September 30, 2024, up from 35.2millionin2023,drivenby35.2 million in 2023, driven by 40.0 million from milestones under the Janssen Agreement and 45.0millionfromtheNovartisLicenseAgreement[70][71]−Collaborationrevenueroseto45.0 million from the Novartis License Agreement[70][71] - Collaboration revenue rose to 314.6 million in 2024, compared to 170.4millionin2023,primarilyduetoincreasedsalesofCARVYKTIundertheJanssenAgreement[72]FinancialLossandImprovement−Thelossfortheperiodwas170.4 million in 2023, primarily due to increased sales of CARVYKTI under the Janssen Agreement[72] Financial Loss and Improvement - The loss for the period was 203.31 million, a significant improvement from a loss of 373.44millioninthesameperiodof2023[14]−Basicanddilutedlosspershareimprovedto373.44 million in the same period of 2023[14] - Basic and diluted loss per share improved to 0.56 from 1.07year−over−year[14]−ThelossfortheninemonthsendedSeptember30,2024,is1.07 year-over-year[14] - The loss for the nine months ended September 30, 2024, is 203.3 million, compared to a loss of 373.4millionforthesameperiodin2023,representinga45.6373.4 million for the same period in 2023, representing a 45.6% improvement[23] - Net loss for the period was 203.3 million, or (0.56)pershare,comparedtoanetlossof0.56) per share, compared to a net loss of 373.4 million, or (1.07)pershare,forthesameperiodin2023,indicatingimprovedfinancialperformance[84]AssetsandLiabilities−TotalassetsasofSeptember30,2024,were1.07) per share, for the same period in 2023, indicating improved financial performance[84] Assets and Liabilities - Total assets as of September 30, 2024, were 1.74 billion, down from 1.85billionattheendof2023[16]−Totalliabilitiesincreasedto1.85 billion at the end of 2023[16] - Total liabilities increased to 619.72 million from 597.24millionattheendof2023[16]−TotalequityasofSeptember30,2024,is597.24 million at the end of 2023[16] - Total equity as of September 30, 2024, is 1,116.1 million, a decrease from 1,339.6millionasofSeptember30,2023[19]−Cashandcashequivalentsdecreasedto1,339.6 million as of September 30, 2023[19] - Cash and cash equivalents decreased to 459.28 million from 1.28billionattheendof2023[16]−CashandcashequivalentsasofSeptember30,2024,totaledapproximately1.28 billion at the end of 2023[16] - Cash and cash equivalents as of September 30, 2024, totaled approximately 0.46 billion, with time deposits of approximately 0.76billion,providingliquiditytofundoperationsinto2026[87][85]CashFlowandInvestmentActivities−CashusedinoperatingactivitiesfortheninemonthsendedSeptember30,2024,is0.76 billion, providing liquidity to fund operations into 2026[87][85] Cash Flow and Investment Activities - Cash used in operating activities for the nine months ended September 30, 2024, is 61.96 million, significantly reduced from 297.63millionin2023[25]−NetcashusedininvestingactivitiesfortheninemonthsendedSeptember30,2024,is297.63 million in 2023[25] - Net cash used in investing activities for the nine months ended September 30, 2024, is 762.70 million, compared to 314.72millionin2023,indicatingincreasedinvestmentactivity[25]−NetcashprovidedbyfinancingactivitiesfortheninemonthsendedSeptember30,2024,was314.72 million in 2023, indicating increased investment activity[25] - Net cash provided by financing activities for the nine months ended September 30, 2024, was 6.0 million, a decrease from 790.6millionin2023,reflectingreducedcapitalraisingactivities[95][96]Expenses−Researchanddevelopmentexpensesroseto790.6 million in 2023, reflecting reduced capital raising activities[95][96] Expenses - Research and development expenses rose to 309.11 million, compared to 276.54millionintheprioryear,reflectinga12276.54 million in the prior year, reflecting a 12% increase[14] - Administrative expenses increased to 102.58 million from 78.06millionyear−over−year,a3178.06 million year-over-year, a 31% rise[14] - The company recognized equity-settled share-based compensation expense of 55.55 million for the nine months ended September 30, 2024, compared to 35.09millionin2023,reflectingincreasedcompensationcosts[25]−ResearchanddevelopmentexpensesfortheninemonthsendedSeptember30,2024,were35.09 million in 2023, reflecting increased compensation costs[25] - Research and development expenses for the nine months ended September 30, 2024, were 309.1 million, an increase of 32.6millionfrom32.6 million from 276.5 million in 2023, reflecting ongoing investment in cilta-cel and solid tumor programs[76] Inventory and Receivables - The company experienced a decrease in trade receivables of 99.34millionintheninemonthsendedSeptember30,2024,comparedtoaminimalchangein2023[23]−Thecompanyreportedaprovisionforinventoryreserveof99.34 million in the nine months ended September 30, 2024, compared to a minimal change in 2023[23] - The company reported a provision for inventory reserve of 6.83 million for the nine months ended September 30, 2024, compared to 1.34millionin2023,indicatingincreasedinventoryriskmanagement[23]−Thereserveforinventoryincreasedto1.34 million in 2023, indicating increased inventory risk management[23] - The reserve for inventory increased to 15.8 million as of September 30, 2024, compared to 8.9millionattheendof2023,indicatinghigherexpiredmaterials[47]ShareholderandFinancingActivities−Thecompanyissuedordinarysharesresultinginatotalincreaseinequityof8.9 million at the end of 2023, indicating higher expired materials[47] Shareholder and Financing Activities - The company issued ordinary shares resulting in a total increase in equity of 234.41 million from private placements and 349.28millionfromregistereddirectofferingsduringtheninemonthsendedSeptember30,2023[19]−Theweightedaveragenumberofordinarysharesinissueincreasedto365,268,372fortheninemonthsendedSeptember30,2024,from348,293,363intheprioryear[40]−Thecompanyissuedandfullypaid366,901,007ordinarysharesasofSeptember30,2024,anincreasefrom363,822,069sharesasofDecember31,2023[55]FutureOutlookandPlans−ThecompanyexpectstoincursignificantcapitalexpendituresinthecomingyearstorampupmanufacturingcapabilitiesforCARVYKTIandadvanceclinicaldevelopmentprograms[85]−Thecompanyexpectsexpensestoincreaseduetoongoingresearchanddevelopment,clinicaltrials,andcommercializationeffortsforCARVYKTI,necessitatingsubstantialadditionalfunding[97]−Existingcashandcashequivalentsareprojectedtofundoperatingexpensesandcapitalexpendituresforatleastthenext12months,despitepotentialfluctuationsincashrequirements[98]−Thecompanyhasabroadportfolioofearlier−stageproductcandidates,butmaynotgeneratenecessarydataformarketingapproval,requiringcontinuedrelianceonadditionalfinancing[99]−Financingneedswillbemetthroughequityofferings,debtfinancings,collaborations,andlicensingarrangements,whichmaydiluteexistingshareholders[100]RegulatoryandMarketDevelopments−ThecompanyreceivedChina′sNMPAapprovalforCARVYKTIforthetreatmentoffourth−lineplusmultiplemyeloma[66]−ThecompanyinitiatedcommercialproductionattheObeliscfacilityinGhent,Belgium,andlaunchedCARVYKTIinSwitzerlandduringthethirdquarter[66]−TheNovartisLicenseAgreement,effectiveDecember28,2023,includesanupfrontpaymentof349.28 million from registered direct offerings during the nine months ended September 30, 2023[19] - The weighted average number of ordinary shares in issue increased to 365,268,372 for the nine months ended September 30, 2024, from 348,293,363 in the prior year[40] - The company issued and fully paid 366,901,007 ordinary shares as of September 30, 2024, an increase from 363,822,069 shares as of December 31, 2023[55] Future Outlook and Plans - The company expects to incur significant capital expenditures in the coming years to ramp up manufacturing capabilities for CARVYKTI and advance clinical development programs[85] - The company expects expenses to increase due to ongoing research and development, clinical trials, and commercialization efforts for CARVYKTI, necessitating substantial additional funding[97] - Existing cash and cash equivalents are projected to fund operating expenses and capital expenditures for at least the next 12 months, despite potential fluctuations in cash requirements[98] - The company has a broad portfolio of earlier-stage product candidates, but may not generate necessary data for marketing approval, requiring continued reliance on additional financing[99] - Financing needs will be met through equity offerings, debt financings, collaborations, and licensing arrangements, which may dilute existing shareholders[100] Regulatory and Market Developments - The company received China's NMPA approval for CARVYKTI for the treatment of fourth-line plus multiple myeloma[66] - The company initiated commercial production at the Obelisc facility in Ghent, Belgium, and launched CARVYKTI in Switzerland during the third quarter[66] - The Novartis License Agreement, effective December 28, 2023, includes an upfront payment of 100 million and potential milestone payments of up to $1.01 billion[36] Economic and Risk Factors - The company has not experienced material impacts on its supply chain due to inflation and rising interest rates, maintaining robust sourcing strategies[67] - Inflation has not materially affected the company's financial condition or results of operations during the nine months ended September 30, 2024 and 2023[105] - The company does not believe it is exposed to any material foreign currency exchange rate risk[106]