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FibroGen(FGEN) - 2025 Q1 - Quarterly Report
FGENFibroGen(FGEN)2025-05-12 20:10
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Financial Performance - For the three months ended March 31, 2025, revenue was 2.739million,asignificantdecreasefrom2.739 million, a significant decrease from 25.364 million in the same period of 2024[132]. - Operating costs and expenses for the same period were 17.659million,downfrom17.659 million, down from 74.546 million year-over-year, primarily due to cost control measures and the termination of certain agreements[132][133]. - The loss from continuing operations for Q1 2025 was 16.766million,or16.766 million, or 0.16 per share, compared to a loss of 49.046million,or49.046 million, or 0.49 per share, in Q1 2024[134]. - For the three months ended March 31, 2025, total revenue decreased by 22.6million,or8922.6 million, or 89%, to 2.7 million compared to 25.4millioninthesameperiodin2024[190].−Drugproductrevenue,net,fellby25.4 million in the same period in 2024[190]. - Drug product revenue, net, fell by 21.9 million, or 89%, to 2.6millionforthethreemonthsendedMarch31,2025,primarilyduetotheterminationoftheAstraZenecaU.S./RoWAgreement[191].−Researchanddevelopmentexpensesdecreasedby2.6 million for the three months ended March 31, 2025, primarily due to the termination of the AstraZeneca U.S./RoW Agreement[191]. - Research and development expenses decreased by 27.3 million, or 75%, to 9.2millionforthethreemonthsendedMarch31,2025,reflectingcostreductionefforts[202].−Operatingcostsandexpensesdecreasedby9.2 million for the three months ended March 31, 2025, reflecting cost reduction efforts[202]. - Operating costs and expenses decreased by 56.9 million, or 76%, to 17.7millionforthethreemonthsendedMarch31,2025,comparedto17.7 million for the three months ended March 31, 2025, compared to 74.5 million in the same period in 2024[198]. - Interest income and other income (expenses), net decreased by 1.8million,or821.8 million, or 82%, compared to the same period a year ago, primarily due to lower interest income[208]. - Loss from continuing operations before income taxes was 16.8 million for the three months ended March 31, 2025, compared to a loss of 49.0millionforthesameperiodin2024[211].−Cashandcashequivalentstotaled49.0 million for the same period in 2024[211]. - Cash and cash equivalents totaled 33.609 million as of March 31, 2025, down from 50.482millionattheendof2024[132].−Cashandcashequivalentsdecreasedto50.482 million at the end of 2024[132]. - Cash and cash equivalents decreased to 33.6 million as of March 31, 2025, from 50.5millionasofDecember31,2024[219].−Netcashprovidedbyoperatingactivitieswas50.5 million as of December 31, 2024[219]. - Net cash provided by operating activities was 2.7 million for the three months ended March 31, 2025, compared to a net cash used of 59.3millionforthesameperiodin2024[222][224].−ThecompanyanticipatescontinuedlossesdespiteexpectedrevenueincreasesfromcommercialsalesofroxadustatinChina,Japan,andEurope[230].−Thereissubstantialdoubtaboutthecompany′sabilitytocontinueasagoingconcernwithin12monthsifadditionalfundingisnotsecured[231].DevelopmentandClinicalTrials−FibroGenisdevelopingFG−3246,apotentialfirst−in−classADCtargetingCD46,withaPhase2studyexpectedtobegininQ32025formetastaticcastration−resistantprostatecancer(mCRPC)[129][143].−ThecompanyanticipatesfeedbackfromtheFDAregardingthedevelopmentplanforroxadustatinlower−riskMDSinQ32025[131].−AsharepurchaseagreementwithAstraZenecaissettocloseinQ32025,involvingthesaleofFibroGenInternationalanditsroxadustatassetsinChina[129].−TheconfirmedobjectiveresponserateforFG−3246inaPhase1studywas2059.3 million for the same period in 2024[222][224]. - The company anticipates continued losses despite expected revenue increases from commercial sales of roxadustat in China, Japan, and Europe[230]. - There is substantial doubt about the company's ability to continue as a going concern within 12 months if additional funding is not secured[231]. Development and Clinical Trials - FibroGen is developing FG-3246, a potential first-in-class ADC targeting CD46, with a Phase 2 study expected to begin in Q3 2025 for metastatic castration-resistant prostate cancer (mCRPC)[129][143]. - The company anticipates feedback from the FDA regarding the development plan for roxadustat in lower-risk MDS in Q3 2025[131]. - A share purchase agreement with AstraZeneca is set to close in Q3 2025, involving the sale of FibroGen International and its roxadustat assets in China[129]. - The confirmed objective response rate for FG-3246 in a Phase 1 study was 20%, with a median duration of response of 7.5 months[146]. - The disease control rate for FG-3246 was 80%, with 48% of patients exceeding 24 weeks of treatment[146]. - The combination treatment of FG-3246 with enzalutamide demonstrated a median radiographic progression-free survival (rPFS) of 10.2 months in a Phase 1b/2 study[147]. - The maximally tolerated dose of FG-3246 was established at 2.1 mg/kg adjusted body weight, combined with enzalutamide 160 mg/day[147]. - In the Phase 2/3 MATTERHORN trial, 47.5% of patients in the roxadustat arm achieved transfusion independence for 56 consecutive days, compared to 33.3% in the placebo arm[157]. - A post-hoc analysis showed that 36.1% of roxadustat patients with a higher transfusion burden achieved transfusion independence, versus 11.5% in the placebo group (p=0.047)[157]. - FibroGen plans to file a Type-C meeting request with the FDA regarding roxadustat for anemia associated with lower-risk MDS in Q2 2025, expecting feedback in Q3 2025[158]. Collaborations and Agreements - The company entered into a Share Purchase Agreement with AstraZeneca for approximately 185 million, including 85millionincashandanadditionalcashamountofapproximately85 million in cash and an additional cash amount of approximately 100 million[160]. - The collaboration with Astellas and AstraZeneca is crucial for the development and commercialization of roxadustat, with total consideration received through March 31, 2025, amounting to 790.1million[175].−FibroGenterminatedtheAstraZenecaU.S./RoWAgreement,effectiveFebruary25,2024,returningallnon−ChinaroxadustatrightsexceptforSouthKorea,withtotalconsiderationreceivedof790.1 million[175]. - FibroGen terminated the AstraZeneca U.S./RoW Agreement, effective February 25, 2024, returning all non-China roxadustat rights except for South Korea, with total consideration received of 439.0 million[179]. - The AstraZeneca China Agreement remains unaffected, with total consideration received through March 31, 2025, amounting to 81.2million[180].−ThecompanyenteredintoaSharePurchaseAgreementwithAstraZenecatosellallequityinterestsofFibroGenInternational,expectedtocloseinQ32025[213].FinancialPositionandLiabilities−AsofMarch31,2025,thecompanyhad81.2 million[180]. - The company entered into a Share Purchase Agreement with AstraZeneca to sell all equity interests of FibroGen International, expected to close in Q3 2025[213]. Financial Position and Liabilities - As of March 31, 2025, the company had 73.4 million in senior secured term loan facilities, with 10.5millionininterestexpectedtobepaidwithinthenext12months[233].−Thecompanyhas10.5 million in interest expected to be paid within the next 12 months[233]. - The company has 61.0 million in liabilities related to the sale of future revenues, with a potential payment cap of 125.0millionanticipatedby2031[234].−Totalnon−cancelablepurchaseobligationsamountedto125.0 million anticipated by 2031[234]. - Total non-cancelable purchase obligations amounted to 2.3 million for general purchases, 0.7millionforroxadustatmanufacturing,and0.7 million for roxadustat manufacturing, and 0.3 million for FG-3246 manufacturing[232]. - The company has established a full valuation allowance against its net deferred tax assets due to cumulative net losses since inception[212]. - The company may issue and sell shares of common stock having an aggregate offering price of up to 30.0millionunderanEquityDistributionAgreementwithBofASecurities[218].OperationalChangesandCostManagement−Employee−relatedcostsdecreasedby30.0 million under an Equity Distribution Agreement with BofA Securities[218]. Operational Changes and Cost Management - Employee-related costs decreased by 7.8 million due to a reduction in force action and cost control efforts[203]. - Clinical trials costs decreased by 6.9 million primarily due to the termination of pamrevlumab programs in response to clinical data results[203]. - SG&A expenses decreased by 8.6 million, or 52%, for the three months ended March 31, 2025, compared to the same period a year ago[204]. - Cost of goods sold dropped by 21.1million,or9921.1 million, or 99%, to 252,000 for the three months ended March 31, 2025, due to the cumulative catch-up adjustment related to the AstraZeneca agreement[199]. - Inventory decreased by 2.9millionduetolowerproductioninChinaafterdecommissioningtheAPImanufacturingfacility[229].−Accountsreceivableincreasedby2.9 million due to lower production in China after decommissioning the API manufacturing facility[229]. - Accounts receivable increased by 24.7 million, primarily driven by a 26.0millionreceivablefromAstraZenecarelatedtopasttransactions[229].−Deferredrevenuedecreasedby26.0 million receivable from AstraZeneca related to past transactions[229]. - Deferred revenue decreased by 10.2 million, with 5.7millionreclassifiedtoaccruedliabilitiesduetochangesinestimatedvariableconsideration[229].−Accruedinterestexpenserelatedtothesaleoffuturerevenuesdecreasedby5.7 million reclassified to accrued liabilities due to changes in estimated variable consideration[229]. - Accrued interest expense related to the sale of future revenues decreased by 3.6 million, with 5.7millioninterestpaidduringthequarter[229].−Thecompanyhasmadefourquarterlypaymentstotaling5.7 million interest paid during the quarter[229]. - The company has made four quarterly payments totaling 5.4 million to Fortis for the development of FG-3246, with the last payment of 1.7millionmadeinQ12024[169].−IftheoptiontoacquireFortisisexercised,thecompanywillpay1.7 million made in Q1 2024[169]. - If the option to acquire Fortis is exercised, the company will pay 80 million and could owe up to $200 million in contingent payments for regulatory approvals[170]. - The preclinical portfolio includes FG-3165 and FG-3175, both targeting immune checkpoints for the treatment of solid tumors[164][166].