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Jaguar Health(JAGX) - 2024 Q2 - Quarterly Report

Financial Performance - Jaguar Health, Inc. reported a net loss of 19.0millionforthesixmonthsendedJune30,2024,comparedtoanetlossof19.0 million for the six months ended June 30, 2024, compared to a net loss of 24.7 million for the same period in 2023[257]. - The company reported a net loss of 18.996millionforthesixmonthsendedJune30,2024,a23.118.996 million for the six months ended June 30, 2024, a 23.1% improvement from a net loss of 24.688 million in the same period of 2023[270]. - Net loss attributable to common stockholders decreased by 2.658millionfrom2.658 million from 12.150 million for the three months ended June 30, 2023, to 9.492millionin2024[289].NetcashusedinoperatingactivitiesforthesixmonthsendedJune30,2024,was9.492 million in 2024[289]. - Net cash used in operating activities for the six months ended June 30, 2024, was 15.2 million, compared to 19.0millionforthesameperiodin2023[309].RevenueandSalesProductrevenueforthesixmonthsendedJune30,2024,was19.0 million for the same period in 2023[309]. Revenue and Sales - Product revenue for the six months ended June 30, 2024, was 5.072 million, a 9.1% increase from 4.648millioninthesameperiodof2023[270].Grossproductsalesincreasedto4.648 million in the same period of 2023[270]. - Gross product sales increased to 7.045 million for the six months ended June 30, 2024, compared to 6.304millionin2023,reflectingan11.86.304 million in 2023, reflecting an 11.8% growth[273]. - Product revenue for the three months ended June 30, 2024, was 2.721 million, an increase of 45,000or1.745,000 or 1.7% compared to 2.676 million in the same period in 2023[289]. Expenses - Research and development expenses are expected to increase due to the start-up costs associated with clinical trials for new indications[262]. - Research and development expenses decreased by 1.087million,or12.01.087 million, or 12.0%, from 9.052 million in the six months ended June 30, 2023, to 7.965millionin2024[278].Salesandmarketingexpensesdecreasedby7.965 million in 2024[278]. - Sales and marketing expenses decreased by 490,000, or 14.2%, from 3.457millioninthesixmonthsendedJune30,2023,to3.457 million in the six months ended June 30, 2023, to 2.967 million in 2024[280]. - Total operating expenses for the three months ended June 30, 2024, were 9.918million,adecreaseof9.918 million, a decrease of 860,000 or 8.0% compared to 10.778millioninthesameperiodin2023[289].Generalandadministrativeexpensesdecreasedby10.778 million in the same period in 2023[289]. - General and administrative expenses decreased by 555,000 from 9.25millionforthesixmonthsendedJune30,2023,to9.25 million for the six months ended June 30, 2023, to 8.7 million in the same period in 2024, primarily due to a 308,000decreaseinpersonnelandrelatedbenefits[282].DebtandFinancingGainonextinguishmentofdebtwas308,000 decrease in personnel and related benefits[282]. Debt and Financing - Gain on extinguishment of debt was 1.245 million for the six months ended June 30, 2024, compared to no gain in the same period of 2023[270]. - Gain on extinguishment of debt increased by 1.2millionfromzerointhesixmonthsendedJune30,2023,to1.2 million from zero in the six months ended June 30, 2023, to 1.2 million for the same period in 2024[287]. - Cash provided by financing activities increased to 24.8millioninthesixmonthsendedJune30,2024,from24.8 million in the six months ended June 30, 2024, from 22.2 million in the same period in 2023[313]. Market and Product Development - The global market for Short Bowel Syndrome (SBS) is projected to exceed 4.6billionby2027,withapproximately10,000to20,000peopleaffectedintheU.S.[249].JaguarplanstolaunchGelclair,anFDAapprovedoralmucositisprescriptionproduct,inthefourthquarterof2024,whichaddressesacommonsideeffectofcancertreatment[244].Crofelemer,Jaguarsleadproduct,isindevelopmentformultipleindications,includingchemotherapyinduceddiarrhea(CID)anddiarrheapredominantirritablebowelsyndrome(IBSD)[251].ThecompanyhasinitiatedclinicaldevelopmentofcrofelemerforSBSpatients,leveragingtheEMAsacceleratedconditionalmarketingauthorizationpathway[249].Jaguarsjointventure,Magdalena,focusesondevelopingplantbasedmedicinesformentalhealth,includingADHD,utilizingalibraryof2,300medicinalplants[253].CanaleviaCA1,anoralplantbasedprescriptiondrugforCIDindogs,hasreceivedconditionalapprovalfromtheFDAandisavailablethroughmultipleveterinarydistributors[255].CostManagementDirectlaborcostsinthecostofproductrevenuedecreasedby4.6 billion by 2027, with approximately 10,000 to 20,000 people affected in the U.S.[249]. - Jaguar plans to launch Gelclair, an FDA-approved oral mucositis prescription product, in the fourth quarter of 2024, which addresses a common side effect of cancer treatment[244]. - Crofelemer, Jaguar's lead product, is in development for multiple indications, including chemotherapy-induced diarrhea (CID) and diarrhea-predominant irritable bowel syndrome (IBS-D)[251]. - The company has initiated clinical development of crofelemer for SBS patients, leveraging the EMA's accelerated conditional marketing authorization pathway[249]. - Jaguar's joint venture, Magdalena, focuses on developing plant-based medicines for mental health, including ADHD, utilizing a library of 2,300 medicinal plants[253]. - Canalevia-CA1, an oral plant-based prescription drug for CID in dogs, has received conditional approval from the FDA and is available through multiple veterinary distributors[255]. Cost Management - Direct labor costs in the cost of product revenue decreased by 144,000, or 26.5%, from 544,000in2023to544,000 in 2023 to 400,000 in 2024[275]. - Material costs decreased by 79,000,or19.479,000, or 19.4%, from 407,000 in 2023 to 328,000in2024,duetoincreasedproductionefficiency[276].Interestexpensedecreasedby328,000 in 2024, due to increased production efficiency[276]. - Interest expense decreased by 5.1 million from 5.6millionforthesixmonthsendedJune30,2023,to5.6 million for the six months ended June 30, 2023, to 503,000 for the same period in 2024[285]. - Interest expense decreased from 3.5millioninQ22023to3.5 million in Q2 2023 to 108,000 in Q2 2024, primarily due to changes in accounting for certain debt instruments[303]. Internal Controls and Legal Matters - As of June 30, 2024, the company concluded that its internal control over financial reporting was effective, providing reasonable assurance regarding the reliability of financial reporting in accordance with U.S. GAAP[316]. - The company is classified as a smaller reporting company and is not subject to auditor attestation requirements under applicable SEC rules[317]. - There were no changes in the internal control over financial reporting that materially affected or are likely to materially affect the internal control[317]. - The company is not currently subject to any material legal proceedings, which could have adverse effects due to defense and settlement costs[319].