Jaguar Health(JAGX)2024-11-13 11:31Financial Performance - Jaguar Health, Inc. reported a net loss of $29.0 million for the nine months ended September 30, 2024, compared to a net loss of $32.6 million for the same period in 2023[312]. - Total revenue for the nine months ended September 30, 2024, was $8.18 million, an increase of 9.6% compared to $7.46 million in the same period in 2023[338]. - Product revenue for the nine months ended September 30, 2024, was $8.095 million, reflecting an increase of 8.5% from $7.461 million in 2023[337]. - License revenue increased to $85,000 in 2024 from $0 in 2023 due to a new license agreement[338]. - Total revenue increased by 10.5% to $3,108,000 in Q3 2024 from $2,813,000 in Q3 2023[361]. - Net product sales rose by 9.0% to $3,066,000 in Q3 2024 from $2,813,000 in Q3 2023, driven by increased sales of Mytesi and Canalevia[364]. - The company reported a net loss of $10,021,000 in Q3 2024, a 26.8% increase from a net loss of $7,904,000 in Q3 2023[361]. Cash and Equity - As of September 30, 2024, the total stockholders' equity was $13.1 million, with an accumulated deficit of $336.6 million and cash of $13.3 million[312]. - Cash provided by financing activities increased to $28.4 million in the nine months ended September 30, 2024, from $23.6 million in the same period in 2023[400]. - Cash used in operating activities decreased by $4.2 million from $25.8 million in the nine months ended September 30, 2023, to $21.6 million in the same period in 2024[394]. - As of September 30, 2024, the company had cash of $13.3 million, sufficient to fund operations for at least one year[383]. - The accumulated deficit as of September 30, 2024, was $336.6 million[382]. Research and Development - The company has not yet generated enough revenue to achieve break-even, continuing to incur significant research and development expenses[312]. - As of September 30, 2024, the Company has incurred approximately $4.8 million on its primary R&D projects, with future expenses dependent on trial outcomes and regulatory requirements[319]. - Research and development expenses decreased by 20.7% to $12.008 million for the nine months ended September 30, 2024, compared to $15.133 million in 2023[338]. - Research and development expenses decreased by 33.5% to $4,043,000 in Q3 2024 from $6,081,000 in Q3 2023, primarily due to reduced clinical and contract manufacturing costs[368]. - The Company expects research and development expenses to decrease further with the Phase 3 OnTarget Trial completion in the first half of 2025[321]. Product Development and Launches - The company initiated the commercial launch of Gelclair in October 2024, a product for managing oral mucositis, which is a common side effect of cancer treatment[295]. - Crofelemer, the company's drug candidate, achieved statistical significance in a subgroup analysis of breast cancer patients in the OnTarget study, indicating its potential to improve adherence to cancer therapies[294]. - Jaguar's marketed drug Mytesi is the only oral plant-based prescription medicine approved by the FDA for noninfectious diarrhea in adults with HIV/AIDS[299]. - The company has entered into an exclusive 5-year in-license agreement with Venture Life for Gelclair, which can be commercialized without clinical development costs[295]. - Crofelemer received Orphan Drug Designation from the FDA for Microvillus Inclusion Disease (MVID) in August 2023, with ongoing Phase 2 trials planned to start in Q4 2024[300]. - Jaguar is focused on expanding its product pipeline, including a second-generation anti-secretory drug (NP-300) for moderate-to-severe diarrhea[306]. - The Company launched Gelclair during the quarter, with revenue recognition expected to commence in future quarters[341]. Expenses - Research and development (R&D) expenses decreased by $3.1 million, from $15.1 million in the nine months ended September 30, 2023, to $12.0 million in the same period in 2024, largely due to a $1.9 million decrease in clinical and contract manufacturing costs[344]. - Sales and marketing expenses increased slightly by 1.0% to $4.977 million for the nine months ended September 30, 2024[338]. - Sales and marketing expenses increased by 36.5% to $2,010,000 in Q3 2024 from $1,472,000 in Q3 2023, largely due to expanded market access activities[372]. - General and administrative (G&A) expenses decreased by $312,000, from $12,783,000 in the nine months ended September 30, 2023, to $12,471,000 in the same period in 2024, primarily due to a $163,000 decrease in personnel and related benefits[353]. - General and Administrative (G&A) expenses increased by $243,000, or 6.9%, from $3.53 million in Q3 2023 to $3.78 million in Q3 2024[375]. - Personnel and related benefits rose by $145,000, or 16.1%, from $901,000 in Q3 2023 to $1.05 million in Q3 2024[375]. - Legal services expenses increased by $99,000, or 33.9%, from $292,000 in Q3 2023 to $391,000 in Q3 2024, primarily due to higher patent fees[376]. - Third-party consulting expenses grew by $109,000, or 41.9%, from $260,000 in Q3 2023 to $369,000 in Q3 2024, driven by increased business development activities[377]. Other Financial Metrics - Interest expense decreased by $5.8 million, from $6.1 million in the nine months ended September 30, 2023, to $341,000 in the same period in 2024, due to changes in accounting for certain debt instruments[356]. - The fair value of financial instruments designated at fair value option (FVO) resulted in a loss of $6.9 million in the nine months ended September 30, 2024, compared to a loss of $3.4 million in the same period in 2023[358]. - Gain on extinguishment of debt decreased by $2.5 million, from $3.7 million in the nine months ended September 30, 2023, to $1.2 million in the same period in 2024, due to modifications of royalty interest agreements[359]. - Direct labor costs decreased by 20.3%, from $794,000 in the nine months ended September 30, 2023, to $633,000 in the same period in 2024[342]. - Stock-based compensation in R&D decreased by $194,000, from $756,000 in the nine months ended September 30, 2023, to $562,000 in the same period in 2024[346]. - Other expenses in S&M increased by 64.1%, from $977,000 in the nine months ended September 30, 2023, to $1,603,000 in the same period in 2024[352]. - The change in fair value of financial instruments designated at FVO resulted in a loss of $3.1 million for Q3 2024, compared to a loss of $2.2 million in Q3 2023[381].