Jaguar Health(US:JAGX)2023-03-27 18:13Financial Data and Key Metrics Changes - Prescription product net revenue for the year ended December 31, 2022, was approximately $11.9 million, an increase of 178.7% compared to approximately $4.3 million for the year ended December 31, 2021 [7][52] - The loss from operations decreased from $40.7 million in 2021 to $34.4 million in 2022, largely due to an improvement in net revenue and decreased costs [24] - Non-GAAP EBITDA showed a net loss of $28.1 million in 2022, compared to a net loss of $37.5 million in 2021 [54] Business Line Data and Key Metrics Changes - Mytesi total prescription volume was approximately 5,947 in 2022, with a slight decrease of about 2% in Q4 2022 compared to Q3 2022 [23][53] - Canalevia-CA1 net revenue was approximately $24,000 in Q4 2022, representing a 100% increase over Q3 2022 [58] Market Data and Key Metrics Changes - The gross to net discount for Mytesi was approximately 20% in 2022, with the transition to specialty pharmacy distribution aiding in the preparation for potential future indication expansions [76] - The global market for chemotherapy-induced nausea and vomiting is projected to reach $3.9 billion by 2029, indicating a significant opportunity for Crofelemer in the CTD market [43] Company Strategy and Development Direction - The company is focused on expanding the approved indication of Mytesi from HIV-related diarrhea to include chemotherapy therapy-related diarrhea (CTD) [39] - Plans include supporting proof-of-concept studies for Crofelemer in patients with short bowel syndrome (SBS) and microvillous inclusion disease (MVID) [16][49] - The company aims to leverage AI technology to improve patient access to Mytesi and reduce reimbursement barriers [28][77] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the transformative potential of key clinical milestones expected in 2023, which could enhance value recognition for the company [30][36] - The company highlighted the importance of addressing the unmet medical need for CTD, as many patients discontinue life-saving cancer therapies due to diarrhea [40] Other Important Information - The company had cash of approximately $15.3 million as of March 24, 2023, which is crucial for achieving clinical milestones [21][37] - The transition to a limited distribution network of specialty pharmacies has resulted in reduced distribution costs and a higher average net price for Mytesi [56] Q&A Session Summary Question: Is the primary completion date still this month, March 2023, for chemotherapy-induced diarrhea? - Management confirmed that enrollment is expected to complete early in the second quarter of 2023, with the primary endpoint targeted for the third quarter [80] Question: Are you planning any cash raises to support your trials this year? - Management indicated that significant expenses are associated with clinical work to expand indications, but cost savings have been realized from distribution changes [82] Question: Does Crofelemer also work on IBS? - Management noted that there is published Phase II data for IBS with Crofelemer, but current focus remains on CTD, SBS, and MVID [90]