Palatin Technologies(US:PTN)2024-10-01 18:55Financial Data and Key Metrics Changes - For the fourth quarter ended June 30, 2024, Palatin did not record any product sales due to the sale of Vyleesi rights, compared to gross product sales of $4.1 million and net product revenue of $1.8 million for the same quarter in 2023 [5][6] - Total operating expenses decreased to $8.7 million for the fourth quarter ended June 30, 2024, from $12.6 million in the comparable quarter last year, primarily due to reduced spending on MCR melanocortin receptor programs and elimination of selling expenses related to Vyleesi [6][7] - The net loss for the quarter was $8.6 million, compared to a net loss of $9.8 million for the same period in 2023 [7] Business Line Data and Key Metrics Changes - Gross product sales of Vyleesi for the fiscal year ended June 30, 2024, were $8.9 million, with net product revenue of $4.5 million, down from gross product sales of $12.5 million and net revenue of $4.9 million in the prior fiscal year [5][6] - The ocular program PL9643 completed its first Phase III trial, MELODY-1, demonstrating significant efficacy in treating dry eye disease, with results indicating excellent ocular tolerability and broad efficacy [9][10] Market Data and Key Metrics Changes - The global market for treatment of retinopathies is estimated to be approximately $30 billion by 2030, indicating a significant opportunity for Palatin's PL9654 program [13] Company Strategy and Development Direction - Palatin aims to continue developing key programs in obesity and dry eye disease while seeking collaborations and partnerships for its ocular programs and ulcerative colitis program [21][22] - The company is actively engaged with multiple parties for potential funding sources to support future operating cash needs [8] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about the growth in pipeline programs and the potential of targeting the melanocortin system to develop differentiated therapeutics [8][9] - The company is preparing for a new drug application filing for PL9643 in the first half of calendar year 2026, following the completion of remaining clinical studies [12][22] Other Important Information - Palatin closed on an asset sale to Cosette Pharmaceuticals for up to $171 million, retaining rights to bremelanotide for obesity and male treatment indications [4] - The company raised total gross proceeds of $21 million during the fiscal year ended June 30, 2024, through registered direct and warrant inducement offerings [5] Q&A Session Summary Question: Weight loss program with GLP-1 - Management indicated that the primary analysis will compare the co-administration of bremelanotide with tirzepatide against tirzepatide alone, looking for a measurable additive effect [24] Question: Pigmentation issues - Management noted that next-generation compounds are being developed to avoid skin darkening by having substantial separation between MCR4 and MCR1 activity [25] Question: Dry eye program maturity - Management confirmed that discussions with corporate partners are progressing well, and they are ready to move forward pending appropriate funding [26] Question: Co-formulation potential - Management acknowledged the feasibility of co-formulating MCR4 agonists with GLP-1 drugs, although no work has been done yet [28]