Palatin Technologies(PTN) - 2019 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - For the quarter ended December 31, 2018, Palatin reported a net loss of $5 million or $0.02 per basic and diluted share, compared to a net income of $3 million or $0.02 per basic and diluted share for the same period in 2017 [7] - Total operating expenses for the quarter were $5.1 million, down from $7.7 million in the comparable quarter in 2017, reflecting the completion of the Vyleesi Phase 3 clinical trial program [8] - Cash and cash equivalents were $24.7 million at December 31, 2018, down from $32.6 million at September 30, 2018, and $38 million at June 30, 2018 [9] Business Line Data and Key Metrics Changes - There were no revenues recorded for the three months ended December 31, 2018, while the previous year had $10.6 million in license and contract revenue from AMAG [7][8] - The Vyleesi program is under development for female hypoactive sexual desire disorder (HSDD), with a PDUFA date set for June 23, 2019, and a potential $60 million milestone payment from AMAG Pharmaceuticals upon approval [5][11] Market Data and Key Metrics Changes - Palatin is in discussions with potential collaboration partners for regions outside North America, China, and South Korea regarding Vyleesi [6] - The European Medicines Agency indicated that only a single Phase 3 study is needed to support a licensing application for Vyleesi in the EU [14] Company Strategy and Development Direction - The company is focusing on expanding its product portfolio by leveraging expertise in melanocortin biology and chemistry, with several drug candidates in various stages of development [15][19] - Palatin aims to conduct a clinical study for PL-8177 to evaluate its safety and activity in autoimmune diseases, anticipated to start in the first half of 2019 [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence that existing capital resources will be sufficient to fund operations through at least March 31, 2020 [9] - The management team is optimistic about the prospects for the company, highlighting the excitement surrounding the upcoming PDUFA date and potential product launches [70] Other Important Information - The company is conducting a study to assess the effects of Vyleesi on blood pressure with short-term daily use, as requested by the FDA [12][24] - PL-8331, a dual Melanocortin receptor-1 and 5 agonist, is expected to start clinical studies in the second half of 2019 [18] Q&A Session Summary Question: Update on clinical data requested by the FDA - Management explained that the FDA requested additional data on blood pressure effects due to a small subset of patients using Vyleesi more frequently than intended, and the study aims to characterize these effects [22][24] Question: Potential for a better label if data comes out clean - Management indicated that if the data from the blood pressure study is clean, it could lead to a more favorable label for Vyleesi [31] Question: Timing of discussions with partners outside North America - Management confirmed that discussions with partners are ongoing and have increased following positive feedback from the EMA regarding trial requirements [45] Question: Launch timing if the drug is approved - Management stated that AMAG anticipates a commercial launch in the third quarter of calendar 2019, assuming approval in June [66][67]