Palatin Technologies(PTN) - 2019 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - For the quarter ended March 31, 2019, the company reported a net loss of $5.7 million or $0.03 per basic and diluted share, compared to a net loss of $0.7 million or zero per basic and diluted share for the same period in 2018, primarily due to the recognition of $9 million in license and contract revenue during the 2018 period [9][10] - Total operating expenses for the quarter ended March 31, 2019, were $5.8 million, down from $9.5 million for the comparable quarter in 2018, reflecting the completion of the Vyleesi Phase 3 clinical trial program [10] - Cash and cash equivalents were $19.8 million at March 31, 2019, compared to $38 million at June 30, 2018, with current liabilities decreasing from $10.8 million to $4.9 million during the same period [11] Business Line Data and Key Metrics Changes - Vyleesi, under development for female hypoactive sexual desire disorder (HSDD), has completed a requested FDA study assessing short-term daily use, with data submitted to the FDA [5][12] - Positive topline results were announced for the oral clinical study of PL-8177 for ulcerative colitis, with Phase 2 studies anticipated to commence in Q4 2019 [7][8] Market Data and Key Metrics Changes - The company is advancing discussions with potential collaboration partners for regions outside North America, including China and South Korea [6] - The Committee for Medicinal Products for Human Use of the European Medicines Agency indicated that only a single Phase 3 study is needed to support a licensing application for Vyleesi in the EU [15] Company Strategy and Development Direction - The company is focused on advancing multiple compounds into clinical studies for various diseases with high unmet medical needs, including ocular inflammatory diseases and autoimmune conditions [23][24] - The strategy includes seeking partnerships for licensing in Europe as a single territory rather than country by country, aiming for multiple regional licenses by the end of 2019 [44][45] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the upcoming FDA decision on the Vyleesi NDA, with expectations for a positive outcome [57] - The company believes existing capital resources will be sufficient to fund operations through at least the second quarter of 2020 [11] Other Important Information - The company is preparing to initiate clinical studies for multiple ocular inflammatory diseases, with dry eye studies anticipated to start in the first half of 2020 [20][24] - PL-3994 is scheduled to start a Phase 2 trial in collaboration with the American Heart Association in the first half of 2019 [21] Q&A Session Summary Question: Comments on the FDA requested study completion - Management confirmed that there are no additional information requests from the FDA and they are currently in labeling discussions, feeling optimistic about the upcoming PDUFA date [28] Question: Additional partnerships for Vyleesi outside the U.S. - The company is in advanced discussions with multiple parties for non-licensed territories, expecting to finalize agreements post-FDA approval [31] Question: Feedback on the ambulatory blood pressure study - No feedback has been received from the FDA regarding the study results, and management is comfortable that the data will support appropriate labeling [42] Question: Structure of European partnerships - The company aims for a centralized European partnership rather than country-specific deals, targeting multiple regions by the end of 2019 [44][45] Question: Timing and size of upcoming studies for PL-8177 - The ulcerative colitis study will involve around 100 patients and will be a randomized controlled trial, with a focus on clinical outcomes and colonoscopy examinations [52]