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Palatin Technologies(PTN) - 2020 Q2 - Earnings Call Transcript
2020-02-11 21:55
Financial Data and Key Metrics Changes - For the quarter ended December 31, 2019, the company recognized revenue of $20,610 from Vyleesi, compared to no revenue in the same quarter of 2018 [9] - Total operating expenses for the quarter were $5.7 million, an increase from $5.1 million in the comparable quarter of 2018, primarily due to a final payment of $625,000 related to the termination of an engagement agreement [10] - Total other income was $397,480 for the quarter, up from $7,871 in the same quarter of 2018, mainly due to increased investment income [11] - Cash, cash equivalents, and accounts receivable were $91.6 million as of December 31, 2019, down from $96.8 million at September 30, 2019 [12] Business Line Data and Key Metrics Changes - The company is advancing discussions for Vyleesi collaborations outside of North America, China, and Korea, with expectations to execute multiple agreements in 2020 [8] - Vyleesi is licensed to Fosun Pharma in China and Kwandong Pharmaceuticals in South Korea, both of which are progressing through the regulatory process [8] Market Data and Key Metrics Changes - The market for dry eye disease treatments represents a substantial commercial opportunity with over $2 billion in annual sales [27] - The company is targeting the melanocortin system to treat ocular diseases, with three active programs in dry eye disease, diabetic retinopathy, and non-infectious uveitis [23] Company Strategy and Development Direction - The company aims to safeguard its rights under the Vyleesi North American license agreement and ensure the value of Vyleesi remains intact during AMAG's divestiture process [36] - The company plans to advance its pipeline programs, including starting the Phase 2 clinical study for PL-9643 in dry eye disease and preparing for Phase 2 studies for PL-8177 in ulcerative colitis [37] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the commercial potential of Vyleesi and indicated that they would not allow the product to be under-marketed [53] - The company is prepared to take back Vyleesi if necessary and has a plan to develop its own commercial infrastructure [54][56] Other Important Information - The company has a strong balance sheet with $92 million in cash as of December 31, 2019, which supports the advancement of its pipeline programs [35] Q&A Session Summary Question: Timeframe for locating a new partner for Vyleesi - Management indicated that AMAG hopes to complete the divestiture process by the end of Q1 or early Q2 of the calendar year [40] Question: Stipulations in the contract regarding timing for divestiture - Management clarified that there are no specific timings for divestiture, but it is in AMAG's interest to proceed quickly [47] Question: Update on regulatory milestones for Vyleesi in China and South Korea - Management confirmed that the milestone numbers are accurate, with expectations for regulatory approvals in late 2021 or early 2022 [51] Question: Potential for AMAG to return Vyleesi to the company - Management stated they are prepared to take back Vyleesi if necessary and would prefer to market it themselves rather than re-partner [54][56] Question: Revenue reporting for Vyleesi - Management assured that the revenue reported is accurate and that they expect to reflect royalties in the first quarter [58]
Palatin Technologies(PTN) - 2020 Q1 - Earnings Call Transcript
2019-11-13 21:19
Palatin Technologies, Inc. (NYSE:PTN) Q1 2020 Earnings Conference Call November 13, 2019 11:00 AM ET Company Participants Carl Spana – President and Chief Executive Officer Steve Wills – Executive Vice President, Chief Financial Officer and Chief Operating Officer Conference Call Participants John Newman – Canaccord Joe Pantginis – H.C. Wainwright Operator Good morning, ladies and gentlemen, and welcome to the Palatin Technologies First Quarter Fiscal Year 2020 Operating Results Conference Call. As a remind ...
Palatin Technologies(PTN) - 2019 Q4 - Earnings Call Transcript
2019-09-12 21:06
Palatin Technologies, Inc. (NYSE:PTN) Q4 2019 Earnings Conference Call September 12, 2019 11:00 AM ET Company Participants Dr. Carl Spana - President and CEO Steve Wills - EVP, CFO and COO Conference Call Participants Justin Zelin - Canaccord Genuity Joe Pantginis - H.C. Wainwright Operator Good morning, ladies and gentlemen, and welcome to the Palatin Technologies Fourth Quarter and Fiscal YearEnd 2019 Operating Results Conference Call. As a reminder, this conference is being recorded. Before we begin our ...
Palatin Technologies(PTN) - 2019 Q3 - Earnings Call Transcript
2019-05-09 20:43
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]
Palatin Technologies(PTN) - 2019 Q2 - Earnings Call Transcript
2019-02-12 19:11
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]