Palatin Technologies(PTN)

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Palatin Technologies(PTN) - 2021 Q3 - Quarterly Report
2021-05-14 20:31
Revenue and Expenses - For the three and nine months ended March 31, 2021, product revenue was $88,741 and $(363,790) respectively, with no contract and license revenue recognized compared to $117,989 for the same period in 2020[127] - Research and development expenses were $2,509,490 and $9,444,759 for the three and nine months ended March 31, 2021, showing a decrease from $3,641,250 and $10,026,363 in the same periods of 2020[128] - Selling, general and administrative expenses increased to $4,010,055 and $11,386,574 for the three and nine months ended March 31, 2021, compared to $2,072,032 and $6,308,567 for the same periods in 2020[133] - A gain of $1,623,795 was recorded for the nine months ended March 31, 2021, due to the Vyleesi Termination Agreement[134] - Net cash used in operating activities was $14,111,599 for the nine months ended March 31, 2021, compared to cash provided of $47,402,881 for the same period in 2020[139] Cash Position and Liabilities - As of March 31, 2021, cash and cash equivalents were $68,641,312, with current liabilities of $10,036,841[141] - Existing capital resources are expected to be adequate to fund operations for at least twelve months, but additional funding will be needed for clinical trials and regulatory submissions[143] Strategic Focus and Development - The company is focusing on maximizing revenue from Vyleesi by marketing it in the U.S. and seeking additional licensees[131] - New product development activities are centered on peptides targeting inflammatory and autoimmune diseases, with potential applications in various conditions[121] - The company aims to enter strategic alliances with pharmaceutical companies to facilitate the development and commercialization of its product candidates[131] - The company plans to utilize existing capital resources for general corporate purposes, including marketing and distribution capabilities for Vyleesi in the U.S. and development of peptide programs[142] Future Outlook and Risks - Significant expenses are anticipated as the company develops marketing and distribution capabilities for Vyleesi, which will adversely affect stockholders' equity, total assets, and working capital[144] - There have been no material changes to the company's contractual obligations outside the ordinary course of business[146] - The company does not have any off-balance sheet arrangements[145] - Smaller reporting companies are not required to provide quantitative and qualitative disclosures about market risk[147]
Palatin Technologies(PTN) - 2021 Q2 - Earnings Call Transcript
2021-02-17 21:28
Palatin Technologies, Inc. (NYSE:PTN) Q2 2021 Earnings Conference Call February 17, 2021 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 Michael Higgins – Ladenburg Thalmann Operator Good day, ladies and gentlemen, and welcome to the Palatin Technologies' Second Quarter Fiscal Year 2021 Operating Results Conference Call. As a rem ...
Palatin Technologies(PTN) - 2021 Q2 - Quarterly Report
2021-02-16 21:21
Revenue and Financial Performance - For the six months ended December 31, 2020, the company recognized $(452,531) in product revenue, a decrease from $117,989 in the same period of 2019 due to regaining all North American rights to Vyleesi[150]. - Net cash used in operating activities was $10,607,131 for the six months ended December 31, 2020, a significant decrease from cash provided by operating activities of $49,914,993 in the same period of 2019[162]. - The company recorded a gain of $1,623,795 for the six months ended December 31, 2020, due to the Vyleesi Termination Agreement[158]. Research and Development - Research and development expenses increased to $6,935,269 for the six months ended December 31, 2020, compared to $6,385,113 for the same period in 2019, primarily due to increased spending on MCr programs[151]. - Cumulative spending on the Vyleesi program reached approximately $311,900,000, while spending on all other programs totaled approximately $161,100,000 as of December 31, 2020[154]. - The company is focusing on developing peptides that target MC1r and other melanocortin receptors for treating inflammatory and autoimmune diseases[143]. - The company is developing potential NPR candidate drugs to treat cardiovascular and fibrotic diseases[144]. Expenses and Liabilities - Selling, general and administrative expenses rose to $7,376,519 for the six months ended December 31, 2020, compared to $4,236,535 for the same period in 2019, driven by increased selling expenses related to Vyleesi[156]. - Significant expenses are anticipated for the development of marketing and distribution capabilities for Vylessi and other product candidates, adversely affecting stockholders' equity and working capital[167]. - Total contractual obligations as of December 31, 2020, amounted to $13,598,447, with current obligations of $1,328,657[170]. - Inventory purchase commitments total $12,344,200, with current commitments of $1,010,250[170]. Cash Flow and Funding - Net cash used in financing activities for the three months ended December 31, 2020, was $89,029, compared to $1,903,055 for the six months ended December 31, 2019[164]. - As of December 31, 2020, cash and cash equivalents were $72,156,110, with current liabilities of $7,249,643[164]. - The company has incurred cumulative negative cash flows from operations since inception and expects to continue substantial expenditures for marketing and distribution of Vylessi[164]. - The company plans to utilize existing capital resources for general corporate purposes and the development of various product programs[165]. - Additional funding will be required to complete clinical trials for other product candidates and regulatory submissions, with potential impacts from the COVID-19 pandemic[166]. - The company believes existing capital resources will be adequate to fund operations for at least twelve months from the date of the financial statements[166]. - There are no off-balance sheet arrangements reported[168]. Strategic Initiatives - The company aims to maximize revenue from Vyleesi by marketing it in the U.S. and seeking additional licensees in other regions[148]. - The company has entered into strategic alliances to facilitate the development and commercialization of its product candidates[148].
Palatin Technologies(PTN) - 2021 Q1 - Earnings Call Transcript
2020-11-17 19:36
Palatin Technologies, Inc. (NYSE:PTN) Q1 2021 Earnings Conference Call November 17, 2020 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 Edward Marks - Ladenburg Thalmann Operator Good day, ladies and gentlemen, and welcome to the Palatin Technologies First Quarter Fiscal Year 2021 Operating Result ...
Palatin Technologies(PTN) - 2020 Q4 - Earnings Call Transcript
2020-09-28 21:09
Palatin Technologies, Inc. (NYSE:PTN) Q4 2020 Results Conference Call September 28, 2020 11:00 AM ET Company Participants Carl Spana - President & CEO Steve Wills - EVP, CFO, & COO Conference Call Participants John Newman - Canaccord Joseph Pantginis - H.C. Wainwright & Co Edward Marks - Ladenburg Thalmann Operator Good day, ladies and gentlemen, and welcome to the Palatin Technologies Fourth Quarter and Fiscal Year-end 2020 Operating Results Conference Call. As a reminder, this conference is being recorded ...
Palatin Technologies(PTN) - 2020 Q3 - Earnings Call Transcript
2020-05-12 18:12
Palatin Technologies, Inc. (NYSE:PTN) Q3 2020 Earnings Conference Call May 12, 2020 11:00 AM ET Company Participants Carl Spana - Co-Founder, President, CEO & Director Stephen Wills - CFO, COO, EVP, Treasurer & Secretary Conference Call Participants John Newman - Canaccord Genuity Joseph Pantginis - H.C. Wainwright & Co. Michael Higgins - Ladenburg Thalmann & Co. Operator Good day, ladies and gentlemen, and welcome to the Palatin Technologies Third Quarter Fiscal Year 2020 Operating Results Conference Call. ...
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]