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Mar 31, 2023
Palatin Technologies Q3 2023 Earnings Report
Palatin Technologies reported financial results for the third quarter of fiscal year 2023, highlighted by Vyleesi's continued revenue growth and progress in clinical development programs.
Key Takeaways
Palatin Technologies announced positive Phase 3 clinical study data for PL9643 in dry eye disease and reported Vyleesi's fifth consecutive quarter of double-digit growth in net product revenue. The company's net loss decreased compared to the same quarter last year, driven by increased Vyleesi revenue.
Phase 3 PL9643 clinical study demonstrated statistically significant positive effects on multiple endpoints for both signs and symptoms in patients with dry eye disease.
Vyleesi achieved its fifth consecutive quarter of double-digit growth in net product revenue and dispenses.
Vyleesi's quarterly net product revenue now exceeds its quarterly operating expenses.
Palatin received $4.7 million of non-dilutive funding through the NJ Economic Development Program.
Palatin Technologies
Palatin Technologies
Forward Guidance
Palatin anticipates several milestones in the coming months, including completion of patient enrollment in the pivotal Phase 3 clinical study for PL9643, interim assessment of the Phase 2 clinical study of oral PL8177, and completion of enrollment in the Bremelanotide BREAKOUT study.
Positive Outlook
- Final data from Phase 3 clinical study of PL9643 expected in the second half of calendar year 2023.
- Interim assessment of Phase 2 clinical study of oral PL8177 expected in the second half of calendar year 2023.
- Enrollment in Bremelanotide BREAKOUT study expected to be completed in the second half of calendar year 2023.
- Continued focus on demonstrating commercial product value of Vyleesi with the objective of re-licensing the U.S. rights.
- Existing cash and cash equivalents and receivables are expected to fund operating expenses through calendar year 2023.
Challenges Ahead
- Potential delays in regulatory review due to the global COVID-19 pandemic.
- Possible manufacturing and supply chain interruptions.
- Potential adverse effects on healthcare systems.
- Disruption of the global economy could impact commercial acceptance of products.
- Uncertainties regarding the outcome and timing of clinical trials and regulatory approvals.