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Sep 30, 2023
Palatin Technologies Q1 2024 Earnings Report
Reported financial results for the first quarter of fiscal year 2024 and provided a corporate update.
Key Takeaways
Palatin Technologies reported an 11% increase in gross product revenue and a 20% increase in net product revenue compared to the prior quarter. Vyleesi's quarterly net product revenue continues to exceed Vyleesi quarterly operating expenses.
Enrollment completed in Phase 3 PL9643 MELODY-1 study in Dry Eye Disease with 570 patients enrolled, and topline data is expected late in the fourth quarter of calendar year 2023.
Phase 2 clinical study of oral PL8177 in patients with Ulcerative Colitis has an interim analysis targeted for the first quarter of calendar year 2024, with topline results expected in the second quarter of calendar year 2024.
Gross product revenue increased 11% over the prior quarter, net product revenue increased 20% over the prior quarter, and prescriptions dispensed increased 14% over the prior quarter.
Vyleesi achieved its 7th consecutive quarter of double-digit growth.
Palatin Technologies
Palatin Technologies
Forward Guidance
Palatin is planning to initiate two clinical studies in Q1 2024, including a Phase 2 study of a melanocortin 4 receptor agonist plus a glucagon like peptide-1 (GLP-1) in obese patients and a Phase 2 clinical study evaluating bremelanotide co-formulated with a PDE5 inhibitor, for the treatment of erectile dysfunction (ED) in patients that do not respond to PDE5i monotherapy.
Positive Outlook
- Phase 3 PL9643 clinical study for DED is fully enrolled, with topline data expected late this calendar year.
- Phase 2 study of oral PL8177 in patients with ulcerative colitis is expected to have an interim analysis readout in the first quarter and topline trial results in the second quarter of calendar year 2024.
- Initiate two clinical studies in the first quarter of calendar year 2024 - a Phase 2 study of a melanocortin 4 receptor agonist plus a glucagon like peptide-1 (GLP-1) in obese patients
- Initiate a Phase 2 clinical study evaluating bremelanotide co-formulated with a PDE5 inhibitor, for the treatment of erectile dysfunction (ED) in patients that do not respond to PDE5i monotherapy.
- Data from Kwangdong Pharmaceuticals is currently anticipated by calendar year end 2023 with a potential regulatory submission in the first half of calendar 2024.
Challenges Ahead
- The Company believes that existing cash, cash equivalents, marketable securities and accounts receivables will be sufficient to fund currently anticipated operating expenses and disbursements into the first half of calendar year 2024.
- Topline data is currently expected late fourth quarter of calendar year 2023 for PL9643 melanocortin agonist for the treatment of dry eye disease (DED)
- Interim assessment is currently expected in the first quarter of calendar year 2024 for PL8177 oral melanocortin agonist for the treatment of ulcerative colitis (UC)
- Topline data is currently expected in the first half of calendar year 2024 for PL8177 oral melanocortin agonist for the treatment of ulcerative colitis (UC)
- Topline results are currently expected in the first half of calendar year 2024 for Bremelanotide BREAKOUT study (BMT 701) in patients with diabetic kidney disease