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Dec 31, 2019
Palatin Technologies Q2 2020 Earnings Report
Palatin Technologies reported results for the second quarter ended December 31, 2019.
Key Takeaways
Palatin Technologies reported a net loss of $5.2 million for the quarter ended December 31, 2019. The company's cash position was enhanced to $92 million as of December 31, 2019, and they are advancing their pipeline programs with two Phase 2 clinical studies starting in the first half of calendar year 2020.
Vyleesi® FDA approval in June 2019 provided a safe and effective treatment option for premenopausal women with HSDD.
Cash position was enhanced to $92 million at December 31, 2019.
Two Phase 2 clinical studies are starting in the first half of calendar year 2020: a dry eye disease study and an ulcerative colitis trial.
AMAG announced plans to divest Vyleesi® based on a change in strategy, not launch performance.
Palatin Technologies
Palatin Technologies
Forward Guidance
Palatin is advancing discussions on Vyleesi collaborations for territories outside North America, China, and Korea, and anticipates executing multiple agreements during calendar year 2020. A Phase 2 clinical study for PL9643 in dry eye disease is expected to commence in Q1 2020, with data readout anticipated in Q4 2020. A Phase 2 proof-of-concept clinical study with an oral formulation of PL8177 in ulcerative colitis patients is anticipated to start mid-calendar year 2020, with data readout mid-calendar year 2021.
Positive Outlook
- Advancing discussions on Vyleesi collaborations for territories outside North America, China, and Korea.
- Anticipates executing multiple agreements during calendar year 2020.
- Phase 2 clinical study for PL9643 in dry eye disease expected to commence in Q1 2020.
- Data readout anticipated in Q4 2020 for the dry eye disease study.
- Phase 2 proof-of-concept clinical study with PL8177 in ulcerative colitis patients anticipated to start mid-calendar year 2020.
Challenges Ahead
- AMAG's planned divestiture of Vyleesi introduces uncertainty.
- Potential need to ensure the value of Vyleesi remains intact and continues to grow during the divestiture process.
- Dependence on AMAG to use commercially reasonable efforts to commercialize Vyleesi.
- Risk of AMAG materially breaching its obligation, potentially leading to termination of the license agreement.
- Need for the assignee of the Vyleesi license to expressly agree to be bound by the existing license agreement.