Palatin Technologies Inc. (NYSE MKT:PTN) Q4 2020 Earnings Conference Call - Final Transcript

Sep 28, 2020 • 11:00 am ET

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Palatin Technologies Inc. (NYSE MKT:PTN) Q4 2020 Earnings Conference Call - Final Transcript

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Executive
Stephen T. Wills

we received in July 2020 from AMAG, plus an additional $4.3 million due from AMAG, March 31, '21, provides us the financial resources to significantly advance our anti-inflammatory and autoimmune programs and make complementary targeted investments to our Vyleesi program.

Moving over to Vyleesi. Vyleesi is FDA-approved for premenopausal women with hypoactive sexual desire disorder, or HSDD. Vyleesi is the first and only FDA-approved product for the as needed treatment for premenopausal women who experience distress or interpersonal difficulty due to low sexual desire. This treatment is available as a subcutaneous self-injection in a prefilled disposable auto-injector pen for use in anticipation of a sexual encounter. It is estimated that HSDD affects one and 10 premenopausal women.

As an historical recap, Palatin licensed the North American rights to Vyleesi to AMAG in the first quarter of 2017, we received $60 million as an upfront payment. During the period of the second quarter of 2017 through the first quarter of 2018, Palatin received $25 million as cost reimbursements, and a $20 million regulatory milestone for the NDA acceptance by the FDA. Vyleesi was approved by the FDA in June of 2019, Palatin received a $60 million regulatory milestone at that time. In the aggregate, we've received approximately $165 million since the first quarter of 2017.

In January of 2020, AMAG announced that after a strategic review of its assets and business model, it decided to commence a process to divest Vyleesi and another female healthcare product. In July of 2020, Palatin announced the mutual termination of its license agreement with AMAG for Vyleesi. Under the terms of the termination agreement, Palatin regained all North American development, commercialization rights for Vyleesi.

AMAG made a $12 million payment to Palatin at closing and will make a $4.3 million payment to Palatin on March 31, 2021. Palatin assumed all Vyleesi manufacturing agreements, and AMAG will transfer all information, data and assets related exclusively to Vyleesi, including, but not limited to existing inventory valued added cost of approximately $15 million. AMAG will provide certain transitional services to Palatin for a period of time to ensure continued patient access to Vyleesi and regulatory compliance during the transition period back to Palatin.

Palatin will reimburse AMAG for the agreed-upon cost of the transition services. We believe that Vyleesi is an important treatment for the millions of premenopausal women suffering from HSDD. Our goal with the Vyleesi program is to demonstrate value in the marketplace by increasing patient demand and access. Our objective is to relicense the U.S. rights to a committed women's healthcare company.

Having taken steps to ensure no disruption for patient access to Vyleesi, we are working to expand awareness of the condition and treatment in a highly targeted and informed manner, enhance and streamline patient access, and increase insurance coverage.

Palatin is exploring its options pertaining to enhancing the commercialization of Vyleesi, including, but not limited to, discussions with potential collaboration partners that currently market female healthcare products. Palatin continues collaboration discussions for territories