Full Press Release Details
Palatin Technologies, Inc. Announces Fourth Quarter
Fiscal Year 2020 Financial Results and Provides a Business
$82.9 Million in Cash and Cash Equivalents at June 30,
Mutual Termination of License Agreement with AMAG
Pharmaceuticals for Vyleesi in July 2020 Resulted in Palatin
Receiving $12 Million from AMAG Plus $4.3 Million Due March 31,
Phase 2 Study Data of PL9643 for the Treatment of Dry Eye Disease
Expected in Fourth Calendar Quarter of
Teleconference and Webcast to be held on September 28,
CRANBURY, NJ September 28, 2020 Palatin
Technologies, Inc. (NYSE American: PTN), a specialized
biopharmaceutical company developing first-in-class medicines based
on molecules that modulate the activity of the melanocortin and
natriuretic peptide receptor systems, today announced financial
results for its fourth quarter and fiscal year ended June 30,
Fourth Quarter and Fiscal Year 2020 Financial
fourth quarter ended June 30, 2020 was $(7.3) million, or $(0.03)
per basic and diluted share, compared to net income of $52.2
million, or $0.25 per basic and $0.23 per diluted share for the
comparable quarter of 2019;
year ended June 30, 2020 was $(22.4) million, or $(0.10) per basic
and diluted share, compared to net income of $35.8 million, or
$0.17 per basic and $0.16 per diluted share for the year ended June
between the quarter and year ended June 30, 2020 compared to the
quarter and year ended June 30, 2019 was due to the recognition of
license and contract revenue pursuant to our license agreement with
AMAG of $60.3 million for the quarter and year ended June 30,
2020, the Company had $82.9 million in cash and cash equivalents,
compared to $43.5 million as of June 30, 2019, and no
Recent Business Highlights and Updates
mutually terminated the January 2017 license agreement granting
AMAG Pharmaceuticals ("AMAG") exclusive North American rights to
market Vyleesi (bremelanotide), the first and only on demand
treatment for premenopausal women suffering from acquired,
generalized, hypoactive sexual desire disorder (HSDD), a condition
affecting one in ten premenopausal women;
enrollment of a Phase 2 clinical study with PL9643 for the
treatment of dry eye disease (DED). Final patient and topline data
readout is targeted for the fourth calendar quarter of
proof-of-concept clinical study with an oral formulation of PL8177
in ulcerative colitis patients is targeted to start in the first
half of calendar year 2021.
"We are pleased to have completed enrollment last month in our
PL9643 Phase 2 clinical study in subjects with dry eye disease.
Data readout is targeted for
the fourth calendar quarter of 2020. We believe that, if approved, PL9643's
potentially quick onset to efficacy and favorable tolerability and
safety profile may provide a treatment option to the millions of
individuals suffering from DED, stated Carl Spana,
Ph.D., President and CEO of Palatin.
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 re-license 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 stream-line
patient access, and increase insurance
Spana further commented, Our strong cash position of $83
million at June 30, 2020 and no debt, coupled with the $12 million
received in July 2020 from AMAG, plus an additional $4.3 million
due from AMAG March 31, 2021, provides us the financial resources
to significantly advance our Anti-Inflammatory and Autoimmune
programs, and make complimentary targeted investments to our
entire Palatin team thanks healthcare workers across the nation for
their selfless efforts in the treatment and care of COVID-19
patients. I would also like to thank all of our employees for their
dedication and commitment to ensure the advancement of our
development programs and clinical trial patient support,
continued Spana. Although Palatin has experienced
limited adverse impact on operations from the pandemic, we are
cognizant there may be further disruptions to business activity
based on a resurgence of the virus and have taken steps to be as
prepared as possible for this potential
Hypoactive Sexual Desire Disorder (HSDD) / Vyleesi
(bremelanotide injection)
In July 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 and commercialization rights for Vyleesi. AMAG made a
$12.0 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. 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 back to Palatin. Palatin will
reimburse AMAG for the agreed upon costs of the transition
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 outside the currently licensed
territories of China and Korea and anticipates executing multiple
agreements through calendar year 2021.
In the interim, the Company's strategy implements an informed and
highly targeted approach to marketing, focusing on telemedicine,
social media, and digital advertising. The Company is committed to