Full Press Release Details
Palatin Technologies, Inc. Reports Fourth Quarter and
Fiscal Year 2018 Results
Vyleesi New Tradename for Bremelanotide
PDUFA Target Action Date of March 23, 2019 for Vyleesi
Teleconference and Webcast to be held on September 13,
CRANBURY, NJ September 13, 2018 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 for the treatment of diseases with significant unmet
medical need and commercial potential, today announced results for
its fourth quarter and fiscal year ended June 30,
The last year has been very productive for Palatin, most
notably the acceptance of the Vyleesi (bremelanotide) NDA by
the FDA, said Carl Spana, Ph.D., CEO and President of
Palatin. Going forward, the first quarter of calendar year
2019 could bring FDA approval for Vylessi a significant
milestone and major inflection point for Palatin, its employees,
its shareholders, and most importantly, the thousands of
premenopausal women seeking treatment for HSDD in the U.S.
2018 Highlights and Recent Events
Vyleesi (bremelanotide)
the trade name for bremelanotide - Under development for Hypoactive
Sexual Desire Disorder ( HSDD ):
June 2018, our exclusive North American Licensee for Vyleesi, AMAG
Pharmaceuticals, Inc. (NASDAQ: AMAG) ( AMAG ), was
notified by the U.S. Food and Drug Administration
( FDA ) of acceptance for the filing of the New Drug
Application ( NDA ) on Vyleesi, with an FDA PDUFA
(Prescription Drug User Fee Act) goal date for completion of the
FDA review of the NDA of March 23, 2019.
acceptance of the NDA triggered a $20 million milestone payment to
Palatin, less expenses paid by AMAG.
is entitled to receive up to $60 million upon regulatory approval
approved, Vyleesi would become the first and only on-demand
pharmacologic option indicated for the treatment of HSDD in
premenopausal women in the U.S.
Entered into a collaboration and license agreement
Pharmaceutical Industrial Development Co. Ltd.
( Fosun ), a subsidiary of Shanghai Fosun
Pharmaceutical (Group) Co., Ltd in September 2017 for exclusive
rights to develop and commercialize Vyleesi in the territories of
mainland China, Taiwan, Hong Kong S.A.R. and Macau
$4,500,000 in October 2017, consisting of an upfront payment of
$5,000,000 less $500,000, which was withheld in accordance with tax
withholding requirements in China.
into a license agreement with Kwangdong Pharmaceutical Co., Ltd.
( Kwangdong ) in November 2017 for exclusive rights to
develop and commercialize Vyleesi in the Republic of
$417,500 in December 2017, consisting of an upfront payment of
$500,000 less $82,500 which was withheld in accordance with tax
withholding requirements in the Republic of Korea.
Melanocortin Receptor 1 (MC1r)
Agonists under development for
the treatment of inflammatory and autoimmune diseases such as dry
eye, uveitis, diabetic retinopathy and inflammatory bowel
subcutaneous dosing of human subjects with PL-8177 in a Phase 1
single and multiple ascending dose clinical safety study, with data
expected in the fourth quarter of calendar 2018.
2018 Presented positive preclinical data on PL-8331 at
TIDES: Oligonucleotide and Peptide Therapeutics 2018
2018 Presented preclinical oral formulation data on
PL-8177, an investigational MC1r agonist for Inflammatory Bowel
Diseases at the 2018 Keystone Symposia on The Resolution of
Inflammation in Health and Disease.
debt from $14.8 million at June 30, 2017 to $7.2 million at June
Added to the Russell 3000
the company's intellectual property portfolio with several
filings and issuances during the year.
Fourth Quarter and Fiscal 2018 Financial Results
reported net income of $11.8 million, or $0.06 per basic and
diluted share, for the fourth quarter ended June 30, 2018, compared
to net income of $13.3 million, or $0.07 per basic and diluted
share, for the same period in 2017.
difference between the three months ended June 30, 2018 and 2017
was primarily attributable to the recognition of contract revenue
pursuant to our license agreement with AMAG of $20.6 million for
the quarter ended June 30, 2018 compared to $33.9 million in
fiscal year ended June 30, 2018, Palatin reported net income of
$24.7 million, or $0.12 per basic and diluted share compared to a
net loss of $(13.3) million, or $(0.07) per basic and diluted share
for the year ended June 30, 2017.
difference in net income for the year ended June 30, 2018, and the
net loss for the year ended June 30, 2017, was primarily
attributable to the recognition of $67.1 million in license and
contract revenue for the year ended June 30, 2018 compared to $44.7
million for the year ended June 30, 2017, and secondarily to a
$14.1 million decrease in operating expenses to $41.2 million for
the year ended June 30, 2018 compared to $55.3 million for the year
ended June 30, 2017.
quarter and year ended June 30, 2018, Palatin recognized $20.6
million and $62.1 million, respectively, in contract revenue
related to our license agreement with AMAG and an additional $5
million in license revenue for the year ended June 30, 2018 related
to our license agreement with Fosun.
quarter and year ended June 30, 2017, Palatin recognized $33.9
million and $44.7 million, respectively, in contract revenue
related to our license agreement with AMAG.
operating expenses for the quarter ended June 30, 2018 were $8.3
million compared to $19.6 million for the comparable quarter of