Full Press Release Details
Palatin Technologies, Inc. Reports First Quarter
Fiscal Year 2021 Results and Provides Business Update
Regained North American Rights to Vyleesi for HSDD with
Palatin Receiving $12 Million from AMAG Plus $4.3 Million Due March
Phase 2 Clinical Results of PL9643 for the Treatment of Dry Eye
Disease on Track for December 2020
$86.6 Million in Cash and Cash Equivalents as of September 30,
Conference Call Today at 11:00 AM ET
CRANBURY, NJ November 17, 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 results for
its first quarter ended September 30, 2020.
First Quarter Ended September 30, 2020 Financial
quarter was $(3.9) million, or $(0.02) per share, compared to a net
loss of $(4.5) million, or $(0.02) per share for the comparable
sales for the period July 25 to September 30 amounted to $809,100.
Recognized $(288,560) in Vyleesi product revenue, net of allowances
no contract and license revenue for the quarter, compared to
$97,379 for the comparable quarter of 2019;
operating expenses for the quarter were $3.7 million, including a
$1.6 million gain on the license termination agreement, compared to
$5.0 million for the comparable quarter of 2019;
of September 30, 2020, the Company had $86.6 million in cash and
cash equivalents and $5.0 million in accounts receivable, compared
to $82.9 million in cash and cash equivalents and no accounts
receivable as of June 30, 2020, with no outstanding
Highlights and Updates
regained exclusive North American rights to market Vyleesi
(bremelanotide injection), 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;
activities: solidified the distribution network and procedures,
improved contact with prescribers and healthcare providers through
virtual meetings, increased insurance reimbursement coverage, and
initiated a highly-selective digital marketing and telemedicine
campaign to rebuild awareness and demand among pre-menopausal women
with initial geo-targeting to top prescriber and digital
enrollment of a Phase 2 clinical study with PL9643 for the
treatment of dry eye disease (DED). Data readout expected December
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 have made significant progress and improvement on Vyleesi
commercial activities, specifically around insurance reimbursement
and expanded coverage. This put us in the proper position as we
initiated a targeted marketing digital campaign to raise condition
and treatment awareness with premenopausal women,
stated Carl Spana, Ph.D.,
President and CEO of Palatin.
"Despite the challenges posed by the ongoing viral pandemic, we are
on track for data readout next month on our PL9643 Phase 2 clinical
study in subjects with dry eye disease. Most people living with dry eye disease suffer
from episodic flare-ups. These flares can be caused by a multitude
of triggers and frequently are not sufficiently addressed by
Hypoactive Sexual Desire Disorder (HSDD) / Vyleesi
(bremelanotide injection)
In July 2020, Palatin announced the mutual termination of its
License Agreement with AMAG Pharmaceutical, Inc, for Vyleesi. Under
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 transferred information,
data, and assets related exclusively to Vyleesi, including existing
inventory. AMAG is providing certain transitional services to
Palatin for a period to ensure continued patient access to Vyleesi
and regulatory compliance during the transition back to Palatin.
Palatin is reimbursing AMAG for the agreed upon costs of the
transition services.
Palatin is exploring its options to enhance the commercialization
of Vyleesi, including 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
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 working with
payers and healthcare professionals to ensure women with HSDD have
continued and affordable access to Vyleesi. Vyleesi remains
commercially available through specialty pharmacies Avella and
BioPlus. Patients also can connect with a healthcare provider
through telemedicine. Patients and healthcare providers can learn
more about HSDD and Vyleesi at www.vyleesi.com.
is the first 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
autoinjector pen for use in anticipation of a sexual
Anti-Inflammatory / Autoimmune Programs
Enrollment in a Phase 2 clinical study with PL9643 for the
treatment of dry eye disease was completed in August 2020. Data
readout is targeted for December of 2020. If results from the Phase 2 study support
advancing to Phase 3, the Company will initiate a Phase 3 efficacy
study as early as mid-calendar year 2021.
A Phase 2 proof-of-concept clinical study with an oral formulation
of PL8177 in ulcerative colitis patients is targeted to start in