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Palatin Reports Financial Results for the Third Fiscal Quarter of 2021 and Provides Corporate Update ● Phase 3 Clinical Study of PL9643 in Patients with Dry Eye Disease Planned for Second Half Calendar 2021 &#x25C

Key Takeaway: Palatin Reports Financial Results for the Third Fiscal Quarter of 2021 and Provides Corporate Update Phase 3 Clinical Study of PL9643 in Patients with Dry Eye Disease Planned for Second Half Calendar 2021 Phase 2 Clinical Study of PL8177 in Patients with Ulcerative Colitis P

Full Press Release Details

Palatin Reports Financial Results for the Third Fiscal Quarter of
2021 and Provides Corporate Update
Phase 3 Clinical Study of PL9643 in Patients with Dry Eye Disease
Planned for Second Half Calendar 2021
Phase 2 Clinical Study of PL8177 in Patients with Ulcerative
Colitis Planned for Second Half Calendar 2021
Vyleesi Gross Product Sales Up 89%, Net Revenue Up 154%,
Prescriptions Increased 24% Compared to Prior Quarter
$68.6 Million in Cash and Cash Equivalents as of March 31,
Teleconference and Webcast to be Held Today at 11:00 AM
CRANBURY, NJ May 17, 2021 Palatin (NYSE American:
PTN), a biopharmaceutical company developing first-in-class
medicines based on molecules that modulate the activity of the
melanocortin peptide receptor system, today announced results for
its third fiscal quarter ended March 31, 2021.
I am excited with Palatin's evolution
and development advancements utilizing our proprietary melanocortin
agonists to treat patients with inflammatory and autoimmune
conditions, stated Carl Spana, Ph.D., President and CEO
of Palatin. We are hosting a KOL webinar on May
to introduce our growing portfolio of
melanocortin agonists to treat the harmful effects of inflammation
in the eye. On the clinical front, we are targeting to commence a
Phase 3 trial of PL9643 in patients with dry eye disease in the
second half of calendar year 2021. The emerging profile of PL9643,
with its rapid therapeutic onset and excellent tolerability
profile, is a potentially distinct advantage over commercially
available dry eye therapies. In addition, we are targeting to
commence a Phase 2 study with an oral formulation of PL8177 in
ulcerative colitis patients in the second half of calendar year
I am also pleased with the progress we have made with the
Vyleesi program, continued Spana. Our quarter ended
March 31, 2021 reflected significant increases in gross sales, net
sales, prescriptions, and insurance coverage over the prior
Business Highlights and Updates
Anti-Inflammatory / Autoimmune Programs
for the treatment of dry eye disease (DED):
positive results from its Phase 2 clinical study reflecting
statistically significant improvements in multiple signs and
symptoms in the moderate to severe patient population after 2 weeks
of dosing and at the 12-week visit. There were no safety signals
identified and PL9643 had excellent ocular
Phase 3 clinical trial is currently planned for the second half of
calendar year 2021, with data readout potentially in the first half
of calendar year 2022.
two presentations of the Company's melanocortin platform,
including Phase 2 clinical trial results for PL9643 in dry eye
disease and preclinical data in retinal disease, at the Association
for Research in Vision and Ophthalmology (ARVO) 2021 Annual
Meeting, held virtually May 1-7, 2021.
for the treatment of ulcerative colitis:
Phase 2 proof-of-concept clinical study with an oral formulation of
PL8177 in ulcerative colitis patients is targeted to start second
half of calendar year 2021, with data readout potentially in
mid-calendar year 2022.
Opinion Leader webinar planned for May 21, 2021 on melanocortin
agonists for treating ocular indications, with a primary focus on
PL9643 and data from the Company's recently completed Phase 2
clinical trial for dry eye disease:
the Company's growing portfolio of melanocortin agonists to
treat the harmful effects of inflammation in the eye.
Vyleesi (bremelanotide injection) / Hypoactive Sexual Desire
ended March 31, 2021 gross product sales increased 89%, net revenue
increased 154%, and prescriptions increased 24%, over the prior
quarter ended December 31, 2020.
marketing efforts expected to drive healthcare provider and
consumer engagement. The current digital campaign applications
reach thousands of healthcare providers and millions of
premenopausal women monthly and has resulted in increased website
and telemedicine traffic and conversions.
Company continues to focus on expanding access and reimbursement
coverage. The Company estimates that it has achieved approximately
75% of commercially insured lives and approximately 50% of
commercial formulary coverage, including two of the three major
pharmacy benefit managers and numerous regional plans.
increases and expanding access and reimbursement coverage have
resulted in more favorable gross-to-net adjustments and positive
quarterly net product revenue for the first time.
has filed an election to extend the patent term of U.S. patent
6,794,489 to June 26, 2025. This Vyleesi patent has claims to the
bremelanotide composition of matter as well as methods for
stimulating sexual response.
Third Quarter 2021 Results
Total net revenues, consisting of net product revenues of Vyleesi,
were $88,741. There was no revenue reported for the third quarter
gross sales amounted to $1,780,020, with net product revenue of
$88,741, net of allowances and accruals, compared to gross sales
for the prior quarter ended December 31, 2020 of $943,950, with net
product revenue of $(163,971), net of allowances and
Total operating expenses were $6.6 million, compared to $5.7
million for the same period in 2020. The increase was mainly due to
commercial expenses related to Vyleesi.
Palatin's net loss was $(5.7) million, or $(0.02) per share,
compared to a net loss of $(5.4) million, or $(0.02) per share, for
the comparable quarter of 2020.
As of March 31, 2021, the Company had $68.6 million in cash and
cash equivalents and $1.9 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
Conference Call / Webcast
Last updated: May 17, 2021