ptn_ex991
Palatin Reports Fourth Quarter and Full Year
Fiscal Year 2021 Financial Results and Provides Corporate
Update
●
Phase 3 Pivotal Study of PL9643 in Patients with Dry Eye Disease
Currently Expected to Start Next Quarter with Top-Line Results
Expected in the Second Half Calendar 2022
●
Phase 2 Clinical Study of PL8177 in Patients with Ulcerative
Colitis Currently Expected to Start Next Quarter with Top-Line
Results Expected in the Second Half Calendar 2022
●
$60.1 Million in Cash and Cash Equivalents at June 30, 2021 –
Projected Cash Runway Through Calendar 2022
●
Teleconference and Webcast today at 11:00 a.m. Eastern
Time
CRANBURY,
NJ, September 29, 2021/PRNewswire/ -- Palatin Technologies, Inc.,
(NYSE American: PTN), a biopharmaceutical company developing
first-in-class medicines based on molecules that modulate the
activity of the melanocortin peptide receptor systems, today
announced results for its fourth quarter and fiscal year ended June
30, 2021.
“During
the past year, we worked diligently advancing our lead
investigational compound PL9643 through a successful Phase 2
clinical trial, towards a pivotal Phase 3 clinical trial for the
treatment of dry eye disease, currently one of the largest markets
in ophthalmology,” stated Carl Spana, Ph.D., President
and CEO of Palatin. “We believe that, if approved,
PL9643’s quick onset of efficacy, favorable tolerability, and
safety profile has the potential to be a first-line therapy for the
millions of individuals suffering from DED.”
Dr.
Spana further commented, “Our strong cash position of $60.1
million at June 30, 2021, provides us with a sufficient operating
cash runway through calendar year 2022, allowing us to advance our
novel melanocortin-based programs, including top-line data readouts
for our Phase 3 DED clinical trial and our PL8177 Phase 2 clinical
trial for ulcerative colitis in the second half of calendar year
2022.”
Recent Highlights and Upcoming Events
●
Anti-Inflammatory / Autoimmune Programs
—
PL9643
melanocortin agonist for the treatment of dry eye disease
(DED):
■
Announced the
completion of its End-of-Phase 2 (EOP2) meeting with the Food and
Drug Administration (FDA). The EOP2 meeting included all aspects of
PL9643's development plan, with the FDA and Palatin reaching
agreement on all key elements of a pivotal Phase 3 clinical
program, including study design, endpoints, interim assessment, and
patient population. In addition, a potential second Phase 3 study
and long-term safety study were discussed to support a New Drug
Application (NDA).
■
Palatin remains on
track to initiate the Phase 3 program in DED patients during the
fourth quarter of calendar year 2021, with data readout expected in
the second half of calendar year 2022.
■
Presented Phase 2
clinical trial results for PL9643 in DED at the American Society of
Cataract and Refractive Surgery Annual Meeting.
■
Presented Phase 2
clinical trial results for PL9643 in DED and preclinical data in
retinal disease, at the Association for Research in Vision and
Ophthalmology (ARVO) 2021 Annual Meeting.
—
PL8177
melanocortin agonist for the treatment of ulcerative
colitis:
■
A Phase 2 oral
formulation study of PL8177 in ulcerative colitis is currently
scheduled to start the fourth quarter of calendar year 2021, with
data readout expected in the second half of calendar year
2022.
—
Two featured
speaker presentations on Vyleesi and two poster presentations of
PL9643 and PL8177 at the TIDES USA hybrid conference.
—
Hosted a Key
Opinion Leader webinar 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. Introduced the Company’s growing portfolio of
melanocortin agonists to treat the harmful effects of inflammation
in the eye.
—
Presenting the
protective effects of PL8331 and PL9654 in mouse models of
retinopathy, scheduled at the 2021 Annual Meeting of the American
Society of Retina Specialists (ASRS), being held October 8-12,
2021.
●
Senior Leadership Additions –
Appointed Michael B. Raizman, M.D. as Chief Medical
Officer; James E. Hattersley as Senior Vice President of
Business Development; and, J. Don Wang, Ph.D. as Vice
President of Product Development.
●
Vyleesi® (bremelanotide injection) /
Hypoactive Sexual Desire Disorder (HSDD). Palatin’s
goal with the Vyleesi program is to demonstrate value in the
marketplace by increasing HCP awareness, patient engagement, and
market access, with an objective of re-licensing the U.S. rights to
a committed women’s healthcare company.
—
For the quarter
ended June 30, 2021:
■
Gross product
sales increased 28%, net revenue increased 149%, and total
prescriptions increased 17%, over the quarter ended December 31,
2020 (Palatin’s first full quarter of Vyleesi
operations).
■
Gross product
sales decreased 32%, net revenue decreased 9%, and total
prescriptions decreased 5%, over the prior quarter ended March 31,
2021.
■
Refill rates
increased over the quarters ended December 31, 2020, and March 31,
2021.
■
Market access and
reimbursement coverage increased over the quarters ended December
31, 2020, and March 31, 2021.
—
Patients and
healthcare providers can learn more about HSDD and Vyleesi at
www.vyleesi.com.
Fourth Quarter and Fiscal Year Ended 2021 Financial
Results
Revenue
Total
net revenues consist of net product revenues of Vyleesi and license
and contract revenue.
Vyleesi
gross sales for the quarter and year ended June 30, 2021, amounted
to $1.2 million and $4.7 million, respectively, with net product
revenue, net of allowances and accruals, of $80,504 and ($283,286),
respectively. Palatin recognized no product revenues for the
quarter and year ended June 30, 2020.
Palatin
recognized $94,689 in the license and contract revenue for the
quarter and year ended June 30, 2021, related to our license
agreement with Kwangdong, compared to $117,989 for the year ended
June 30, 2020, related to our license agreement with AMAG
Pharmaceuticals.
Operating Expenses
Total
operating expenses for the quarter and year ended June 30, 2021,
were $13.9 million and $33.2 million, respectively, compared to
$7.4 million and $23.7 million, respectively, for the same periods
of 2020.
The
increase in operating expenses for 2021 was primarily due to the
recognition of non-cash expenses on the Vyleesi license termination
agreement and the increase in selling, general and administrative
expenses, offset by a decrease in research and development
expenses.
Other Income/Expense, net
Total
other expense, net, for the quarter and year ended June 30, 2021,
was $231,551 and $212,394, respectively, compared to total other
income, net of $90,667 and $1.2 million, respectively, for the same
periods in 2020.
The
differences are related primarily to the decrease in investment
income and secondarily to the recognition of foreign currency
losses.
Cash Flows
Palatin’s
net cash used in operations for the quarter and year ended June 30,
2021, was $8.5 million and $22.6 million, respectively, compared to
net cash used in operations of $6.1 million and net cash provided
by operations of $41.3 million, respectively, for the same periods
in 2020.
Net Loss
Palatin’s
net loss for the quarter and year ended June 30, 2021, was $13.9
million and $33.6 million, or $0.06 and $0.14 per basic and diluted
common share, respectively, compared to a net loss of $7.3 million
and $22.4 million, or $0.03 and $0.10 per basic and diluted common
share, respectively, for the same periods in 2020.
The
difference between the quarter and year ended June 30, 2021, and
2020, was primarily due to an increase in selling, general and
administrative expenses pursuant to Palatin’s reacquisition
of all development and commercialization rights to Vyleesi in North
America in July 2020, and secondarily, related to the recognition
of a non-cash loss on the Vyleesi license termination
agreement.
Cash Position
As of
June 30, 2021, Palatin’s cash and cash equivalents were $60.1
million with $1.6 million of accounts receivable, compared to cash
and cash equivalents of $82.9 million with no accounts receivable,
as of June 30, 2020. Based on its current operating plan, Palatin
believes that existing cash and cash equivalents will be sufficient
to fund currently anticipated operating expenses through the end of
calendar year 2022.
Conference Call / Webcast
Palatin
will host a conference call and audio webcast on September 29,
2021, at 11:00 a.m. Eastern Time to discuss the results of
operations in greater detail and provide an update on corporate
developments. Individuals interested in listening to the conference
call live can dial 1-800-437-2398 (US/Canada) or 1-856-344-9206
(international), conference ID 3395813. The audio webcast and
replay can be accessed by logging on to the
“Investor/Webcasts” section of Palatin’s website
at http://www.palatin.com. A telephone and audio webcast replay
will be available approximately one hour after the completion of
the call. To access the telephone replay, dial 1-888-203-1112
(US/Canada) or 1-719-457-0820 (international), passcode 3395813.
The webcast and telephone replay will be available through October
6, 2021.
About Melanocortin Receptor Agonists and Inflammation
The
melanocortin receptor ("MCr") system has effects on inflammation,
immune system responses, metabolism, food intake, and sexual
function. There are five melanocortin receptors, MC1r through MC5r.
Modulation of these receptors, through use of receptor-specific
agonists, which activate receptor function, or receptor-specific
antagonists, which block receptor function, can have medically
significant pharmacological effects.
Many
tissues and immune cells located in the eye (and other places, like
the gut and kidney) express melanocortin receptors, empowering our
opportunity to directly activate natural pathways to resolve
disease inflammation.
About Palatin
Palatin
is a biopharmaceutical company developing first-in-class medicines
based on molecules that modulate the activity of the melanocortin
and natriuretic peptide receptor systems, with targeted,
receptor-specific product candidates for the treatment of diseases
with significant unmet medical need and commercial potential.
Palatin’s strategy is to develop products and then form
marketing collaborations with industry leaders to maximize their
commercial potential. For additional information regarding Palatin,
please visit Palatin’s website at
www.palatin.com.
Forward-looking Statements
Statements
in this press release that are not historical facts, including
statements about future expectations of Palatin Technologies, Inc.,
such as statements about market potential of Vyleesi and other
Palatin products in development, clinical trial results, potential
actions by regulatory agencies including the FDA, regulatory plans,
development programs, proposed indications for product candidates,
market potential for product candidates, and potential adverse
impacts due to the global COVID-19 pandemic such as delays in
regulatory review, manufacturing and supply chain interruptions,
adverse effects on healthcare systems and disruption of the global
economy, are “forward-looking statements” within the
meaning of Section 27A of the Securities Act of 1933, Section 21E
of the Securities Exchange Act of 1934 and as that term is defined
in the Private Securities Litigation Reform Act of 1995. Palatin
intends that such forward-looking statements be subject to the safe
harbors created thereby. Such forward-looking statements involve
known and unknown risks, uncertainties and other factors that could
cause Palatin’s actual results to be materially different
from its historical results or from any results expressed or
implied by such forward-looking statements. Palatin’s actual
results may differ materially from those discussed in the
forward-looking statements for reasons including, but not limited
to, Palatin's ability to establish and maintain the capability for
manufacturing, marketing and distribution of Vyleesi, sales of
Vyleesi in the United States and elsewhere in the world, results of
clinical trials, regulatory actions by the FDA and other regulatory
and the need for regulatory approvals, Palatin’s ability to
fund development of its technology and establish and successfully
complete clinical trials, the length of time and cost required to
complete clinical trials and submit applications for regulatory
approvals, products developed by competing pharmaceutical,
biopharmaceutical and biotechnology companies, commercial
acceptance of Palatin’s products, and other factors discussed
in Palatin’s periodic filings with the Securities and
Exchange Commission. Palatin is not responsible for updating for
events that occur after the date of this press
release.
Palatin
Investor Inquiries:
|
|
Palatin Media Inquiries:
|
Stephen T. Wills,
CPA, MST
|
|
Paul Arndt, MBA,
LifeSci Advisors
|
CFO/COO (609)
495-2200
|
|
Managing Director
(646) 597-6992
|
Info@Palatin.com
|
|
Paul@LifeSciAdvisors.com
|
Vyleesi®
is a registered trademark of Palatin.
(Financial Statement Data Follows)
PALATIN
TECHNOLOGIES, INC.
|
|
Consolidated
Statements of Operations
|
|
|
|
|
|
|
|
Three
Months Ended June 30,
|
|
|
|
|
|
|
|
|
|
|
|
REVENUES
|
|
|
|
|
Product revenue,
net
|
$80,504
|
$-
|
$(283,286)
|
$-
|
License and
contract
|
94,689
|
-
|
94,689
|
117,989
|
|
175,193
|
-
|
(188,597)
|
117,989
|
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
|
Cost of products
sold
|
37,800
|
-
|
147,840
|
-
|
Research and
development
|
3,481,800
|
3,933,034
|
12,926,559
|
13,959,397
|
Selling, general
and administrative
|
5,950,339
|
3,456,805
|
17,336,913
|
9,765,372
|
Loss on license
termination agreement
|
4,407,987
|
-
|
2,784,192
|
-
|
Total operating
expenses
|
13,877,926
|
7,389,839
|
33,195,504
|
23,724,769
|
|
|
|
|
|
Loss from
operations
|
(13,702,733)
|
(7,389,839)
|
(33,384,101)
|
(23,606,780)
|
|
|
|
|
|
OTHER (EXPENSE)
INCOME
|
|
|
|
|
Investment
income
|
3,803
|
98,977
|
23,572
|
1,200,898
|
Foreign currency
loss
|
(221,274)
|
-
|
(212,526)
|
-
|
Interest
expense
|
(14,080)
|
(8,310)
|
(23,440)
|
(20,141)
|
Total other
(expense) income, net
|
(231,551)
|
90,667
|
(212,394)
|
1,180,757
|
|
|
|
|
|
NET
LOSS
|
$(13,934,284)
|
$(7,299,172)
|
$(33,596,495)
|
$(22,426,023)
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
net loss per common share
|
$(0.06)
|
$(0.03)
|
$(0.14)
|
$(0.10)
|
|
|
|
|
|
Weighted average
number of common shares outstanding used in computing basic and
diluted net loss per common share
|
237,025,231
|
235,394,831
|
236,650,101
|
234,684,776
|
|
|
|
|
|
(Financial Statement Data Follows)
PALATIN TECHNOLOGIES, INC.
|
|
Consolidated
Balance Sheets
|
|
|
|
|
|
|
|
ASSETS
|
|
|
Current
assets:
|
|
|
Cash and cash
equivalents
|
$60,104,919
|
$82,852,270
|
Accounts
receivable
|
1,580,443
|
-
|
Inventories
|
1,162,000
|
-
|
Prepaid expenses
and other current assets
|
3,059,679
|
738,216
|
Total current
assets
|
65,907,041
|
83,590,486
|
|
|
|
Property and
equipment, net
|
94,817
|
140,216
|
Right-of-use
assets
|
1,237,813
|
1,266,132
|
Other
assets
|
56,916
|
56,916
|
Total
assets
|
$67,296,587
|
$85,053,750
|
|
|
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|
|
Current
liabilities:
|
|
|
Accounts
payable
|
$640,650
|
$715,672
|
Accrued
expenses
|
5,797,378
|
2,899,097
|
Short-term
operating lease liabilities
|
351,853
|
312,784
|
Other current
liabilities
|
3,721,907
|
-
|
Total current
liabilities
|
10,511,788
|
3,927,553
|
|
|
|
Long-term operating
lease liabilities
|
900,520
|
953,348
|
Other long-term
liabilities
|
6,232,907
|
-
|
Total
liabilities
|
17,645,215
|
4,880,901
|
|
|
|
|
|
|
Stockholders’
equity:
|
|
|
Preferred stock of
$0.01 par value – authorized 10,000,000 shares; shares issued
and outstanding designated as follows:
|
|
|
Series A
Convertible: authorized 264,000 shares: issued and outstanding
4,030 shares as of June 30, 2021 and June 30, 2020
|
40
|
40
|
Common stock of
$0.01 par value – authorized 300,000,000 shares:
|
|
|
issued and
outstanding 230,049,691 shares as of June 30, 2021 and 229,258,400
shares as of June 30, 2020
|
2,300,497
|
2,292,584
|
Additional paid-in
capital
|
399,146,232
|
396,079,127
|
Accumulated
deficit
|
(351,795,397)
|
(318,198,902)
|
Total
stockholders’ equity
|
49,651,372
|
80,172,849
|
Total liabilities
and stockholders’ equity
|
$67,296,587
|
$85,053,750
|
|
|
|