CRANBURY, N.J., Feb. 15, 2022 /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 and natriuretic peptide
receptor systems, today announced results for its fiscal
second quarter ended December 31,
2021.
"We are pleased to have initiated a Phase 3 pivotal study of
PL9643 in patients with dry eye disease and expect topline results
in the second half of calendar year 2022," stated Carl Spana, Ph.D., President and CEO of Palatin.
"Regarding Vyleesi, our focused plan continues to show positive
trends for our targeted value metrics related to commercial
insurance reimbursement and net revenue per dispensed
prescription."
Dr. Spana further commented, "Our strong cash position of
approximately $47 million at
December 31, 2021, provides us with a
sufficient operating cash runway through at least March 2023, including advancing our novel and
differentiating melanocortin-based programs, including topline data
readouts in the second half of calendar year 2022 for our Phase 3
pivotal study of PL9643 in dry eye disease and for our Phase 2
clinical trial of PL8177 in ulcerative colitis."
Second Quarter Ended Fiscal Year 2022 Financial
Highlights
- Net loss for the quarter ended December
31, 2021, was $8.7 million, or
$0.04 per common share, compared to a
net loss of $10.0 million, or
$0.04 per common share, for the same
period in 2020.
- As of December 31, 2021, the
Company had cash and investments of $47.3
million, compared to $53.4
million as of September 30,
2021, and $60.1 million as of
June 30, 2021, and no debt.
Business Highlights and Updates
- Anti-Inflammatory / Autoimmune Programs
-
- PL9643 melanocortin agonist for the treatment of dry eye
disease (DED):
-
- Initiated pivotal Phase 3 clinical program in DED patients in
December 2021. Topline data readout
expected in the second half of calendar year 2022.
- PL8177 melanocortin agonist for the treatment of ulcerative
colitis (UC):
-
- Presented the positive effects of PL8177 on treating UC in an
animal disease model, including genomic data characterizing the
anti-inflammatory effects of melanocortin agonists at the 2022
Crohn's and Colitis Congress.
- A Phase 2 oral formulation study of PL8177 in UC is currently
scheduled to start in the first half of calendar year 2022. Topline
data readout currently expected in the second half of calendar year
2022.
- Presented the protective effects of PL8331 and PL9654 in mouse
models of retinopathy, at the 2021 Annual Meeting of the American
Society of Retina Specialists (ASRS). Awarded "Top Ten Poster"
Designation.
- Vyleesi® (bremelanotide injection) / Hypoactive Sexual
Desire Disorder (HSDD): Goal of the Vyleesi program is to
demonstrate product value in the marketplace with an objective of
re-licensing the U.S. rights to a committed women's healthcare
company.
-
- For the quarter ended December 31,
2021:
-
- Gross product sales decreased 18% and net product revenue
increased 144%, over the comparable quarter in 2020.
- Gross product sales decreased 46% and net product revenue
decreased 55%, over the prior quarter ended September 30, 2021. This decrease was primarily a
result of the pharmacy distributors minimizing their end of year
inventory levels.
- Total prescriptions dispensed were flat compared to the same
period in 2020, and the prior quarter ended September 30, 2021.
- Commercial insurance reimbursement and net revenue per
prescription dispensed increased over the comparable quarter in
2020, and the prior quarter ended September
30, 2021.
- Patients and healthcare providers can learn more about HSDD and
Vyleesi at www.vyleesi.com and www.vyleesipro.com
- Research and Development Infrastructure: Continued to
strengthen the R&D department with key appointments who have
demonstrated a high-level of expertise in their fields to support
the advancement of our programs.
Second Fiscal Quarter Ended December
31, 2021 Financial Results
Revenue
Total revenue consists of gross product sales of Vyleesi, net of
allowances and accruals, and license and contract revenue.
Vyleesi gross product sales to pharmacy distributors for the
quarter ended December 31, 2021,
amounted to $0.8 million, with net
product revenue of $72,140, compared
to gross product sales of $0.9
million, with negative net product revenue of $(163,971), for the comparable quarter in 2020.
Gross product sales decreased 18% and net product revenue increased
144%, over the comparable quarter in 2020.
For the quarter ended December 31,
2021, Palatin recognized $250,000 in license and contract revenue pursuant
to its license agreement with Fosun Pharma. There were no license
revenues recognized during the comparable quarter in 2020.
Operating Expenses
Total operating expenses for the quarter ended December 31, 2021, were $8.8 million, compared to $9.1 million for the comparable quarter in
2020.
The decrease in operating expenses was the result of decreased
commercial expenses related to Vyleesi, offset by increased
research and development expenses primarily related to the
advancement of PL9643 into a pivotal phase 3 clinical trial.
Other (Expenses) / Income
Total other expenses, net, consist mainly of unrealized foreign
currency losses of $234,078 and
$745,002, respectively, for the
quarters ended December 31, 2021 and
2020.
Cash Flows
Palatin's net cash used in operations for the quarter ended
December 31, 2021, was $6.3 million, compared to net cash used in
operations of $14.4 million for the
same period in 2020. The decrease is mainly due to a one-time
negotiated payment of approximately $7
million in the quarter ended December
31, 2020 related to inventory purchase commitments of
Vyleesi, assumed as part of our Termination Agreement with AMAG
Pharmaceuticals, which included $16.3
million of payments by AMAG to Palatin.
Net Loss
Palatin's net loss for the quarter ended December 31, 2021, was $8.7 million, or $0.04 per basic and diluted common share compared
to a net loss of $10.0 million, or
$0.04 per basic and diluted common
share, for the same period in 2020.
The difference between the quarter ended December 31, 2021, and the quarter ended
December 31, 2020, was due to the
combination of the increase in revenue recognized, the decrease in
operating expenses and the decrease in unrealized foreign currency
losses recorded for the quarter ended December 31, 2021, compared to the same period in
2020.
Cash Position
As of December 31, 2021, Palatin's
cash and cash equivalents were $47.3
million with $0.6 million of
accounts receivable, compared to cash and cash equivalents of
$53.4 million with $0.9 million of accounts receivable as of
September 30, 2021 and $60.1 million of cash and cash equivalents with
$1.6 million of accounts receivable
as of June 30, 2021.
Based on its current operating plan, Palatin believes that
existing cash and cash equivalents will be sufficient to fund
currently anticipated operating expenses through at least
March 31, 2023.
Conference Call / Webcast
Palatin will host a conference call and audio webcast on
February 15, 2022 at 11:00 a.m. Eastern Time to discuss the quarter
ended December 31, 2021 results of
operations in greater detail and provide an update on corporate
developments. Individuals interested in listening to the conference
call live can dial 1-800-289-0720 (US/Canada) or 1-856-344-9142 (International),
conference ID 8966903. 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 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 8966903. The webcast and telephone replay
will be available through February 22,
2022.
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, for example 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 and follow
Palatin on Twitter at @PalatinTech.
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 Technologies® and Vyleesi® are registered trademarks of
Palatin Technologies, Inc.
(Financial Statement Data Follows)
PALATIN
TECHNOLOGIES, INC.
|
and
Subsidiary
|
Consolidated
Statements of Operations
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
December 31,
|
|
Six Months Ended
December 31,
|
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
|
|
|
|
|
|
|
|
|
|
REVENUES
|
|
|
|
|
|
|
|
|
Product
revenue, net
|
$
72,140
|
|
$
(163,971)
|
|
$
231,622
|
|
$
(452,531)
|
|
License
and contract
|
250,000
|
|
-
|
|
250,000
|
|
-
|
|
|
322,140
|
|
(163,971)
|
|
481,622
|
|
(452,531)
|
|
OPERATING
EXPENSES
|
|
|
|
|
|
|
|
|
Cost of products sold
|
29,171
|
|
29,400
|
|
83,104
|
|
54,600
|
|
Research
and development
|
5,426,397
|
|
4,011,418
|
|
8,911,161
|
|
6,935,269
|
|
Selling,
general and administrative
|
3,317,760
|
|
5,044,913
|
|
7,154,302
|
|
7,376,519
|
|
Gain on
license termination agreement
|
-
|
|
-
|
|
-
|
|
(1,623,795)
|
|
Total operating expenses
|
8,773,328
|
|
9,085,731
|
|
16,148,567
|
|
12,742,593
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
(8,451,188)
|
|
(9,249,702)
|
|
(15,666,945)
|
|
(13,195,124)
|
|
|
|
|
|
|
|
|
|
|
OTHER (EXPENSE)
INCOME
|
|
|
|
|
|
|
|
|
Investment income
|
1,563
|
|
4,800
|
|
2,973
|
|
16,935
|
|
Foreign
currency loss
|
(234,078)
|
|
(745,002)
|
|
(126,719)
|
|
(745,002)
|
|
Interest
expense
|
(2,773)
|
|
(1,871)
|
|
(8,404)
|
|
(9,360)
|
|
Total other (expense), net
|
(235,288)
|
|
(742,073)
|
|
(132,150)
|
|
(737,427)
|
|
|
|
|
|
|
|
|
|
|
NET LOSS
|
$
(8,686,476)
|
|
$
(9,991,775)
|
|
$(15,799,095)
|
|
$(13,932,551)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
$
(0.04)
|
|
$
(0.04)
|
|
$
(0.07)
|
|
$
(0.06)
|
|
|
|
|
|
|
|
|
|
|
Weighted average
number of common shares outstanding used in computing basic and
diluted net loss per common share
|
238,276,793
|
|
236,405,065
|
|
238,256,318
|
|
236,375,463
|
|
PALATIN
TECHNOLOGIES, INC.
|
and
Subsidiary
|
Consolidated
Balance Sheets
|
(unaudited)
|
|
|
|
|
|
December 31,
2021
|
|
June 30,
2021
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and
cash equivalents
|
$
47,325,547
|
|
$
60,104,919
|
Accounts
receivable
|
583,991
|
|
1,580,443
|
Inventories
|
1,078,896
|
|
1,162,000
|
Prepaid expenses and other current
assets
|
2,379,693
|
|
3,059,679
|
Total current assets
|
51,368,127
|
|
65,907,041
|
|
|
|
|
Property and
equipment, net
|
511,316
|
|
94,817
|
Right-of-use assets -
operating leases
|
1,058,241
|
|
1,237,813
|
Other
assets
|
56,916
|
|
56,916
|
Total assets
|
$
52,994,600
|
|
$
67,296,587
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
160,180
|
|
$
640,650
|
Accrued
expenses
|
6,178,200
|
|
5,797,378
|
Short-term operating lease liabilities
|
360,655
|
|
351,853
|
Short-term finance lease liabilities
|
96,924
|
|
-
|
Other
current liabilities
|
7,068,033
|
|
3,721,907
|
Total current liabilities
|
13,863,992
|
|
10,511,788
|
|
|
|
|
Long-term operating
lease liabilities
|
715,893
|
|
900,520
|
Long-term finance
lease liabilities
|
204,908
|
|
-
|
Other long-term
liabilities
|
3,013,500
|
|
6,232,907
|
Total liabilities
|
17,798,293
|
|
17,645,215
|
|
|
|
|
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 December 31, 2021
and June 30, 2021
|
40
|
|
40
|
Common
stock of $0.01 par value – authorized 300,000,000
shares:
|
|
|
|
issued and outstanding 231,695,273 shares as of
December 31, 2021 and
230,049,691 shares as of June 30,
2021
|
2,316,953
|
|
2,300,497
|
Additional paid-in capital
|
400,473,806
|
|
399,146,232
|
Accumulated deficit
|
(367,594,492)
|
|
(351,795,397)
|
Total stockholders' equity
|
35,196,307
|
|
49,651,372
|
Total liabilities and stockholders'
equity
|
$
52,994,600
|
|
$
67,296,587
|
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SOURCE Palatin Technologies, Inc.