CRANBURY, N.J., Sept. 12, 2019 /PRNewswire/ -- 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, whose product candidates are
targeted, receptor-specific therapeutics 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, 2019.
"The last year was a landmark one for Palatin. We are proud of
the recent FDA approval of Vyleesi and the continued advancement of
our pipeline programs," said Carl
Spana, Ph.D., President and Chief Executive Officer of
Palatin. "The FDA approval is an incredible achievement and
milestone, and we are excited that premenopausal women now have a
safe and effective, as-needed option available to them for the
treatment of acquired, generalized HSDD. Our cash and accounts
receivable balances at June 30, 2019
of $102 million is sufficient to
cover planned operations through at least calendar year
2021. We remain focused on advancing discussions on Vyleesi
collaborations for territories outside the currently licensed
territories of North America,
China, and Korea, and initiating
multiple clinical trials for our pipeline programs over the next
several quarters for the treatment of dry eye disease,
non-infectious uveitis and ulcerative colitis."
2019 Fiscal Year Highlights and Recent Events
Hypoactive Sexual Desire Disorder / Vyleesi™
(bremelanotide injection)
The U.S. Food and Drug
Administration (FDA) granted marketing approval of AMAG
Pharmaceuticals, Inc.'s New Drug Application (NDA) for Vyleesi™
(bremelanotide injection), a melanocortin receptor agonist
developed by Palatin, indicated for the treatment of premenopausal
women with acquired, generalized hypoactive sexual desire disorder
(HSDD). The FDA's approval of the NDA on June 21, 2019 triggered a $60 million milestone payment to Palatin under
its North American license agreement with AMAG that was received in
July. Additionally, Palatin is entitled to receive tiered royalties
on net sales ranging from high single-digit to low double-digit
percentages, and sales milestones based on escalating annual net
sales thresholds, the first of which is $25
million, triggered at annual net sales of $250 million.
Vyleesi is the first as needed treatment for premenopausal women
with acquired, generalized HSDD. Vyleesi is currently available
through specialty pharmacies, Avella and BioPlus, and AMAG will
launch Vyleesi nationally with its full sales force in
mid-September.
Anti-Inflammatory / Autoimmune
Programs
Melanocortin agonist products are under
development for the treatment of inflammatory and autoimmune
diseases such as dry eye, uveitis, diabetic retinopathy and
inflammatory bowel diseases (ulcerative colitis).
We announced positive results of a micro-dose study of
radiolabeled PL8177, a selective melanocortin receptor 1 ("MC1r")
peptide agonist, using an oral, delayed-release, polymer
formulation. The study met all primary and secondary
endpoints. PL8177 has potential application in treatment of
ulcerative colitis and other inflammatory bowel diseases. The
FDA has granted orphan drug designation for PL8177 for the
treatment of non-infectious intermediate, posterior, pan and
chronic anterior uveitis. Non-infectious uveitis (NIU) is a group
of inflammatory diseases that produces swelling and destroys eye
tissue and can result in vision loss. A Phase 2
proof-of-concept clinical study with a systemic formulation in NIU
patients is anticipated to commence in the fourth quarter of
calendar year 2019. A Phase 2 proof-of-concept clinical study
with an oral formulation in ulcerative colitis patients is
anticipated to commence in the first quarter of calendar year
2020.
An IND application for PL9643, a melanocortin peptide agonist,
and commencement of a Phase 2 clinical study in dry eye disease,
are currently anticipated in the first quarter of calendar year
2020.
Natriuretic Peptide Receptor ("NPR") System
Program
The Company has designed and is developing
potential drug candidates that are selective agonist for one or
more different natriuretic peptide receptors, including natriuretic
peptide receptor-A ("NPR-A"), natriuretic peptide receptor B
("NPR-B"), and natriuretic peptide receptor C ("NPR-C").
Active collaborations with several institutions are ongoing for
PL3994, an NPR-A agonist that has potential utility in the
treatment of a number of cardiovascular diseases, including genetic
and orphan diseases resulting from a deficiency of endogenous
active NPR-A, and PL5028, a dual NPR-A and NPR-C agonist in
development for cardiovascular diseases, including reducing cardiac
hypertrophy and fibrosis. A Phase 2A clinical trial
evaluating PL3994 in heart failure patients with preserved left
ventricular ejection fraction will begin enrollment in the latter
half of calendar year 2019. This trial is supported by a grant from
the American Heart Association.
Genetic Obesity Program
The Company's
melanocortin receptor 4 ("MC4r") peptide PL8905 and orally-active
small molecule PL9610 are currently under investigation for the
treatment of rare genetic metabolic and obesity disorders.
These programs are under internal evaluation for orphan designation
and potential development.
Corporate
Cash and accounts receivable balances
at June 30, 2019 of $102 million is sufficient to cover planned
operations through at least calendar year 2021. Included in
the accounts receivable balance is a $60
million milestone payment due from AMAG for the Vyleesi FDA
approval, which was received in July
2019.
Debt and related liabilities decreased from $7.2 million at June 30,
2018 to $0.8 million at
June 30, 2019, with a final payment
remitted in July 2019.
Fourth Quarter and Fiscal 2019 Financial
Results
Palatin reported net income of $52.2 million, or $0.25 per basic and $0.23 per diluted share, for the fourth quarter
ended June 30, 2019, compared to net
income of $11.8 million, or
$0.06 per basic and diluted share,
for the same period in 2018.
The difference between the three months ended June 30, 2019 and 2018 was attributable to the
recognition of license and contract revenue pursuant to our license
agreement with AMAG of $60.3 million
for the quarter ended June 30, 2019
compared to $20.6 million in
2018.
For the year ended June 30, 2019,
Palatin reported net income of $35.8
million, or $0.17 per basic
and $0.16 per diluted share, compared
to net income of $24.7 million, or
$0.12 per basic and diluted share for
the year ended June 30, 2018.
The difference in net income for the years ended June 30, 2019 and 2018, was primarily the result
of a $16.6 million decrease in
operating expenses to $24.6 million
for the year ended June 30, 2019,
compared to $41.2 million for the
year ended June 30, 2018, partially
offset by the recognition of license and contract revenue of
$60.3 million for the year ended
June 30, 2019, compared to
$67.1 million of license and contract
revenue for the year ended June 30,
2018.
Revenue
For the quarter and year ended June 30, 2019, Palatin recognized $60.3 million in license and contract revenue
related to our license agreement with AMAG.
For the quarter and year ended June 30,
2018, Palatin recognized $20.6
million and $62.1 million,
respectively, in license and 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.
Operating Expenses
Total operating expenses for the
quarter ended June 30, 2019 were
$8.1 million, compared to
$8.3 million for the comparable
quarter of 2018. For the year ended June 30, 2019, Palatin incurred $24.6 million of operating expenses, compared to
$41.2 million for the year ended
June 30, 2018.
The decrease in operating expenses reflects the completion of
the Vyleesi Phase 3 clinical trial program and ancillary studies
necessary to file the NDA with the FDA in March 2018.
Other Income/Expense
Total other income, net, for the
quarter and year ended June 30, 2019
was approximately $38,000 and
$29,000, respectively.
Total other expense, net, for the quarter and year ended
June 30, 2018 was $0.2 million and $1.1
million, respectively.
Total other income (expense), net consisted of investment income
offset by interest expense related to venture debt.
Income Tax
Palatin recorded no income tax expense for
the quarter and year ended June 30,
2019 as a result of the utilization of net operating
losses.
Income tax expense was $0.3 and
$0.1 million, respectively, for the
quarter and year ended June 30, 2018.
Income tax expense for the year ended June
30, 2018 related to $0.6
million in tax withholding requirements related to our Fosun
and Kwangdong license agreements that was recorded as an expense
during the fiscal year ended June 30,
2018 offset by a tax benefit of $0.5
million related to the release of a valuation allowance
against Palatin's federal alternative minimum tax credit as a
result of the Tax Cuts and Jobs Act.
Cash Position
Palatin's cash and cash equivalents were
$43.5 million with accounts
receivable of $60.3 million at
June 30, 2019, compared to cash and
cash equivalents and no accounts receivable of $38.0 million at June 30,
2018. Included in the accounts receivable balance at
June 30, 2019 is a $60 million milestone payment due from AMAG for
the Vyleesi FDA approval, which was received in July 2019. Current liabilities were $4.2 million as of June
30, 2019, compared to $10.8
million at June 30, 2018.
Palatin Drug Discovery Programs
During the conference
call and webcast, management will update and discuss next steps in
Palatin's portfolio of drug development programs. These
include Palatin's melanocortin MC1r agonist peptides for treatment
of inflammatory indications and natriuretic peptide receptor
agonist compounds for treatment of cardiovascular and fibrotic
diseases.
Conference Call / Webcast
Palatin will host a
conference call and audio webcast on September 12, 2019 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 1-888-254-3590 (U.S./Canada) or 1-323-994-2093 (international),
conference ID 1394071. 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
webcast replay will be available approximately one hour after the
completion of the call. To access the telephone replay, dial
1-888-203-1112 (U.S./Canada) or
1-719-457-0820 (international), passcode 1394071. The webcast
and telephone replay will be available through September 19, 2019.
About Palatin Technologies, Inc.
Palatin
Technologies, Inc. is a specialized 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 in order 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 clinical trial results, potential actions by
regulatory agencies including the FDA, regulatory plans,
development programs, proposed indications for product candidates
and market potential for product candidates, 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, 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.
Vyleesi™ is a trademark of AMAG Pharmaceuticals, Inc. in
North America and of Palatin
Technologies, Inc. elsewhere in the
world.
(Financial Statement Data Follows)
PALATIN
TECHNOLOGIES, INC.
|
and
Subsidiary
|
Consolidated
Statements of Operations
|
(unaudited)
|
|
|
|
|
|
|
|
Year Ended June
30,
|
|
2019
|
|
2018
|
|
2017
|
|
|
|
|
|
|
REVENUES
|
|
|
|
|
|
License and
contract
|
$
60,300,476
|
|
$
67,134,758
|
|
$
44,723,827
|
|
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
|
|
Research and
development
|
14,857,095
|
|
32,566,217
|
|
45,683,174
|
General and
administrative
|
9,699,061
|
|
8,641,976
|
|
9,610,147
|
Total operating
expenses
|
24,556,156
|
|
41,208,193
|
|
55,293,321
|
|
|
|
|
|
|
Income (loss) from
operations
|
35,744,320
|
|
25,926,565
|
|
(10,569,494)
|
|
|
|
|
|
|
OTHER INCOME
(EXPENSE)
|
|
|
|
|
|
Investment
income
|
446,268
|
|
310,663
|
|
26,270
|
Interest
expense
|
(417,561)
|
|
(1,452,014)
|
|
(2,288,309)
|
Total other income
(expense), net
|
28,707
|
|
(1,141,351)
|
|
(2,262,039)
|
|
|
|
|
|
|
Income (loss) before
income taxes
|
35,773,027
|
|
24,785,214
|
|
(12,831,533)
|
Income tax
expense
|
-
|
|
(82,500)
|
|
(500,000)
|
|
|
|
|
|
|
NET INCOME
(LOSS)
|
$
35,773,027
|
|
$
24,702,714
|
|
$
(13,331,533)
|
|
|
|
|
|
|
Basic net income
(loss) per common share
|
$
0.17
|
|
$
0.12
|
|
$
(0.07)
|
|
|
|
|
|
|
Diluted net income
(loss) income per common share
|
$
0.16
|
|
$
0.12
|
|
$
(0.07)
|
|
|
|
|
|
|
Weighted average
number of common shares outstanding
used in computing basic net income (loss) per common
share
|
207,670,607
|
|
198,101,060
|
|
184,087,719
|
|
|
|
|
|
|
Weighted average
number of common shares outstanding
used in computing diluted net income (loss) per common
share
|
217,133,374
|
|
207,007,558
|
|
184,087,719
|
|
|
|
|
|
|
PALATIN
TECHNOLOGIES, INC.
|
and
Subsidiary
|
Consolidated
Balance Sheets
|
(unaudited)
|
|
|
|
|
|
June 30,
2019
|
|
June 30,
2018
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
43,510,422
|
|
$
38,000,171
|
Accounts
receivable
|
60,265,970
|
|
-
|
Prepaid expenses and
other current assets
|
637,289
|
|
513,688
|
Total current
assets
|
104,413,681
|
|
38,513,859
|
|
|
|
|
Property and
equipment, net
|
141,539
|
|
164,035
|
Other
assets
|
179,916
|
|
338,916
|
Total
assets
|
$
104,735,136
|
|
$
39,016,810
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
504,787
|
|
$
2,223,693
|
Accrued
expenses
|
2,848,692
|
|
2,103,021
|
Notes payable, net of
discount
|
332,896
|
|
5,948,763
|
Other current
liabilities
|
499,517
|
|
487,488
|
Total current
liabilities
|
4,185,892
|
|
10,762,965
|
|
|
|
|
Notes payable, net of
discount
|
-
|
|
332,898
|
Deferred
revenue
|
-
|
|
500,000
|
Other non-current
liabilities
|
-
|
|
456,038
|
Total
liabilities
|
4,185,892
|
|
12,051,901
|
|
|
|
|
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, 2019 and June 30, 2018
|
40
|
|
40
|
Common stock of $0.01
par value – authorized 300,000,000 shares:
|
|
|
|
issued and
outstanding 226,815,363 shares as of June 30, 2019 and
200,554,205 shares as of June 30, 2018
|
2,268,154
|
|
2,005,542
|
Additional paid-in
capital
|
394,053,929
|
|
357,005,233
|
Accumulated
deficit
|
(295,772,879)
|
|
(332,045,906)
|
Total stockholders'
equity
|
100,549,244
|
|
26,964,909
|
Total liabilities and
stockholders' equity
|
$
104,735,136
|
|
$
39,016,810
|
|
|
|
|
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SOURCE Palatin Technologies, Inc.