CRANBURY, N.J., Sept. 13, 2018 /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 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, 2018.
"The last year has been very productive for Palatin, most
notably the acceptance of the Vyleesi™ (bremelanotide) NDA by the
FDA," said Carl Spana, Ph.D., CEO
and President of Palatin. "Going forward, the first quarter of
calendar year 2019 could bring FDA approval for Vylessi – a
significant milestone and major inflection point for Palatin, its
employees, its shareholders, and most importantly, the thousands of
premenopausal women seeking treatment for HSDD in the U.S."
2018 Highlights and Recent Events
Vyleesi (bremelanotide)
- Vyleesi™, the trade name for bremelanotide - Under
development for Hypoactive Sexual Desire Disorder ("HSDD"):
-
- In June 2018, our exclusive North
American Licensee for Vyleesi, AMAG Pharmaceuticals, Inc. (NASDAQ:
AMAG) ("AMAG"), was notified by the U.S. Food and Drug
Administration ("FDA") of acceptance for the filing of the New Drug
Application ("NDA") on Vyleesi, with an FDA PDUFA (Prescription
Drug User Fee Act) goal date for completion of the FDA review of
the NDA of March 23, 2019.
-
- FDA's acceptance of the NDA triggered a $20 million milestone payment to Palatin, less
expenses paid by AMAG.
- Palatin is entitled to receive up to $60
million upon regulatory approval by the FDA.
-
- If approved, Vyleesi would become the first and only on-demand
pharmacologic option indicated for the treatment of HSDD in
premenopausal women in the U.S.
- Entered into a collaboration and license agreement with
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
("Fosun"), a subsidiary of Shanghai Fosun Pharmaceutical (Group)
Co., Ltd in September 2017 for
exclusive rights to develop and commercialize Vyleesi in the
territories of mainland China,
Taiwan, Hong Kong S.A.R. and Macau
S.A.R.
-
- Received $4,500,000 in
October 2017, consisting of an
upfront payment of $5,000,000 less
$500,000, which was withheld in
accordance with tax withholding requirements in China.
- Entered into a license agreement with Kwangdong Pharmaceutical
Co., Ltd. ("Kwangdong") in November
2017 for exclusive rights to develop and commercialize
Vyleesi in the Republic of Korea.
-
- Received $417,500 in December 2017, consisting of an upfront payment
of $500,000 less $82,500 which was withheld in accordance with tax
withholding requirements in the Republic of Korea.
PL-8177 / PL-8331
- Melanocortin Receptor 1 (MC1r) Agonists under
development for the treatment of inflammatory and autoimmune
diseases such as dry eye, uveitis, diabetic retinopathy and
inflammatory bowel diseases:
-
- Completed subcutaneous dosing of human subjects with PL-8177 in
a Phase 1 single and multiple ascending dose clinical safety study,
with data expected in the fourth quarter of calendar 2018.
- May 2018 – Presented positive
preclinical data on PL-8331 at TIDES: Oligonucleotide and Peptide
Therapeutics 2018 Meeting.
- April 2018 – Presented
preclinical oral formulation data on PL-8177, an investigational
MC1r agonist for Inflammatory Bowel Diseases at the 2018 Keystone
Symposia on "The Resolution of Inflammation in Health and
Disease."
Corporate
- Decreased debt from $14.8 million
at June 30, 2017 to $7.2 million at June 30,
2018.
- Added to the Russell 3000® Index in June 2018.
- Grew the company's intellectual property portfolio with several
filings and issuances during the year.
Fourth Quarter and Fiscal 2018 Financial
Results
Palatin reported net income of $11.8 million, or $0.06 per basic and diluted share, for the fourth
quarter ended June 30, 2018, compared
to net income of $13.3 million, or
$0.07 per basic and diluted share,
for the same period in 2017.
The difference between the three months ended June 30, 2018 and 2017 was primarily attributable
to the recognition of contract revenue pursuant to our license
agreement with AMAG of $20.6 million
for the quarter ended June 30, 2018
compared to $33.9 million in
2017.
For the fiscal year ended June 30,
2018, Palatin reported net income of $24.7 million, or $0.12 per basic and diluted share compared to a
net loss of $(13.3) million, or
$(0.07) per basic and diluted share
for the year ended June 30, 2017.
The difference in net income for the year ended June 30, 2018, and the net loss for the year
ended June 30, 2017, was primarily
attributable to the recognition of $67.1
million in license and contract revenue for the year ended
June 30, 2018 compared to
$44.7 million for the year ended
June 30, 2017, and secondarily to a
$14.1 million decrease in operating
expenses to $41.2 million for the
year ended June 30, 2018 compared to
$55.3 million for the year ended
June 30, 2017.
Revenue
For the quarter and year ended June 30, 2018, Palatin recognized $20.6 million and $62.1
million, respectively, in 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.
For the quarter and year ended June 30,
2017, Palatin recognized $33.9
million and $44.7 million,
respectively, in contract revenue related to our license agreement
with AMAG.
Operating Expenses
Total operating expenses for the
quarter ended June 30, 2018 were
$8.3 million compared to $19.6 million for the comparable quarter of
2017. For the year ended June 30,
2018, Palatin incurred $41.2
million of operating expenses, compared to $55.3 million for the year ended June 30, 2017.
The decrease in operating expenses was mainly attributable to
the completion of Phase 3 clinical trials and less other
development of Vyleesi for HSDD.
Other Income/Expense
Total other expense, net, was
$0.2 million for the quarter ended
June 30, 2018, compared to
$0.5 million for the quarter ended
June 30, 2017. For the year
ended June 30, 2018, total other
expense, net, was $1.1 million,
compared to $2.3 million for the year
ended June 30, 2017. Total
other expense, net for both fiscal years ended June 30, 2018 and June 30,
2017 consisted mainly of interest expense related to venture
debt.
Income Tax
Income tax expense was $0.3 and $0.1
million, respectively, for the quarter and year ended
June 30, 2018 compared to
$0.5 million in alternative minimum
tax for the quarter and year ended June 30,
2017.
Income tax expense for the year ended June 30, 2018 relates 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 signed
in December 2017. Accordingly, $0.5
million is included in other long-term assets at
June 30, 2018.
Cash Position
Palatin's cash and cash equivalents were
$38.0 million and no accounts
receivable at June 30, 2018, compared
to cash, cash equivalents and investments of $40.5 million, and accounts receivable of
$15.1 million at June 30, 2017. Current liabilities were
$10.8 million as of June 30, 2018, compared to $19.9 million, net of deferred revenue of
$35.1 million, as of June 30, 2017.
Palatin believes that existing capital resources will be
sufficient to fund our planned operations through at least
September 30, 2019.
Palatin Drug Discovery Programs
In 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 receptor1 and receptor-5 agonist
peptides for treatment of inflammatory indications and natriuretic
peptide receptor agonist compounds for treatment of cardiovascular
and pulmonary indications.
Conference Call / Webcast
Palatin will host a
conference call and audio webcast on September 13, 2018 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 1-855-719-5012 (U.S./Canada) or 1-334-323-0522 (international),
conference ID 5577225. 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 5577225. The webcast
and telephone replay will be available through September 20, 2018.
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, results of clinical trials,
regulatory actions by the FDA 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)
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PALATIN
TECHNOLOGIES, INC.
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and
Subsidiary
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Consolidated
Statements of Operations
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Year Ended June
30,
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2018
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2017
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2016
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REVENUES
|
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License and
contract
|
$
67,134,758
|
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$
44,723,827
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$
-
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OPERATING
EXPENSES
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Research and
development
|
32,566,217
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45,683,174
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43,071,051
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General and
administrative
|
8,641,976
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9,610,147
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6,179,084
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Total
operating expenses
|
41,208,193
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55,293,321
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49,250,135
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Income (loss)
from operations
|
25,926,565
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|
(10,569,494)
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(49,250,135)
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OTHER INCOME
(EXPENSE)
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Investment
income
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310,663
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26,270
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50,226
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Interest
expense
|
(1,452,014)
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|
(2,288,309)
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|
(2,513,027)
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Total other
expense, net
|
(1,141,351)
|
|
(2,262,039)
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|
(2,462,801)
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Income (loss)
before income taxes
|
24,785,214
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|
(12,831,533)
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|
(51,712,936)
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Income tax
expense
|
(82,500)
|
|
(500,000)
|
|
-
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NET INCOME
(LOSS)
|
$
24,702,714
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|
$
(13,331,533)
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|
$
(51,712,936)
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Basic net
income (loss) per common share
|
$
0.12
|
|
$
(0.07)
|
|
$
(0.33)
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|
Diluted net income
(loss) income per common share
|
$
0.12
|
|
$
(0.07)
|
|
$
(0.33)
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|
Weighted average
number of common shares outstanding used in computing basic net
income (loss) per common share
|
198,101,060
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|
184,087,719
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|
156,553,534
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Weighted average
number of common shares outstanding used in computing diluted
income (loss) income per common share
|
207,007,558
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|
184,087,719
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|
156,553,534
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PALATIN
TECHNOLOGIES, INC.
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and
Subsidiary
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Consolidated
Balance Sheets
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June 30,
2018
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June 30,
2017
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ASSETS
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Current
assets:
|
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Cash and cash
equivalents
|
$
38,000,171
|
|
$
40,200,324
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Available-for-sale
investments
|
-
|
|
249,837
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Accounts
receivable
|
-
|
|
15,116,822
|
Prepaid expenses and
other current assets
|
513,688
|
|
1,011,221
|
Total current
assets
|
38,513,859
|
|
56,578,204
|
|
|
|
|
Property and
equipment, net
|
164,035
|
|
198,153
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Other
assets
|
338,916
|
|
56,916
|
Total
assets
|
$
39,016,810
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$
56,833,273
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LIABILITIES AND
STOCKHOLDERS' EQUITY (DEFICIENCY)
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Current
liabilities:
|
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Accounts
payable
|
$
2,223,693
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$
1,551,367
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Accrued
expenses
|
2,103,021
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10,521,098
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Notes payable, net of
discount
|
5,948,763
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7,824,935
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Capital lease
obligations
|
-
|
|
14,324
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Deferred
revenue
|
-
|
|
35,050,572
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Other current
liabilities
|
487,488
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|
-
|
Total current
liabilities
|
10,762,965
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|
54,962,296
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Notes payable, net of
discount
|
332,898
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6,281,660
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Deferred
revenue
|
500,000
|
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-
|
Other non-current
liabilities
|
456,038
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|
753,961
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Total
liabilities
|
12,051,901
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|
61,997,917
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Stockholders' equity
(deficiency):
|
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|
Preferred stock of
$0.01 par value – authorized 10,000,000 shares:
|
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Series A
Convertible: issued and outstanding 4,030 shares as of
June 30, 2018 and June 30, 2017
|
40
|
|
40
|
Common stock of $0.01
par value – authorized 300,000,000 shares;
|
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issued
and outstanding 200,554,205 shares as of June 30, 2018 and
160,515,361 as of June 30, 2017
|
2,005,542
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1,605,153
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Additional paid-in
capital
|
357,005,233
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349,974,538
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Accumulated other
comprehensive loss
|
-
|
|
(590)
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Accumulated
deficit
|
(332,045,906)
|
|
(356,743,785)
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Total
stockholders' equity (deficiency)
|
26,964,909
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|
(5,164,644)
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Total
liabilities and stockholders' equity (deficiency)
|
$
39,016,810
|
|
$
56,833,273
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SOURCE Palatin Technologies, Inc.