CRANBURY, N.J., Sept. 25, 2017 /PRNewswire/ -- Palatin
Technologies, Inc. (NYSE MKT: PTN), a biopharmaceutical company
developing targeted, receptor-specific peptide 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, 2017.
Recent and Fiscal Year Significant Highlights
- Bremelanotide - Under development for Hypoactive Sexual
Desire Disorder ("HSDD"):
-
- November 2016 reported positive
Phase 3 clinical results - both pivotal trials met the
pre-specified co-primary efficacy endpoints of improvement in
desire and decrease in distress associated with low sexual
desire.
- Closed an exclusive North American license agreement with AMAG
Pharmaceuticals, Inc. ("AMAG") to develop and commercialize
bremelanotide in February 2017.
-
- Received $60 million upfront
payment
- Entered into a collaboration and license agreement with
Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd., a
subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd
("Fosun Pharma") in September 2017
for exclusive rights to develop and commercialize bremelanotide in
the territories of mainland China,
Taiwan, Hong Kong S.A.R. and Macau
S.A.R.
-
- Will receive $5 million upfront
payment
- Working closely with AMAG on completing the tasks and
activities necessary to file a New Drug Application ("NDA") with
the Food and Drug Administration ("FDA").
- Target NDA filing with the FDA for early calendar year
2018.
- U.S. Patent 7,700,592 issued July 11,
2017, on methods of treating female sexual dysfunction and
HSDD with bremelanotide. The patent will expire in November 2033.
"In the last year we made tremendous progress with our lead
development program, bremelanotide for HSDD. We met our Phase 3
co-primary endpoints and we licensed the North American rights to
AMAG and the China rights to Fosun
Pharma. These were truly transformational events for Palatin,"
said Carl Spana, Ph.D., President
and Chief Executive Officer of Palatin Technologies. "In addition
to advancing the activities required to file an NDA for
bremelanotide with the FDA in early calendar year 2018, we are also
progressing with licensing discussions and negotiations with
multiple potential partners for other regions around the globe. We
are also excited to now be able to devote resources and attention
to our other development programs, which address indications such
as heart failure, ophthalmic disorders and inflammatory bowel
diseases using targeted, receptor-specific peptides which we
developed."
- Financial Transactions:
-
- August 2016, Palatin closed on an
underwritten offering of units with gross proceeds of $9.25 million, with net proceeds, after deducting
offering expenses, of approximately $8.5
million. Palatin issued:
-
- 11,481,481 shares of common stock and ten-year prefunded Series
I warrants to purchase 2,218,045 shares of common stock at an
exercise price of $0.01 per
share
- Series H warrants to purchase 10,274,646 shares of common stock
at an exercise price of $0.70 per
share
- December 2016, Palatin closed on
an underwritten public offering of units with gross proceeds of
$16.5 million, with net proceeds,
after deducting offering expenses, of approximately $15.4 million. Palatin issued:
-
- 25,384,616 shares of common stock and five year Series J
warrants to purchase 12,692,310 shares of common stock at an
exercise price of $0.80 per
share
Fourth Quarter and Fiscal 2017 Financial
Results
Palatin reported net income of $13.3 million, or $0.07 per basic and diluted share, for the
quarter ended June 30, 2017, compared
to a net loss of $(13.4) million, or
$(0.09) per basic and diluted share,
for the same period in 2016.
The difference between the three months ended June 30, 2017 and 2016 was primarily attributable
to the recognition of $33.9 million
in contract revenue pursuant to our license agreement with
AMAG.
For the year ended June 30, 2017,
Palatin reported a net loss of $(13.3)
million, or $(0.07) per basic
and diluted share compared to a net loss of $(51.7) million, or $(0.33) per basic and diluted share for the year
ended June 30, 2016.
The decrease in net loss for the year ended June 30, 2017, compared to the net loss for the
year ended June 30, 2016, was
primarily attributable to the recognition of $44.7 million in contract revenue pursuant to our
license agreement with AMAG.
Revenue
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.
There were no revenues recorded in the quarter or year ended
June 30, 2016.
Operating Expenses
Total operating expenses for the
quarter ended June 30, 2017 were
$19.6 million compared to
$12.7 million for the comparable
quarter of 2016. For the year ended June 30, 2017, Palatin incurred $55.3 million of operating expenses, compared to
$49.3 million for the year ended
June 30, 2016.
The increase in operating expenses was mainly attributable to
the continued progress of Phase 3 clinical trial and development of
bremelanotide for HSDD as well as to the professional services
incurred related to closing our license agreement with AMAG.
Other Income/Expense
Total other expense, net, was
$0.5 million for the quarter ended
June 30, 2017, compared to
$0.6 million for the quarter ended
June 30, 2016. For the year ended
June 30, 2017, total other expense,
net, was $2.3 million, compared to
$2.5 million for the year ended
June 30, 2016. Total other
expense, net for both fiscal year ended June
30, 2017 and June 30, 2016
consisted mainly of interest expense related to venture debt.
Income Tax
Income tax expense was $0.5 million for the quarter and year ended
June 30, 2017 compared to no income
tax expense or benefit for the quarter and year ended June 30, 2016. Income tax expense relates to
alternative minimum tax which results from the accelerated
recognition of revenue related to the AMAG agreement for tax
purposes. Alternative minimum tax is generated for fiscal year 2017
since NOLs can only offset 90 percent of our federal alternative
minimum taxable income.
Cash Position
Palatin's cash, cash equivalents and
investments were $40.5 million and
accounts receivable was $15.1 million
as of June 30, 2017, compared to
cash, cash equivalents and investments of $9.4 million, and no accounts receivable, at
June 30, 2016. Current liabilities
were $19.9 million, net of deferred
revenue of $35.1 million, as of
June 30, 2017, compared to
$13.9 million as of June 30, 2016.
Palatin believes that existing capital resources, along with the
additional proceeds from our September
2017 license agreement with Fosun Pharma, will be adequate
to fund our planned operations through at least calendar year
2018.
Palatin Drug Discovery Programs
In the conference call
and webcast, management will discuss next steps in Palatin's
portfolio of drug development programs. These include Palatin's
melanocortin receptorĀ1 and receptor-5 agonist peptides for
treatment of inflammatory indications, natriuretic peptide
receptorĀA agonist compounds for treatment of cardiovascular and
pulmonary indications.
Conference Call / Webcast
Palatin will host a
conference call and audio webcast on September 25, 2017 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 1-866-548-4713 (U.S./Canada) or 1-323-794-2093 (international),
conference ID 6109932. 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 6109932. The webcast and
telephone replay will be available through October 2, 2017.
About Palatin Technologies, Inc.
Palatin
Technologies, Inc. is a biopharmaceutical company developing
targeted, receptor-specific peptide therapeutics 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.
PALATIN
TECHNOLOGIES, INC.
|
and
Subsidiary
|
Consolidated
Statements of Operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended June
30,
|
|
2017
|
|
2016
|
|
2015
|
|
|
|
|
|
|
REVENUES
|
|
|
|
|
|
License and
contract
|
$
44,723,827
|
|
$
-
|
|
$
12,951,730
|
|
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
|
|
Research and
development
|
45,683,174
|
|
43,071,051
|
|
24,560,233
|
General and
administrative
|
9,610,147
|
|
6,179,084
|
|
5,677,654
|
Total operating
expenses
|
55,293,321
|
|
49,250,135
|
|
30,237,887
|
|
|
|
|
|
|
Loss from
operations
|
(10,569,494)
|
|
(49,250,135)
|
|
(17,286,157)
|
|
|
|
|
|
|
OTHER INCOME
(EXPENSE)
|
|
|
|
|
|
Investment
income
|
26,270
|
|
50,226
|
|
35,439
|
Interest
expense
|
(2,288,309)
|
|
(2,513,027)
|
|
(661,697)
|
Foreign exchange
transaction loss
|
-
|
|
-
|
|
(284,656)
|
Total other expense,
net
|
(2,262,039)
|
|
(2,462,801)
|
|
(910,914)
|
|
|
|
|
|
|
Loss before income
taxes
|
(12,831,533)
|
|
(51,712,936)
|
|
(18,197,071)
|
Income tax (expense)
benefit
|
(500,000)
|
|
-
|
|
531,508
|
|
|
|
|
|
|
NET LOSS
|
$
(13,331,533)
|
|
$
(51,712,936)
|
|
$
(17,665,563)
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
$
(0.07)
|
|
$
(0.33)
|
|
$
(0.15)
|
|
|
|
|
|
|
Weighted average
number of common shares
outstanding used in computing basic and diluted net
loss per common share
|
184,087,719
|
|
156,553,534
|
|
121,014,506
|
PALATIN
TECHNOLOGIES, INC.
|
and
Subsidiary
|
Consolidated
Balance Sheets
|
|
|
|
|
|
June 30,
2017
|
|
June 30,
2016
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
40,200,324
|
|
$
8,002,668
|
Available-for-sale
investments
|
249,837
|
|
1,380,556
|
Accounts
receivable
|
15,116,822
|
|
-
|
Prepaid expenses and
other current assets
|
1,011,221
|
|
1,313,841
|
Total current
assets
|
56,578,204
|
|
10,697,065
|
|
|
|
|
Property and
equipment, net
|
198,153
|
|
97,801
|
Other
assets
|
56,916
|
|
63,213
|
Total
assets
|
$
56,833,273
|
|
$
10,858,079
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' DEFICIENCY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
1,551,367
|
|
$
713,890
|
Accrued
expenses
|
10,521,098
|
|
7,767,733
|
Notes payable, net of
discount
|
7,824,935
|
|
5,374,951
|
Capital lease
obligations
|
14,324
|
|
27,424
|
Deferred
revenue
|
35,050,572
|
|
-
|
Total current
liabilities
|
54,962,296
|
|
13,883,998
|
|
|
|
|
Notes payable, net of
discount
|
6,281,660
|
|
14,106,594
|
Capital lease
obligations
|
-
|
|
14,324
|
Other non-current
liabilities
|
753,961
|
|
439,130
|
Total
liabilities
|
61,997,917
|
|
28,444,046
|
|
|
|
|
Stockholders'
deficiency:
|
|
|
|
Preferred stock of
$0.01 par value ā authorized 10,000,000 shares:
|
|
|
|
Series A Convertible:
issued and outstanding 4,030 shares as of
June 30, 2017 and June 30, 2016
|
40
|
|
40
|
Common stock of $0.01
par value ā authorized 300,000,000 shares;
|
|
|
|
issued and
outstanding 160,515,361 shares as of June 30, 2017
and 68,568,055 as of June 30, 2016, respectively
|
1,605,153
|
|
685,680
|
Additional paid-in
capital
|
349,974,538
|
|
325,142,509
|
Accumulated other
comprehensive loss
|
(590)
|
|
(1,944)
|
Accumulated
deficit
|
(356,743,785)
|
|
(343,412,252)
|
Total stockholders'
deficiency
|
(5,164,644)
|
|
(17,585,967)
|
Total liabilities and
stockholders' deficiency
|
$
56,833,273
|
|
$
10,858,079
|
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SOURCE Palatin Technologies, Inc.