CRANBURY, N.J., Feb. 12, 2018 /PRNewswire/ -- Palatin
Technologies, Inc. (NYSE American: 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 second
quarter ended December 31,
2017.
Recent Highlights
- Bremelanotide - Under development for Hypoactive Sexual
Desire Disorder ("HSDD"):
-
- Entered into a license agreement with Kwangdong Pharmaceutical
Co., Ltd. ("Kwangdong") in November
2017 for exclusive rights to develop and commercialize
bremelanotide 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.
- Entered into a 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 bremelanotide 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.
- Working closely with AMAG Pharmaceuticals, Inc. ("AMAG"), our
licensee for North America, on
completing the tasks and activities necessary to file a New Drug
Application ("NDA") with the Food and Drug Administration
("FDA").
-
- NDA filing with the FDA by AMAG targeted by March 31, 2018.
- Melanocortin Receptor 1 Agonist ("MC1r") – under
development for inflammatory bowel diseases:
-
- Initiated Subject Dosing in First-in-Human Clinical Study of
PL-8177, an MC1r agonist.
- Received FDA Clearance of Investigational New Drug ("IND")
Application for PL-8177 For Ulcerative Colitis.
Second Quarter Fiscal 2018 Financial Results
Palatin
reported net income of $3.0 million,
or $0.02 per basic and $0.01 per diluted share, for the quarter ended
December 31, 2017, compared to a net
loss of $(10.0) million, or
$(0.06) per basic and diluted share,
for the same period in 2016.
The difference in financial results between the three months
ended December 31, 2017 and 2016 was
primarily attributable to the recognition of $10.6 million in license and contract revenue
during the 2017 period pursuant to our license agreement with AMAG,
and a reduction of $2.1 million in
research and development expenses.
Revenue
For the quarter ended December 31, 2017, 100% of the revenue Palatin
recognized was related to our license agreement with AMAG.
There were no revenues recorded in the quarter ended
December 31, 2016.
Operating Expenses
Total operating expenses for the
quarter ended December 31, 2017 were
$7.7 million compared to $9.4 million for the comparable quarter of
2016. The decrease in operating expenses was mainly
attributable to the relative development stages of bremelanotide
for HSDD as we continue our progress of filing an NDA with the
FDA.
Other Income/Expense
Total other expense, net was
$0.3 million for the quarter ended
December 31, 2017 compared to
$0.6 million for the quarter ended
December 31, 2016. Total other
expense, net for both periods consisted primarily of interest
expense related to Palatin's venture debt.
Income Tax
Pursuant to the license agreements with
Fosun and Kwangdong, $500,000 and
$82,500, respectively, was withheld
in accordance with tax withholding requirements in China and the Republic of Korea, respectively,
and will be recorded as an expense during the fiscal year ending
June 30, 2018. For the quarter ended
December 31, 2017, Palatin recorded
$100,880 in income tax expense
related to those withholding amounts utilizing an estimated
effective annual income tax rate applied to income for the quarter
and the remaining balance of $256,365
was included in prepaid expenses and other current assets at
December 31, 2017. Any potential
credit to be received by Palatin on its United States tax returns is currently offset
by Palatin's valuation allowance. The $100,880 of income tax expense is offset by a
$500,000 tax benefit that Palatin
recorded in the quarter ended December 31,
2017 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,
$500,000 is included in other
long-term assets at December 31,
2017.
Cash Position
Palatin's cash, and cash equivalents
were $35.0 million as of December 31, 2017, compared to cash, cash
equivalents, accounts receivable and investments of $55.6 million at June
30, 2017. Current liabilities were $14.1 million, net of deferred revenue of
$9.5 million, as of December 31, 2017, 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 the next
12 months.
CONFERENCE CALL / WEBCAST
Palatin will host a
conference call and webcast on February 12,
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
1-800-289-0449 (domestic) or 1-323-794-2093 (international),
conference ID 6111978. The 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 (domestic) or 1-719-457-0820 (international),
passcode 6111978. The webcast and telephone replay will be
available through February 19,
2018.
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
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
Three Months Ended
December 31,
|
|
Six Months Ended
December 31,
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
|
|
|
|
|
|
|
|
REVENUES:
|
|
|
|
|
|
|
|
License and
contract revenue
|
$
10,612,153
|
|
$
-
|
|
$
37,553,661
|
|
$
-
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES:
|
|
|
|
|
|
|
|
Research and
development
|
6,045,884
|
|
8,134,575
|
|
20,208,981
|
|
19,360,659
|
General and
administrative
|
1,625,189
|
|
1,306,300
|
|
3,169,764
|
|
2,515,646
|
Total operating expenses
|
7,671,073
|
|
9,440,875
|
|
23,378,745
|
|
21,876,305
|
|
|
|
|
|
|
|
|
Income
(Loss) from operations
|
2,941,080
|
|
(9,440,875)
|
|
14,174,916
|
|
(21,876,305)
|
|
|
|
|
|
|
|
|
OTHER INCOME
(EXPENSE):
|
|
|
|
|
|
|
|
Interest
income
|
81,356
|
|
5,991
|
|
133,082
|
|
12,636
|
Interest
expense
|
(391,363)
|
|
(594,535)
|
|
(848,040)
|
|
(1,218,520)
|
Total other expense, net
|
(310,007)
|
|
(588,544)
|
|
(714,958)
|
|
(1,205,884)
|
|
|
|
|
|
|
|
|
Income (Loss) before income taxes
|
2,631,073
|
|
(10,029,419)
|
|
13,459,958
|
|
(23,082,189)
|
Income tax benefit,
net
|
399,120
|
|
-
|
|
173,865
|
|
-
|
|
|
|
|
|
|
|
|
NET INCOME
(LOSS)
|
$
3,030,193
|
|
$
(10,029,419)
|
|
$
13,633,823
|
|
$
(23,082,189)
|
|
|
|
|
|
|
|
|
Basic net income
(loss) per common share
|
$
0.02
|
|
$
(0.06)
|
|
$
0.07
|
|
$
(0.13)
|
|
|
|
|
|
|
|
|
Diluted net income
(loss) per common share
|
$
0.01
|
|
$
(0.06)
|
|
$
0.07
|
|
$
(0.13)
|
|
|
|
|
|
|
|
|
Weighted average
number of common shares
outstanding used in computing basic net
income (loss) per common share
|
197,238,056
|
|
177,798,511
|
|
197,175,316
|
|
171,823,390
|
|
|
|
|
|
|
|
|
Weighted average
number of common shares
outstanding used in computing diluted net
income (loss) per common share
|
202,711,616
|
|
177,798,511
|
|
200,430,824
|
|
171,823,390
|
PALATIN
TECHNOLOGIES, INC.
|
and
Subsidiary
|
Consolidated
Balance Sheets
|
(unaudited)
|
|
|
|
|
|
December 31,
2017
|
|
June 30,
2017
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
34,958,048
|
|
$
40,200,324
|
Available-for-sale investments
|
-
|
|
249,837
|
Accounts
receivable
|
-
|
|
15,116,822
|
Prepaid
expenses and other current assets
|
1,288,504
|
|
1,011,221
|
Total current assets
|
36,246,552
|
|
56,578,204
|
|
|
|
|
Property and
equipment, net
|
178,767
|
|
198,153
|
Other
assets
|
556,916
|
|
56,916
|
Total assets
|
$
36,982,235
|
|
$
56,833,273
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY (DEFICIENCY)
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
703,767
|
|
$
1,551,367
|
Accrued
expenses
|
5,527,776
|
|
10,521,098
|
Notes payable,
net of discount and debt issuance costs
|
7,889,152
|
|
7,824,935
|
Capital lease
obligations
|
-
|
|
14,324
|
Deferred
revenue
|
9,548,228
|
|
35,050,572
|
Total current liabilities
|
23,668,923
|
|
54,962,296
|
|
|
|
|
Notes payable, net of
discount and debt issuance costs
|
2,321,124
|
|
6,281,660
|
Deferred
revenue
|
500,000
|
|
-
|
Other non-current
liabilities
|
866,135
|
|
753,961
|
Total liabilities
|
27,356,182
|
|
61,997,917
|
|
|
|
|
Stockholders' equity
(deficiency):
|
|
|
|
Preferred
stock of $0.01 par value – authorized 10,000,000 shares:
|
|
|
|
Series
A Convertible: issued and outstanding 4,030 shares as of
December 31, 2017 and June 30, 2017
|
40
|
|
40
|
Common stock
of $0.01 par value – authorized 300,000,000 shares:
|
|
|
|
issued
and outstanding 195,373,239 shares as of December 31,
2017 and 160,515,361 shares as of June 30, 2017,
respectively
|
1,953,732
|
|
1,605,153
|
Additional
paid-in capital
|
350,787,078
|
|
349,974,538
|
Accumulated
other comprehensive loss
|
-
|
|
(590)
|
Accumulated
deficit
|
(343,114,797)
|
|
(356,743,785)
|
Total
stockholders' equity (deficiency)
|
9,626,053
|
|
(5,164,644)
|
Total
liabilities and stockholders' equity (deficiency)
|
$
36,982,235
|
|
$
56,833,273
|
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SOURCE Palatin Technologies, Inc.