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| 8-K - CURRENT REPORT - PALATIN TECHNOLOGIES INC | ptn_8k.htm |
Exhibit 99.1
Palatin Technologies, Inc. Reports Second Quarter
Fiscal Year 2018 Results;
Teleconference and Webcast to be held on February 12,
2018
CRANBURY, NJ – February 12, 2018 – 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.
-More-
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.
-More-
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, commercialacceptance 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.
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Investor Inquiries:
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Media Inquiries:
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Stephen T. Wills, CPA, MST
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Paul
Arndt, MBA, LifeSci Advisors
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CFO/COO (609) 495-2200
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Managing
Director (646) 597-6992
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Info@Palatin.com
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Paul@LifeSciAdvisors.com
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####
(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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(unaudited)
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Three Months
Ended
December
31,
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Six Months
Ended
December
31,
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2017
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2016
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2017
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2016
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REVENUES:
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License and
contract revenue
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$10,612,153
|
$-
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$37,553,661
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$-
|
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|
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OPERATING
EXPENSES:
|
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Research and
development
|
6,045,884
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8,134,575
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20,208,981
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19,360,659
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General and
administrative
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1,625,189
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1,306,300
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3,169,764
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2,515,646
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Total operating
expenses
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7,671,073
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9,440,875
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23,378,745
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21,876,305
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Income (Loss) from
operations
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2,941,080
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(9,440,875)
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14,174,916
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(21,876,305)
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OTHER INCOME
(EXPENSE):
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Interest
income
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81,356
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5,991
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133,082
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12,636
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Interest
expense
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(391,363)
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(594,535)
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(848,040)
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(1,218,520)
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Total other
expense, net
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(310,007)
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(588,544)
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(714,958)
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(1,205,884)
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Income (Loss)
before income taxes
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2,631,073
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(10,029,419)
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13,459,958
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(23,082,189)
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Income tax benefit,
net
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399,120
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-
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173,865
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-
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NET INCOME
(LOSS)
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$3,030,193
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$(10,029,419)
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$13,633,823
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$(23,082,189)
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Basic net income
(loss) per common share
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$0.02
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$(0.06)
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$0.07
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$(0.13)
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Diluted net income
(loss) per common share
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$0.01
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$(0.06)
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$0.07
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$(0.13)
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Weighted average
number of common shares outstanding used in computing basic net
income (loss) per common share
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197,238,056
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177,798,511
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197,175,316
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171,823,390
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Weighted average
number of common shares outstanding used in computing diluted net
income (loss) per common share
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202,711,616
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177,798,511
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200,430,824
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171,823,390
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PALATIN TECHNOLOGIES, INC.
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and
Subsidiary
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Consolidated
Balance Sheets
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(unaudited)
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December
31,
2017
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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
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$34,958,048
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$40,200,324
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Available-for-sale
investments
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-
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249,837
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Accounts
receivable
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-
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15,116,822
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Prepaid expenses
and other current assets
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1,288,504
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1,011,221
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Total current
assets
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36,246,552
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56,578,204
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Property and
equipment, net
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178,767
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198,153
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Other
assets
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556,916
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56,916
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Total
assets
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$36,982,235
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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
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$703,767
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$1,551,367
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Accrued
expenses
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5,527,776
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10,521,098
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Notes payable, net
of discount and debt issuance costs
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7,889,152
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7,824,935
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Capital lease
obligations
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-
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14,324
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Deferred
revenue
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9,548,228
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35,050,572
|
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Total current
liabilities
|
23,668,923
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54,962,296
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Notes payable, net
of discount and debt issuance costs
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2,321,124
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6,281,660
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Deferred
revenue
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500,000
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-
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Other non-current
liabilities
|
866,135
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753,961
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Total
liabilities
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27,356,182
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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 December 31,
2017 and June 30, 2017
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40
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40
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Common stock of
$0.01 par value – authorized 300,000,000 shares:
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issued and
outstanding 195,373,239 shares as of December 31, 2017 and
160,515,361 shares as of June 30, 2017, respectively
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1,953,732
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1,605,153
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Additional paid-in
capital
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350,787,078
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349,974,538
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Accumulated other
comprehensive loss
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-
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(590)
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Accumulated
deficit
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(343,114,797)
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(356,743,785)
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Total
stockholders’ equity (deficiency)
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9,626,053
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(5,164,644)
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Total liabilities
and stockholders’ equity (deficiency)
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$36,982,235
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$56,833,273
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