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| 8-K - CURRENT REPORT - PALATIN TECHNOLOGIES INC | ptn_8k.htm |
Exhibit 99.1
Palatin Technologies, Inc. Reports Fourth Quarter and
Fiscal Year 2018 Results
Vyleesi™ New Tradename for Bremelanotide
PDUFA Target Action Date of March 23, 2019 for Vyleesi
Teleconference and Webcast to be held on September 13,
2018
CRANBURY, NJ – September 13, 2018 – 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)
‒
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.
-More-
‒
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.
-More-
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.
-More-
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.
-More-
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.
|
Investor Inquiries:
|
Media Inquiries:
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Stephen T. Wills, CPA, MST
|
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
|
Paul@LifeSciAdvisors.com
|
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
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$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
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32,566,217
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45,683,174
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43,071,051
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General and
administrative
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8,641,976
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9,610,147
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6,179,084
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Total operating
expenses
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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
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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
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(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
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(1,141,351)
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(2,262,039)
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(2,462,801)
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Income (loss)
before income taxes
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24,785,214
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(12,831,533)
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(51,712,936)
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Income tax
expense
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(82,500)
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(500,000)
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-
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NET INCOME
(LOSS)
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$24,702,714
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$(13,331,533)
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$(51,712,936)
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Basic net income
(loss) per common share
|
$0.12
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$(0.07)
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$(0.33)
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Diluted net income
(loss) income per common share
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$0.12
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$(0.07)
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$(0.33)
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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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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
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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
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$38,000,171
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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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513,688
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1,011,221
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Total current
assets
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38,513,859
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56,578,204
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Property and
equipment, net
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164,035
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198,153
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Other
assets
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338,916
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56,916
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Total
assets
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$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
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$2,223,693
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$1,551,367
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Accrued
expenses
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2,103,021
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10,521,098
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Notes payable, net
of discount
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5,948,763
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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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-
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35,050,572
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Other current
liabilities
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487,488
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-
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Total current
liabilities
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10,762,965
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54,962,296
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Notes payable, net
of discount
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332,898
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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
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456,038
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753,961
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Total
liabilities
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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
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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 200,554,205 shares as of June 30, 2018 and 160,515,361
as of June 30, 2017
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2,005,542
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1,605,153
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Additional paid-in
capital
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357,005,233
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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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(332,045,906)
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(356,743,785)
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Total
stockholders’ equity (deficiency)
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26,964,909
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(5,164,644)
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Total liabilities
and stockholders’ equity (deficiency)
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$39,016,810
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$56,833,273
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