DGAP-News: Prothena Reports Second Quarter 2013 Financial Results
(firmenpresse) - Prothena Corporation
12.08.2013 22:05
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DUBLIN, Ireland, 2013-08-12 22:05 CEST (GLOBE NEWSWIRE) --
Prothena Corporation plc (Nasdaq:PRTA), a clinical stage biotechnology company
focused on the discovery and development of novel antibodies for the potential
treatment of a broad range of diseases, today reported financial results for
the second quarter and six months ended June 30, 2013 and provided an update on
research and development.
Prothena reported a net loss of $11.3 million and $20.3 million for the second
quarter and first six months of 2013, respectively, as compared to a net loss
of $9.7 million and $20.5 million for the second quarter and first six months
of 2012, respectively. Net loss per share for the second quarter and first six
months of 2013 was $0.64 and $1.15, respectively, as compared to a net loss per
share of $0.67 and $1.42 for the second quarter and first six months of 2012,
respectively. As of June 30, 2013, Prothena had $112.5 million in cash and cash
equivalents and no outstanding debt. These figures should be read in connection
with 'Second Quarter and First Six Months of 2013 Financial Results and 2013
Guidance' below.
'Prothena targets proteins in novel ways to resolve unmet clinical needs in
patients. We were productive in the second quarter as we continued to advance
our pipeline of novel therapeutic antibodies,' said Dale Schenk, PhD, President
and Chief Executive Officer of Prothena. 'Our lead candidate for amyloidosis,
NEOD001, entered the clinic during the quarter. We are pleased with patient
enrollment to date and remain on track to announce results from our Phase 1
trial of NEOD001 in AL amyloidosis during 2014. Our Parkinson's disease
candidate, PRX002, is also moving forward as planned with IND enabling
toxicology studies initiated in the quarter.'
'Our strong balance sheet continues to provide the financial resources to
progress on all three of our lead programs, NEOD001, PRX002, and PRX003-which
targets inflammatory disease and metastatic cancers,' added Dr. Schenk.
Research and Development Pipeline Highlights
Prothena's research and development pipeline includes three lead therapeutic
antibody programs that the company continues to advance in 2013 and several
discovery programs staged for future value.
NEOD001 is a monoclonal antibody targeting AL and AA amyloid for the potential
treatment of amyloidosis
-- Ongoing multi-center Phase 1 clinical trial is designed to evaluate the
safety, tolerability pharmacokinetics and immunogenicity of NEOD001 in
patients with AL amyloidosis and to determine a recommended dose for Phase
2 trials; the study is also evaluating specific markers for cardiac, renal
and hepatic organ function
PRX002 is a monoclonal antibody targeting alpha-synuclein for the potential
treatment of Parkinson's disease
-- Initiated pre-clinical IND enabling studies in second quarter of 2013
-- IND filing and a Phase 1 trial in Parkinson's disease patients are planned
for 1H14
PRX003 is a monoclonal antibody targeting MCAM (melanoma cell adhesion
molecule) for the potential treatment of inflammatory disease and metastatic
cancers
-- Lead candidate has been selected
-- IND filing and Phase 1 trial planned for 2015
Second Quarter and First Six Months of 2013 Financial Results and 2013 Guidance
Prior to December 21, 2012, the Prothena Business consisted of a substantial
portion of Elan Corporation plc's former drug discovery business platform which
historically operated as part of Elan and not as a separate stand-alone entity.
The carve-out financial results for the quarter and six months ended June 30,
2012 presented in this release have been prepared in accordance with GAAP
(generally accepted accounting principles in the United States), but do not
necessarily represent the financial position or results of operations of
Prothena had it been operated as a separate independent entity. Prothena did
not have any ordinary shares outstanding prior to December 21, 2012. The
discussion of basic and diluted net loss per share included in this press
release assumes that the 14.5 million shares issued to Elan shareholders in
connection with the separation from Elan have been outstanding for all periods
presented and that the 3.2 million shares purchased by Elan upon separation
have been outstanding since December 20, 2012. For more information, see the
sections entitled 'Management's Discussion and Analysis of Financial Condition
and Results of Operations - Critical Accounting Policies and Estimates' and
'Note 1 of Notes to Consolidated Financial Statements' in each case included in
the Company's Annual Report on Form 10-K for the year ended December 31, 2012
filed with the Securities and Exchange Commission (SEC) on March 29, 2013.
Prothena reported a net loss of $11.3 million and $20.3 million for the second
quarter and first six months of 2013, respectively, as compared to a net loss
of $9.7 million and $20.5 million for the second quarter and first six months
of 2012, respectively. Net loss per share for the second quarter and first six
months of 2013 was $0.64 and $1.15, respectively, as compared to a net loss per
share of $0.67 and $1.42 for the second quarter and first six months of 2012,
respectively.
Net loss for the second quarter and first six months of 2013 included
share-based compensation expense of $0.7 million and $1.1 million,
respectively, as compared to $2.1 million and $6.1 million of share-based
compensation expense for the second quarter and first six months of 2012,
respectively.
Research and development (R&D) expenses totaled $8.1 million and $14.1 million
for the second quarter and first six months of 2013, respectively, as compared
to $8.0 million and $16.8 million for the second quarter and first six months
of 2012, respectively. The decrease in R&D expenses for the first six months of
2013 was primarily due to decreases in share-based compensation expense,
headcount attributable to Prothena programs, and external expenses related to
NEOD001, partially offset by an increase in PRX002 and PRX003 related costs.
R&D expenses for the second quarter and first six months of 2013 included
share-based compensation expense of $0.2 million and $0.3 million,
respectively, as compared to $1.7 million and $5.2 million of share-based
compensation expense for the second quarter and first six months of 2012,
respectively.
General and administrative (G&A) expenses totaled $3.2 million and $6.4 million
for the second quarter and first six months of 2013, respectively, as compared
to $2.4 million and $4.9 million for the second quarter and first six months of
2012, respectively. G&A expenses in the second quarter and first six months of
2013 consisted primarily of professional services fees (including payments to
Elan under a transitional services agreement), internal personnel costs and
$0.5 million and $0.8 million, respectively, in share-based compensation
expense. The second quarter and first six months of 2012 was presented on a
'carve-out' basis as the Prothena Business consisted of a substantial portion
of Elan's former drug discovery business platform. Accordingly, the G&A
expenses during these periods consisted of $0.3 million and $0.8 million,
respectively, of direct expense incurred by the Prothena Business and $2.1
million and $4.1 million, respectively, of indirect expenses which was based on
an allocation to the Prothena Business by Elan. G&A expenses included
share-based compensation expense of $0.5 million and $0.8 million for the
second quarter and first six months of 2013, respectively, as compared to $0.4
million and $0.9 million for the second quarter and first six months of 2012,
respectively.
As of June 30, 2013, Prothena had $112.5 million in cash and cash equivalents,
no outstanding debt and 17.7 million ordinary shares outstanding.
As previously announced, the Company expects a cash burn of $34 to $40 million
for 2013, ending the year with approximately $88 million in cash. The 2013 cash
burn is primarily driven by an estimated net loss of $36 to $42 million, which
includes an estimated $2.5 million of share-based compensation expense. The
Company intends to use the anticipated 2013 spend to progress patient
enrollment and dosing at multiple sites for its NEOD001 Phase 1 clinical trial,
complete IND enabling toxicology studies for PRX002, select a first indication
for PRX003 and further advance its discovery programs.
About Prothena
Prothena Corporation plc is a clinical stage biotechnology company focused on
the discovery and development of novel antibodies for the potential treatment
of a broad range of diseases that involve protein misfolding and cell adhesion,
particularly on the discovery and development of potential therapeutic
monoclonal antibodies directed specifically to disease-causing proteins. These
potential therapies have a broad range of indications, including AL and AA
forms of amyloidosis (NEOD001), Parkinson's disease and related
synucleinopathies (PRX002), and novel cell adhesion targets involved in
inflammatory disease and metastatic cancers (PRX003).
For more information, please visit the company's web site at www.prothena.com.
Forward-looking Statements
This press release contains forward-looking statements within the meaning of
the Section 27A of the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934. These statements relate to, among other things, the
conduct of our Phase 1 clinical trial for NEOD001, the potential to advance
such product candidate through further clinical trials, our ability to receive
regulatory approval for such product candidate in one or more indications,
including with orphan drug designations, and our anticipated cash burn rate and
intended uses of such cash in 2013 and beyond. These forward-looking statements
are identified by their use of terms and phrases such as 'anticipate,'
'believe,' 'could,' 'should,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,'
'predict,' 'project,' 'potential,' 'target,' 'will' and similar terms and
phrases, including references to assumptions. These statements are based on
assumptions that may not prove accurate. Actual results could differ materially
from those anticipated due to known and unknown risks, uncertainties and other
factors including, but not limited to the risks and uncertainties described in
the 'Risk Factors' section of our Annual Report on Form 10-K filed with the
Securities and Exchange Commission (SEC) on March 29, 2013, the 'Risk Factors'
section of our Quarterly Reports on Form 10-Q that we file with the SEC from
time to time, as well as the following risks: our ability to obtain additional
financing; our ability to successfully complete research and development of our
drug candidates and the size of the markets for those drug candidates; our
ability to develop and commercialize products before competitors or that are
superior to the alternatives developed by such competitors; our ability to
protect our patents and other intellectual property; any loss of key employees;
the impact of our separation from Elan and risks relating to our ability to
operate effectively as a stand-alone, publicly traded company, including,
without limitation, our ability to achieve benefits from our separation;
restrictions on our taking certain actions due to tax rules and covenants with
Elan; changes in our cost structure, management, financing and business
operations following the separation and distribution; growth in costs and
expenses; our ability to maintain financial flexibility and sufficient cash,
cash equivalents, and investments and other assets capable of being monetized
to meet our liquidity requirements; disruptions in the U.S. and global capital
and credit markets; fluctuations in foreign currency exchange rates; extensive
government regulation; risks from potential environmental liabilities; the
volatility of our share price; general changes in GAAP; and business
disruptions caused by information technology failures or events beyond our
control. Prothena undertakes no obligation to update publicly any
forward-looking statements contained in this press release as a result of new
information, future events or changes in Prothena's expectations.
PROTHENA CORPORATION PLC
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited - amounts in thousands except per share data)
Three Months Ended Six Months Ended
June 30, June 30,
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2013 2012 2013 2012
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Revenue - related party $ 167 $ 735 $ 338 $ 1,139
Operating expenses:
Research and development 8,147 8,019 14,104 16,776
General and administrative 3,212 2,427 6,393 4,885
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Total operating expenses 11,359 10,446 20,497 21,661
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Loss from operations (11,192) (9,711) (20,159) (20,522)
Interest and other income 14 -- 36 --
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Loss before income taxes (11,178) (9,711) (20,123) (20,522)
Provision for income taxes 124 -- 130 --
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Net loss $ (11,302) $ (9,711) $ (20,253) $ (20,522)
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Basic and diluted loss per share $ (0.64) $ (0.67) $ (1.15) $ (1.42)
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Shares used to compute basic and 17,679 14,497 17,679 14,497
diluted loss per share
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PROTHENA CORPORATION PLC
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited - amounts in thousands)
June 30, December 31,
2013 2012------------------------
Cash and cash equivalents $ 112,507 $ 124,860
Prepaid and other current assets 1,087 981
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Total current assets 113,594 125,841
Plant and equipment, net 3,729 3,442
Other non-current assets 607 --
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Total assets $ 117,930 $ 129,283
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Accrued research and development expenses $ 5,698 $ 47
Other current liabilities 3,385 1,697
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Total current liabilities 9,083 1,744
Other non-current liabilities 1,618 1,055
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Total liabilities 10,701 2,799
Total shareholders' equity 107,229 126,484
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Total liabilities and shareholders' equity $ 117,930 $ 129,283
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CONTACT: Investors: Tran Nguyen, CFO650-837-8535, IR(at)prothena.comMedia: Anita
Kawatra646-256-5116, anita.kawatra(at)prothena.com
News Source: NASDAQ OMX
12.08.2013 Dissemination of a Corporate News, transmitted by DGAP -
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