DGAP-News: Prothena Reports Third Quarter 2013 Financial Results
(firmenpresse) - Prothena Corporation
12.11.2013 22:05
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DUBLIN, Ireland, 2013-11-12 22:05 CET (GLOBE NEWSWIRE) --
Prothena Corporation plc (Nasdaq:PRTA), a clinical stage biotechnology company
focused on the discovery, development and commercialization of novel antibodies
for the potential treatment of a broad range of diseases, today reported
financial results for the third quarter and nine months ended September 30,
2013 and provided an update on research and development.
Prothena reported a net loss of $9.7 million and $29.9 million for the third
quarter and first nine months of 2013, respectively, as compared to a net loss
of $8.7 million and $29.2 million for the third quarter and first nine months
of 2012, respectively. Net loss per share for the third quarter and first nine
months of 2013 was $0.55 and $1.69, respectively, as compared to a net loss per
share of $0.60 and $2.01 for the third quarter and first nine months of 2012,
respectively. As of September 30, 2013, Prothena had $101.9 million in cash and
cash equivalents and no outstanding debt. In October 2013, Prothena raised net
proceeds of $84.7 million through a public offering of 4.2 million ordinary
shares. These figures should be read in connection with 'Third Quarter and
First Nine Months of 2013 Financial Results and 2013 Guidance' below.
'Prothena targets proteins in novel ways to resolve unmet clinical needs in
patients. In the third quarter, we continued to advance our pipeline of novel
therapeutic antibodies,' said Dale Schenk, PhD, President and Chief Executive
Officer of Prothena. 'We remain pleased with how our ongoing Phase 1 trial with
NEOD001 in AL amyloidosis is moving forward in the clinic, and we remain on
track to communicate Phase 1 data in 2014. With respect to PRX002, our
Parkinson's disease candidate, we have completed IND enabling toxicology
studies in the third quarter and we anticipate moving forward with an IND
submission and entering the clinic during 2014.'
'We have also strengthened our balance sheet with the recent completion of a
successful public offering of ordinary shares, generating net proceeds of $84.7
million, to further support progress on our lead programs,' 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
-- The ongoing multi-center Phase 1 clinical trial is evaluating the safety,
tolerability, pharmacokinetics and immunogenicity of NEOD001 in AL
amyloidosis patients. The study is designed to define a maximally tolerated
dose and/or recommended dose(s) for Phase 2. The study is also evaluating
exploratory biomarkers for cardiac, renal and hepatic function. For more
information, please visit www.clinicaltrials.gov and search identifier
NCT01707264
-- Communication of Phase 1 data is planned for 2014
PRX002 is a monoclonal antibody targeting alpha-synuclein for the potential
treatment of Parkinson's disease
-- Completed IND enabling toxicology studies
-- IND filing and a Phase 1 trial in Parkinson's disease patients are planned
for 2014
PRX003 is a monoclonal antibody targeting MCAM (melanoma cell adhesion
molecule) for the potential treatment of inflammatory diseases and cancers
-- Selected lead candidate
-- IND filing and Phase 1 trial(s) planned for 2015
Third Quarter and First Nine 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 nine months ended September
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 ordinary 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 ordinary 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 $9.7 million and $29.9 million for the third
quarter and first nine months of 2013, respectively, as compared to a net loss
of $8.7 million and $29.2 million for the third quarter and first nine months
of 2012, respectively. Net loss per share for the third quarter and first nine
months of 2013 was $0.55 and $1.69, respectively, as compared to a net loss per
share of $0.60 and $2.01 for the third quarter and first nine months of 2012,
respectively.
Net loss for the third quarter and first nine months of 2013 included
share-based compensation expense of $1.0 million and $2.0 million,
respectively, as compared to $0.8 million and $6.9 million of share-based
compensation expense for the third quarter and first nine months of 2012,
respectively.
Research and development (R&D) expenses totaled $6.3 million and $20.5 million
for the third quarter and first nine months of 2013, respectively, as compared
to $7.5 million and $24.3 million for the third quarter and first nine months
of 2012, respectively. The decrease in R&D expenses for the quarter and first
nine months of 2013 was primarily due to a decrease in share-based compensation
expense and lower NEOD001 program costs, partially offset by increases in
personnel costs and external expenses attributable to our PRX002 and PRX003
programs. R&D expenses for the third quarter and first nine months of 2013
included share-based compensation expense of $0.3 million and $0.6 million,
respectively, as compared to $0.5 million and $5.7 million of share-based
compensation expense for the third quarter and first nine months of 2012,
respectively.
General and administrative (G&A) expenses totaled $3.4 million and $9.8 million
for the third quarter and first nine months of 2013, respectively, as compared
to $2.1 million and $7.0 million for the third quarter and first nine months of
2012, respectively. G&A expenses in the third quarter and first nine months of
2013 consisted primarily of professional services fees (including payments to
Elan under a transitional services agreement), internal personnel costs and
share-based compensation expense. The third quarter and first nine 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 $1.2 million, respectively, of direct expense incurred by the Prothena
Business and $1.8 million and $5.8 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 $0.6 million and $1.4 million for
the third quarter and first nine months of 2013, respectively, as compared to
$0.3 million and $1.2 million for the third quarter and first nine months of
2012, respectively.
As of September 30, 2013, Prothena had $101.9 million in cash and cash
equivalents, no outstanding debt and 17.7 million ordinary shares outstanding.
In October 2013, Prothena raised net proceeds of $84.7 million through a public
offering of 4.2 million ordinary shares.
Prothena expects a cash burn of $34 to $40 million for 2013, ending the year
with approximately $173 million in cash (mid-point). The 2013 cash burn is
primarily driven by an estimated net loss of $36 to $42 million, which includes
an estimated $3.0 million of share-based compensation expense. Prothena intends
to use the remaining anticipated 2013 spend to progress patient enrollment and
dosing at multiple sites for its NEOD001 Phase 1 clinical trial, prepare for
anticipated IND submission for PRX002 in 2014, select initial indication(s) for
PRX003 and further advance its discovery programs.
Upcoming Events
Members of the management team will present and/or participate in one-on-one
investor meetings at these upcoming conferences:
-- 2013 Credit Suisse Healthcare Conference on Wednesday, November 13th at
4:00 pm ET at The Phoenician Hotel in Scottsdale, AZ.
-- 2013 RBC Capital Markets' Healthcare Investor Day on Thursday, November
21st at the JW Marriott in Denver, CO.
A live webcast of the Credit Suisse presentation can be accessed through the
investor relations section of the Company's website at www.prothena.com.
Following the live presentation, a replay of the webcast will be available on
the Company's website for 90 days following the presentation date.
About Prothena
Prothena Corporation plc. is a clinical stage biotechnology company focused on
the discovery, development and commercialization of novel antibodies for the
potential treatment of a broad range of diseases that involve protein
misfolding and cell adhesion, particularly on the discovery, development and
commercialization 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 and timing of our Phase 1 clinical trial for NEOD001, the potential to
advance such product candidate through further clinical trials and our ability
to receive regulatory approval for such product candidate in one or more
indications, including with orphan drug designations, the conduct and planned
timing of our other lead candidate programs (PRX002 and PRX003), including the
planned schedule of IND filings and potential Phase 1 trials for such product
candidates. 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 growth of the markets for those drug candidates; our
ability to develop and commercialize products before competitors 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;
tax treatment of our separation from Elan and subsequent distribution of our
ordinary shares; restrictions on our taking certain actions due to tax rules
and covenants with Elan; 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, changes in our cost structure, management, financing and
business operations and 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; the failure to comply with anti-kickback,
false claims and other applicable laws in the United States; extensive
government regulation; the volatility of our share price; general changes in
U.S. GAAP and International Financial Reporting Standards as adopted by the
European Union; 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 Nine Months Ended
September 30, September 30,
---------------------------------------------
2013 2012 2013 2012
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Revenues - related party $ 171 $ 944 $ 509 $ 2,083
Operating expenses:
Research and development 6,348 7,530 20,452 24,306
General and administrative 3,389 2,082 9,782 6,967
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Total operating expenses 9,737 9,612 30,234 31,273
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Loss from operations (9,566) (8,668) (29,725) (29,190)
Interest 14 -- 50 --
---------------------------------------------
Loss before income taxes (9,552) (8,668) (29,675) (29,190)
Provision for income taxes 137 -- 267 --
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Net loss $ (9,689) $ (8,668) $ (29,942) $ (29,190)
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Basic and diluted net loss per $ (0.55) $ (0.60) $ (1.69) $ (2.01)
share
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Shares used to compute basic and 17,679 14,497 17,679 14,497
diluted net loss per share
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PROTHENA CORPORATION PLC
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited - amounts in thousands)
September 30, December 31,
2013 2012
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Cash and cash equivalents $ 101,859 $ 124,860
Other current assets 1,079 981
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Total current assets 102,938 125,841
Property and equipment, net 3,581 3,442
Other non-current assets 1,417 --
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Total assets $ 107,936 $ 129,283
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Accrued research and development expenses $ 3,117 $ 47
Other current liabilities 4,598 1,697
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Total current liabilities 7,715 1,744
Other non-current liabilities 1,440 1,055
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Total liabilities 9,155 2,799
Total shareholders' equity 98,781 126,484
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Total liabilities and shareholders' equity $ 107,936 $ 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
12.11.2013 Dissemination of a Corporate News, transmitted by DGAP -
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Language: English
Company: Prothena Corporation
Ireland
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ISIN: IE00B91XRN20
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