Prothena Corporation plc
Nov 2, 2015

Prothena Reports Third Quarter 2015 Financial Results and Provides R&D Update

DUBLIN, Nov. 02, 2015 (GLOBE NEWSWIRE) -- Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company focused on the discovery, development and commercialization of novel protein immunotherapies, today reported financial results for the third quarter and first nine months of 2015 and provided an update on its R&D programs.

"We've made important additions to our protein immunotherapy programs in order to optimize and accelerate development timelines, capture relevant data for engagement with regulatory agencies, and advance new programs toward the clinic," said Dale Schenk, PhD, President and CEO of Prothena. "We recently announced PRONTO, a global trial of NEOD001 that will evaluate the cardiac functional biomarker NT-proBNP as its primary endpoint, to provide an additional opportunity to engage with European regulators in a dialogue around conditional approval. In addition to a strong focus on our clinical pipeline, our exceptional research team continues to advance novel antibodies for our development pipeline, including preclinical candidates that selectively bind to amyloidogenic forms of the transthyretin (ATTR) protein."

Dr. Schenk continued, "We have a strong balance sheet to advance our pipeline of novel protein immunotherapies and look forward to reporting data on several of our clinical-stage programs in 2016 as part of our effort to bring innovative therapies to patients."

Recent Highlights and Program Updates:

Upcoming Research and Development Milestones

Prothena's clinical development pipeline includes three lead protein immunotherapy programs.

NEOD001 is a monoclonal antibody for the potential treatment of AL amyloidosis:

PRX002 is a monoclonal antibody for the potential treatment of Parkinson's disease and other related synucleinopathies, and is the primary focus of Prothena's worldwide collaboration with Roche:

PRX003 is a monoclonal antibody for the potential treatment of psoriasis and other inflammatory diseases:

Third Quarter and First Nine Months of 2015 Financial Results and Guidance

Prothena reported a net loss of $23.0 million and $56.5 million for the third quarter and first nine months of 2015, respectively, as compared to a net loss of $13.2 million for the third quarter of 2014 and net income of $6.0 million for the first nine months of 2014. Net loss per share for the third quarter and first nine months of 2015 was $0.73 and $1.89, respectively, as compared to a net loss per share for the third quarter of 2014 of $0.48 and net income per share for the first nine months of 2014 of $0.24 on a fully diluted basis.

Prothena reported total revenue of $0.4 million and $1.3 million for the third quarter and first nine months of 2015, respectively, as compared to total revenue of $1.5 million and $48.8 million for the third quarter and first nine months of 2014, respectively. The decrease in revenue for the third quarter and first nine months was primarily due to lower revenue from our collaboration agreement with Roche.

Research and development (R&D) expenses totaled $17.2 million and $40.5 million for the third quarter and first nine months of 2015, respectively, as compared to $10.4 million and $28.3 million for the third quarter and first nine months of 2014, respectively. The increase in R&D expenses for the third quarter was primarily due to increased external expenses related to clinical trials and increased personnel cost. The increase in R&D expense for the first nine months was primarily due to increased external expenses related to clinical trials and increased personnel costs, offset in part by lower external product manufacturing expenses. R&D expenses included non-cash share-based compensation expense of $1.2 million and $3.0 million for the third quarter and first nine months of 2015, respectively, as compared to $0.6 million and $1.7 million for the third quarter and first nine months of 2014, respectively.

General and administrative (G&A) expenses totaled $5.9 million and $16.5 million for the third quarter and first nine months of 2015, respectively, as compared to $4.2 million and $14.0 million for third quarter and first nine months of 2014, respectively. The increase in G&A expenses for the third quarter and first nine months was primarily due to increases in personnel costs. G&A expenses included non-cash share-based compensation expense of $1.8 million and $4.2 million in the third quarter and first nine months of 2015, respectively, as compared to $0.8 million and $2.5 million in the third quarter and first nine months of 2014, respectively.

Total non-cash share-based compensation expense was $3.0 million and $7.1 million for the third quarter and first nine months of 2015, respectively, as compared to $1.4 million and $4.2 million for the third quarter and first nine months of 2014, respectively.

As of September 30, 2015, Prothena had $387.8 million in cash and cash equivalents and no outstanding debt. As of October 23, 2015, Prothena had 31,522,750 ordinary shares outstanding.

The Company continues to expect the full year 2015 net cash burn from operating and investing activities to be $66 to $72 million, ending the year with approximately $356 million in cash (mid-point). The estimated full year 2015 net cash burn from operating and investing activities is primarily driven by an estimated net loss of $77 to $83 million, which includes an estimated $9 million of non-cash share-based compensation expense.

About Prothena

Prothena Corporation plc is a late-stage clinical biotechnology company focused on the discovery, development and commercialization of novel protein immunotherapies for the potential treatment of diseases that involve amyloid or cell adhesion. The Company is developing antibody-based product candidates that target a number of potential indications including AL amyloidosis (NEOD001), Parkinson's disease and other related synucleinopathies (PRX002), and psoriasis and other inflammatory diseases (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. These statements relate to, among other things, the ability of our cash position to fund continued advancement of multiple programs; the potential for our PRONTO trial to provide an additional opportunity to engage with European regulators on conditional approval of NEOD001; the potential for our antibodies to prevent deposition and enhance clearance of TTR amyloid; the timing of providing an update on the enrollment timeline for our VITAL Amyloidosis Study; the timing of reporting data from the expansion cohort of our Phase 1/2 study for NEOD001, from our Phase 1 multiple ascending dose study for PRX002 and from our Phase 1 single ascending dose study for PRX003; the timing of initiating our Phase 1 multiple ascending dose study for PRX003; our anticipated net cash burn from operating and investing activities for 2015 and expected cash balance at the end of 2015; and our estimated net loss and non-cash share-based compensation expense for 2015. These statements are based on estimates, projections and assumptions that may prove not to be accurate, and 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, uncertainties and other factors described in the "Risk Factors" sections of our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 13, 2015 and our subsequent Quarterly Reports on Form 10-Q filed with the SEC. 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
September 30,
 Nine Months Ended
September 30,
  2015 2014 2015 2014
Collaboration revenue $429  $1,349  $1,300  $48,429 
Revenue—related party   137    412 
Total revenue 429  1,486  1,300  48,841 
Operating expenses:        
Research and development 17,185  10,388  40,549  28,345 
General and administrative 5,905  4,230  16,476  14,040 
Total operating expenses 23,090  14,618  57,025  42,385 
Income (loss) from operations (22,661) (13,132) (55,725) 6,456 
Other income (expense), net (77) 191  (31) 192 
Income (loss) before income taxes (22,738) (12,941) (55,756) 6,648 
Provision for income taxes 238  241  699  688 
Net income (loss) $(22,976) $(13,182) $(56,455) $5,960 
Net income (loss) per share attributable to holders of ordinary shares        
Basic $(0.73) $(0.48) $(1.89) $0.25 
Diluted $(0.73) $(0.48) $(1.89) $0.24 
Shares used to compute net income (loss) per share attributable to holders of ordinary shares        
Basic 31,441  27,370  29,893  23,758 
Diluted 31,441  27,370  29,893  24,722 
             

PROTHENA CORPORATION PLC
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited - amounts in thousands)

 September 30, December 31,
 2015 2014
Assets   
Cash and cash equivalents$387,802  $293,579 
Other current assets5,774  5,696 
Total current assets393,576  299,275 
Property and equipment, net2,930  3,121 
Other assets2,424  1,720 
Total non-current assets5,354  4,841 
Total assets$398,930  $304,116 
Liabilities and Shareholders' Equity   
Accrued research and development9,522  2,285 
Other current liabilities9,036  9,754 
Total current liabilities18,558  12,039 
Non-current liabilities:2,419  2,188 
Total liabilities20,977  14,227 
Total shareholders' equity377,953  289,889 
Total liabilities and shareholders' equity$398,930  $304,116 
        


Contact
Investors: Tran Nguyen, CFO
650-837-8535, IR@prothena.com

Media: Ellen Rose, Head of Communications
650-922-2405, ellen.rose@prothena.com