Prothena Corporation plc
Feb 14, 2017

Prothena Reports Fourth Quarter and Full Year 2016 Financial Results, and Provides Financial Guidance and R&D Update

DUBLIN, Ireland, Feb. 14, 2017 (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 fourth quarter and full year 2016. In addition, the Company provided 2017 financial guidance and an update on its R&D programs.

"In 2016 we were saddened by the loss of Dale Schenk, PhD, our friend and former CEO, and a true scientific pioneer," said Gene Kinney, PhD, President and Chief Executive Officer of Prothena. "As a testament to our team's talent and commitment, our business continued to gain momentum and 2016 was a year of significant progress where we reported positive data for each of our three clinical programs. As our pipeline continues to mature, several key milestones in 2017 and into 2018 keep us on track towards our goal of delivering novel disease modifying therapies to patients. For NEOD001 in patients with AL amyloidosis, we expect to complete enrollment in the PRONTO study during the next several weeks and in the VITAL study during the second quarter. Also in 2017, for PRX002/RG7935, we expect to initiate, with our partners at Roche, a Phase 2 clinical study in patients with Parkinson's disease. For PRX003 we expect to report full topline results from a Phase 1b multiple ascending dose, proof-of-biology study in patients with psoriasis, and for PRX004 we continue to advance our preclinical work toward the start of a Phase 1 clinical study in patients with ATTR amyloidosis."

Full Year 2016 and Recent Highlights:

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

PRX002/RG7935 is a monoclonal antibody for the potential treatment of Parkinson's disease and related synucleinopathies, and is the primary focus of Prothena's worldwide collaboration with Roche:

PRX003 is a monoclonal antibody for the potential treatment of inflammatory diseases, including psoriasis and psoriatic arthritis:

PRX004 is a monoclonal antibody for the potential treatment of ATTR amyloidosis:

Corporate:

Upcoming Research and Development Milestones

Prothena's pipeline includes four protein immunotherapy programs.

NEOD001

PRX002

PRX003

PRX004

Fourth Quarter and Full Year of 2016 Financial Results and 2017 Financial Guidance

Prothena reported a net loss of $48.9 million and $160.1 million for the fourth quarter and full year of 2016, respectively, as compared to a net loss of $24.2 million and $80.6 million for the fourth quarter and full year of 2015, respectively. Net loss per share for the fourth quarter and full year of 2016 was $1.41 and $4.66, respectively, as compared to a net loss per share for the fourth quarter and full year of 2015 of $0.76 and $2.66, respectively.

Prothena reported total revenue of $0.2 million and $1.1 million for the fourth quarter and full year of 2016, respectively, as compared to total revenue of $0.3 million and $1.6 million for the fourth quarter and full year of 2015, respectively. The decrease in revenue for the fourth quarter and full year of 2016 was primarily due to lower revenue from Prothena's collaboration agreement with Roche.

Research and development (R&D) expenses totaled $39.8 million and $119.5 million for the fourth quarter and full year of 2016, respectively, as compared to $17.9 million and $58.4 million for the fourth quarter and full year of 2015, respectively. The increase in R&D expenses for the fourth quarter and full year of 2016 was primarily due to increased expenses for product manufacturing, clinical trials and personnel cost. R&D expenses included non-cash share-based compensation expense of $1.9 million and $7.1 million for the fourth quarter and full year of 2016, respectively, as compared to $1.3 million and $4.3 million for the fourth quarter and full year of 2015, respectively.

General and administrative (G&A) expenses totaled $9.6 million and $41.1 million for the fourth quarter and full year of 2016, respectively, as compared to $6.6 million and $23.1 million for the fourth quarter and full year of 2015, respectively. The increase in G&A expenses for the fourth quarter and full year of 2016 was primarily due to increases in personnel costs. The full year costs included $7.7 million of non-cash share-based compensation expense related to the accelerated vesting of stock options and payments due to the estate of our former Chief Executive Officer, Dr. Dale B. Schenk, upon his passing. G&A expenses included non-cash share-based compensation expense of $3.3 million and $17.8 million in the fourth quarter and full year of 2016, respectively (including $6.5 million, of non-cash share-based compensation expense in 2016 related to the accelerated vesting of Dr. Schenk's stock options), as compared to $1.9 million and $6.1 million in the fourth quarter and full year of 2015, respectively.

Total non-cash share-based compensation expense was $5.2 million and $24.9 million for the fourth quarter and full year of 2016, respectively, as compared to $3.3 million and $10.4 million for the fourth quarter and full year of 2015, respectively.

As of December 31, 2016, Prothena had $391.0 million in cash, cash equivalents and restricted cash and no debt.

As of February 10, 2017, Prothena had approximately 35.0 million ordinary shares outstanding.

The Company expects the full year 2017 net cash burn from operating and investing activities to be $160 to $170 million, including an expected milestone payment from Roche upon initiation of the Phase 2 study of PRX002, and  ending the year with approximately $224 million in cash (mid-point). The estimated full year 2017 net cash burn from operating and investing activities is primarily driven by an estimated net loss of $177 to $191 million, which includes an estimated $26 million of non-cash share-based compensation expense.

Upcoming Investor Conferences

Members of the senior management team will present and participate in investor meetings at the following upcoming investor conferences:

A live webcast of the presentations can be accessed through the investor relations section of the Company's website at www.prothena.com. Following the live presentations, a replay of the webcast will be available on the Company's website for at least 90 days following the presentation date.

Conference Call Details

Prothena management will discuss these results and its 2017 outlook in a live audio webcast and conference call today, Tuesday, February 14, 2017, at 4:30 PM ET. The webcast will be made available on the Company's website at www.prothena.com under the Investors tab in the Events and Presentations section. Following the live audio webcast, a replay will be available on the Company's website for 90 days.

To access the call via dial-in, please dial (877) 887-5215 (U.S. toll free) or (315) 625-3069 (international) five minutes prior to the start time and refer to conference ID number 56336849. A replay of the call will be available until February 28, 2017 via dial-in at (855) 859-2056 (U.S. toll free) or (404) 537-3406 (international), Conference ID Number 56336849.

About Prothena

Prothena Corporation plc is a global, late-stage clinical biotechnology company establishing fully-integrated research, development and commercial capabilities. Fueled by its deep scientific understanding built over decades of research in protein misfolding and cell adhesion — the root causes of many serious or currently untreatable amyloid and inflammatory diseases — Prothena seeks to fundamentally change the course of progressive diseases associated with this biology. The Company's pipeline of antibody therapeutic candidates targets a number of indications including AL amyloidosis (NEOD001), Parkinson's disease and other related synucleinopathies (PRX002), inflammatory diseases, including psoriasis and psoriatic arthritis (PRX003), and ATTR amyloidosis (PRX004). The company continues discovery of additional novel therapeutic candidates where its deep scientific understanding of disease pathology can be leveraged. For more information, please visit the company's website at www.prothena.com.

Forward-looking Statements

This press release contains forward-looking statements. These statements relate to, among other things, our goal of delivering therapies to patients; the sufficiency of our cash position; the timing of completing enrollment in the Phase 2b and Phase 3 studies and announcing topline results from the Phase 2b study of NEOD001; the timing of initiating a Phase 2 study of PRX002; the timing of announcing full topline results from the Phase 1b study of PRX003; the timing of advancing PRX004 into a Phase 1 clinical study; our anticipated net cash burn from operating and investing activities for 2017 and expected cash balance at the end of 2017; and our estimated net loss and non-cash share-based compensation expense for 2017. 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 February 25, 2016, our subsequent Quarterly Reports on Form 10-Q filed with the SEC and our Annual Report on Form 10-K to be filed with the SEC for our fiscal year 2016. 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
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited - amounts in thousands except per share data)

 Three Months Ended
December 31,
 Twelve Months Ended
December 31,
 2016 2015 2016 2015
Collaboration revenue$171  $307  $1,055  $1,607 
Revenue—related party       
Total revenue171  307  1,055  1,607 
Operating expenses:       
Research and development39,844  17,890  119,534  58,439 
General and administrative9,604  6,629  41,056  23,105 
Total operating expenses49,448  24,519  160,590  81,544 
Loss from operations(49,277) (24,212) (159,535) (79,937)
Other income, net:727  57  571  26 
Loss before income taxes(48,550) (24,155) (158,964) (79,911)
Provision for income taxes353  2  1,144  701 
Net loss$(48,903) $(24,157) $(160,108) $(80,612)
Basic and diluted net loss per share$(1.41) $(0.76) $(4.66) $(2.66)
Shares used to compute basic and diluted net loss per share 34,603  31,611  34,351  30,326 


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

 December 31,
 2016 2015
Assets   
Cash and cash equivalents$386,923  $370,586 
Other current assets4,439  6,817 
Total current assets391,362  377,403 
Property and equipment, net56,452  3,862 
Restricted cash4,056   
Other assets8,106  3,971 
Total non-current assets68,614  7,833 
Total assets$459,976  $385,236 
Liabilities and Shareholders' Equity   
Accrued research and development$19,073  $12,794 
Other current liabilities22,002  9,422 
Total current liabilities41,075  22,216 
Non-current liabilities:53,498  2,351 
Total liabilities94,573  24,567 
Total shareholders' equity365,403  360,669 
Total liabilities and shareholders' equity $459,976  $385,236 

 

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

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