Document


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
_______________________________________________________
FORM 8-K 
_______________________________________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 7, 2018
_______________________________________________________
PROTHENA CORPORATION PUBLIC LIMITED COMPANY
(Exact Name of Registrant as Specified in its Charter)
_______________________________________________________
 
 
 
 
 
Ireland
 
001-35676
 
98-1111119
(State or Other Jurisdiction
of Incorporation)
 
(Commission
File Number)
 
(IRS Employer
Identification No.)
 
 
 
Adelphi Plaza
Upper George's Street
Dún Laoghaire
Co. Dublin, A96 T927, Ireland
(Address of principal executive offices including Zip Code)
Registrant’s telephone number, including area code: 011-353-1-236-2500
(Former Name or Former Address, if Changed Since Last Report.) 
_______________________________________________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
o
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company o

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o





Item 2.02.
Results of Operations and Financial Condition.
The information in Item 2.02 of this Current Report on Form 8-K and Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. It may only be incorporated by reference in another filing under the Exchange Act or the Securities Act of 1933, as amended, if such subsequent filing specifically incorporate by reference the information furnished pursuant to Item 2.02 (including Exhibit 99.1) of this Current Report.
On August 7, 2018, Prothena Corporation plc issued a press release announcing its financial results for the second quarter ended June 30, 2018. A copy of that press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 9.01.
Financial Statements and Exhibits
(d) Exhibits.
 
 
 
Exhibit No.
 
Description
99.1
 


SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date:
August 7, 2018
PROTHENA CORPORATION PLC
 
 
 
 
 
 
 
By:
 
/s/ Tran B. Nguyen
 
 
Name:
 
Tran B. Nguyen
 
 
Title:
 
Chief Operating Officer and Chief Financial Officer



Exhibit


Exhibit 99.1
                                                
http://api.tenkwizard.com/cgi/image?quest=1&rid=23&ipage=12394972&doc=3
Prothena Reports Second Quarter 2018 Financial Results and Provides R&D Update

Net loss was $59.9 million in the second quarter and $108.6 million, for the first six months ended June 30, 2018
Net cash from operating and investing activities was $58.0 million in the second quarter and $26.3 million in the first six months of 2018; quarter-end cash and restricted cash position of $490.3 million, provides funding to advance a broad neuroscience pipeline
Published results from the Phase 1b multiple ascending dose study of prasinezumab (PRX002/RG7935) in patients with Parkinson’s disease in JAMA Neurology

DUBLIN, Ireland - August 7, 2018 - Prothena Corporation plc (NASDAQ:PRTA), a clinical-stage neuroscience company, today reported financial results for the second quarter and first six months of 2018. In addition, the Company provided an update on its R&D programs.

“We are developing a broad and novel pipeline targeting devastating neurological diseases and steadily advancing both our proprietary programs as well as our collaboration programs with Roche and Celgene,” said Gene Kinney, PhD, President and Chief Executive Officer of Prothena. “Enrollment in the ongoing clinical studies of PRX004 and prasinezumab (PRX002/RG7935) is continuing and we expect initial data from these programs in 2019 and 2020, respectively. Additionally, we are advancing multiple discovery-stage programs towards the clinic with the potential to offer significant benefit to patients who suffer from neurological diseases with tremendous unmet medical need.”

Second Quarter 2018 and Recent Highlights:
Published results from the Phase 1b multiple ascending dose study of prasinezumab (PRX002/RG7935) in patients with Parkinson’s disease in JAMA Neurology. The paper is entitled “Safety and Tolerability of Multiple Ascending Doses of PRX002/RG7935, an Anti-α-Synuclein Monoclonal Antibody, in Patients With Parkinson Disease: A Randomized Clinical Trial.”
Appointed Tran B. Nguyen as Chief Operating Officer, in addition to his responsibilities as Chief Financial Officer. Mr. Nguyen had been Prothena’s Chief Financial Officer since 2013 and has more than 20 years of experience including strategic leadership positions in the biotech, banking and private equity industries.
Initiated a reorganization and updated financial guidance to align the Company’s resources on advancing its broad neuroscience pipeline.

Upcoming Research and Development Milestones

Prasinezumab (PRX002/RG7935)





The Phase 2 PASADENA study, which is being conducted by Roche and was initiated in the second quarter of 2017, continues to enroll patients with early Parkinson’s disease, and data from this study are expected in 2020
PRX004
The Phase 1 study of PRX004, initiated in the second quarter of 2018, continues to enroll patients with ATTR amyloidosis, and pharmacodynamic data from the lower doses of this study are expected in 2019
Discovery
The preclinical tau program (a worldwide collaboration with Celgene) is expected to initiate cell line development of a lead candidate in 2019
The preclinical Aβ (Amyloid beta) program is expected to initiate cell line development of a lead candidate in 2019

Second Quarter and First Six Months of 2018 Financial Results
For the second quarter and first six months of 2018, Prothena reported a net loss of $59.9 million and $108.6 million, respectively, which includes restructuring charges of $20.9 million associated with the discontinuation of the NEOD001 program, as compared to a net loss of $17.7 million and $53.1 million for the second quarter and first six months of 2017, respectively. Net loss per share for the second quarter and first six months of 2018 was $1.50 and $2.77, respectively, as compared to a net loss per share of $0.46 and $1.44 for the second quarter and first six months of 2017, respectively.

Prothena reported total revenue from its collaboration with Roche of $0.3 million and $0.5 million for the second quarter and first six months of 2018, respectively, as compared to total revenue of $26.8 million and $27.1 million for the second quarter and first six months of 2017, respectively.

Research and development (R&D) expenses totaled $31.5 million and $66.2 million for the second quarter and first six months of 2018, respectively, as compared to $34.0 million and $59.7 million for the second quarter and first six months of 2017, respectively. The decrease in R&D expenses for the second quarter compared to the same period in the prior year was primarily due to lower product manufacturing expenses and to a lesser extent lower clinical trial costs, offset in part by higher expenses associated with prasinezumab (PRX002/RG7935). The increase in R&D expenses for the first six months compared to the same period in the prior year was primarily due to higher expenses associated with prasinezumab, higher consulting expenses and higher personnel costs, which were partially offset by lower product manufacturing expenses and to a lesser extent lower clinical trial costs. R&D expenses included non-cash share-based compensation expense of $2.6 million and $4.8 million for the second quarter and first six months of 2018, respectively, as compared to $2.7 million and $5.0 million for the second quarter and first six months of 2017, respectively.

General and administrative (G&A) expenses totaled $11.0 million and $25.2 million for the second quarter and first six months of 2018, respectively, as compared to $10.9 million and $21.7 million for second quarter and first six months of 2017, respectively. The increase in G&A expenses for the first six months compared to the same periods in the prior year was primarily due to higher personnel costs and to a lesser extent higher legal expenses. G&A expenses included non-cash share-based compensation expense of $3.8 million and $8.4 million for the second quarter and first six months of 2018, respectively, as compared to $3.9 million and $7.2 million for the second quarter and first six months of 2017, respectively.

Total non-cash share-based compensation expense was $8.8 million and $15.7 million for the second quarter and first six months of 2018, respectively, which included $2.5 million of non-cash share-based compensation





expense included in the restructuring costs, as compared to $6.7 million and $12.3 million for the second quarter and first six months of 2017, respectively.

As of June 30, 2018, Prothena had $490.3 million in cash, cash equivalents and restricted cash (including the $100 million upfront payment received from Celgene in April 2018) and no debt.

As of July 20, 2018, Prothena had approximately 39.8 million ordinary shares outstanding.

The Company expects its 2018 net cash burn from operating and investing activities to be $40 to $50 million, which includes $110 million of cash provided by operating activities associated with the Celgene collaboration, and to end the year with approximately $421 million in cash (mid-point). The estimated 2018 net cash burn from operating and investing activities is primarily driven by an estimated net loss of $170 to $185 million, which includes an estimated $25 million of non-cash share-based compensation expense. The estimated 2018 net loss includes $80 to $85 million of operating expenses associated with NEOD001 and the Company’s reorganization, including research, development, manufacturing and pre-commercial expenses, severance costs and contract termination fees related to manufacturing obligations and approximately $8 million of non-cash share-based compensation expense.

About Prothena

Prothena Corporation plc is a clinical-stage neuroscience company focused on the discovery and development of novel therapies with the potential to fundamentally change the course of progressive, life-threatening diseases. Fueled by its deep scientific understanding built over decades of neuroscience research, Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets including Parkinson’s disease and other related synucleinopathies (prasinezumab - PRX002/RG7935) and ATTR amyloidosis (PRX004), as well as tau, Aβ (Amyloid beta) and TDP-43 where its scientific understanding of disease pathology can be leveraged. For more information, please visit the Company's website at www.prothena.com and follow us on Twitter @ProthenaCorp.

Forward-looking Statements

This press release contains forward-looking statements. These statements relate to, among other things, the sufficiency of our funding to advance a broad neuroscience pipeline; or goal of developing a broad and novel pipeline targeting neurological diseases; the potential of our multiple discovery-stage programs to eventually offer significant benefit to patients; the expected timing of having data from our Phase 2 study of prasinezumab (PRX002/RG7935) and our Phase 1 study of PRX004; the expected timing of initiating cell line development of lead candidates from our preclinical tau and Aβ programs; our expected net cash burn from operating and investing activities for 2018 and cash balance at the end of 2018; and our estimated net loss and non-cash share-based compensation expense for 2018. 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 26, 2018 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
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited - amounts in thousands except per share data)


 
 
Three Months Ended
June 30,
 
Six Months Ended
June 30,
 
 
2018
 
2017
 
2018
 
2017
Collaboration revenue
 
$
279

 
$
26,812

 
$
506

 
$
27,071

Total revenue
 
279

 
26,812

 
506

 
27,071

Operating expenses:
 
 
 
 
 
 
 
 
Research and development
 
31,452

 
34,032

 
66,158

 
59,730

General and administrative
 
10,992

 
10,912

 
25,221

 
21,744

Restructuring costs
 
20,904

 

 
20,904

 

Total operating expenses
 
63,348

 
44,944

 
112,283

 
81,474

Loss from operations
 
(63,069
)
 
(18,132
)
 
(111,777
)
 
(54,403
)
Other income (expense), net
 
1,241

 
(856
)
 
1,169

 
(1,630
)
Loss before income taxes
 
(61,828
)
 
(18,988
)
 
(110,608
)
 
(56,033
)
Benefit from income taxes
 
(1,946
)
 
(1,287
)
 
(1,983
)
 
(2,948
)
Net loss
 
$
(59,882
)
 
$
(17,701
)
 
$
(108,625
)
 
$
(53,085
)
Basic and diluted net loss per share
 
$
(1.50
)
 
$
(0.46
)
 
$
(2.77
)
 
$
(1.44
)
Shares used to compute basic and diluted net loss per share
 
39,824

 
38,073

 
39,257

 
36,922







PROTHENA CORPORATION PLC
CONSOLIDATED BALANCE SHEETS
(unaudited - amounts in thousands)
 
June 30,
 
December 31,
 
2018
 
2017
Assets
 
 
 
Cash and cash equivalents
$
486,212

 
$
417,620

Accounts receivable
8

 
240

Other current assets
7,817

 
8,467

Total current assets
494,037

 
426,327

Property and equipment, net
53,398

 
54,990

Restricted cash
4,056

 
4,056

Other assets
11,809

 
10,956

Total non-current assets
69,263

 
70,002

Total assets
$
563,300

 
$
496,329

Liabilities and Shareholders’ Equity
 
 
 
Accrued research and development
$
10,160

 
$
13,509

Restructuring liability
18,396

 

Other current liabilities
17,576

 
23,862

Total current liabilities
46,132

 
37,371

Deferred revenue
110,242

 

Other non-current liabilities
50,920

 
51,769

     Total non-current liabilities
161,162

 
51,769

Total liabilities
207,294

 
89,140

Total shareholders’ equity
356,006

 
407,189

Total liabilities and shareholders’ equity
$
563,300

 
$
496,329



Media and Investor Contact:

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