Prothena Corporation plc
Prothena Corp plc (Form: 8-K, Received: 08/04/2014 16:19:55)


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 4, 2014
_______________________________________________________

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.)
 
 
 
Alexandra House
The Sweepstakes, Ballsbridge
Dublin 4, Ireland
(Address of principal executive offices including Zip Code)
Registrant’s telephone number, including area code: 011-353-1-902-3519
(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))





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 4, 2014 , Prothena Corporation plc issued a press release announcing the Company's financial results for the second quarter ended June 30, 2014 . A copy of this press release entitled “ Prothena Reports Second Quarter 2014 Financial Results and R&D Progress” 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
 
Press Release dated August 4, 2014.


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 4, 2014
PROTHENA CORPORATION PLC
 
 
 
 
 
 
 
By:
 
/s/ Tran B. Nguyen
 
 
Name:
 
Tran B. Nguyen
 
 
Title:
 
Chief Financial Officer





EXHIBIT INDEX
 
 
 
 
Exhibit No.
 
Description of Exhibit
99.1
 
Press Release dated August 4, 2014.





Exhibit 99.1

Prothena Reports Second Quarter 2014 Financial Results and R&D Progress
Completion of successful public equity offering netting $102.5 million and net cash provided by operating activities of $6.2 million in second quarter 2014 contributed to strengthen cash position to $303.9 million
Promising interim results of ongoing Phase 1 study of NEOD001 in patients with AL amyloidosis and persistent organ dysfunction presented at International Symposium on Amyloidosis (ISA)
Successful first dosing in Phase 1 single and multiple ascending dose studies of PRX002 in healthy subjects and patients with Parkinson’s disease, respectively

DUBLIN, Ireland - August 4, 2014 - 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 diseases that involve protein misfolding or cell adhesion, today reported financial results for the second quarter and six months ended June 30, 2014 and provided an update on its lead programs.

Prothena reported net income of $1.3 million and $19.1 million for the second quarter and first six months of 2014, respectively, as compared to a net loss of $11.3 million and $20.3 million for the second quarter and first six months of 2013, respectively. Net income per share for the second quarter and first six months of 2014 was $0.06 and $0.83 on a diluted basis, respectively, as compared to a net loss per share of $0.64 and $1.15 for the second quarter and first six months of 2013, respectively.

As of June 30, 2014 , Prothena had $303.9 million in cash and cash equivalents and no outstanding debt. In June 2014, Prothena raised net proceeds of $102.5 million through a public offering of 4,750,000 ordinary shares (included in the cash balance reported as of June 30, 2014). In July 2014, Prothena raised an additional $14.9 million (not included in the June 30, 2014 cash balance) through the sale of 712,500 ordinary shares when the underwriters exercised their option in full to purchase additional shares, bringing aggregate net proceeds of the public offering to $117.4 million. These amounts should be read in connection with “Second Quarter and First Six Months of 2014 Financial Results and Guidance” below.

“Building on the promising interim cardiac biomarker responses and the favorable safety and tolerability profile presented at ISA from the ongoing Phase 1 study of NEOD001 in patients with AL amyloidosis, we are working closely with appropriate regulatory authorities to determine the optimal endpoints for the Phase 2/3 study, which we expect to initiate in the fourth quarter of this year,” said Dale Schenk, PhD, President and Chief Executive Officer of Prothena. “In addition, together with Roche, we announced the successful initial dosing in both single and multiple ascending dose clinical trials of PRX002 in healthy subjects and patients with Parkinson’s disease, respectively, to investigate the safety, tolerability, pharmacokinetics and pharmacodynamic properties of this novel antibody.”

“Importantly, we completed a successful public offering, netting $117.4 million , which further strengthened our balance sheet and allows us to advance each of our three lead programs to mid-to-late stages of development.”

Second Quarter 2014 and Recent Highlights


1



Presented interim data demonstrating safety, tolerability and encouraging cardiac biomarker responses from the ongoing Phase 1 study of NEOD001 in patients with AL amyloidosis and persistent organ dysfunction at ISA
Together with Roche, advanced PRX002 into Phase 1 studies:
Single ascending dose study in healthy subjects in April 2014 and received $15 million milestone payment from Roche in May 2014; and
Multiple ascending dose study in patients with Parkinson’s disease in July 2014
Continued to bolster leadership team with the appointment of Bill Homan as Chief Legal Officer
Raised aggregate net proceeds of $117.4 million through the issuance of 5,462,500 ordinary shares in the recent public offering in June and July 2014
 
Research and Development Pipeline Highlights

Prothena's research and development pipeline includes three lead therapeutic antibody programs that the Company plans to continue to advance in the second half of 2014.

NEOD001 is a monoclonal antibody targeting AL and AA amyloid for the potential treatment of systemic amyloidosis.

Presented encouraging NT-proBNP responses from ongoing Phase 1 study at ISA in April 2014
Expect additional data from the ongoing Phase 1 clinical trial of NEOD001 to be shared later in 2014
Initiation of Phase 2/3 clinical trial in patients with AL amyloidosis who have cardiac involvement, planned for the fourth quarter of 2014

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

Successful first dosing in Phase 1 single ascending dose clinical study in healthy subjects in April 2014 and received $15 million clinical milestone from Roche in May 2014
Successful first dosing in Phase 1 multiple ascending dose clinical study in patients with Parkinson’s disease

PRX003 is a monoclonal antibody targeting MCAM (melanoma cell adhesion molecule) for the potential treatment of inflammatory diseases and cancers.

Communication of initial indication(s) planned for the fourth quarter of 2014
Continue to conduct Investigational New Drug (IND) enabling toxicology studies and preparative CMC activities during the second half of 2014
Initiation of Phase 1 clinical trial(s) planned for 2015

Second Quarter and First Six Months of 2014 Financial Results and Guidance

Prothena reported net income of $1.3 million and $19.1 million for the second quarter and first six months

2



of 2014, respectively, as compared to a net loss of $11.3 million and $20.3 million for the second quarter and first six months of 2013, respectively. Net income per share for the second quarter and first six months of 2014 was $0.06 and $0.83 , respectively, on a diluted basis as compared to a net loss per share of $0.64 and $1.15 for the second quarter and first six months of 2013, respectively.

Prothena reported total revenue of $15.1 million and $47.4 million in the second quarter and first six months of 2014, respectively, as compared to total revenue of $0.2 million and $0.3 million for the second quarter and first six months of 2013, respectively. The increase was primarily due to $15.0 million and $47.1 million in collaboration revenue recognized in relation to the PRX002 collaboration with Roche in the second quarter and first six months of 2014, respectively.

Research and development (R&D) expenses totaled $8.6 million and $18.0 million for the second quarter and first six months of 2014, respectively, as compared to $8.1 million and $14.1 million for the second quarter and first six months of 2013, respectively. The increase in R&D expenses was primarily due to increased external expenses related to clinical trials and product manufacturing and higher personnel costs. R&D expenses included non-cash share-based compensation expense of $0.6 million and $1.0 million for the second quarter and first six months of 2014, respectively, as compared to $0.2 million and $0.3 million of the second quarter and first six months of 2013, respectively.

General and administrative (G&A) expenses totaled $4.9 million and $9.8 million for the second quarter and first six months of 2014, respectively, as compared to $3.2 million and $6.4 million for second quarter and first six months of 2013, respectively. The increase in G&A expenses was primarily due to increases in personnel costs, and higher external legal and consulting expenses. G&A expenses included non-cash share-based compensation expense of $0.9 million and $1.7 million for the second quarter and first six months of 2014, respectively, as compared to $0.5 million and $0.8 million for the second quarter and first six months of 2013, respectively.

Total non-cash share-based compensation expense for the second quarter and first six months of 2014 was $1.4 million and $2.8 million , respectively, as compared to $0.7 million and $1.1 million for the second quarter and first six months of 2013, respectively.

As of June 30, 2014 , Prothena had $303.9 million in cash and cash equivalents and no outstanding debt. As of July 25, 2014 , Prothena had 27,375,937 ordinary shares outstanding.

The Company continues to expect a net cash burn from operating activities of $7 to $12 million for 2014, and now expects to end the year with approximately $285 million in cash (mid-point). The estimated 2014 net cash burn from operating activities is primarily driven by an estimated net loss of $13 to $18 million, which includes an estimated $6 million of non-cash share-based compensation expense.

Upcoming Investor Conference

Members of the management team will attend the following upcoming investor conferences:
Wedbush Securities Life Sciences Management Access Conference on Tuesday, August 12, 2014 at 10:55 am EDT at Le Parker Meridien in New York, NY
JMP Securities Biotech Day on Friday, September 5, 2014 at The Langham Hotel in Boston, MA

A live webcast of the Wedbush Securities 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

3



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 diseases that involve protein misfolding or cell adhesion. The Company focuses on therapeutic monoclonal antibodies directed specifically to disease-causing proteins and its antibody-based product candidates target a number of potential indications including AL and AA forms of amyloidosis (NEOD001), Parkinson’s disease and related synucleinopathies (PRX002) and novel cell adhesion targets involved in inflammatory diseases and cancers (PRX003).

For more information, please visit the Company’s website 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 planned Phase 2/3 study for NEOD001; our ability to advance each of our three lead programs to mid-to-late stages of development; the timing of sharing additional data from the ongoing Phase 1 clinical trial of NEOD001; the conduct and timing of initial indication(s), IND-enabling toxicology studies and preparative CMC activities, and Phase 1 clinical trial(s) for PRX003; our anticipated net cash burn from operating activities for 2014 and expected cash balance at the end of 2014; and our estimated net loss and non-cash share-based compensation expense for 2014. 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 7, 2014, and the “Risk Factors” section of 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.





4



PROTHENA CORPORATION PLC
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited - amounts in thousands except per share data)
 

 
 
Three Months Ended June 30,
 
Six Months Ended
June 30,
 
 
2014
 
2013
 
2014
 
2013
Collaboration revenue
 
$
14,984

 
$

 
$
47,080

 
$

Revenue—related party
 
137

 
167

 
275

 
338

Total revenue
 
15,121

 
167

 
47,355

 
338

Operating expenses:
 
 
 
 
 
 
 
 
Research and development
 
8,615

 
8,147

 
17,957

 
14,104

General and administrative
 
4,937

 
3,212

 
9,810

 
6,393

Total operating expenses
 
13,552

 
11,359

 
27,767

 
20,497

Income (loss) from operations
 
1,569

 
(11,192
)
 
19,588

 
(20,159
)
Other income, net
 
17

 
14

 
1

 
36

Income (loss) before income taxes
 
1,586

 
(11,178
)
 
19,589

 
(20,123
)
Provision for income taxes
 
296

 
124

 
447

 
130

Net income (loss)
 
$
1,290

 
$
(11,302
)
 
$
19,142

 
$
(20,253
)
Net income (loss) per share attributable to holders of ordinary shares
 
 
 
 
 
 
 
 
Basic
 
$
0.06

 
$
(0.64
)
 
$
0.87

 
$
(1.15
)
Diluted
 
$
0.06

 
$
(0.64
)
 
$
0.83

 
$
(1.15
)
Shares used to compute net income (loss) per share attributable to holders of ordinary shares
 
 
 
 
 
 
 
 
Basic
 
21,959

 
17,679

 
21,922

 
17,679

Diluted
 
22,898

 
17,679

 
22,927

 
17,679



5



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

 
June 30,
 
December 31,

 
2014
 
2013
Assets
 
 
 
Cash and cash equivalents
$
303,851

 
$
176,677

Other current assets
3,168

 
1,545

Total current assets
307,019

 
178,222

Property and equipment, net
3,340

 
3,372

Other non-current assets
1,326

 
816

Total assets
$
311,685

 
$
182,410

Liabilities and Shareholders’ Equity
 
 
 
Accrued research and development
5,730

 
1,542

Other current liabilities
5,581

 
5,864

Total current liabilities
11,311

 
7,406

Non-current liabilities:
1,955

 
1,734

Total liabilities
13,266

 
9,140

Total shareholders’ equity
298,419

 
173,270

Total liabilities and shareholders’ equity
$
311,685

 
$
182,410


Contact
Investors:  Tran Nguyen, CFO
650-837-8535,  IR@prothena.com
Media:  Anita Kawatra
646-256-5116,  anita.kawatra@prothena.com



6