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): March 25, 2013
Prothena Corporation plc
(Exact name of registrant as specified in its charter)
Ireland
(State or other jurisdiction of incorporation)
|
|
|
|
|
001-35676
(Commission File Number)
|
|
Not Applicable
(IRS Employer Identification Number)
|
650 Gateway Boulevard
South San Francisco, California 94080
(Address of principal executive
offices, including Zip Code)
Registrant’s telephone number, including area code: (650) 837-8550
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:
|
¨
|
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
|
|
¨
|
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
|
|
¨
|
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
|
|
¨
|
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 and the 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. This Item 2.02 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 references the information furnished pursuant to Item 2.02 of this Current Report.
On March 28, 2013, Prothena Corporation plc (“Prothena” or “Parent”) announced its financial results for its
fourth quarter and year ended December 31, 2012 in the press release attached hereto as Exhibit 99.1.
Item 5.02 Departure of
Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
Appointment of Tran Nguyen as Chief Financial Officer
On March 25, 2013, Prothena announced the appointment of Tran Nguyen, age 39, as its Chief Financial Officer, effective as of March 25, 2013 pursuant to the terms of an employment offer letter
(the “Nguyen Offer Letter”), dated March 20, 2013, between Mr. Nguyen and Prothena Biosciences Inc, an indirect wholly-owned subsidiary of Parent (the “Company”). Mr. Nguyen has 15 years of finance experience in
the healthcare, banking and private equity industries. From April 2010 to February 2011, Mr. Nguyen was Vice President, Chief Financial Officer of Somaxon Pharmaceuticals, Inc. and from February 2011 held the position of Senior Vice President,
Chief Financial Officer until its sale in March 2013. Prior to Somaxon, from March 2009 to January 2010, Mr. Nguyen was Vice President, Chief Financial Officer and Investor Relations at Metabasis Therapeutics, Inc., until its sale in January
2010. Prior to Metabasis, from 2007 to January 2009, Mr. Nguyen was a Vice President in the Healthcare Investment Banking group at Citi Global Markets, Inc. Prior to Citi, from 2004 to 2007, Mr. Nguyen served in a variety of capacities as
a healthcare investment banker at Lehman Brothers, Inc. Mr. Nguyen earned his BA in Economics and Psychology from Claremont McKenna College and his MBA from the Anderson School of Management at UCLA.
Pursuant to the Nguyen Offer Letter, Mr. Nguyen will receive an annual base salary of $330,000 and a signing bonus of $25,000.
Mr. Nguyen is also eligible to receive an annual incentive cash bonus initially targeted at 40% of his annual base salary. Annual incentive cash bonuses are intended to compensate executives for the achievement of Company goals. Cash bonuses
are generally calculated as a percentage of the applicable executive’s base salary with the size of the payment dependent on the extent to which corporate goals and individual performance objectives, as applicable, are achieved.
Additionally, pursuant to the Nguyen Offer Letter, the Company, subject to approval by Parent’s Compensation Committee of its Board
of Directors, has agreed to grant Mr. Nguyen a stock option to purchase 180,000 ordinary shares of Parent (the “Nguyen Option Grant”) at an exercise price equal to the closing price of Parent’s ordinary shares as listed on The
NASDAQ Global Market on the date of grant, expected to be April 1, 2013, pursuant to Parent’s 2012 Long Term Incentive Plan. The Nguyen Option Grant shall vest as to 25% of the shares upon the one-year anniversary of Mr. Nguyen’s
start date with the Company and 1/48th of the shares subject to the grant will vest on each successive month following the one-year anniversary of Mr. Nguyen’s start date, subject to Mr. Nguyen’s continued service to the Company,
until vested in full on the fourth anniversary of Mr. Nguyen’s start date.
Mr. Nguyen will also be entitled to the change of control and severance benefits for
the “Leadership I” category of the Company’s severance and change in control policies (the “Severance Policies”), as described in Parent’s Current Report on Form 8-K filed with the SEC on March 8, 2013, which is
incorporated by reference herein. Mr. Nguyen will further be entitled to certain benefits in connection with his relocation to the Company’s South San Francisco offices.
Appointment of Martin Koller as Chief Medical Officer
On
March 25, 2013, Prothena announced the appointment of Dr. Martin Koller, age 62, as its Chief Medical Officer, effective as of March 25, 2013 pursuant to the terms of an employment offer letter, dated March 19, 2013, between
Dr. Koller and the Company (the “Koller Offer Letter”). Dr. Koller is a board-certified neurologist with over 20 years of pharmaceutical industry experience in drug development from Phases 1-4 and has been involved with a number
of INDs and NDAs in several indications (e.g., Alzheimer’s disease, Multiple Sclerosis, cervical dystonia, pain, anti-epileptics, migraine, stroke, anxiety, depression). Most recently, Dr. Koller served as Chief Medical Officer of Sonexa
Therapeutics, Inc., a privately held pharmaceutical company, from September 2009 to February 2013. Prior to Sonexa, Dr. Koller worked at Athena Neurosciences from 1994 to 1996 (when it was acquired by Elan Pharmaceuticals) and then at Elan
Pharmaceuticals from 1996 to 2007 where he served as Vice President of Clinical Development from 2002 to 2007 overseeing a national, and then international, drug development group. From 2007 to September 2009, Dr. Koller was an independent
consultant to various small and medium sized pharmaceutical and biotechnology companies. Dr. Koller also held past positions at Syntex Corporation and Wyeth Pharmaceuticals, Inc. Dr. Koller earned his BA from Franklin and Marshall College,
his MD from the University of Maryland at Baltimore and his MPH with an emphasis in epidemiology from the University of Texas at Houston.
Pursuant to the Koller Offer Letter, Dr. Koller will be a part-time employee, working 75% of full-time service to the Company. He will receive an annual base salary of $255,000 (prorated from a
full-time equivalent of $340,000). Dr. Koller is also eligible to receive an annual incentive cash bonus initially targeted at 40% of his annual earned base salary.
Additionally, pursuant to the Koller Offer Letter, the Company, subject to approval by Parent’s Compensation Committee of its Board of Directors, has agreed to grant Dr. Koller a stock option to
purchase 125,000 ordinary shares of Parent (the “Koller Option Grant”) at an exercise price equal to the closing price of Parent’s ordinary shares as listed on The NASDAQ Global Market on the date of grant, expected to be
April 1, 2013, pursuant to Parent’s 2012 Long Term Incentive Plan. The Koller Option Grant shall vest as to 25% of the shares upon the one-year anniversary of Dr. Koller’s start date with the Company and 1/48th of the shares
subject to the grant will vest on each successive month following the one-year anniversary of Dr. Koller’s start date, subject to Dr. Koller’s continued service to the Company, until vested in full on the fourth anniversary of
Dr. Koller’s start date.
Dr. Koller will also be entitled to the change of control and severance benefits for
the “Leadership II” category of the Severance Policies.
The foregoing descriptions of the material terms of the
Nguyen Offer Letter and the Koller Offer Letter are qualified in their entirety by the terms of Exhibits 10.1 and 10.2 to this report, respectively, and are incorporated by reference herein.
A copy of the press release announcing the appointments of Mr. Nguyen and Dr. Koller is filed as Exhibit 99.2 to this report.
Item 9.01 Financial Statements and Exhibits.
|
|
|
|
|
Exhibit No.
|
|
Description
|
|
|
|
|
10.1
|
|
Offer Letter dated March 20, 2013, by and between Prothena Biosciences Inc and Tran Nguyen.
|
|
|
|
|
10.2
|
|
Offer Letter dated March 19, 2013, by and between Prothena Biosciences Inc and Martin Koller.
|
|
|
|
|
99.1
|
|
Press Release dated March 28, 2013 announcing financial results.
|
|
|
|
|
99.2
|
|
Press Release dated March 25, 2013 announcing the appointments of Mr. Nguyen and Dr. Koller.
|
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
|
|
|
|
|
|
Date: March 28, 2013
|
|
PROTHENA CORPORATION PLC
|
|
|
|
|
|
|
|
By:
|
|
/s/ Dale B. Schenk
|
|
|
|
Name:
|
|
Dale B. Schenk
|
|
|
|
Title:
|
|
Chief Executive Officer
|
EXHIBIT INDEX
|
|
|
|
|
Exhibit No.
|
|
Description
|
|
|
|
|
10.1
|
|
Offer Letter dated March 20, 2013, by and between Prothena Biosciences Inc and Tran Nguyen.
|
|
|
|
|
10.2
|
|
Offer Letter dated March 19, 2013, by and between Prothena Biosciences Inc and Martin Koller.
|
|
|
|
|
99.1
|
|
Press Release dated March 28, 2013 announcing financial results.
|
|
|
|
|
99.2
|
|
Press Release dated March 25, 2013 announcing the appointments of Mr. Nguyen and Dr. Koller.
|
Exhibit 10.1
REVISED
March 16,
2013
Dear Tran:
I am pleased to confirm this offer to join Prothena Biosciences Inc
(“Prothena” or the “Company”). We are confident in your knowledge, expertise and judgment, and believe your performance will meet the high-quality objectives and standards set by Prothena’s Board of Directors, Leadership and
Management.
You will be employed as
Chief Financial Officer
, reporting to Dale Schenk (President and Chief Executive Officer),
although your duties, title and reporting relationship may change, based on the Company’s needs and priorities. This is a full-time, exempt position.
Your starting salary will be
$330,000.00
annually, paid twice per month. Your pay is subject to applicable taxes and withholdings.
We agree to pay you a retention bonus of
$25,000.00 (gross)
which will be fully earned in the event that you remain employed with Prothena for one year. We agree to advance you the entire bonus in
your first paycheck, less applicable taxes and withholdings. This bonus will be earned on a pro-rata basis for each week worked during your initial one-year period of employment at Prothena. The unearned portion of this bonus will be repayable by
you to Prothena on a pro-rata basis if you cease employment at Prothena prior to the one-year anniversary of your Start Date of employment, unless your employment ends for a reason that would make you eligible for severance benefits in accordance
with the Prothena Biosciences Inc Severance Plan.
Prothena embraces a pay-for-performance philosophy. All employees are currently eligible
for an annual cash bonus under the terms of the Company’s cash incentive plan (Prothena Biosciences Inc Incentive Compensation Plan). Cash incentive awards are determined by a number of factors, including industry competitiveness,
Prothena’s business strategy, and the degree to which Company, function and/or individual goals are met. The target bonus opportunity for your position is currently
40%
of plan year salaried-earnings.
1
A condition to earning a cash incentive award is that an employee
remains employed through the pay date of the award, which will be not later than March 15 in the year following the conclusion of the plan year. The cash bonus plan is operated at the sole discretion of Prothena, is subject to review on a
regular basis and may change from time to time.
You will be eligible to receive an option to purchase
180,000
ordinary shares of
Prothena Corporation plc (“Parent”), the parent corporation of Prothena, in connection with your commencement of employment. This award is at the discretion of Parent’s Board of Directors and is subject to its approval, the terms of
the Prothena Corporation plc 2012 Long Term Incentive Plan, and Parent’s standard nonstatutory stock option agreement. The Grant Date of the option will be the first business day of the month following your Start Date with Prothena. The
Exercise Price will be set as the closing price of Parent’s ordinary shares on the NASDAQ Global Market listing on the Grant Date. The option will vest with respect to 25% of the total number of shares subject to the option after the first year
of active service from the Start Date, and monthly at a rate of 1/48th of the total number of shares subject to the option thereafter, such that the award will fully vest after a four-year period of continuous employment from the Start Date.
|
1
|
For the 2013 performance year, rather than using your actual salary earned, your annualized base salary of $330,000.00 will be used as your salaried-earnings.
|
On the first day of the month following your Start Date of employment, you will be eligible to
participate in Prothena’s comprehensive benefits program, including the company’s health and welfare and retirement benefits plans, as well as the Prothena Biosciences Inc Severance Plan.
2
Details about these and other applicable plans will be provided
separately. Further, Prothena offers a comprehensive program to assist in your relocation. A copy of this policy is attached for your review. If needed, our relocation company is available to discuss your relocation benefits and needs, and address
any questions that you may have.
You must sign and return all documents provided in this New Hire packet, including this letter, the Employee
Proprietary Information and Invention Assignment Agreement, our Code of Conduct and any other documents. Further information regarding other onboarding requirements and/or documents needed before your Start Date (e.g., I-9 completion process, direct
deposit information, W-4 allowance elections) will be provided separately.
Prothena’s offer of employment is contingent upon our
receiving satisfactory results from your background check and drug screening, as well as any other pre-employment testing that may be required due to the specific nature of our industry and/or your position. Your employment is “at will.”
This means that you and Prothena each has the right to terminate the employment relationship at any time, with or without cause. Nothing in this letter should be taken as a guarantee of continued employment or a specific term of employment. Further,
all benefits and compensation provided by the Company are contingent upon your continued employment.
To accept our offer, please sign this
letter and return to Kevin Hickey by Tuesday, March 19. By signing this letter, you acknowledge that it sets out our entire agreement between the parties and supersedes all prior oral and written agreements, understandings, commitments and
practices between the parties. No amendments to this agreement may be made except in writing signed by a duly authorized representative of Prothena.
We look forward to having you join Prothena. If you have any questions, or would like additional information to help you reach a decision, please feel free to contact Kevin at (650) 278-1762.
Sincerely,
/s/ Dale Schenk
Dale Schenk
President and CEO
Prothena Biosciences Inc
|
|
|
|
|
ACCEPTANCE:
|
|
|
|
|
|
|
/s/ Tran Nguyen
|
|
3/20/2013
|
|
Tran Nguyen
|
|
Date
|
|
2
|
You will be entitled to the change of control and severance benefits for the Leadership I category of the Company’s severance and change in control policies, as
described in the Company’s Current Report on Form 8-K filed with the SEC on March 8, 2013 (see attached). The Company agrees that the benefits described in such Form 8-K will be the lowest level of benefits provided to you by the Company
with respect to severance (i.e., any potential, future reductions to the benefits levels provided by the policies for the Leadership I category shall not apply to you).
|
Exhibit 10.2
REVISED
March 19,
2013
Dear Marty:
I am pleased to confirm this offer to join Prothena Biosciences Inc
(“Prothena” or the “Company”). We are confident in your knowledge, expertise and judgment, and believe your performance will meet the high-quality objectives and standards set by Prothena’s Board of Directors, Leadership and
Management.
You will be employed as
Chief Medical Officer
, reporting to Dale Schenk (President and Chief Executive Officer), although
your duties, title and reporting relationship may change, based on the Company’s needs and priorities. This is a part-time
1
, exempt position.
Your starting salary will be
$340,000.00
annually, which will be pro-rated for part-time service to the Company. During the initial six (6) month period following your Start Date with the
Company, Prothena will assume your service will entail seventy-five percent (75%) of full-time service, which generates a
$255,000.00
pro-rated, annualized salary. As soon as administratively practicable following the six (6) month
anniversary of your Start Date – and each six (6) month period thereafter, while still a part-time employee – the Chief Executive Officer and Head of Human Resources will work with you to determine the appropriate proration of your
annual salary rate consistent with the amount of your business time used in service with the Company, which shall not be reduced below seventy-five percent (75%) of full-time service while you are employed by the Company. Your base salary will
be paid to you in substantially equal installments twice per month and is subject to applicable taxes and withholdings.
Prothena embraces a
pay-for-performance philosophy. All employees are currently eligible for an annual cash bonus under the terms of the Company’s cash incentive plan (Prothena Biosciences Inc Incentive Compensation Plan). Cash incentive awards are determined by a
number of factors, including industry competitiveness, Prothena’s business strategy, and the degree to which Company, function and/or individual goals are met. The target bonus opportunity for your position is currently
40%
of plan year
salaried-earnings. A condition to earning a cash incentive award is that an employee remains employed through the pay date of the award, which will be not later than March 15 in the year following the conclusion of the plan year. The cash bonus
plan is operated at the sole discretion of Prothena, is subject to review on a regular basis and may change from time to time.
You will be
eligible to receive an option to purchase
125,000
ordinary shares of Prothena Corporation plc (“Parent”), the parent corporation of Prothena, in connection with your commencement of employment. This award is at the discretion of
Parent’s Board of Directors and is subject to its approval, the terms of the Prothena Corporation plc 2012 Long Term Incentive Plan, and Parent’s standard nonstatutory stock option agreement. The Grant Date of the option will be the first
business day of the month following your Start Date with Prothena. The Exercise Price will be set as the closing price of Parent’s ordinary shares on the NASDAQ Global Market listing on the Grant Date. The option will vest with respect to 25%
of the total number of shares subject to the option after the first year of active service from the Start Date, and monthly at a rate of 1/48th of the total number of shares subject to the option thereafter, such that the award will fully vest after
a four-year period of continuous employment from the Start Date.
|
1
|
As discussed/agreed, your expected working time is 75% of full-time
|
On the first day of the month following your Start Date of employment, you will be eligible to
participate in Prothena’s comprehensive benefits program, including the company’s health and welfare and retirement benefits plans, as well as the Prothena Biosciences Inc Severance Plan.
2
Details about these and other applicable plans will be provided
separately.
You must sign and return all documents provided in this New Hire packet, including this letter, the Employee Proprietary
Information and Invention Assignment Agreement, our Code of Conduct and any other documents. Further information regarding other onboarding requirements and/or documents needed before your Start Date (e.g., I-9 completion process, direct deposit
information, W-4 allowance elections) will be provided separately.
Prothena’s offer of employment is contingent upon our receiving
satisfactory results from your background check and drug screening, as well as any other pre-employment testing that may be required due to the specific nature of our industry and/or your position. Your employment is “at will.” This means
that you and Prothena each has the right to terminate the employment relationship at any time, with or without cause. Nothing in this letter should be taken as a guarantee of continued employment or a specific term of employment. Further, all
benefits and compensation provided by the Company are contingent upon your continued employment.
To accept our offer, please sign this letter
and return to Kevin Hickey by Tuesday, March 19. By signing this letter, you acknowledge that it sets out our entire agreement between the parties and supersedes all prior oral and written agreements, understandings, commitments and practices
between the parties. No amendments to this agreement may be made except in writing signed by a duly authorized representative of Prothena.
We
look forward to having you join Prothena. If you have any questions, or would like additional information to help you reach a decision, please feel free to contact Kevin at (650) 278-1762.
Sincerely,
/s/ Dale Schenk
Dale Schenk
President and CEO
Prothena Biosciences Inc
|
|
|
|
|
|
|
ACCEPTANCE:
|
|
|
|
|
|
|
|
|
|
/s/ Martin Koller
|
|
3/19/2013
|
|
|
|
Martin Koller
|
|
Date
|
|
|
|
2
|
You will be entitled to the change of control and severance benefits for the Leadership II category of the Company’s severance and change in control policies, as
described in the Company’s Current Report on Form 8-K filed with the SEC on March 8, 2013 (see attached).
|
Exhibit 99.1
PROTHENA REPORTS FOURTH QUARTER AND FULL YEAR 2012 FINANCIAL RESULTS AND PROVIDES RESEARCH AND
DEVELOPMENT UPDATE
Company Advances Pipeline with Strong Capital Position Following 2012 Spin-Off NEOD001 to Enter
Clinic in Early 2013
DUBLIN, Ireland, Mar. 28, 2013 – Prothena Corporation plc (NASDAQ:PRTA), a biotechnology company focused on the
discovery and development of novel antibodies for the potential treatment of a broad range of diseases, today reported financial results for the fourth quarter and full year ended December 31, 2012 and provided an update on research and
development.
“Prothena targets proteins in novel ways to resolve unmet clinical need in patients. We achieved significant milestones in
2012, the FDA accepted our IND for NEOD001, and we established Prothena as an independent company. We expect to continue our positive momentum in 2013 by initiating a Phase 1 clinical trial for NEOD001 and advancing our research pipeline toward
the clinic,” said Dale Schenk, PhD, President and Chief Executive Officer of Prothena.
“Our research and clinical progress has been
supported by our success in building a seasoned board and solid management team,” continued Dr. Schenk. “We have a strong capital position to advance our lead assets further in clinical development including NEOD001 through Phase 2
proof of concept data, and PRX002 and PRX003 through Phase 1 clinical trials. We look forward to continued progress toward these goals in 2013.”
2012 Highlights
|
|
•
|
|
Completed separation from Elan and listing on Nasdaq as a public company; capitalized with $125 million in cash
|
|
|
•
|
|
NEOD001 was granted orphan drug designation for both AL and AA amyloidoses by U.S. Food and Drug Administration (FDA)
|
|
|
•
|
|
NEOD001 Investigational New Drug (IND) application for both AL and AA amyloidoses filed and accepted by FDA
|
|
|
•
|
|
PRX002 (formerly NEOD002) pre-clinical proof of concept and clinical supply manufacturing efforts progressed
|
|
|
•
|
|
PRX003 established pre-clinical proof of concept
|
Research and Development Pipeline Highlights
Prothena’s research and development
pipeline includes three lead therapeutic antibody programs that the company plans to advance aggressively in 2013 and several discovery programs staged for future value.
NEOD001
, a monoclonal antibody targeting AL and AA amyloid for the potential treatment of amyloidosis
|
|
•
|
|
Granted orphan designation by the European Medicines Agency for the treatment of AL amyloidosis
|
|
|
•
|
|
Phase 1 clinical trial in AL amyloidosis planned for early 2013
|
PRX002 (formerly NEOD002)
, a monoclonal antibody targeting synuclein for the potential treatment of Parkinson’s disease
|
|
•
|
|
IND enabling studies and pre-clinical safety testing planned for 2013
|
|
|
•
|
|
IND filing and Phase 1 trial in Parkinson’s disease patients planned for 2014
|
PRX003
, a monoclonal antibody targeting MCAM (melanoma cell adhesion molecule) for the potential treatment of inflammatory disease and metastatic
cancers
|
|
•
|
|
Selected lead candidate
|
|
|
•
|
|
IND filing and Phase 1 trial planned for 2015
|
2012 Financial Results
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 period from January 1
to December 21, 2012 presented in this release have been prepared in accordance with U.S. GAAP, but do not necessarily represent the financial position or results of operations of Prothena had it been operated as a separate independent entity.
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 2 of Notes to the Carve-out
Combined
Financial Statements” in each case included in the Company’s Information Statement, dated
December 17, 2012, attached as Exhibit 99.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on December 21, 2012.
Prothena reported a net loss of $12.2 million for the fourth quarter of 2012 and $41.4 million for the full year of 2012. This compares to a net loss of $9.6 million for the fourth quarter of 2011 and
$29.7 million for the full year of 2011. Net loss per share for the fourth quarter and full year of 2012 was $0.82 per share and $2.84 per share, respectively, compared to a net loss of $0.66 per share and $2.05 per share for the respective prior
periods.
Net loss for the fourth quarter and for the full year of 2012 included $0.4 million and $6.1 million, respectively, of share-based
compensation expense, compared to $0.6 million and $3.0 million for the respectiveprior year periods. The majority of share-based compensation expense is reflected in research and development expenses.
Research and development (R&D) expenses totaled $9.8 million for the fourth quarter of 2012 and $34.1 million for the full year of 2012, compared to
$8.2 million for the fourth quarter of 2011 and $24.2 million for the full year of 2011. R&D expenses increased in 2012 due to an increase in share-based compensation expense, headcount attributable to Prothena programs, and external expenses
related to PRX002 and PRX003, offset by a decrease in NEOD001 related costs. R&D expenses for the fourth quarter and full year of 2012 included $0.4 million and $6.1 million, respectively, of share-based compensation expense, compared to $0.5
million and $2.8 million for the respective prior year periods.
General and administrative (G&A) expenses totaled $3.0 million for the
fourth quarter of 2012 and $9.9 million for the full year of 2012, compared to $1.3 million for the fourth quarter of 2011 and $5.6 million for the full year of 2011. The increase in G&A expenses was primarily due to an increase in support costs
allocated to the Prothena Business by Elan.
As of December 31, 2012, Prothena had $124.9 million in cash and cash equivalents, no
outstanding debt and approximately 17.7 million outstanding ordinary shares.
2013 Financial Outlook
The Company expects a cash burn of $34 to $40 million for 2013, ending the year with approximately $88 million in cash. The 2013 cash burn is primarily
driven by an estimated net lossof $36 to $42 million, which includes an estimated $2.5 million of depreciation and share-based compensation expense. The Company intends to use the
anticipated 2013 spend to initiate and progress patient enrollment and dosing at multiple sites for its NEOD001 Phase 1 clinical trial, complete IND enabling toxicology studies for PRX002, select
a first orphan indication for PRX003, and further advance its discovery programs.
Conference Call Information
Prothena will provide an update on the company and discuss fourth quarter and full year 2012 results via conference call and webcast on Thursday,
March 28, 2013 at 4:30 p.m. EDT.
To access the call, please dial (877) 312-5854 (U.S. toll free) or (408) 774-4003
(international) five minutes prior to the start time and refer to conference ID number 24106806. Live audio webcast is available via http://ir.prothena.com.
A replay of the call will be available beginning March 28 until April 4, 2013. To access, please dial (855) 859-2056 (U.S. toll free) or (404) 537-3406 (international) and refer
to conference ID number 24106806. The webcast will be available at http://ir.prothena.com
.
About Prothena
Prothena Corporation plc (NASDAQ:PRTA) is a biotechnology company focused on the discovery and development of novel antibodies for the potential treatment
of a broad range of diseases that involve protein misfolding or cell adhesion, particularly on the discovery and development 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, Parkinson’s disease and related synucleinopathies, and novel cell adhesion targets involved in inflammatory disease and metastatic cancers. For more information,
please visit 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 status and timing of our products in research, Prothena’s plans to advance such products, their effectiveness as potential therapies, our ability to execute on our strategy, our 2013 estimates for
net loss and cash burn and its anticipated uses. 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 the information statement included as Exhibit 99.1 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on December 21,
2012. 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.
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 period from January 1 to December 21, 2012 presented in this release have been prepared in
accordance with U.S. GAAP, but do not necessarily represent the financial position or results of operations of Prothena had it been operated as a separate independent entity. 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 2 of Notes to the Carve-out Combined Financial Statements” in each case included in the
Company’s Information Statement, dated December 17, 2012, attached as Exhibit 99.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on December 21, 2012.
PROTHENA CORPORATION PLC
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited - amounts in thousands except per
share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
Twelve Months Ended
|
|
|
|
|
December 31,
|
|
|
December 31,
|
|
|
|
|
2012
|
|
|
2011
|
|
|
2012
|
|
|
2011
|
|
|
Revenue - related party
|
|
$
|
575
|
|
|
$
|
127
|
|
|
$
|
2,658
|
|
|
$
|
507
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses
|
|
|
9,833
|
|
|
|
8,247
|
|
|
|
34,139
|
|
|
|
24,172
|
|
|
General and administrative expenses
|
|
|
2,962
|
|
|
|
1,315
|
|
|
|
9,929
|
|
|
|
5,579
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
12,795
|
|
|
|
9,562
|
|
|
|
44,068
|
|
|
|
29,751
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(12,220
|
)
|
|
|
(9,435
|
)
|
|
|
(41,410
|
)
|
|
|
(29,244
|
)
|
|
Interest income
|
|
|
5
|
|
|
|
—
|
|
|
|
5
|
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes
|
|
|
(12,215
|
)
|
|
|
(9,435
|
)
|
|
|
(41,405
|
)
|
|
|
(29,244
|
)
|
|
Provision for income taxes
|
|
|
6
|
|
|
|
118
|
|
|
|
6
|
|
|
|
426
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(12,221
|
)
|
|
$
|
(9,553
|
)
|
|
$
|
(41,411
|
)
|
|
$
|
(29,670
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share
|
|
$
|
(0.82
|
)
|
|
$
|
(0.66
|
)
|
|
$
|
(2.84
|
)
|
|
$
|
(2.05
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used to compute basic and diluted loss per share
|
|
|
14,886
|
|
|
|
14,497
|
|
|
|
14,593
|
|
|
|
14,497
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PROTHENA CORPORATION PLC
CONSOLIDATED BALANCE SHEETS
(unaudited - amounts in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31,
|
|
|
|
|
2012
|
|
|
2011
|
|
|
Cash and cash equivalents
|
|
$
|
124,860
|
|
|
$
|
—
|
|
|
Prepaid and other current assets
|
|
|
981
|
|
|
|
124
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
125,841
|
|
|
|
124
|
|
|
Plant and equipment, net
|
|
|
3,393
|
|
|
|
2,539
|
|
|
Other non-current assets
|
|
|
49
|
|
|
|
955
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
129,283
|
|
|
$
|
3,618
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
—
|
|
|
$
|
380
|
|
|
Accrued research and development expenses
|
|
|
47
|
|
|
|
5,542
|
|
|
Other current liabilities
|
|
|
1,697
|
|
|
|
2,482
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
1,744
|
|
|
|
8,404
|
|
|
Other non-current liabilities
|
|
|
1,055
|
|
|
|
1,650
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
2,799
|
|
|
|
10,054
|
|
|
Total shareholders’ equity
|
|
|
126,484
|
|
|
|
(6,436
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and shareholders’ deficit
|
|
$
|
129,283
|
|
|
$
|
3,618
|
|
|
|
|
|
|
|
|
|
|
|
Contact
Investors: Tran Nguyen, CFO
650-837-8535,
IR@prothena.com
Media: Anita Kawatra
646-256-5116,
anita.kawatra@prothena.com
Exhibit 99.2
Prothena announces appointments of Chief Medical Officer and Chief Financial Officer
DUBLIN, Ireland, Mar. 25, 2013 – Prothena Corporation plc (Nasdaq:PRTA), a biotechnology company focused on the discovery and development of novel
antibodies for the potential treatment of a broad range of diseases, today announced that two senior executives have joined the Company. Prothena has appointed Martin Koller, MD, MPH as Chief Medical Officer and Tran Nguyen as Chief Financial
Officer.
“Marty and Tran bring a wealth of biotech expertise to Prothena and will play pivotal roles as we advance our research and
clinical pipeline. I am pleased to welcome them to our management team,” said Dr. Dale Schenk, President and Chief Executive Officer, Prothena. “Marty’s decades of clinical leadership will forge strong trial strategy and
design in multiple indications. Tran’s financial strategy, planning and management experience with public life science companies will provide critical support for the advancement of our pipeline.”
Martin Koller, MD
Martin Koller, MD is
a board-certified neurologist with more than 20 years of experience in the life sciences industry, developing small molecules and biologic therapeutics for a diverse array of indications. Prior to joining Prothena, Dr. Koller served
as Chief Medical Officer at Sonexa Therapeutics. Previously, Dr. Koller held clinical development roles and leadership positions at life sciences companies including Athena Neurosciences, Elan Pharmaceuticals, Syntex Pharmaceuticals
and Wyeth Pharmaceuticals. Dr. Koller has extensive expertise in clinical trial design, having been involved in the clinical development of numerous INDs and NDAs targeting a broad array of indications, including Alzheimer’s
disease, multiple sclerosis, cervical dystonia, pain, epilepsy, migraine, stroke, anxiety, and depression. Dr. Koller has a BA from Franklin and Marshall College, an MPH with an emphasis in epidemiology from the University of Texas at Houston
and his MD from the University of Maryland, Baltimore. Dr. Koller completed fellowship training in neuromuscular diseases at the University of Southern California.
Tran Nguyen
Tran Nguyen has 15 years of finance experience in the healthcare, banking and private equity industries. Prior to joining Prothena, he held management positions at Somaxon Pharmaceuticals, Inc.,
including Senior Vice President, Vice President, Chief Financial Officer, and Investor Relations, until its sale in 2013. Previously, Mr. Nguyen was Vice President, Chief Financial Officer and Investor Relations at Metabasis Therapeutics,
Inc., until its sale in 2010. Before entering the biotech industry, Mr. Nguyen was a vice president in the Healthcare Investment Banking group at Citi Global Markets, Inc., and served in healthcare investment banking at Lehman Brothers,
Inc. Mr. Nguyen has a BA from Claremont McKenna College and an MBA from UCLA Anderson School of Management.
About Prothena
Prothena Corporation plc (Nasdaq:PRTA) is a biotechnology company focused on the discovery and development of novel antibodies
for the potential treatment of a broad range of diseases that involve protein misfolding or cell adhesion, particularly on the discovery and development 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, Parkinson’s disease and related synucleinopathies, and novel cell adhesion targets involved in
inflammatory disease and metastatic cancers. For more information, please visit
www.prothena.com
.
Contact
Investors: Tran Nguyen
650-837-8535,
IR@prothena.com
Media: Anita Kawatra
646-256-5116,
anita.kawatra@prothena.com