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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Prothena Corporation PLC | NASDAQ:PRTA | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.89 | 4.04% | 22.93 | 21.76 | 24.31 | 23.70 | 22.74 | 22.99 | 653,662 | 01:00:00 |
x
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
o
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
Ireland
|
|
98-1111119
|
(State or other jurisdiction of
incorporation or organization)
|
|
(I.R.S. Employer
Identification Number)
|
Adelphi Plaza
Upper George's Street Dún Laoghaire Co. Dublin, A96 T927, Ireland |
(Address of principal executive offices including Zip Code)
|
Large accelerated filer
|
x
|
Accelerated filer
|
o
|
|
|
|
|
Non-accelerated filer
|
o
(Do not check if a smaller reporting company)
|
Smaller reporting company
|
o
|
|
|
Emerging growth company
|
o
|
If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, 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
|
|
Page
|
|
|
Condensed Consolidated Balance Sheets as of June 30, 2018 and December 31, 2017
|
|
Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2018 and 2017
|
|
Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2018 and 2017
|
|
|
|
|
|
|
|
|
June 30, 2018
|
|
December 31, 2017
|
||||
Assets
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
486,212
|
|
|
$
|
417,620
|
|
Receivable from Roche
|
8
|
|
|
240
|
|
||
Prepaid expenses and other current assets
|
7,817
|
|
|
8,467
|
|
||
Total current assets
|
494,037
|
|
|
426,327
|
|
||
Non-current assets:
|
|
|
|
||||
Property and equipment, net
|
53,398
|
|
|
54,990
|
|
||
Deferred tax assets
|
11,307
|
|
|
8,113
|
|
||
Restricted cash
|
4,056
|
|
|
4,056
|
|
||
Other non-current assets
|
502
|
|
|
2,843
|
|
||
Total non-current assets
|
69,263
|
|
|
70,002
|
|
||
Total assets
|
$
|
563,300
|
|
|
$
|
496,329
|
|
Liabilities and Shareholders’ Equity
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
10,052
|
|
|
$
|
13,633
|
|
Accrued research and development
|
10,160
|
|
|
13,509
|
|
||
Income taxes payable, current
|
946
|
|
|
311
|
|
||
Build-to-suit lease obligation, current
|
1,474
|
|
|
733
|
|
||
Restructuring liability
|
18,396
|
|
|
—
|
|
||
Other current liabilities
|
5,104
|
|
|
9,185
|
|
||
Total current liabilities
|
46,132
|
|
|
37,371
|
|
||
Non-current liabilities:
|
|
|
|
||||
Deferred revenue
|
110,242
|
|
|
—
|
|
||
Deferred rent
|
229
|
|
|
254
|
|
||
Build-to-suit lease obligation, non-current
|
50,691
|
|
|
51,515
|
|
||
Total non-current liabilities
|
161,162
|
|
|
51,769
|
|
||
Total liabilities
|
207,294
|
|
|
89,140
|
|
||
Commitments and contingencies (Note 7)
|
|
|
|
||||
Shareholders’ equity:
|
|
|
|
||||
Euro deferred shares, €22 nominal value:
|
—
|
|
|
—
|
|
||
Authorized shares — 10,000 at June 30, 2018 and December 31, 2017
|
|
|
|
||||
Issued and outstanding shares — none at June 30, 2018 and December 31, 2017
|
|
|
|
||||
Ordinary shares, $0.01 par value:
|
398
|
|
|
385
|
|
||
Authorized shares — 100,000,000 at June 30, 2018 and December 31, 2017
|
|
|
|
||||
Issued and outstanding shares — 39,831,836 and 38,482,764 at June 30, 2018 and December 31, 2017, respectively
|
|
|
|
||||
Additional paid-in capital
|
906,583
|
|
|
849,154
|
|
||
Accumulated deficit
|
(550,975
|
)
|
|
(442,350
|
)
|
||
Total shareholders’ equity
|
356,006
|
|
|
407,189
|
|
||
Total liabilities and shareholders’ equity
|
$
|
563,300
|
|
|
$
|
496,329
|
|
|
|
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):
|
|
|
|
|
|
|
|
|
||||||||
Interest income (expense), net
|
|
831
|
|
|
18
|
|
|
1,031
|
|
|
(346
|
)
|
||||
Other income (expense), net
|
|
410
|
|
|
(874
|
)
|
|
138
|
|
|
(1,284
|
)
|
||||
Total 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
|
|
|
Six Months Ended June 30,
|
||||||
|
2018
|
|
2017
|
||||
Operating activities
|
|
|
|
||||
Net loss
|
$
|
(108,625
|
)
|
|
$
|
(53,085
|
)
|
Adjustments to reconcile net loss to cash used in operating activities:
|
|
|
|
||||
Depreciation and amortization
|
1,596
|
|
|
1,518
|
|
||
Share-based compensation
|
13,211
|
|
|
12,255
|
|
||
Restructuring share-based compensation
|
2,512
|
|
|
—
|
|
||
Deferred income taxes
|
(1,198
|
)
|
|
157
|
|
||
Interest expense under build-to-suit lease obligation
|
1,825
|
|
|
1,830
|
|
||
Gain from early lease retirement
|
—
|
|
|
(2,096
|
)
|
||
Loss (gain) from disposal of fixed assets
|
101
|
|
|
(5
|
)
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Accounts receivable
|
232
|
|
|
(30,062
|
)
|
||
Prepaid and other assets
|
2,991
|
|
|
(8,744
|
)
|
||
Deferred revenue
|
110,242
|
|
|
—
|
|
||
Accounts payable, accruals and other liabilities
|
(12,222
|
)
|
|
4,311
|
|
||
Restructuring liability
|
15,884
|
|
|
—
|
|
||
Net cash provided by (used in) operating activities
|
26,549
|
|
|
(73,921
|
)
|
||
Investing activities
|
|
|
|
||||
Purchases of property and equipment
|
(280
|
)
|
|
(2,712
|
)
|
||
Proceeds from disposal of fixed assets
|
—
|
|
|
105
|
|
||
Net cash used in investing activities
|
(280
|
)
|
|
(2,607
|
)
|
||
Financing activities
|
|
|
|
||||
Proceeds from issuance of ordinary shares in public offering, net
|
—
|
|
|
150,323
|
|
||
Proceeds from subscription of ordinary shares
|
39,758
|
|
|
—
|
|
||
Proceeds from issuance of ordinary shares upon exercise of stock options
|
4,473
|
|
|
12,013
|
|
||
Reduction of build-to-suit lease obligation
|
(1,908
|
)
|
|
(1,002
|
)
|
||
Net cash provided by financing activities
|
42,323
|
|
|
161,334
|
|
||
Net increase in cash, cash equivalents and restricted cash
|
68,592
|
|
|
84,806
|
|
||
Cash, cash equivalents and restricted cash, beginning of the year
|
421,676
|
|
|
390,979
|
|
||
Cash, cash equivalents and restricted cash, end of the period
|
$
|
490,268
|
|
|
$
|
475,785
|
|
|
|
|
|
||||
Supplemental disclosures of cash flow information
|
|
|
|
||||
Cash paid for income taxes, net of refunds
|
$
|
576
|
|
|
$
|
691
|
|
|
|
|
|
||||
Supplemental disclosures of non-cash investing and financing activities
|
|
|
|
||||
Acquisition of property and equipment included in accounts payable and accrued liabilities
|
$
|
—
|
|
|
$
|
393
|
|
Offering costs included in accounts payable and accrued liabilities
|
$
|
—
|
|
|
$
|
31
|
|
|
Six Months Ended June 30,
|
||||||
|
2018
|
|
2017
|
||||
Cash and cash equivalents
|
$
|
486,212
|
|
|
$
|
471,729
|
|
Restricted cash
|
4,056
|
|
|
4,056
|
|
||
Total Cash, cash equivalents and restricted cash, end of the period
|
$
|
490,268
|
|
|
$
|
475,785
|
|
1.
|
Organization
|
2.
|
Summary of Significant Accounting Policies
|
3.
|
Fair Value Measurements
|
Level 2 —
|
Include other inputs that are based upon quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active, and model-based valuation techniques for which all significant inputs are observable in the market or can be derived from observable market data. Where applicable, these models project future cash flows and discount the future amounts to a present value using market-based observable inputs including interest rate curves, foreign exchange rates, and credit ratings.
|
Level 3 —
|
Unobservable inputs that are supported by little or no market activities, which would require the Company to develop its own assumptions.
|
4.
|
Composition of Certain Balance Sheet Items
|
|
June 30,
2018
|
|
December 31, 2017
|
||||
Machinery and equipment
|
$
|
9,084
|
|
|
$
|
9,078
|
|
Leasehold improvements
|
579
|
|
|
579
|
|
||
Purchased computer software
|
1,299
|
|
|
1,316
|
|
||
Build-to-suit property
|
51,760
|
|
|
51,760
|
|
||
|
62,722
|
|
|
62,733
|
|
||
Less: accumulated depreciation and amortization
|
(9,324
|
)
|
|
(7,743
|
)
|
||
Property and equipment, net
|
$
|
53,398
|
|
|
$
|
54,990
|
|
|
June 30, 2018
|
|
December 31, 2017
|
||||
Payroll and related expenses
|
$
|
3,914
|
|
|
$
|
7,342
|
|
Professional services
|
641
|
|
|
438
|
|
||
Deferred rent
|
49
|
|
|
49
|
|
||
Other
|
500
|
|
|
1,356
|
|
||
Other current liabilities
|
$
|
5,104
|
|
|
$
|
9,185
|
|
5.
|
Net Loss Per Ordinary Share
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Numerator:
|
|
|
|
|
|
|
|
||||||||
Net loss
|
$
|
(59,882
|
)
|
|
$
|
(17,701
|
)
|
|
$
|
(108,625
|
)
|
|
$
|
(53,085
|
)
|
Denominator:
|
|
|
|
|
|
|
|
||||||||
Weighted-average ordinary shares outstanding
|
39,824
|
|
|
38,073
|
|
|
39,257
|
|
|
36,922
|
|
||||
Net loss per share:
|
|
|
|
|
|
|
|
||||||||
Basic and diluted net loss per share
|
$
|
(1.50
|
)
|
|
$
|
(0.46
|
)
|
|
$
|
(2.77
|
)
|
|
$
|
(1.44
|
)
|
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
||||||||
|
2018
|
|
2017
|
2018
|
|
2017
|
||||
Stock options to purchase ordinary shares
|
7,719
|
|
|
4,608
|
|
7,719
|
|
|
4,608
|
|
Year Ended December 31,
|
|
Operating Lease
|
||
2018 (6 months)
|
|
$
|
141
|
|
2019
|
|
242
|
|
|
2020
|
|
242
|
|
|
2021
|
|
242
|
|
|
2022
|
|
242
|
|
|
Thereafter
|
|
644
|
|
|
Total
|
|
$
|
1,753
|
|
Year Ended December 31,
|
|
Expected Cash Payments Under Build-To-Suit Lease Obligation
|
||
2018 (6 months)
|
|
$
|
2,749
|
|
2019
|
|
5,803
|
|
|
2020
|
|
5,979
|
|
|
2021
|
|
6,165
|
|
|
2022
|
|
6,350
|
|
|
Thereafter
|
|
6,535
|
|
|
Total
|
|
$
|
33,581
|
|
|
|
Total
|
|
2018
|
|
2019
|
|
2020
|
|
2021
|
|
2022
|
|
Thereafter
|
||||||||||||||
Purchase Obligations
|
|
$
|
5,946
|
|
|
$
|
5,946
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Contractual obligations under license agreements
(1)
|
|
1,595
|
|
|
215
|
|
|
235
|
|
|
105
|
|
|
105
|
|
|
90
|
|
|
845
|
|
|||||||
Obligations under restructuring plan
|
|
16,574
|
|
|
6,510
|
|
|
5,508
|
|
|
4,556
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||
Total
|
|
$
|
24,115
|
|
|
$
|
12,671
|
|
|
$
|
5,743
|
|
|
$
|
4,661
|
|
|
$
|
105
|
|
|
$
|
90
|
|
|
$
|
845
|
|
•
|
up to
$350.0 million
upon the achievement of development, regulatory and various first commercial sales milestones;
|
•
|
up to an additional
$175.0 million
upon achievement of ex-U.S. commercial sales milestones; and
|
•
|
tiered, high single-digit to high double-digit royalties in the teens on ex-U.S. annual net sales, subject to certain adjustments.
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Research and development
|
$
|
2,553
|
|
|
$
|
2,735
|
|
|
$
|
4,810
|
|
|
$
|
5,043
|
|
General and administrative
|
3,756
|
|
|
3,918
|
|
|
8,401
|
|
|
7,212
|
|
||||
Restructuring costs
(1)
|
2,512
|
|
|
—
|
|
|
2,512
|
|
|
—
|
|
||||
Total share-based compensation expense
|
$
|
8,821
|
|
|
$
|
6,653
|
|
|
$
|
15,723
|
|
|
$
|
12,255
|
|
(1)
|
Restructuring costs for the three and
six months ended June 30, 2018
includes
$2.5 million
of share-based compensation expense related to the contractual acceleration of vesting of certain stock options granted to executive officers.
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||
|
2018
|
|
2017
|
|
2018
|
|
2017
|
Expected volatility
|
83.9%
|
|
72.2%
|
|
79.4%
|
|
72.8%
|
Risk-free interest rate
|
2.8%
|
|
2.0%
|
|
2.8%
|
|
2.0%
|
Expected dividend yield
|
—%
|
|
—%
|
|
—%
|
|
—%
|
Expected life (in years)
|
6.0
|
|
6.0
|
|
6.0
|
|
6.0
|
Weighted average grant date fair value
|
$11.28
|
|
$35.37
|
|
$13.82
|
|
$35.32
|
|
Options
|
|
Weighted
Average Exercise Price |
|
Weighted
Average Remaining Contractual Term (years) |
|
Aggregate
Intrinsic Value (in thousands) |
|||||
Outstanding at December 31, 2017
|
4,406,752
|
|
|
$
|
38.93
|
|
|
7.60
|
|
$
|
30,455
|
|
Granted
|
4,046,300
|
|
|
20.39
|
|
|
|
|
|
|||
Exercised
|
(174,536
|
)
|
|
25.63
|
|
|
|
|
|
|||
Canceled
|
(559,092
|
)
|
|
49.80
|
|
|
|
|
|
|||
Outstanding at June 30, 2018
|
7,719,424
|
|
|
$
|
28.73
|
|
|
7.78
|
|
$
|
4,882
|
|
Vested and expected to vest at June 30, 2018
|
7,271,257
|
|
|
$
|
28.99
|
|
|
7.70
|
|
$
|
4,880
|
|
Vested at June 30, 2018
|
2,505,501
|
|
|
$
|
31.82
|
|
|
5.67
|
|
$
|
4,869
|
|
|
|
Restructuring Liability
|
||||||||||||||
|
|
Termination Benefits
|
|
Contract Termination Costs
|
|
Other
|
|
Total
|
||||||||
Balance at March 31, 2018
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Restructuring charges
|
|
8,507
|
|
|
9,875
|
|
|
—
|
|
|
18,382
|
|
||||
Non cash charges
|
|
2,512
|
|
|
—
|
|
|
—
|
|
|
2,512
|
|
||||
Reductions for cash payments
|
|
(2,119
|
)
|
|
(96
|
)
|
|
—
|
|
|
(2,215
|
)
|
||||
Foreign Exchange
|
|
(5
|
)
|
|
(278
|
)
|
|
—
|
|
|
(283
|
)
|
||||
Balance at June 30, 2018
|
|
$
|
8,895
|
|
|
$
|
9,501
|
|
|
$
|
—
|
|
|
$
|
18,396
|
|
•
|
our ability to obtain additional financing in future offerings and/or obtain funding from future collaborations;
|
•
|
our operating losses;
|
•
|
our ability to successfully complete research and development of our drug candidates;
|
•
|
our ability to develop, manufacture and commercialize products;
|
•
|
our collaborations with third parties, including Roche and Celgene;
|
•
|
our ability to protect our patents and other intellectual property;
|
•
|
our ability to hire and retain key employees;
|
•
|
tax treatment of our separation from Elan and subsequent distribution of our ordinary shares;
|
•
|
our ability to maintain financial flexibility and sufficient cash, cash equivalents and investments and other assets capable of being monetized to meet our liquidity requirements;
|
•
|
potential disruptions in the U.S. and global capital and credit markets;
|
•
|
government regulation of our industry;
|
•
|
the volatility of our ordinary share price;
|
•
|
business disruptions; and
|
•
|
the other risks and uncertainties described in Item 1A - Risk Factors of this Form 10-K.
|
|
Three Months Ended
June 30, |
|
Percentage Change
|
|||||||
2018
|
|
2017
|
|
|||||||
(Dollars in thousands)
|
|
|
||||||||
Collaboration revenue
|
$
|
279
|
|
|
$
|
26,812
|
|
|
(99
|
)%
|
Total revenue
|
$
|
279
|
|
|
$
|
26,812
|
|
|
(99
|
)%
|
|
Six Months Ended
June 30, |
|
Percentage Change
|
|||||||
2018
|
|
2017
|
|
|||||||
(Dollars in thousands)
|
|
|
||||||||
Collaboration revenue
|
$
|
506
|
|
|
$
|
27,071
|
|
|
(98
|
)%
|
Total revenue
|
$
|
506
|
|
|
$
|
27,071
|
|
|
(98
|
)%
|
|
Three Months Ended
June 30, |
|
Percentage Change
|
|||||||
2018
|
|
2017
|
|
|||||||
(Dollars in thousands)
|
|
|
||||||||
Research and development
|
$
|
31,452
|
|
|
$
|
34,032
|
|
|
(8
|
)%
|
General and administrative
|
10,992
|
|
|
10,912
|
|
|
1
|
%
|
||
Restructuring costs
|
20,904
|
|
|
—
|
|
|
nm
|
|
||
Total operating expenses
|
$
|
63,348
|
|
|
$
|
44,944
|
|
|
41
|
%
|
|
Six Months Ended
June 30, |
|
Percentage Change
|
|||||||
2018
|
|
2017
|
|
|||||||
(Dollars in thousands)
|
|
|
||||||||
Research and development
|
66,158
|
|
|
$
|
59,730
|
|
|
11
|
%
|
|
General and administrative
|
25,221
|
|
|
21,744
|
|
|
16
|
%
|
||
Restructuring costs
|
20,904
|
|
|
—
|
|
|
nm
|
|
||
Total operating expenses
|
$
|
112,283
|
|
|
$
|
81,474
|
|
|
38
|
%
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
|
Cumulative to Date
|
||||||||||||||
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
|
|||||||||||
NEOD001
(1)
|
|
$
|
19,747
|
|
|
$
|
26,226
|
|
|
$
|
45,343
|
|
|
$
|
44,446
|
|
|
$
|
297,551
|
|
PRX002/RG7935
(2)
|
|
4,525
|
|
|
218
|
|
|
7,132
|
|
|
2,196
|
|
|
57,880
|
|
|||||
PRX003
(3)
|
|
169
|
|
|
2,555
|
|
|
363
|
|
|
5,170
|
|
|
59,037
|
|
|||||
PRX004
(4)
|
|
4,308
|
|
|
4,222
|
|
|
8,380
|
|
|
6,652
|
|
|
38,545
|
|
|||||
Other R&D
(5)
|
|
2,703
|
|
|
811
|
|
|
4,940
|
|
|
1,266
|
|
|
|
||||||
|
|
$
|
31,452
|
|
|
$
|
34,032
|
|
|
$
|
66,158
|
|
|
$
|
59,730
|
|
|
|
(1)
|
Cumulative R&D costs to date for NEOD001 include the costs incurred from the date when the program has been separately tracked in preclinical development. Expenditures in the early discovery stage are not tracked by program and accordingly have been excluded from this cumulative amount. In April 2018, we announced that we were discontinuing development of NEOD001. Since that date have incurred costs associated with the close out of our Phase 2b PRONTO, Phase 3 VITAL as well as the open label extension studies of NEOD001.
|
(2)
|
Cumulative R&D costs to date for PRX002/RG7935 and related antibodies include the costs incurred from the date when the program was separately tracked in nonclinical development. Expenditures in the early discovery stage are not tracked by program and accordingly have been excluded from this cumulative amount. PRX002/RG7935 cost include payments to Roche for our share of the development expenses incurred by Roche related to PRX002/RG7935 programs and
,
through December 31, 2017, is net of reimbursements from Roche for development and supply services recorded as an offset to R&D expense. For the
three and six months ended
June 30, 2018
,
$0.3 million
and
$0.5
|
(3)
|
Cumulative R&D costs to date for PRX003 include the costs incurred from the date when the program was separately tracked in nonclinical development. Expenditures in the early discovery stage are not tracked by program and accordingly have been excluded from this cumulative amount. Based on the Phase 1b multiple ascending dose study results announced in September 2017, we announced that we will not advance PRX003 into mid-stage clinical development for psoriasis or psoriatic arthritis as previously planned.
|
(4)
|
Cumulative R&D costs to date for PRX004 include the costs incurred from the date when the program was separately tracked in nonclinical development. Expenditures in the early discovery stage are not tracked by program and accordingly have been excluded from this cumulative amount.
|
(5)
|
Other R&D is comprised of preclinical development and discovery programs that have not progressed to first patient dosing in a Phase 1 clinical trial.
|
|
Three Months Ended June 30,
|
|
Percentage Change
|
|||||||
2018
|
|
2017
|
|
|||||||
(Dollars in thousands)
|
|
|
||||||||
Interest income
|
$
|
1,748
|
|
|
$
|
932
|
|
|
88
|
%
|
Interest expense
|
(917
|
)
|
|
(914
|
)
|
|
—
|
%
|
||
Interest income, net
|
831
|
|
|
18
|
|
|
4,517
|
%
|
||
Other income (expense)
|
410
|
|
|
(874
|
)
|
|
(147
|
)%
|
||
Total other income(expense), net
|
$
|
1,241
|
|
|
$
|
(856
|
)
|
|
(245
|
)%
|
|
Six Months Ended
June 30, |
|
Percentage Change
|
|||||||
2018
|
|
2017
|
|
|||||||
(Dollars in thousands)
|
|
|
||||||||
Interest income
|
$
|
2,856
|
|
|
$
|
1,484
|
|
|
92
|
%
|
Interest expense
|
(1,825
|
)
|
|
(1,830
|
)
|
|
—
|
%
|
||
Interest income (expense), net
|
1,031
|
|
|
(346
|
)
|
|
(398
|
)%
|
||
Other income (expense)
|
138
|
|
|
(1,284
|
)
|
|
(111
|
)%
|
||
Total other income(expense), net
|
$
|
1,169
|
|
|
$
|
(1,630
|
)
|
|
(172
|
)%
|
|
Three Months Ended June 30,
|
|
Percentage Change
|
|||||||
2018
|
|
2017
|
|
|||||||
(Dollars in thousands)
|
|
|
||||||||
Benefit from income taxes
|
$
|
(1,946
|
)
|
|
$
|
(1,287
|
)
|
|
51
|
%
|
|
Six Months Ended
June 30, |
|
Percentage Change
|
|||||||
2018
|
|
2017
|
|
|||||||
(Dollars in thousands)
|
|
|
||||||||
Benefit from income taxes
|
$
|
(1,983
|
)
|
|
$
|
(2,948
|
)
|
|
(33
|
)%
|
|
June 30,
|
|
December 31,
|
||||
|
2018
|
|
2017
|
||||
Working capital
|
$
|
447,905
|
|
|
$
|
388,956
|
|
Cash and cash equivalents
|
486,212
|
|
|
417,620
|
|
||
Total assets
|
563,300
|
|
|
496,329
|
|
||
Total liabilities
|
207,294
|
|
|
89,140
|
|
||
Total shareholders’ equity
|
356,006
|
|
|
407,189
|
|
|
Six Months Ended
June 30, |
||||||
|
2018
|
|
2017
|
||||
Net cash provided by (used in) operating activities
|
$
|
26,549
|
|
|
$
|
(73,921
|
)
|
Net cash used in investing activities
|
(280
|
)
|
|
(2,607
|
)
|
||
Net cash provided by financing activities
|
42,323
|
|
|
161,334
|
|
||
Net increase in cash and cash equivalents and restricted cash
|
$
|
68,592
|
|
|
$
|
84,806
|
|
|
|
Total
|
|
2018
|
|
2019
|
|
2020
|
|
2021
|
|
2022
|
|
Thereafter
|
||||||||||||||
Operating leases
(1)
|
|
$
|
1,753
|
|
|
$
|
141
|
|
|
$
|
242
|
|
|
$
|
242
|
|
|
$
|
242
|
|
|
$
|
242
|
|
|
$
|
644
|
|
Minimum cash payments under build-to-suit lease obligation
(1)
|
|
33,581
|
|
|
2,749
|
|
|
5,803
|
|
|
5,979
|
|
|
6,165
|
|
|
6,350
|
|
|
6,535
|
|
|||||||
Purchase obligations
|
|
5,946
|
|
|
5,946
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||
Obligations under restructuring plan
(3)
|
|
16,574
|
|
|
6,510
|
|
|
5,508
|
|
|
4,556
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||
Contractual obligations under license agreements
(2)
|
|
1,595
|
|
|
215
|
|
|
235
|
|
|
105
|
|
|
105
|
|
|
90
|
|
|
845
|
|
|||||||
Total
|
|
$
|
59,449
|
|
|
$
|
15,561
|
|
|
$
|
11,788
|
|
|
$
|
10,882
|
|
|
$
|
6,512
|
|
|
$
|
6,682
|
|
|
$
|
8,024
|
|
•
|
support the Phase 2 PASADENA clinical trial for PRX002/RG7935 (prasinezumab) being conducted by Roche, conduct our Phase 1 clinical trial for PRX004 and possibly initiate additional clinical trials for these and other programs;
|
•
|
develop and commercialize our product candidates, including PRX002/RG7935 and PRX004;
|
•
|
undertake nonclinical development of other product candidates and initiate clinical trials, if supported by nonclinical data; and
|
•
|
pursue our early stage research and seek to identify additional drug candidates and potentially acquire rights from third parties to drug candidates through licenses, acquisitions or other means.
|
•
|
the timing of initiation, progress, results and costs of our clinical trials, including the Phase 2 clinical trial for PRX002/RG7935 and our Phase 1 clinical trial for PRX004;
|
•
|
the timing, initiation, progress, results and costs of these and our other research, development and commercialization activities;
|
•
|
the results of our research and nonclinical studies;
|
•
|
the costs of manufacturing our drug candidates for clinical development as well as for future commercialization needs;
|
•
|
the costs of preparing for commercialization of our drug candidates;
|
•
|
the costs of preparing, filing and prosecuting patent applications and maintaining, enforcing and defending intellectual property-related claims;
|
•
|
our ability to establish research collaborations, strategic collaborations, licensing or other arrangements;
|
•
|
the timing, receipt and amount of any payments or royalties that we might receive under current or potential future collaborations;
|
•
|
the costs to satisfy our obligations under current and potential future collaborations; and
|
•
|
the timing, receipt and amount of revenues or royalties, if any, from any approved drug candidates.
|
•
|
terminate or delay clinical trials or other development for one or more of our drug candidates;
|
•
|
delay arrangements for activities that may be necessary to commercialize our drug candidates;
|
•
|
curtail or eliminate our drug research and development programs that are designed to identify new drug candidates; or
|
•
|
cease operations.
|
•
|
offer improvement over existing treatment options;
|
•
|
be proven safe and effective in clinical trials; or
|
•
|
meet applicable regulatory standards.
|
•
|
obtaining and maintaining commercial manufacturing arrangements with third-party manufacturers;
|
•
|
developing the marketing and sales capabilities, internal and/or in collaboration with pharmaceutical companies or contract sales organizations, to market and sell any approved drug; and
|
•
|
acceptance of any approved drug in the medical community and by patients and third-party payors.
|
•
|
collaborators have significant discretion in determining the efforts and resources that they will apply to a collaboration, and might not commit sufficient efforts and resources or might misapply those efforts and resources;
|
•
|
we may have limited influence or control over the approaches to development and commercialization of products candidates in the territories in which our collaboration partners lead development and commercialization;
|
•
|
collaborators might not pursue research, development and commercialization of collaboration product candidates or might elect not to continue or renew research, development or commercialization programs based on clinical trial results, changes in their strategic focus due to the acquisition of competing products, availability of funding or other factors, such as a business combination that diverts resources or creates competing priorities;
|
•
|
collaborators might delay, provide insufficient resources to, or modify or stop clinical trials for collaboration product candidates or require a new formulation of a product candidate for clinical testing;
|
•
|
collaborators could develop or acquire products outside of the collaboration that compete directly or indirectly with our product candidates or require a new formulation of a product candidate for clinical testing;
|
•
|
collaborators with sales, marketing and distribution rights to one or more product candidates might not commit sufficient resources to sales, marketing and distribution or might otherwise fail to successfully commercialize those product candidates;
|
•
|
collaborators might not properly maintain or defend our intellectual property rights or might use our intellectual property improperly or in a way that jeopardizes our intellectual property or exposes us to potential liability;
|
•
|
collaboration activities might result in the collaborator having intellectual property covering our activities or product candidates, which could limit our rights or ability to research, develop or commercialize our product candidates;
|
•
|
disputes might arise between us and a collaborator that could cause a delay or termination of the collaboration or result in costly litigation that diverts management attention and resources; and
|
•
|
collaborations might be terminated, which could result in a need for additional capital to pursue further development or commercialization of our product candidates.
|
•
|
conditions imposed on us by the FDA, the EMA or other comparable regulatory authorities regarding the scope or design of our clinical trials;
|
•
|
delays in obtaining, or our inability to obtain, required approvals from institutional review boards (“IRBs”) or other reviewing entities at clinical sites selected for participation in our clinical trials;
|
•
|
insufficient supply or deficient quality of our drug candidates or other materials necessary to conduct our clinical trials;
|
•
|
delays in obtaining regulatory agency agreement for the conduct of our clinical trials;
|
•
|
lower than anticipated enrollment and/or retention rate of subjects in our clinical trials, which can be impacted by a number of factors, including size of patient population, design of trial protocol, trial length, eligibility criteria, perceived risks and benefits of the study drug, patient proximity to trial sites, patient referral practices of physicians, availability of other treatments for the relevant disease and competition from other clinical trials;
|
•
|
slower than expected rates of events in trials with a composite primary endpoint that is event-based;
|
•
|
serious and unexpected drug-related side effects experienced by subjects in clinical trials; or
|
•
|
failure of our third-party contractors and collaborators to meet their contractual obligations to us or otherwise meet their development or other objectives in a timely manner.
|
•
|
failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols;
|
•
|
inspection of the clinical trial operations or trial sites by the FDA, the EMA or other regulatory authorities resulting in the imposition of a clinical hold on or imposition of additional conditions for the conduct of the trial;
|
•
|
interpretation of data by the FDA, the EMA or other regulatory authorities;
|
•
|
requirement by the FDA, the EMA or other regulatory authorities to perform additional studies;
|
•
|
failure to achieve primary or secondary endpoints or other failure to demonstrate efficacy or adequate safety;
|
•
|
unforeseen safety issues; or
|
•
|
lack of adequate funding to continue the clinical trial.
|
•
|
the FDA, the EMA or comparable regulatory authorities may disagree with the design, implementation or conduct of our clinical trials;
|
•
|
we may be unable to demonstrate to the satisfaction of the FDA, the EMA or comparable regulatory authorities that a drug candidate is safe and effective for its proposed indication;
|
•
|
the results of clinical trials may not meet the level of statistical significance required by the FDA, the EMA or comparable regulatory authorities for approval;
|
•
|
we may be unable to demonstrate that a drug candidate’s clinical and other benefits outweigh its safety risks;
|
•
|
the FDA, the EMA or comparable regulatory authorities may disagree with our interpretation of data from nonclinical studies or clinical trials;
|
•
|
the data collected from clinical trials of our drug candidates may not be sufficient to support the submission of a Biologic License Application (“BLA”) to the FDA, a Marketing Authorization Application (“MAA”) to the EMA or similar applications to comparable regulatory authorities;
|
•
|
the FDA, the EMA or comparable regulatory authorities may fail to approve the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; or
|
•
|
the approval policies or regulations of the FDA, the EMA or comparable regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.
|
•
|
restrictions on the marketing of our products or their manufacturing processes;
|
•
|
warning letters;
|
•
|
civil or criminal penalties;
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•
|
fines;
|
•
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injunctions;
|
•
|
product seizures or detentions;
|
•
|
import or export bans;
|
•
|
voluntary or mandatory product recalls and related publicity requirements;
|
•
|
suspension or withdrawal of regulatory approvals;
|
•
|
total or partial suspension of production; and
|
•
|
refusal to approve pending applications for marketing approval of new products or supplements to approved applications.
|
•
|
regulatory authorities may withdraw their approval of the product;
|
•
|
regulatory authorities may require the addition of labeling statements, such as warnings or contraindications, or impose additional safety monitoring or reporting requirements;
|
•
|
we may be required to change the way the product is administered, conduct additional clinical trials;
|
•
|
we could be sued and held liable for harm caused to patients; and
|
•
|
our reputation may suffer.
|
•
|
the indication and label for the product and the timing of introduction of competitive products;
|
•
|
demonstration of clinical safety and efficacy compared to other products;
|
•
|
prevalence and severity of adverse side effects;
|
•
|
availability of coverage and adequate reimbursement from managed care plans and other third-party payors;
|
•
|
convenience and ease of administration;
|
•
|
cost-effectiveness;
|
•
|
other potential advantages of alternative treatment methods; and
|
•
|
the effectiveness of marketing and distribution support of the product.
|
•
|
an annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents, apportioned among these entities according to their market share in certain government healthcare programs;
|
•
|
an increase in the minimum rebates a manufacturer must pay under the U.S. Medicaid Drug Rebate Program to 23.1% and 13.0% of the average manufacturer price for branded and generic drugs, respectively;
|
•
|
expansion of healthcare fraud and abuse laws, including the U.S. False Claims Act and the U.S. Anti-Kickback Statute, new government investigative powers and enhanced penalties for non-compliance;
|
•
|
a new Medicare Part D coverage gap discount program, under which manufacturers must agree to offer 50 percent point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D;
|
•
|
extension of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;
|
•
|
expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals and by adding new mandatory eligibility categories for certain individuals with income at or below 133% of the federal poverty level, thereby potentially increasing a manufacturer’s Medicaid rebate liability;
|
•
|
a licensure framework for follow-on biologic products;
|
•
|
expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program;
|
•
|
new requirements under the federal Open Payments program and its implementing regulations;
|
•
|
a new requirement to annually report drug samples that manufacturers and distributors provide to physicians; and
|
•
|
a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research.
|
•
|
significantly greater financial, technical and human resources than we have and may be better equipped to discover, develop, manufacture and commercialize drug candidates;
|
•
|
more extensive experience in nonclinical testing and clinical trials, obtaining regulatory approvals and manufacturing and marketing pharmaceutical products;
|
•
|
drug candidates that have been approved or are in late-stage clinical development; and/or
|
•
|
collaborative arrangements in our target markets with leading companies and research institutions.
|
•
|
the U.S. Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase or recommendation of an item or service reimbursable under a federal healthcare program, such as the Medicare and Medicaid programs;
|
•
|
U.S. federal and state false claims laws, including the False Claims Act, which impose criminal and civil penalties, including civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;
|
•
|
the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program and making false statements in connection with the delivery of or payment for healthcare benefits, items or services, and under the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH”) imposes obligations, including mandatory contractual terms, on certain types of individuals and entities with respect to safeguarding the privacy, security and transmission of individually identifiable health information and places restrictions on the use of such information for marketing communications;
|
•
|
the U.S. Physician Payment Sunshine Act, which requires applicable manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to the Centers for Medicare & Medicaid Services (“CMS”) information related to “payments or other transfers of value” made to physicians and teaching hospitals and applicable manufacturers and applicable group purchasing organizations to report annually to CMS ownership and investment interests held by the physicians and their immediate family members;
|
•
|
laws and regulations that apply to sales or marketing arrangements; apply to healthcare items or services reimbursed by non-governmental third-party payors, including private insurers; require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines; that restrict payments that may be made to healthcare providers; require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and
|
•
|
similar and other laws and regulations in the U.S. (federal, state and local), in the EU (including member countries) and other countries and jurisdictions.
|
•
|
decreased demand for any approved drug candidates;
|
•
|
impairment of our business reputation;
|
•
|
withdrawal of clinical trial participants;
|
•
|
costs of related litigation;
|
•
|
distraction of management’s attention;
|
•
|
substantial monetary awards to patients or other claimants; and
|
•
|
loss of revenues; and the inability to successfully commercialize any approved drug candidates.
|
•
|
the patentability of our inventions relating to our drug candidates; and/or
|
•
|
the enforceability, validity or scope of protection offered by our patents relating to our drug candidates.
|
•
|
incur substantial monetary damages;
|
•
|
encounter significant delays in bringing our drug candidates to market; and/or
|
•
|
be precluded from participating in the manufacture, use or sale of our drug candidates or methods of treatment requiring licenses.
|
•
|
our ability to obtain financing as needed;
|
•
|
progress in and results from our ongoing or future clinical trials;
|
•
|
our collaborations with third parties, including with Roche and Celgene;
|
•
|
failure or delays in advancing our nonclinical drug candidates or other drug candidates we may develop in the future into clinical trials;
|
•
|
results of clinical trials conducted by others on drugs that would compete with our drug candidates;
|
•
|
issues in manufacturing our drug candidates;
|
•
|
regulatory developments or enforcement in the U.S. and other countries;
|
•
|
developments or disputes concerning patents or other proprietary rights;
|
•
|
introduction of technological innovations or new commercial products by our competitors;
|
•
|
changes in estimates or recommendations by securities analysts, if any, who cover our company;
|
•
|
public concern over our drug candidates;
|
•
|
litigation;
|
•
|
future sales of our ordinary shares;
|
•
|
general market conditions;
|
•
|
changes in the structure of healthcare payment systems;
|
•
|
failure of any of our drug candidates, if approved, to achieve commercial success;
|
•
|
economic and other external factors or other disasters or crises;
|
•
|
period-to-period fluctuations in our financial results;
|
•
|
overall fluctuations in U.S. equity markets;
|
•
|
our quarterly or annual results, or those of other companies in our industry;
|
•
|
announcements by us or our competitors of significant acquisitions or dispositions;
|
•
|
the operating and ordinary share price performance of other comparable companies;
|
•
|
investor perception of our company and the drug development industry;
|
•
|
natural or environmental disasters that investors believe may affect us;
|
•
|
changes in tax laws or regulations applicable to our business or the interpretations of those tax laws and regulations by taxing authorities; or
|
•
|
fluctuations in the budgets of federal, state and local governmental entities around the world.
|
|
|
|
|
Previously Filed
|
|
||||
Exhibit
No.
|
|
Description
|
|
Form
|
|
File No.
|
Filing Date
|
Exhibit
|
Filed Herewith
|
10.1#
|
|
|
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
|
|
|
10.2#
|
|
|
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
|
|
|
10.3#
|
|
|
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
|
|
|
31.1
|
|
|
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
|
|
|
31.2
|
|
|
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
|
|
|
32.1*
|
|
|
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
|
|
|
101.INS+
|
|
XBRL Instance Document
|
|
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
|
|
101.SCH+
|
|
XBRL Taxonomy Extension Schema Document
|
|
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
|
|
101.CAL+
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
|
|
101.DEF+
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
|
|
101.LAB+
|
|
XBRL Taxonomy Extension Label Linkbase Document
|
|
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
|
|
101.PRE+
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
|
|
|
|
|
X
|
#
|
Indicates management contract or compensatory plan or arrangement.
|
*
|
Exhibit 32.1 is being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall such exhibit be deemed to be incorporated by reference in any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise specifically stated in such filing.
|
+
|
XBRL information is furnished and not filed for purposes of Sections 11 and 12 of the Securities Act of 1933 and Section 18 of the Securities Exchange Act of 1934, and is not subject to liability under those sections, is not part of any registration
|
Dated:
|
August 7, 2018
|
Prothena Corporation plc
(Registrant)
|
||
|
|
|
||
|
|
/s/ Gene G. Kinney
|
||
|
|
Gene G. Kinney
|
||
|
|
President and Chief Executive Officer
|
||
|
|
|
||
|
|
/s/ Tran B. Nguyen
|
||
|
|
Tran B. Nguyen
|
||
|
|
Chief Operating Officer and Chief Financial Officer
|
1 Year Prothena Chart |
1 Month Prothena Chart |
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