|
|
|
x
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
¨
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
|
|
Delaware
|
|
77-0551645
|
(State or other jurisdiction of
incorporation or organization)
|
|
(I.R.S. Employer
Identification Number)
|
|
|
|
7555 Gateway Boulevard
Newark, California 94560
(510) 742-3400
(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)
|
|
Large accelerated filer
|
¨
|
Accelerated filer
|
x
|
|
|
|
|
Non-accelerated filer
|
¨
(Do not check if a smaller reporting company)
|
Smaller reporting company
|
¨
|
|
|
|
|
|
|
Emerging growth company
|
x
|
|
|
|
June 30,
|
|
December 31,
|
||||
|
2018
|
|
2017
|
||||
ASSETS
|
|||||||
CURRENT ASSETS
|
|
|
|
||||
Cash and cash equivalents
|
$
|
39,282
|
|
|
$
|
282,896
|
|
Short-term investments
|
194,452
|
|
|
—
|
|
||
Prepaid expenses and other current assets
|
9,148
|
|
|
2,315
|
|
||
Total current assets
|
242,882
|
|
|
285,211
|
|
||
Property and equipment, net
|
12,196
|
|
|
9,250
|
|
||
Restricted cash
|
730
|
|
|
580
|
|
||
Other non-current assets
|
3,315
|
|
|
658
|
|
||
TOTAL ASSETS
|
$
|
259,123
|
|
|
$
|
295,699
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|||||||
CURRENT LIABILITIES
|
|
|
|
||||
Accounts payable
|
$
|
5,435
|
|
|
$
|
6,805
|
|
Accruals and other current liabilities
|
13,569
|
|
|
12,225
|
|
||
Deferred revenue, current portion
|
9,320
|
|
|
—
|
|
||
Financing obligations
|
—
|
|
|
1,872
|
|
||
Total current liabilities
|
28,324
|
|
|
20,902
|
|
||
Derivative liability associated with Medicis settlement
|
2,717
|
|
|
2,613
|
|
||
Deferred revenue, net of current portion
|
14,800
|
|
|
—
|
|
||
Deferred rent
|
3,427
|
|
|
3,339
|
|
||
TOTAL LIABILITIES
|
49,268
|
|
|
26,854
|
|
||
Commitments and Contingencies (Note 8)
|
|
|
|
||||
STOCKHOLDERS’ EQUITY
|
|
|
|
||||
Common stock, par value $0.001 per share — 95,000,000 shares authorized as of June 30, 2018 and December 31, 2017; 36,917,723 and 36,516,075 shares issued and outstanding as of June 30, 2018 and December 31, 2017, respectively
|
37
|
|
|
37
|
|
||
Additional paid-in capital
|
821,326
|
|
|
810,975
|
|
||
Accumulated other comprehensive loss
|
(224
|
)
|
|
—
|
|
||
Accumulated deficit
|
(611,284
|
)
|
|
(542,167
|
)
|
||
TOTAL STOCKHOLDERS’ EQUITY
|
209,855
|
|
|
268,845
|
|
||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$
|
259,123
|
|
|
$
|
295,699
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Revenue
|
$
|
686
|
|
|
$
|
75
|
|
|
$
|
880
|
|
|
$
|
150
|
|
Operating expenses:
|
|
|
|
|
|
|
|
||||||||
Research and development
|
22,871
|
|
|
18,307
|
|
|
45,111
|
|
|
37,714
|
|
||||
General and administrative
|
12,734
|
|
|
8,609
|
|
|
26,350
|
|
|
16,363
|
|
||||
Total operating expenses
|
35,605
|
|
|
26,916
|
|
|
71,461
|
|
|
54,077
|
|
||||
Loss from operations
|
(34,919
|
)
|
|
(26,841
|
)
|
|
(70,581
|
)
|
|
(53,927
|
)
|
||||
Interest income
|
1,081
|
|
|
347
|
|
|
2,103
|
|
|
658
|
|
||||
Interest expense
|
—
|
|
|
(141
|
)
|
|
(44
|
)
|
|
(335
|
)
|
||||
Change in fair value of derivative liability associated with Medicis settlement
|
(70
|
)
|
|
(107
|
)
|
|
(104
|
)
|
|
(167
|
)
|
||||
Other expense, net
|
(172
|
)
|
|
(132
|
)
|
|
(492
|
)
|
|
(258
|
)
|
||||
Net loss
|
(34,080
|
)
|
|
(26,874
|
)
|
|
(69,118
|
)
|
|
(54,029
|
)
|
||||
Unrealized gain (loss) on available for sale securities
|
52
|
|
|
(17
|
)
|
|
(224
|
)
|
|
(69
|
)
|
||||
Comprehensive loss
|
$
|
(34,028
|
)
|
|
$
|
(26,891
|
)
|
|
$
|
(69,342
|
)
|
|
$
|
(54,098
|
)
|
Basic and Diluted net loss attributable to common stockholders
|
$
|
(34,080
|
)
|
|
$
|
(26,874
|
)
|
|
$
|
(69,118
|
)
|
|
$
|
(54,029
|
)
|
Basic and Diluted net loss per share attributable to common stockholders (Note 2)
|
$
|
(0.94
|
)
|
|
$
|
(0.90
|
)
|
|
$
|
(1.92
|
)
|
|
$
|
(1.84
|
)
|
Basic and Diluted weighted-average number of shares used in computing net loss per share attributable to common stockholders
|
36,123,659
|
|
|
29,776,893
|
|
|
36,037,604
|
|
|
29,295,220
|
|
|
Six Months Ended
June 30, |
||||||
|
2018
|
|
2017
|
||||
CASH FLOWS FROM OPERATING ACTIVITIES
|
|
|
|
||||
Net loss
|
$
|
(69,118
|
)
|
|
$
|
(54,029
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
||||
Depreciation
|
807
|
|
|
722
|
|
||
Amortization of premium (discount) on investment
|
(610
|
)
|
|
326
|
|
||
Change in fair value of derivative liability associated with Medicis settlement
|
104
|
|
|
167
|
|
||
Stock-based compensation expense
|
8,330
|
|
|
6,674
|
|
||
Capitalized interest
|
(16
|
)
|
|
(16
|
)
|
||
Effective interest on financing obligations
|
44
|
|
|
155
|
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Prepaid expenses and other current assets
|
(6,970
|
)
|
|
(1,139
|
)
|
||
Other non-current assets
|
(2,291
|
)
|
|
(504
|
)
|
||
Accounts payable
|
(958
|
)
|
|
469
|
|
||
Accruals and other liabilities
|
(1,143
|
)
|
|
1,693
|
|
||
Deferred revenue
|
24,120
|
|
|
—
|
|
||
Net cash used in operating activities
|
(47,701
|
)
|
|
(45,482
|
)
|
||
CASH FLOWS FROM INVESTING ACTIVITIES
|
|
|
|
||||
Purchases of property and equipment
|
(2,335
|
)
|
|
(1,507
|
)
|
||
Proceeds from maturities of investments
|
18,000
|
|
|
45,655
|
|
||
Proceeds from sales of property and equipment
|
146
|
|
|
—
|
|
||
Purchases of investments
|
(212,197
|
)
|
|
(36,028
|
)
|
||
Payment for acquisition of in-process research and development
|
(100
|
)
|
|
(100
|
)
|
||
Net cash provided by (used in) investing activities
|
(196,486
|
)
|
|
8,020
|
|
||
CASH FLOWS FROM FINANCING ACTIVITIES
|
|
|
|
||||
Proceeds from issuance of common stock, net of at-the-market offering commissions
|
—
|
|
|
29,100
|
|
||
Principal payments made on financing obligations
|
(932
|
)
|
|
(1,842
|
)
|
||
Net settlement of restricted stock awards for employee taxes
|
(1,813
|
)
|
|
(397
|
)
|
||
Proceeds from the exercise of stock options and employee stock purchase plan
|
3,834
|
|
|
1,561
|
|
||
Payment of offering costs
|
(366
|
)
|
|
(267
|
)
|
||
Net cash provided by financing activities
|
723
|
|
|
28,155
|
|
||
NET DECREASE IN CASH, CASH EQUIVALENTS, AND RESTRICTED CASH
|
(243,464
|
)
|
|
(9,307
|
)
|
||
CASH, CASH EQUIVALENTS, AND RESTRICTED CASH — Beginning of period
|
283,476
|
|
|
64,082
|
|
||
CASH, CASH EQUIVALENTS, AND RESTRICTED CASH — End of period
|
$
|
40,012
|
|
|
$
|
54,775
|
|
|
Six Months Ended
June 30, |
||||||
|
2018
|
|
2017
|
||||
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:
|
|
|
|
||||
Cash paid for interest
|
$
|
16
|
|
|
$
|
196
|
|
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING INFORMATION:
|
|
|
|
||||
Property and equipment purchases included in accounts payable and accruals and other current liabilities
|
$
|
2,128
|
|
|
$
|
68
|
|
Deferred offering costs
|
$
|
—
|
|
|
$
|
115
|
|
|
As of June 30,
|
||||
|
2018
|
|
2017
|
||
Outstanding common stock options
|
3,530,799
|
|
|
3,372,698
|
|
Outstanding common stock warrants
|
34,113
|
|
|
61,595
|
|
Unvested restricted stock awards
|
668,619
|
|
|
553,283
|
|
|
June 30, 2018
|
|
December 31, 2017
|
||||||||||||||||||||||||||||
|
|
|
Gross Unrealized
|
|
|
|
|
|
Gross Unrealized
|
|
|
||||||||||||||||||||
|
Cost
|
|
Gains
|
|
Losses
|
|
Fair Value
|
|
Cost
|
|
Gains
|
|
Losses
|
|
Fair Value
|
||||||||||||||||
Money market funds
|
$
|
34,884
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
34,884
|
|
|
$
|
236,744
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
236,744
|
|
U.S. treasury securities
|
115,818
|
|
|
—
|
|
|
(137
|
)
|
|
115,681
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||||
U.S. government agency obligations
|
78,858
|
|
|
—
|
|
|
(87
|
)
|
|
78,771
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||||
Total cash equivalents and available-for-sale securities
|
$
|
229,560
|
|
|
$
|
—
|
|
|
$
|
(224
|
)
|
|
$
|
229,336
|
|
|
$
|
236,744
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
236,744
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Classified as:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Cash equivalents
|
|
|
|
|
|
|
$
|
34,884
|
|
|
|
|
|
|
|
|
$
|
236,744
|
|
||||||||||||
Short-term investments
|
|
|
|
|
|
|
194,452
|
|
|
|
|
|
|
|
|
—
|
|
||||||||||||||
Total cash equivalents and available-for-sale securities
|
|
|
|
|
|
|
$
|
229,336
|
|
|
|
|
|
|
|
|
$
|
236,744
|
|
•
|
Level 1 — Observable inputs, such as quoted prices in active markets for identical assets or liabilities;
|
•
|
Level 2 — Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities; and
|
•
|
Level 3 — Valuations based on unobservable inputs to the valuation methodology and including data about assumptions market participants would use in pricing the asset or liability based on the best information available under the circumstances.
|
|
As of June 30, 2018
|
||||||||||||||
|
Fair Value
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||
Assets
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
$
|
34,884
|
|
|
$
|
34,884
|
|
|
$
|
—
|
|
|
$
|
—
|
|
U.S. treasury securities
|
115,681
|
|
|
115,681
|
|
|
—
|
|
|
—
|
|
||||
U.S. government agency obligations
|
78,771
|
|
|
—
|
|
|
78,771
|
|
|
—
|
|
||||
Total assets measured at fair value
|
$
|
229,336
|
|
|
$
|
150,565
|
|
|
$
|
78,771
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
||||||||
Liabilities
|
|
|
|
|
|
|
|
||||||||
Derivative liability associated with Medicis settlement
|
$
|
2,717
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2,717
|
|
Total liabilities measured at fair value
|
$
|
2,717
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2,717
|
|
|
As of December 31, 2017
|
||||||||||||||
|
Fair Value
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||
Assets
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
$
|
236,744
|
|
|
$
|
236,744
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total assets measured at fair value
|
$
|
236,744
|
|
|
$
|
236,744
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
||||||||
Liabilities
|
|
|
|
|
|
|
|
||||||||
Derivative liability associated with Medicis settlement
|
$
|
2,613
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2,613
|
|
Total liabilities measured at fair value
|
$
|
2,613
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2,613
|
|
|
Derivative Liability Associated with Medicis Settlement
|
||
Fair value as of December 31, 2017
|
$
|
2,613
|
|
Change in fair value
|
104
|
|
|
Fair value as of June 30, 2018
|
$
|
2,717
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||
Expected term (in years)
|
6.0
|
|
|
6.0
|
|
|
6.0
|
|
|
6.0
|
|
Expected volatility
|
60.2
|
%
|
|
67.0
|
%
|
|
60.7
|
%
|
|
68.1
|
%
|
Risk-free interest rate
|
2.8
|
%
|
|
2.0
|
%
|
|
2.7
|
%
|
|
2.1
|
%
|
Expected dividend rate
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||
Expected term (in years)
|
9.0
|
|
|
9.0
|
|
|
8.9
|
|
|
9.0
|
|
Expected volatility
|
63.8
|
%
|
|
70.0
|
%
|
|
63.9
|
%
|
|
70.0
|
%
|
Risk-free interest rate
|
2.9
|
%
|
|
2.2
|
%
|
|
2.8
|
%
|
|
2.2
|
%
|
Expected dividend rate
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
Three and Six Months Ended
June 30, |
||||
|
2018
|
|
2017
|
||
Expected term (in years)
|
0.5
|
|
|
0.5
|
|
Expected volatility
|
59.3
|
%
|
|
72.4
|
%
|
Risk-free interest rate
|
1.6
|
%
|
|
0.7
|
%
|
Expected dividend rate
|
—
|
%
|
|
—
|
%
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
2018
|
|
2017
|
|
2018
|
|
2017
|
|||||||||
Research and development
|
$
|
1,868
|
|
|
$
|
1,504
|
|
|
$
|
3,791
|
|
|
$
|
2,808
|
|
General and administrative
|
2,304
|
|
|
2,015
|
|
|
4,539
|
|
|
3,866
|
|
||||
Total stock-based compensation expense
|
$
|
4,172
|
|
|
$
|
3,519
|
|
|
$
|
8,330
|
|
|
$
|
6,674
|
|
ITEM 2.
|
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
•
|
our expectations regarding the results, timing and completion of our clinical trials and regulatory submissions needed for the approval of RT002 injectable for the treatment of glabellar (frown) lines, muscle movement disorders, including cervical dystonia, and plantar fasciitis, in the United States, Europe and other countries;
|
•
|
our expectations regarding our future development of RT002 injectable and our topical product candidate for other indications, including upper limb spasticity and chronic migraine;
|
•
|
our expectations regarding the development of future product candidates;
|
•
|
the potential for commercialization by us of RT002 injectable, if approved;
|
•
|
our expectations regarding the potential market size, opportunity and growth potential for RT002 injectable and our topical product candidate, if approved for commercial use;
|
•
|
our belief that RT002 injectable and our topical product candidate can expand overall demand for botulinum toxin;
|
•
|
our ability to build our own sales and marketing capabilities, or seek collaborative partners including distributors, to commercialize our product candidates, if approved;
|
•
|
our ability to manufacture in our facility and to scale up our manufacturing capabilities and those of future third-party manufacturers if our product candidates are approved;
|
•
|
estimates of our expenses, future revenue, capital requirements and our needs for additional financing;
|
•
|
the timing or likelihood of regulatory filings and approvals;
|
•
|
our ability to advance product candidates into, and successfully complete, clinical trials;
|
•
|
the implementation of our business model, and strategic plans for our business, product candidates and technology;
|
•
|
the initiation, timing, progress and results of future preclinical studies and clinical trials and our research and development programs;
|
•
|
the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology;
|
•
|
our ability to establish collaborations or obtain additional funding;
|
•
|
our expectations regarding the time during which we will be an emerging growth company under the Jumpstart Our Business Startups Act of 2012, or the JOBS Act;
|
•
|
our financial performance, including future revenue targets; and
|
•
|
developments and projections relating to our competitors and our industry.
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||||||
|
2018
|
|
2017
|
|
Change
|
|
2018
|
|
2017
|
|
Change
|
||||||||
|
(In thousands, except percentages)
|
||||||||||||||||||
Milestone
|
$
|
686
|
|
|
$
|
—
|
|
|
100%
|
|
$
|
880
|
|
|
$
|
—
|
|
|
100%
|
Relastin Royalty
|
—
|
|
|
75
|
|
|
(100)%
|
|
—
|
|
|
150
|
|
|
(100)%
|
||||
Total revenue
|
$
|
686
|
|
|
$
|
75
|
|
|
815%
|
|
$
|
880
|
|
|
$
|
150
|
|
|
487%
|
•
|
salaries and related expenses for personnel in research and development functions, including stock-based compensation;
|
•
|
expenses related to the initiation and completion of clinical trials for RT002 injectable and our topical product candidate, including expenses related to production of clinical supplies;
|
•
|
fees paid to clinical consultants, clinical trial sites, clinical research organizations (CROs) and other vendors, including all related fees for investigator grants, patient screening fees, laboratory work and statistical compilation and analysis;
|
•
|
other consulting fees paid to third parties;
|
•
|
expenses related to establishment and maintenance of our own manufacturing facilities;
|
•
|
expenses related to the manufacture of drug substance and drug product supplies for ongoing and future preclinical and clinical trials;
|
•
|
expenses to support our product development and establish manufacturing capabilities to support potential future commercialization of any products for which we may obtain regulatory approval;
|
•
|
expenses related to license fees and milestone payments under in-licensing agreements;
|
•
|
expenses related to compliance with drug development regulatory requirements in the United States, the European Union and other foreign jurisdictions; and
|
•
|
depreciation and other allocated expenses.
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||||
|
2018
|
|
2017
|
|
Change
|
|
2018
|
|
2017
|
|
Change
|
||||||
|
(In thousands, except percentages)
|
||||||||||||||||
Finance and administration
|
7,030
|
|
|
5,311
|
|
|
32
|
%
|
|
13,799
|
|
|
10,823
|
|
|
27
|
%
|
Commercial
|
3,400
|
|
|
1,283
|
|
|
165
|
%
|
|
8,012
|
|
|
1,674
|
|
|
379
|
%
|
Stock-based compensation
|
2,304
|
|
|
2,015
|
|
|
14
|
%
|
|
4,539
|
|
|
3,866
|
|
|
17
|
%
|
Total general and administrative expenses
|
12,734
|
|
|
8,609
|
|
|
48
|
%
|
|
26,350
|
|
|
16,363
|
|
|
61
|
%
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||||||
|
2018
|
|
2017
|
|
Change
|
|
2018
|
|
2017
|
|
Change
|
||||||||
|
(In thousands, except percentages)
|
||||||||||||||||||
Interest income
|
$
|
1,081
|
|
|
$
|
347
|
|
|
212%
|
|
$
|
2,103
|
|
|
$
|
658
|
|
|
220%
|
Interest expense
|
—
|
|
|
(141
|
)
|
|
(100)%
|
|
(44
|
)
|
|
(335
|
)
|
|
(87)%
|
||||
Change in fair value of derivative liability associated with Medicis settlement
|
(70
|
)
|
|
(107
|
)
|
|
(35)%
|
|
(104
|
)
|
|
(167
|
)
|
|
(38)%
|
||||
Other expense, net
|
(172
|
)
|
|
(132
|
)
|
|
30%
|
|
(492
|
)
|
|
(258
|
)
|
|
91%
|
||||
Total net non-operating income (expenses)
|
$
|
839
|
|
|
$
|
(33
|
)
|
|
(2,642)%
|
|
$
|
1,463
|
|
|
$
|
(102
|
)
|
|
(1,534)%
|
|
June 30,
2018
|
|
December 31, 2017
|
|
Change
|
||||||
|
(In thousands)
|
||||||||||
Cash, cash equivalents, and investments
|
$
|
233,734
|
|
|
$
|
282,896
|
|
|
$
|
(49,162
|
)
|
Financing obligations
|
—
|
|
|
1,872
|
|
|
(1,872
|
)
|
|||
Working Capital
|
214,558
|
|
|
264,309
|
|
|
(49,751
|
)
|
|||
Stockholders' Equity
|
209,855
|
|
|
268,845
|
|
|
(58,990
|
)
|
|
Six Months Ended June 30,
|
||||||
|
2018
|
|
2017
|
||||
Net cash provided by (used in):
|
|
|
|
||||
Operating activities
|
$
|
(47,701
|
)
|
|
$
|
(45,482
|
)
|
Investing activities
|
(196,486
|
)
|
|
8,020
|
|
||
Financing activities
|
723
|
|
|
28,155
|
|
•
|
the results of our clinical trials for RT002 injectable and preclinical trials of our topical product candidate or any future product candidates;
|
•
|
the timing of, and the costs involved in, obtaining regulatory approvals for RT002 injectable, or any future product candidates including topical;
|
•
|
the number and characteristics of any additional product candidates we develop or acquire;
|
•
|
the scope, progress, results and costs of researching and developing and conducting preclinical and clinical trials of RT002 injectable, topical, or any future product candidates;
|
•
|
the cost of commercialization activities if RT002 injectable or any future product candidates including topical are approved for sale, including marketing, sales and distribution costs;
|
•
|
the cost of manufacturing RT002 injectable, topical, or any future product candidates and any products we successfully commercialize and maintaining our related facilities;
|
•
|
our ability to establish and maintain strategic collaborations, licensing or other arrangements including the Mylan collaboration, and the terms of and timing such arrangements;
|
•
|
the degree and rate of market acceptance of any future approved products;
|
•
|
the emergence, approval, availability, perceived advantages, relative cost, relative safety and relative efficacy of alternative products or treatments;
|
•
|
any product liability or other lawsuits related to our products;
|
•
|
the expenses needed to attract and retain skilled personnel;
|
•
|
any litigation, including litigation costs and the outcome of such litigation;
|
•
|
the costs associated with being a public company;
|
ITEM 3.
|
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
|
ITEM 4.
|
CONTROLS AND PROCEDURES
|
ITEM 1.
|
LEGAL PROCEEDINGS
|
ITEM 1A.
|
RISK FACTORS
|
•
|
timely completion of, or need to conduct additional, clinical trials, including our clinical trials for RT002 injectable, topical, and any future product candidates, which may be significantly slower or cost more than we currently anticipate and will depend substantially upon the number and design of such trials and the accurate and satisfactory performance of third-party contractors;
|
•
|
our ability to demonstrate the effectiveness and differentiation of our products on a consistent basis as compared to existing or future therapies;
|
•
|
our ability to demonstrate to the satisfaction of the FDA, the safety and efficacy of RT002 injectable, our topical product candidate, or any future product candidates through clinical trials;
|
•
|
whether we are required by the FDA or other similar foreign regulatory agencies to conduct additional clinical trials to support the approval of RT002 injectable, our topical product candidate, or any future product candidates;
|
•
|
our success in educating physicians and patients about the benefits, administration and use of RT002 injectable, our topical product candidate, or any future product candidates, if approved;
|
•
|
the prevalence and severity of adverse events experienced with our product candidates or future approved products;
|
•
|
the timely receipt of necessary marketing approvals from the FDA and similar foreign regulatory authorities;
|
•
|
the ability to raise additional capital on acceptable terms and in the time frames necessary to achieve our goals;
|
•
|
achieving and maintaining compliance with all regulatory requirements applicable to RT002 injectable, our topical product candidate, or any future product candidates or approved products;
|
•
|
the availability, perceived advantages, relative cost, relative safety and relative efficacy of alternative treatments;
|
•
|
the effectiveness of our own or our future potential strategic collaborators’ marketing, sales and distribution strategy and operations;
|
•
|
our ability to manufacture clinical trial supplies of RT002 injectable, our topical product candidate, or any future product candidates and to develop, validate and maintain a commercially viable manufacturing process that is compliant with current good manufacturing practices, or cGMP;
|
•
|
our ability to successfully commercialize RT002 injectable, our topical product candidate, or any future product candidates, if approved for marketing and sale, whether alone or in collaboration with others;
|
•
|
our ability to enforce our intellectual property rights in and to RT002 injectable, our topical product candidate, or any future product candidates;
|
•
|
our ability to avoid third-party patent interference or intellectual property infringement claims;
|
•
|
acceptance of RT002 injectable, our topical product candidate, or any future product candidates, if approved, as safe and effective by patients and the medical community; and
|
•
|
the continued acceptable safety profile of RT002 injectable, our topical product candidate, or any future product candidates following approval.
|
•
|
our inability to demonstrate to the satisfaction of the FDA or an applicable foreign regulatory body that RT002 injectable, topical, or any future product candidates are safe and effective for the requested indication;
|
•
|
our inability to demonstrate preclinical proof of concept of topical or other products in future, new indications;
|
•
|
the FDA’s or an applicable foreign regulatory agency’s disagreement with the trial protocol or the interpretation of data from preclinical studies or clinical trials;
|
•
|
our inability to demonstrate that clinical and other benefits of RT002 injectable, topical, or any future product candidates outweigh any safety or other perceived risks;
|
•
|
the FDA’s or an applicable foreign regulatory agency’s requirement for additional preclinical or clinical studies;
|
•
|
the FDA’s or an applicable foreign regulatory agency’s non-approval of the formulation, labeling or the specifications of RT002 injectable, topical, or any future product candidates;
|
•
|
the FDA’s or an applicable foreign regulatory agency’s failure to approve our manufacturing processes or facilities, or the manufacturing processes or facilities of third-party manufacturers with which we contract; or
|
•
|
the potential for approval policies or regulations of the FDA or an applicable foreign regulatory agency to significantly change in a manner rendering our clinical data insufficient for approval.
|
•
|
the results of our clinical trials for RT002 injectable and preclinical trials of our topical product candidate or any future product candidates;
|
•
|
the timing of, and the costs involved in, obtaining regulatory approvals for RT002 injectable, or any future product candidates including topical;
|
•
|
the number and characteristics of any additional product candidates we develop or acquire;
|
•
|
the scope, progress, results and costs of researching and developing and conducting preclinical and clinical trials of RT002 injectable, topical, or any future product candidates;
|
•
|
the cost of commercialization activities if RT002 injectable or any future product candidates including topical are approved for sale, including marketing, sales and distribution costs;
|
•
|
the cost of manufacturing RT002 injectable, topical, or any future product candidates and any products we successfully commercialize and maintaining our related facilities;
|
•
|
our ability to establish and maintain strategic collaborations, licensing or other arrangements including the Mylan collaboration, and the terms of and timing such arrangements;
|
•
|
the degree and rate of market acceptance of any future approved products;
|
•
|
the emergence, approval, availability, perceived advantages, relative cost, relative safety and relative efficacy of alternative products or treatments;
|
•
|
any product liability or other lawsuits related to our products;
|
•
|
the expenses needed to attract and retain skilled personnel;
|
•
|
any litigation, including litigation costs and the outcome of such litigation;
|
•
|
the costs associated with being a public company;
|
•
|
the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims, including litigation costs and the outcome of such litigation; and
|
•
|
the timing, receipt and amount of sales of, or royalties on, future approved products, if any.
|
•
|
the effectiveness and duration of effect of our product as compared to existing and future therapies;
|
•
|
physician willingness to adopt a new therapy to treat glabellar lines, cervical dystonia, plantar fasciitis, adult upper limb spasticity, chronic migraine or other aesthetic or therapeutic indications;
|
•
|
patient satisfaction with the results and administration of our product and overall treatment experience;
|
•
|
patient demand for the treatment of glabellar lines, cervical dystonia, plantar fasciitis or other aesthetic or therapeutic indications;
|
•
|
the willingness of third-party payors to reimburse physicians or patients for RT002 injectable and any future products we may commercialize for therapeutic indications; and
|
•
|
the revenue and profitability that our product will offer a physician as compared to alternative therapies.
|
•
|
the safety and efficacy of the product as demonstrated in clinical trials;
|
•
|
the clinical indications for which the product is approved;
|
•
|
acceptance by physicians, major operators of clinics and patients of the product as a safe and effective treatment;
|
•
|
the proper training and administration of our products by physicians and medical staff;
|
•
|
the potential and perceived advantages of our products over alternative treatments;
|
•
|
the cost of treatment in relation to alternative treatments and willingness to pay for our products, if approved, on the part of payors and patients;
|
•
|
the willingness of patients to pay for RT002 injectable, our topical product candidate, and other aesthetic treatments in general, relative to other discretionary items, especially during economically challenging times;
|
•
|
the willingness of third-party payors to reimburse physicians or patients for RT002 injectable and any future products we may commercialize for therapeutic indications;
|
•
|
the relative convenience and ease of administration;
|
•
|
the prevalence and severity of adverse events; and
|
•
|
the effectiveness of our sales and marketing efforts.
|
•
|
obtain regulatory approval to commence a trial;
|
•
|
reach agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;
|
•
|
obtain institutional review board, or IRB, approval at each site;
|
•
|
recruit suitable subjects to participate in a trial;
|
•
|
have subjects complete a trial or return for post-treatment follow-up;
|
•
|
ensure clinical sites observe trial protocol or continue to participate in a trial;
|
•
|
address any patient safety concerns that arise during the course of a trial;
|
•
|
address any conflicts with new or existing laws or regulations;
|
•
|
add a sufficient number of clinical trial sites; or
|
•
|
manufacture sufficient quantities of product candidate for use in clinical trials.
|
•
|
manage our clinical trials and manufacturing operations effectively;
|
•
|
identify, recruit, retain, incentivize and integrate additional employees;
|
•
|
manage our internal development efforts effectively while carrying out our contractual obligations to third parties; and
|
•
|
continue to improve our operational, financial and management controls, reporting systems and procedures.
|
•
|
the success of any sales and marketing programs that we, or any third parties we engage, undertake, and as to which we have limited experience;
|
•
|
the extent to which physicians recommend RT002 injectable to their patients;
|
•
|
the extent to which RT002 injectable satisfies patient expectations;
|
•
|
our ability to properly train physicians in the use of RT002 injectable or such that their patients do not experience excessive discomfort during treatment or adverse side effects;
|
•
|
the cost, safety and effectiveness of RT002 injectable versus other aesthetic treatments;
|
•
|
consumer sentiment about the benefits and risks of aesthetic procedures generally and RT002 injectable in particular;
|
•
|
the success of any direct-to-consumer marketing efforts we may initiate; and
|
•
|
general consumer confidence, which may be impacted by general economic and political conditions.
|
•
|
decreased demand for RT002 injectable or any future product candidates or products we develop;
|
•
|
injury to our reputation and significant negative media attention;
|
•
|
withdrawal of clinical trial participants or cancellation of clinical trials;
|
•
|
costs to defend the related litigation;
|
•
|
a diversion of management’s time and our resources;
|
•
|
substantial monetary awards to trial participants or patients;
|
•
|
regulatory investigations, product recalls, withdrawals or labeling, marketing or promotional restrictions;
|
•
|
loss of revenue; and
|
•
|
the inability to commercialize any products we develop.
|
•
|
the research methodology used may not be successful in identifying potential product candidates;
|
•
|
competitors may develop alternatives that render our product candidates obsolete or less attractive;
|
•
|
product candidates we develop may nevertheless be covered by third parties’ patents or other exclusive rights;
|
•
|
a product candidate may on further study be shown to have harmful side effects or other characteristics that indicate it is unlikely to be effective or otherwise does not meet applicable regulatory criteria;
|
•
|
a product candidate may not be capable of being produced in commercial quantities at an acceptable cost, or at all;
|
•
|
a product candidate may not be accepted as safe and effective by patients, the medical community or third-party payors, if applicable; and
|
•
|
intellectual property rights of third parties may potentially block our entry into certain geographies or make such entry economically impracticable.
|
•
|
warning letters;
|
•
|
civil and criminal penalties;
|
•
|
injunctions;
|
•
|
withdrawal of approved products;
|
•
|
product seizure or detention;
|
•
|
product recalls;
|
•
|
total or partial suspension of production; and
|
•
|
refusal to approve pending BLAs or supplements to approved BLAs.
|
•
|
a product candidate may not be deemed safe, effective, or of required quality;
|
•
|
FDA officials may not find the data from preclinical studies and clinical trials sufficient;
|
•
|
the FDA might not approve our third-party manufacturers’ processes or facilities; or
|
•
|
the FDA may change its approval policies or adopt new regulations.
|
•
|
restrictions on the marketing or manufacturing of the product, withdrawal of the product from the market, or voluntary or mandatory product recalls;
|
•
|
fines, warning letters or holds on clinical trials;
|
•
|
refusal by the FDA to approve pending applications or supplements to approved applications submitted by us or our strategic collaborators, or suspension or revocation of product license approvals;
|
•
|
product seizure or detention, or refusal to permit the import or export of products; and
|
•
|
injunctions or the imposition of civil or criminal penalties.
|
•
|
changes to manufacturing methods;
|
•
|
recall, replacement, or discontinuance of one or more of our products; and
|
•
|
additional recordkeeping.
|
•
|
regulatory or legal developments in the United States and foreign countries;
|
•
|
results from or delays in clinical trials of our product candidates, including our ongoing SAKURA Phase 3 clinical program in glabellar lines our ongoing ASPEN Phase 3 clinical program in cervical dystonia and our Phase 2 program in plantar fasciitis all with RT002 injectable;
|
•
|
announcements of regulatory approval or disapproval of RT002 injectable or any future product candidates;
|
•
|
FDA or other U.S. or foreign regulatory actions or guidance affecting us or our industry;
|
•
|
introductions and announcements of new products by us, any commercialization partners or our competitors, and the timing of these introductions and announcements;
|
•
|
variations in our financial results or those of companies that are perceived to be similar to us;
|
•
|
changes in the structure of healthcare payment systems;
|
•
|
announcements by us or our competitors of significant acquisitions, licenses, strategic partnerships, joint ventures or capital commitments;
|
•
|
market conditions in the pharmaceutical and biotechnology sectors and issuance of securities analysts’ reports or recommendations;
|
•
|
quarterly variations in our results of operations or those of our future competitors;
|
•
|
changes in financial estimates or guidance, including our ability to meet our future revenue and operating profit or loss estimates or guidance;
|
•
|
sales of substantial amounts of our stock by insiders and large stockholders, or the expectation that such sales might occur;
|
•
|
general economic, industry and market conditions;
|
•
|
additions or departures of key personnel;
|
•
|
intellectual property, product liability or other litigation against us;
|
•
|
expiration or termination of our potential relationships with customers and strategic partners; and
|
•
|
other factors described in this “Risk Factors” section.
|
•
|
only one of our three classes of directors will be elected each year;
|
•
|
no cumulative voting in the election of directors;
|
•
|
the ability of our board of directors to issues shares of preferred stock and determine the price and other terms of those shares, including preferences and voting rights, without stockholder approval;
|
•
|
the exclusive right of our board of directors to elect a director to fill a vacancy or newly created directorship;
|
•
|
stockholders will not be permitted to take actions by written consent;
|
•
|
stockholders cannot call a special meeting of stockholders;
|
•
|
stockholders must give advance notice to nominate directors or submit proposals for consideration at stockholder meetings;
|
•
|
the ability of our board of directors, by a majority vote, to amend the bylaws; and
|
•
|
the requirement for the affirmative vote of at least 66 2/3% or more of the outstanding common stock to amend many of the provisions described above.
|
•
|
We will indemnify our directors and officers for serving us in those capacities, or for serving other business enterprises at our request, to the fullest extent permitted by Delaware law. Delaware law provides that a corporation may indemnify such person if such person acted in good faith and in a manner such person reasonably believed to be in or not opposed to the best interests of the registrant and, with respect to any criminal proceeding, had no reasonable cause to believe such person’s conduct was unlawful.
|
•
|
We may, in our discretion, indemnify employees and agents in those circumstances where indemnification is permitted by applicable law.
|
•
|
We are required to advance expenses, as incurred, to our directors and officers in connection with defending a proceeding, except that such directors or officers shall undertake to repay such advances if it is ultimately determined that such person is not entitled to indemnification.
|
•
|
We will not be obligated pursuant to our amended and restated bylaws to indemnify a person with respect to proceedings initiated by that person against us or our other indemnitees, except with respect to proceedings authorized by our board of directors or brought to enforce a right to indemnification.
|
•
|
The rights conferred in our amended and restated bylaws are not exclusive, and we are authorized to enter into indemnification agreements with our directors, officers, employees and agents and to obtain insurance to indemnify such persons.
|
•
|
We may not retroactively amend our amended and restated bylaw provisions to reduce our indemnification obligations to directors, officers, employees and agents.
|
ITEM 2.
|
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
|
Period
|
Total Number of Shares Purchased (i)
|
|
Weighted-Average Price Paid per Share (ii)
|
|
Total Number of Share Purchased as Part of Publicly Announced Plan or Programs
|
|
Approximate Dollar Value of Shares that May Yet Be Purchased Under the Plan or Programs (in thousands)
|
|||||
April 1 through April 30, 2018
|
2,543
|
|
|
$
|
32.75
|
|
|
—
|
|
|
—
|
|
May 1 through May 31, 2018
|
1,518
|
|
|
29.50
|
|
|
—
|
|
|
—
|
|
|
June 1 through June 30, 2018
|
595
|
|
|
31.50
|
|
|
—
|
|
|
—
|
|
|
Total
|
4,656
|
|
|
$
|
31.53
|
|
|
—
|
|
|
—
|
|
ITEM 3.
|
DEFAULTS UPON SENIOR SECURITIES
|
ITEM 4.
|
MINE SAFETY DISCLOSURES
|
ITEM 5.
|
OTHER INFORMATION
|
ITEM 6.
|
EXHIBITS
|
Exhibit
Number
|
|
Exhibit Description
|
|
Incorporated by Reference to the Company's
|
|
Filed
Herewith
|
||||||
Form
|
|
File No.
|
|
Exhibit No.
|
|
Filed On
|
||||||
3.1
|
|
|
8-K
|
|
001-36297
|
|
3.1
|
|
February 11, 2014
|
|
|
|
3.2
|
|
|
S-1
|
|
333-193154
|
|
3.4
|
|
December 31, 2013
|
|
|
|
4.2
|
|
|
S-1/A
|
|
333-193154
|
|
4.4
|
|
February 3, 2014
|
|
|
|
10.1*
|
|
|
|
|
|
|
|
|
|
|
X
|
|
10.2
|
|
|
8-K
|
|
001-36297
|
|
10.1
|
|
May 11, 2018
|
|
|
|
10.3+
|
|
|
|
|
|
|
|
|
|
|
X
|
|
31.1
|
|
|
|
|
|
|
|
|
|
|
X
|
|
31.2
|
|
|
|
|
|
|
|
|
|
|
X
|
|
32.1†
|
|
|
|
|
|
|
|
|
|
|
X
|
|
32.2†
|
|
|
|
|
|
|
|
|
|
|
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 Labels Linkbase Document
|
|
|
|
|
|
|
|
|
|
X
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
|
|
|
|
|
|
|
|
X
|
*
|
Indicates a management contract or compensatory plan or arrangement.
|
+
|
Confidential treatment has been requested for portions of this exhibit. Omitted portions have been filed separately with the Securities and Exchange Commission.
|
†
|
The certifications attached as Exhibit 32.1 and 32.2 that accompany this Quarterly Report on Form 10-Q pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes Oxley Act of 2002, and shall not be deemed filed with the Securities and Exchange Commission for purposes of Section 18 of the Exchange Act. Such certifications shall not be deemed incorporated by reference into any filing of Revance Therapeutics, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except to the extent that the registrant specifically incorporates it by reference.
|
**
|
Users of this data are advised that, pursuant to Rule 406T of Regulation S-T, these interactive data files are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933 or Section 18 of the Securities Exchange Act of 1934 and otherwise are not subject to liability under these sections.
|
|
|
|
|
|
|
|
|
|
|
|
REVANCE THERAPEUTICS, INC.
|
||
|
|
|
|
|||
Date: August 3, 2018
|
|
|
|
By:
|
|
/s/ L. Daniel Browne
|
|
|
|
|
|
|
L. Daniel Browne
|
|
|
|
|
|
|
President and Chief Executive Officer
(Duly Authorized Principal Executive Officer)
|
|
|
|
|
|||
Date: August 3, 2018
|
|
|
|
By:
|
|
/s/ Cyril Allouche
|
|
|
|
|
|
|
Cyril Allouche
|
|
|
|
|
|
|
Head of Finance and Corporate Controller
(Duly Authorized Principal Financial and Accounting Officer)
|
9.
|
Section 11.5 in the Original Agreement,
Notices
, is hereby amended as follows:
|
Revance Therapeutics, Inc.
By:
/s/ Abhay Joshi
Abhay Joshi, Ph.D.
Chief Operating Officer
Date:
4/12/2018
|
Bachem Americas, Inc.
By:
/s/ Brian Gregg
Name:
Brain Gregg
Title:
COO
Date:
4/13/2018
|
Attribute/Test
|
Type of Method
|
Acceptance Criteria
|
Responsibility
|
[*]
|
[*]
|
[*]
|
[*]
|
1.
|
I have reviewed this Form 10-Q of Revance Therapeutics, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
(a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
(b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
(c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
(d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
(a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
(b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
|
|
|
|
|
/s/ L. Daniel Browne
|
|
L. Daniel Browne
|
|
President and Chief Executive Officer
(Principal Executive Officer)
|
1.
|
I have reviewed this Form 10-Q of Revance Therapeutics, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
(a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
(b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
(c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
(d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
(a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
(b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
|
|
|
|
|
/s/ Cyril Allouche
|
|
Cyril Allouche
|
|
Head of Finance and Corporate Controller
(Duly Authorized Principal Financial and Accounting Officer)
|
1.
|
The Company’s Quarterly Report on Form 10-Q for the period ended
June 30, 2018
, to which this Certification is attached as Exhibit 32.1 (the “Periodic Report”), fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and
|
2.
|
The information contained in the Periodic Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
/s/ L. Daniel Browne
|
L. Daniel Browne
|
President and Chief Executive Officer
|
1.
|
The Company’s Quarterly Report on Form 10-Q for the period ended
June 30, 2018
, to which this Certification is attached as Exhibit 32.2 (the “Periodic Report”), fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and
|
2.
|
The information contained in the Periodic Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
/s/ Cyril Allouche
|
Cyril Allouche
|
Head of Finance and Corporate Controller
(Duly Authorized Principal Financial and Accounting Officer)
|