|
|
|
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
|
¨
|
|
|
|
|
Non-accelerated filer
|
x
(Do not check if a smaller reporting company)
|
Smaller reporting company
|
¨
|
|
|
|
September 30,
|
|
December 31,
|
||||
|
2015
|
|
2014
|
||||
ASSETS
|
|||||||
CURRENT ASSETS
|
|
|
|
||||
Cash and cash equivalents
|
$
|
90,494
|
|
|
$
|
171,032
|
|
Short-term investments
|
51,364
|
|
|
—
|
|
||
Restricted cash, current portion
|
35
|
|
|
75
|
|
||
Prepaid expenses and other current assets
|
1,604
|
|
|
1,624
|
|
||
Total current assets
|
143,497
|
|
|
172,731
|
|
||
Property and equipment, net
|
19,254
|
|
|
19,274
|
|
||
Long-term investments
|
2,357
|
|
|
—
|
|
||
Restricted cash, net of current portion
|
400
|
|
|
435
|
|
||
Other non-current assets
|
6
|
|
|
29
|
|
||
TOTAL ASSETS
|
$
|
165,514
|
|
|
$
|
192,469
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|||||||
CURRENT LIABILITIES
|
|
|
|
||||
Accounts payable
|
$
|
2,731
|
|
|
$
|
3,149
|
|
Accruals and other current liabilities
|
5,990
|
|
|
4,145
|
|
||
Financing obligation, current portion
|
3,018
|
|
|
307
|
|
||
Notes payable, current portion and net of discount
|
—
|
|
|
2,635
|
|
||
Total current liabilities
|
11,739
|
|
|
10,236
|
|
||
Financing obligation, net of current portion
|
6,176
|
|
|
598
|
|
||
Derivative liabilities associated with Medicis settlement
|
1,481
|
|
|
1,541
|
|
||
Deferred rent
|
3,762
|
|
|
3,725
|
|
||
TOTAL LIABILITIES
|
23,158
|
|
|
16,100
|
|
||
Commitments and Contingencies (Note 9)
|
|
|
|
||||
STOCKHOLDERS’ EQUITY
|
|
|
|
||||
Common stock, par value $0.001 per share — 95,000,000 shares authorized both as of September 30, 2015 and December 31, 2014, respectively; 24,313,222 and 23,774,465 shares issued and outstanding as of September 30, 2015 and December 31, 2014, respectively
|
24
|
|
|
24
|
|
||
Additional paid-in capital
|
452,501
|
|
|
435,142
|
|
||
Accumulated other comprehensive income
|
10
|
|
|
—
|
|
||
Accumulated deficit
|
(310,179
|
)
|
|
(258,797
|
)
|
||
TOTAL STOCKHOLDERS’ EQUITY
|
142,356
|
|
|
176,369
|
|
||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$
|
165,514
|
|
|
$
|
192,469
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2015
|
|
2014
|
|
2015
|
|
2014
|
||||||||
Revenue
|
$
|
75
|
|
|
$
|
75
|
|
|
$
|
225
|
|
|
$
|
308
|
|
Operating expenses:
|
|
|
|
|
|
|
|
||||||||
Research and development
|
13,016
|
|
|
8,600
|
|
|
32,573
|
|
|
24,261
|
|
||||
General and administrative
|
5,827
|
|
|
5,300
|
|
|
18,183
|
|
|
14,250
|
|
||||
Total operating expenses
|
18,843
|
|
|
13,900
|
|
|
50,756
|
|
|
38,511
|
|
||||
Loss from operations
|
(18,768
|
)
|
|
(13,825
|
)
|
|
(50,531
|
)
|
|
(38,203
|
)
|
||||
Interest income
|
68
|
|
|
14
|
|
|
144
|
|
|
18
|
|
||||
Interest expense
|
(390
|
)
|
|
(228
|
)
|
|
(834
|
)
|
|
(10,336
|
)
|
||||
Change in fair value of derivative liabilities associated with the convertible notes
|
—
|
|
|
—
|
|
|
—
|
|
|
4,032
|
|
||||
Changes in fair value of derivative liabilities associated with Medicis settlement
|
13
|
|
|
67
|
|
|
60
|
|
|
(426
|
)
|
||||
Change in fair value of common stock warrant liability
|
—
|
|
|
—
|
|
|
—
|
|
|
(2,151
|
)
|
||||
Change in fair value of convertible preferred stock warrant liability
|
—
|
|
|
—
|
|
|
—
|
|
|
(210
|
)
|
||||
Loss on settlement of preferred stock warrant
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,356
|
)
|
||||
Other expense, net
|
(98
|
)
|
|
(5
|
)
|
|
(221
|
)
|
|
(73
|
)
|
||||
Net loss
|
(19,175
|
)
|
|
(13,977
|
)
|
|
(51,382
|
)
|
|
(48,705
|
)
|
||||
Unrealized gain on available for sale securities
|
22
|
|
|
—
|
|
|
10
|
|
|
—
|
|
||||
Comprehensive loss
|
$
|
(19,153
|
)
|
|
$
|
(13,977
|
)
|
|
$
|
(51,372
|
)
|
|
$
|
(48,705
|
)
|
Net loss attributable to common stockholders (Note 12):
|
|
|
|
|
|
|
|
||||||||
Basic
|
$
|
(19,175
|
)
|
|
$
|
(13,977
|
)
|
|
$
|
(51,382
|
)
|
|
$
|
(48,705
|
)
|
Diluted
|
$
|
(19,175
|
)
|
|
$
|
(13,977
|
)
|
|
$
|
(51,382
|
)
|
|
$
|
(48,705
|
)
|
Net loss per share attributable to common stockholders:
|
|
|
|
|
|
|
|
||||||||
Basic
|
$
|
(0.81
|
)
|
|
$
|
(0.60
|
)
|
|
$
|
(2.17
|
)
|
|
$
|
(2.70
|
)
|
Diluted
|
$
|
(0.81
|
)
|
|
$
|
(0.60
|
)
|
|
$
|
(2.17
|
)
|
|
$
|
(2.70
|
)
|
Weighted-average number of shares used in computing net loss per share attributable to common stockholders:
|
|
|
|
|
|
|
|
||||||||
Basic
|
23,755,199
|
|
|
23,331,104
|
|
|
23,625,869
|
|
|
18,009,537
|
|
||||
Diluted
|
23,755,199
|
|
|
23,331,104
|
|
|
23,625,869
|
|
|
18,009,537
|
|
|
Nine Months Ended
September 30, |
||||||
|
2015
|
|
2014
|
||||
CASH FLOWS FROM OPERATING ACTIVITIES
|
|
|
|
||||
Net loss
|
$
|
(51,382
|
)
|
|
$
|
(48,705
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
||||
Depreciation
|
1,586
|
|
|
1,561
|
|
||
Amortization of premium on investment
|
364
|
|
|
—
|
|
||
Amortization of discount on debt and capital leases
|
5
|
|
|
1,198
|
|
||
Amortization of debt issuance cost
|
39
|
|
|
148
|
|
||
Change in fair value of derivative liabilities associated with the convertible notes
|
—
|
|
|
(4,032
|
)
|
||
Changes in fair value of derivative liabilities associated with Medicis settlement
|
(60
|
)
|
|
426
|
|
||
Change in fair value of common stock warrant liability
|
—
|
|
|
2,151
|
|
||
Change in fair value of convertible preferred stock warrant liability
|
—
|
|
|
210
|
|
||
Loss on settlement of preferred stock warrant
|
—
|
|
|
1,356
|
|
||
Loss on extinguishment of 2013 Notes
|
—
|
|
|
8,331
|
|
||
Stock-based compensation expense
|
7,314
|
|
|
4,611
|
|
||
Interest for 2013 Notes and Essex Notes upon issuance, non-cash
|
—
|
|
|
271
|
|
||
Capitalized interest
|
—
|
|
|
(649
|
)
|
||
Effective interest on financing obligation
|
226
|
|
|
66
|
|
||
Loss on disposal of fixed assets
|
29
|
|
|
—
|
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Prepaid expenses and other current assets
|
(134
|
)
|
|
(2,654
|
)
|
||
Other non-current assets
|
24
|
|
|
(1,238
|
)
|
||
Accounts payable
|
(477
|
)
|
|
(3,524
|
)
|
||
Accruals and other current liabilities
|
3,096
|
|
|
1,178
|
|
||
Payments against Medicis liabilities
|
—
|
|
|
(7,073
|
)
|
||
Deferred rent
|
152
|
|
|
500
|
|
||
Deferred revenue
|
—
|
|
|
(83
|
)
|
||
Net cash used in operating activities
|
(39,218
|
)
|
|
(45,951
|
)
|
||
CASH FLOWS FROM INVESTING ACTIVITIES
|
|
|
|
||||
Purchases of property and equipment
|
(2,849
|
)
|
|
(5,444
|
)
|
||
Purchases of investments
|
(54,087
|
)
|
|
—
|
|
||
Change in restricted cash
|
75
|
|
|
75
|
|
||
Net cash used in investing activities
|
(56,861
|
)
|
|
(5,369
|
)
|
||
CASH FLOWS FROM FINANCING ACTIVITIES
|
|
|
|
||||
Proceeds from issuance of common stock, net of deferred follow-on public offering costs
|
—
|
|
|
131,882
|
|
||
Proceeds from issuance of common stock, net of deferred initial public offering costs
|
—
|
|
|
102,672
|
|
||
Proceeds from issuance of convertible notes and notes payable
|
—
|
|
|
6,750
|
|
||
Proceeds from issuance of common stock, net of deferred at-the-market offering costs
|
10,154
|
|
|
—
|
|
||
Principal payments made on capital leases and financing obligation
|
(1,768
|
)
|
|
(146
|
)
|
||
Net settlement of restricted stock awards to settle employee taxes
|
(762
|
)
|
|
—
|
|
Principal payments made on notes payable
|
(2,652
|
)
|
|
(6,230
|
)
|
||
Proceeds from sale and leaseback financing
|
9,831
|
|
|
—
|
|
||
Proceeds from the exercise of stock options and employee stock purchase plan
|
738
|
|
|
1,402
|
|
||
Payments to settle warrants
|
—
|
|
|
(1,438
|
)
|
||
Net cash provided by financing activities
|
15,541
|
|
|
234,892
|
|
||
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
(80,538
|
)
|
|
183,572
|
|
||
CASH AND CASH EQUIVALENTS — Beginning of period
|
171,032
|
|
|
3,914
|
|
||
CASH AND CASH EQUIVALENTS — End of period
|
90,494
|
|
|
187,486
|
|
||
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:
|
|
|
|
||||
Cash paid for interest
|
564
|
|
|
971
|
|
||
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING INFORMATION:
|
|
|
|
||||
Property and equipment purchases included in accounts payable and accruals and other current liabilities
|
95
|
|
|
832
|
|
||
Write-off of fixed assets
|
28
|
|
|
—
|
|
||
Conversion of Series E-1, E-2, E-3, E-4 and E-5 preferred stock into common stock
|
—
|
|
|
123,982
|
|
||
Conversion of 2013 Notes into common stock
|
—
|
|
|
26,206
|
|
||
Issuance of common stock upon net exercise of common stock warrants in connection with IPO
|
—
|
|
|
6,490
|
|
||
Fair value in excess of debt host for derivative liabilities associated with convertible notes
|
—
|
|
|
1,050
|
|
||
Deferred public offering costs
|
84
|
|
|
4,574
|
|
||
Conversion of preferred stock warrants to common stock warrants
|
—
|
|
|
1,441
|
|
||
Conversion of Essex Notes into financing obligations
|
—
|
|
|
1,095
|
|
||
Termination of stock option repurchase right
|
—
|
|
|
58
|
|
||
Issuance of common stock warrants in connection with the 2013 Notes
|
—
|
|
|
981
|
|
||
Issuance of convertible preferred stock warrants
|
—
|
|
|
80
|
|
|
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.
|
|
|
|
|
|
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.
|
|
September 30, 2015
|
|
December 31, 2014
|
||||||||||||||||||||||||||||
|
|
|
Gross Unrealized
|
|
|
|
|
|
Gross Unrealized
|
|
|
||||||||||||||||||||
|
Cost
|
|
Gains
|
|
Losses
|
|
Fair Value
|
|
Cost
|
|
Gains
|
|
Losses
|
|
Fair Value
|
||||||||||||||||
Money market funds
|
$
|
72,454
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
72,454
|
|
|
$
|
166,038
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
166,038
|
|
U.S. government agency obligations
|
53,711
|
|
|
12
|
|
|
(2
|
)
|
|
53,721
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||||
Total cash equivalents and available-for-sale securities
|
$
|
126,165
|
|
|
$
|
12
|
|
|
$
|
(2
|
)
|
|
$
|
126,175
|
|
|
$
|
166,038
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
166,038
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Classified as:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Cash equivalents
|
|
|
|
|
|
|
$
|
72,454
|
|
|
|
|
|
|
|
|
$
|
166,038
|
|
||||||||||||
Short-term investments
|
|
|
|
|
|
|
51,364
|
|
|
|
|
|
|
|
|
—
|
|
||||||||||||||
Long-term investments
|
|
|
|
|
|
|
2,357
|
|
|
|
|
|
|
|
|
—
|
|
||||||||||||||
Total cash equivalents and available-for-sale securities
|
|
|
|
|
|
|
$
|
126,175
|
|
|
|
|
|
|
|
|
$
|
166,038
|
|
|
As of September 30, 2015
|
||||||||||||||
|
Fair Value
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||
Assets
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
$
|
72,454
|
|
|
$
|
72,454
|
|
|
$
|
—
|
|
|
$
|
—
|
|
U.S. government agency obligations
|
53,721
|
|
—
|
|
|
53,721
|
|
—
|
|
||||||
Total assets measured at fair value
|
$
|
126,175
|
|
|
$
|
72,454
|
|
|
$
|
53,721
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
||||||||
Liabilities
|
|
|
|
|
|
|
|
||||||||
Derivative liabilities associated with the Medicis settlement
|
$
|
1,481
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,481
|
|
Total liabilities measured at fair value
|
$
|
1,481
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,481
|
|
|
As of December 31, 2014
|
||||||||||||||
|
Fair Value
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||
Assets
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
$
|
166,038
|
|
|
$
|
166,038
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total assets measured at fair value
|
$
|
166,038
|
|
|
$
|
166,038
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
||||||||
Liabilities
|
|
|
|
|
|
|
|
||||||||
Derivative liabilities associated with the Medicis settlement
|
$
|
1,541
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,541
|
|
Total liabilities measured at fair value
|
$
|
1,541
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,541
|
|
|
Derivative Liability Associated with the Medicis Settlement
|
||
Fair value as of December 31, 2014
|
$
|
1,541
|
|
Change in fair value
|
(60
|
)
|
|
Fair value as of September 30, 2015
|
$
|
1,481
|
|
Year Ending December 31,
|
|
||
2015
|
$
|
1,054
|
|
2016
|
4,217
|
|
|
2017
|
3,971
|
|
|
2018
|
949
|
|
|
Total payments
|
$
|
10,191
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2015
|
|
2014
|
|
2015
|
|
2014
|
||||||||
Interest expense
|
|
|
|
|
|
|
|
||||||||
Cash related interest expense (1)
|
$
|
(264
|
)
|
|
$
|
(276
|
)
|
|
$
|
(564
|
)
|
|
$
|
(971
|
)
|
|
|
|
|
|
|
|
|
||||||||
Non-cash interest expense
|
|
|
|
|
|
|
|
||||||||
Non-cash interest expense — debt issuance costs
|
—
|
|
|
(48
|
)
|
|
(39
|
)
|
|
(148
|
)
|
||||
Non-cash interest expense — warrant and derivative related debt discounts
|
—
|
|
|
(76
|
)
|
|
(5
|
)
|
|
(219
|
)
|
||||
Non-cash interest expense — convertible notes
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,250
|
)
|
||||
Loss on extinguishment of 2013 Notes
|
—
|
|
|
—
|
|
|
—
|
|
|
(8,331
|
)
|
||||
Effective interest on financing obligation
|
(126
|
)
|
|
(66
|
)
|
|
(226
|
)
|
|
(66
|
)
|
||||
Non-cash capitalized interest expense (2)
|
—
|
|
|
238
|
|
|
—
|
|
|
649
|
|
||||
Total non-cash interest expense
|
(126
|
)
|
|
48
|
|
|
(270
|
)
|
|
(9,365
|
)
|
||||
|
|
|
|
|
|
|
|
||||||||
Total interest expense
|
$
|
(390
|
)
|
|
$
|
(228
|
)
|
|
$
|
(834
|
)
|
|
$
|
(10,336
|
)
|
(1)
|
Cash related interest expense includes interest payments to Hercules Notes Payable, Essex Notes, and Financing Obligations.
|
(2)
|
Interest expense capitalized pursuant to Accounting Standards Codification Topic 835, Interest.
|
Year Ending December 31,
|
|
||
2015
|
$
|
1,269
|
|
2016
|
5,222
|
|
|
2017
|
5,394
|
|
|
2018
|
5,578
|
|
|
2019 and thereafter
|
32,354
|
|
|
Total payments
|
$
|
49,817
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended September 30,
|
||||||||
|
2015
|
|
2014
|
|
2015
|
|
2014
|
||||
Expected term (in years)
|
6.1
|
|
|
6.2
|
|
|
6.3
|
|
|
6.1
|
|
Expected volatility
|
61.3
|
%
|
|
61.5
|
%
|
|
62.7
|
%
|
|
57.4
|
%
|
Risk-free interest rate
|
1.7
|
%
|
|
1.6
|
%
|
|
1.5
|
%
|
|
1.9
|
%
|
Expected dividend rate
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
Three Months Ended
September 30, |
|
Nine Months Ended September 30,
|
||||||||
|
2015
|
|
2014
|
|
2015
|
|
2014
|
||||
Expected term (in years)
|
8.2
|
|
|
8.9
|
|
|
8.4
|
|
|
9.1
|
|
Expected volatility
|
73.5
|
%
|
|
57.2
|
%
|
|
72.4
|
%
|
|
57.5
|
%
|
Risk-free interest rate
|
2.0
|
%
|
|
2.5
|
%
|
|
2.0
|
%
|
|
2.5
|
%
|
Expected dividend rate
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
Three Months Ended
September 30, |
|
Nine Months Ended September 30,
|
||||||||
|
2015
|
|
2014
|
|
2015
|
|
2014
|
||||
Expected term (in years)
|
0.5
|
|
|
0.5
|
|
|
0.5
|
|
|
0.5
|
|
Expected volatility
|
50.8
|
%
|
|
42.5
|
%
|
|
50.5
|
%
|
|
46.4
|
%
|
Risk-free interest rate
|
0.1
|
%
|
|
0.1
|
%
|
|
0.1
|
%
|
|
0.1
|
%
|
Expected dividend rate
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
Three Months Ended
September 30, |
|
Nine Months Ended September 30,
|
||||||||||||
2015
|
|
2014
|
|
2015
|
|
2014
|
|||||||||
Research and development
|
$
|
1,182
|
|
|
$
|
557
|
|
|
$
|
2,879
|
|
|
$
|
1,644
|
|
General and administrative
|
1,408
|
|
|
1,728
|
|
|
4,435
|
|
|
2,967
|
|
||||
Total stock based compensation expense
|
$
|
2,590
|
|
|
$
|
2,285
|
|
|
$
|
7,314
|
|
|
$
|
4,611
|
|
|
Unrealized Gains and Losses on Available-for-Sale Securities
|
||
Balance at December 31, 2014
|
$
|
—
|
|
Other comprehensive income (loss) before reclassifications
|
10
|
|
|
Reclassifications from accumulated other comprehensive income (loss)
|
—
|
|
|
Net current period other comprehensive income (loss)
|
10
|
|
|
Balance at September 30, 2015
|
$
|
10
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2015
|
|
2014
|
|
2015
|
|
2014
|
||||||||
Net loss attributable to common stockholders, basic
|
$
|
(19,175
|
)
|
|
$
|
(13,977
|
)
|
|
$
|
(51,382
|
)
|
|
$
|
(48,705
|
)
|
Net loss attributable to common stockholders, diluted
|
$
|
(19,175
|
)
|
|
$
|
(13,977
|
)
|
|
$
|
(51,382
|
)
|
|
$
|
(48,705
|
)
|
Net loss per share attributable to common stockholders
|
|
|
|
|
|
|
|
||||||||
Basic
|
$
|
(0.81
|
)
|
|
$
|
(0.60
|
)
|
|
$
|
(2.17
|
)
|
|
$
|
(2.70
|
)
|
Diluted
|
$
|
(0.81
|
)
|
|
$
|
(0.60
|
)
|
|
$
|
(2.17
|
)
|
|
$
|
(2.70
|
)
|
Weighted-average shares used in computing net loss per share attributable to common stockholders:
|
|
|
|
|
|
|
|
||||||||
Basic
|
23,755,199
|
|
|
23,331,104
|
|
|
23,625,869
|
|
|
18,009,537
|
|
||||
Diluted
|
23,755,199
|
|
|
23,331,104
|
|
|
23,625,869
|
|
|
18,009,537
|
|
|
As of September 30,
|
||||
|
2015
|
|
2014
|
||
Stock options
|
2,374,055
|
|
|
1,877,949
|
|
Common stock warrants
|
198,662
|
|
|
153,909
|
|
Unvested restricted stock awards
|
308,193
|
|
|
253,625
|
|
Shares expected to be purchased on December 31 under the 2014 ESPP
|
7,945
|
|
|
6,426
|
|
ITEM 2.
|
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
•
|
our expectations regarding the results and the timing of clinical trials in our development of RT001 for the treatment of crow’s feet, hyperhidrosis or other indications;
|
•
|
our expectations regarding the results and the timing of clinical trials of RT002 for the treatment of glabellar lines, muscle movement disorders, including cervical dystonia, or other indications;
|
•
|
our expectations regarding our future development of RT001 and RT002 for other therapeutic or aesthetic indications;
|
•
|
our expectation regarding the timing of our regulatory submissions for approval of RT001 for the treatment of crow’s feet in the United States, Europe and other countries or for the treatment of hyperhidrosis in the United States;
|
•
|
the potential for commercialization of RT001 and RT002, if approved, by us;
|
•
|
our expectations regarding the potential market size, opportunity and growth potential for RT001 and RT002, if approved for commercial use;
|
•
|
our belief that RT001 and RT002 can expand the overall botulinum toxin market;
|
•
|
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 transfer manufacturing from third parties to our facility and to scale up our manufacturing capabilities 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, 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; and
|
•
|
developments and projections relating to our competitors and our industry.
|
|
Three Months Ended
September 30, |
|
|
|
Nine Months Ended
September 30, |
|
|
||||||||||||
|
2015
|
|
2014
|
|
Change
|
|
2015
|
|
2014
|
|
Change
|
||||||||
|
(In thousands, except percentages)
|
||||||||||||||||||
Relastin Royalty
|
$
|
75
|
|
|
$
|
75
|
|
|
—%
|
|
$
|
225
|
|
|
$
|
225
|
|
|
—%
|
Licensing Revenue
|
—
|
|
|
—
|
|
|
N/A
|
|
—
|
|
|
83
|
|
|
100%
|
||||
Total revenue
|
$
|
75
|
|
|
$
|
75
|
|
|
—%
|
|
$
|
225
|
|
|
$
|
308
|
|
|
(3)%
|
|
Three Months Ended
September 30, |
|
|
Nine Months Ended
September 30, |
|
|
||||||||||||
|
2015
|
|
2014
|
|
Change
|
2015
|
|
2014
|
Change
|
|
||||||||
|
(In thousands, except percentages)
|
|
||||||||||||||||
Research and development
|
$
|
13,016
|
|
|
$
|
8,600
|
|
|
51%
|
$
|
32,573
|
|
|
$
|
24,261
|
|
34%
|
|
General and administrative
|
5,827
|
|
|
5,300
|
|
|
10%
|
18,183
|
|
|
14,250
|
|
28%
|
|
||||
Total operating expenses
|
$
|
18,843
|
|
|
$
|
13,900
|
|
|
36%
|
$
|
50,756
|
|
|
$
|
38,511
|
|
32%
|
|
|
Three Months Ended
September 30, |
|
|
|
Nine Months Ended
September 30, |
|
||||||||||||
|
2015
|
|
2014
|
|
Change
|
|
2015
|
|
2014
|
Change
|
||||||||
|
(In thousands, except percentages)
|
|||||||||||||||||
Interest expense
|
|
|
|
|
|
|
|
|
|
|
||||||||
Cash related interest expense
(1)
|
$
|
(264
|
)
|
|
$
|
(276
|
)
|
|
(4)%
|
|
$
|
(564
|
)
|
|
$
|
(971
|
)
|
(42)%
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Non-cash interest expense
|
|
|
|
|
|
|
|
|
|
|
||||||||
Non-cash interest expense — debt issuance costs
|
—
|
|
|
(48
|
)
|
|
(100)%
|
|
(39
|
)
|
|
(148
|
)
|
(74)%
|
||||
Non-cash interest expense — warrant and derivative related debt discounts
|
—
|
|
|
(76
|
)
|
|
(100)%
|
|
(5
|
)
|
|
(219
|
)
|
(98)%
|
||||
Non-cash interest expense — convertible notes
|
—
|
|
|
—
|
|
|
N/A
|
|
—
|
|
|
(1,250
|
)
|
(100)%
|
||||
Loss on extinguishment of 2013 Notes
|
—
|
|
|
—
|
|
|
N/A
|
|
—
|
|
|
(8,331
|
)
|
(100)%
|
||||
Non-cash interest expense - financing obligation
|
(126
|
)
|
|
(66
|
)
|
|
91%
|
|
(226
|
)
|
|
(66
|
)
|
242%
|
||||
Non-cash capitalized interest expense
(2)
|
$
|
—
|
|
|
$
|
238
|
|
|
(100)%
|
|
$
|
—
|
|
|
$
|
649
|
|
(100)%
|
Total non-cash interest expense
|
$
|
(126
|
)
|
|
$
|
48
|
|
|
(363)%
|
|
$
|
(270
|
)
|
|
$
|
(9,365
|
)
|
(97)%
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Total interest expense
|
$
|
(390
|
)
|
|
$
|
(228
|
)
|
|
71%
|
|
$
|
(834
|
)
|
|
$
|
(10,336
|
)
|
(92)%
|
|
(1)
|
Cash related interest expense included interest payments to the Hercules Facility, Essex Capital Facility, and Financing Obligations.
|
(2)
|
Interest expense capitalized pursuant to
Accounting Standards Codification Topic 835, Interest
.
|
|
Three Months Ended
September 30, |
|
|
|
Nine Months Ended
September 30, |
|
|
|
||||||||||||
|
2015
|
|
2014
|
|
Change
|
|
2015
|
|
2014
|
|
Change
|
|
||||||||
|
(In thousands, except percentages)
|
|||||||||||||||||||
Interest income
|
$
|
68
|
|
|
$
|
14
|
|
|
385%
|
|
$
|
144
|
|
|
$
|
18
|
|
|
699%
|
|
Interest expense
|
(390
|
)
|
|
(228
|
)
|
|
71%
|
|
(834
|
)
|
|
(10,336
|
)
|
|
(92)%
|
|
||||
Change in fair value of derivative liabilities associated with convertible notes
|
—
|
|
|
—
|
|
|
N/A
|
|
—
|
|
|
4,032
|
|
|
(100)%
|
|
||||
Change in fair value of derivative liabilities associated with the Medicis settlement
|
13
|
|
|
67
|
|
|
(81)%
|
|
60
|
|
|
(426
|
)
|
|
(114)%
|
|
||||
Change in fair value of common stock warrant liability
|
—
|
|
|
—
|
|
|
N/A
|
|
—
|
|
|
(2,151
|
)
|
|
(100)%
|
|
||||
Change in fair value of convertible preferred stock warrant liability
|
—
|
|
|
—
|
|
|
N/A
|
|
—
|
|
|
(210
|
)
|
|
(100)%
|
|
||||
Loss on settlement of preferred stock warrant
|
—
|
|
|
—
|
|
|
N/A
|
|
—
|
|
|
(1,356
|
)
|
|
(100)%
|
|
||||
Other expense, net
|
(98
|
)
|
|
(5
|
)
|
|
1,857%
|
|
(221
|
)
|
|
(73
|
)
|
|
203%
|
|
||||
Total other expense
|
$
|
(407
|
)
|
|
$
|
(152
|
)
|
|
168%
|
|
$
|
(851
|
)
|
|
$
|
(10,502
|
)
|
|
(92)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended
September 30, |
||||||
|
2015
|
|
2014
|
||||
Net cash used in operating activities
|
$
|
(39,218
|
)
|
|
$
|
(45,951
|
)
|
Net cash used in investing activities
|
(56,861
|
)
|
|
(5,369
|
)
|
||
Net cash provided by financing activities
|
15,541
|
|
|
234,892
|
|
•
|
the results of our clinical trials for RT001 and RT002;
|
•
|
the timing of, and the costs involved in, obtaining regulatory approvals for RT001, RT002 or any future product candidates;
|
•
|
the number and characteristics of any additional product candidates we develop or acquire;
|
•
|
the scope, progress, results and costs of researching and developing RT001, RT002 or any future product candidates, and conducting preclinical and clinical trials;
|
•
|
the cost of commercialization activities if RT001, RT002 or any future product candidates are approved for sale, including marketing, sales and distribution costs;
|
•
|
the cost of manufacturing RT001, RT002 or any future product candidates and any products we successfully commercialize;
|
•
|
our ability to establish and maintain strategic collaborations, licensing or other arrangements and the terms of and timing such arrangements;
|
•
|
the degree and rate of market acceptance of any future approved products;
|
•
|
the emergence, availability, perceived advantages, relative cost, relative safety and relative efficacy of alternative and competing treatments;
|
•
|
any litigation, including litigation costs and the outcome of such litigation;
|
•
|
any product liability or other lawsuits related to our products;
|
•
|
the expenses needed to attract and retain skilled personnel;
|
•
|
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.
|
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 RT001, RT002 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 duration of effect of our product 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 RT001, RT002 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 RT001, RT002 or any future product candidates;
|
•
|
the acceptance of parameters for regulatory approval, including our proposed indication, primary endpoint assessment and primary endpoint measurement relating to our lead indications of RT001;
|
•
|
our success in educating physicians and patients about the benefits, administration and use of RT001, RT002 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 RT001, RT002 or any future product candidates or approved products;
|
•
|
the availability, perceived advantages, relative cost, relative safety and relative efficacy of alternative and competing 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 RT001, RT002 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 RT001, RT002 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 RT001, RT002 or any future product candidates;
|
•
|
our ability to avoid third party patent interference or intellectual property infringement claims;
|
•
|
acceptance of RT001, RT002 or any future product candidates, if approved, as safe and effective by patients and the medical community; and
|
•
|
the continued acceptable safety profile of RT001, RT002 or any future product candidates following approval.
|
•
|
our inability to demonstrate to the satisfaction of the FDA or the applicable foreign regulatory body that RT001, RT002 or any future product candidates are safe and effective for the requested indication;
|
•
|
the FDA’s or the applicable foreign regulatory agency’s disagreement with our trial protocol or the interpretation of data from preclinical studies or clinical trials;
|
•
|
our inability to demonstrate that clinical and other benefits of RT001, RT002 or any future product candidates outweigh any safety or other perceived risks;
|
•
|
the FDA’s or the applicable foreign regulatory agency’s requirement for additional preclinical or clinical studies;
|
•
|
the FDA’s or the applicable foreign regulatory agency’s non-approval of the formulation, labeling or the specifications of RT001, RT002 or any future product candidates;
|
•
|
the FDA’s or the 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 the applicable foreign regulatory agencies to significantly change in a manner rendering our clinical data insufficient for approval.
|
•
|
the results of our clinical trials for RT001 and RT002;
|
•
|
the timing of, and the costs involved in, obtaining regulatory approvals for RT001, RT002 or any future product candidates;
|
•
|
the number and characteristics of any additional product candidates we develop or acquire;
|
•
|
the scope, progress, results and costs of researching and developing RT001, RT002 or any future product candidates, and conducting preclinical and clinical trials;
|
•
|
the cost of commercialization activities if RT001, RT002 or any future product candidates are approved for sale, including marketing, sales and distribution costs;
|
•
|
the cost of manufacturing RT001, RT002 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 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 and competing 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 therapies;
|
•
|
physician willingness to adopt a new therapy to treat crow’s feet, hyperhidrosis, glabellar lines, cervical dystonia or other therapeutic indications;
|
•
|
overcoming any biases physicians or patients may have toward injectable procedures for the treatment of crow’s feet, hyperhidrosis or other indications;
|
•
|
patient satisfaction with the results and administration of our product and overall treatment experience;
|
•
|
patient demand for the treatment of crow’s feet, hyperhidrosis, glabellar lines, cervical dystonia or other 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;
|
•
|
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 physicians and patients;
|
•
|
the willingness of patients to pay for RT001, RT002 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 for RT001, RT002 and any future products we may commercialize;
|
•
|
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.
|
•
|
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 RT001 or RT002 to their patients;
|
•
|
the extent to which RT001 or RT002 satisfies patient expectations;
|
•
|
our ability to properly train physicians in the use of RT001 or RT002 such that their patients do not experience excessive discomfort during treatment or adverse side effects;
|
•
|
the cost, safety and effectiveness of RT001 or RT002 versus other aesthetic treatments;
|
•
|
consumer sentiment about the benefits and risks of aesthetic procedures generally and RT001 or RT002 in particular;
|
•
|
the success of any direct-to-consumer marketing efforts we may initiate; and
|
•
|
general consumer confidence, which may be impacted by economic and political conditions.
|
•
|
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.
|
•
|
decreased demand for RT001, RT002 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 markets, 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, pure or potent;
|
•
|
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 filed 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 Phase 3 clinical program for RT001 and our Phase 2 clinical program for RT002;
|
•
|
announcements of regulatory approval or disapproval of RT001, RT002 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 health care 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 biopharmaceutical 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)
|
|||||
July 1 through July 31, 2015
|
120
|
|
|
$
|
31.03
|
|
|
—
|
|
|
—
|
|
August 1 through August 31, 2015
|
504
|
|
|
29.98
|
|
|
—
|
|
|
—
|
|
|
September 1 through September 30, 2015
|
4,071
|
|
|
30.27
|
|
|
—
|
|
|
—
|
|
|
Total
|
4,695
|
|
|
$
|
30.26
|
|
|
—
|
|
|
—
|
|
ITEM 3.
|
DEFAULTS UPON SENIOR SECURITIES
|
ITEM 4.
|
MINE SAFETY DISCLOSURES
|
ITEM 5.
|
OTHER INFORMATION
|
ITEM 6.
|
EXHIBITS
|
|
|
|
|
|
|
|
|
|
|
|
REVANCE THERAPEUTICS, INC.
|
||
|
|
|
|
|||
Date: November 10, 2015
|
|
|
|
By:
|
|
/s/ L. Daniel Browne
|
|
|
|
|
|
|
L. Daniel Browne
|
|
|
|
|
|
|
President and Chief Executive Officer
(Duly Authorized Principal Executive Officer)
|
|
|
|
|
|||
Date: November 10, 2015
|
|
|
|
By:
|
|
/s/ Lauren P. Silvernail
|
|
|
|
|
|
|
Lauren P. Silvernail
|
|
|
|
|
|
|
Chief Financial Officer and Executive Vice President of Corporate Development
(Duly Authorized Principal Financial Officer)
|
Exhibit
Number
|
|
Exhibit Description
|
|
Incorporated by Reference to the Company's
|
|
Filed
Herewith
|
||||||
Form
|
|
File No.
|
|
Exhibit No.
|
|
Filed On
|
||||||
3.1
|
|
Amended and Restated Certificate of Incorporation
|
|
8-K
|
|
001-36297
|
|
3.1
|
|
February 11, 2014
|
|
|
3.2
|
|
Amended and Restated Bylaws
|
|
S-1
|
|
333-193154
|
|
3.4
|
|
December 31, 2013
|
|
|
4.1
|
|
Amended and Restated Investor Rights Agreement, effective as of February 5, 2014, among Revance Therapeutics, Inc. and certain of its stockholders
|
|
S-1/A
|
|
333-193154
|
|
4.3
|
|
January 27, 2014
|
|
|
4.2
|
|
Form of Common Stock Certificate
|
|
S-1/A
|
|
333-193154
|
|
4.4
|
|
February 3, 2014
|
|
|
10.1+
|
|
Second Amendment to Development and Supply Agreement, dated August 31, 2015, between Revance Therapeutics, Inc and Hospira Worldwide, Inc.
|
|
|
|
|
|
|
|
|
|
X
|
10.2*
|
|
Form of Restricted Stock Unit Award Agreement and Grant Notice for Revance Therapeutics, Inc. 2014 Equity Incentive Plan
|
|
|
|
|
|
|
|
|
|
X
|
10.3*
|
|
Form of Stock Option Agreement and Grant Notice for Revance Therapeutics, Inc. 2014 Equity Incentive Plan
|
|
|
|
|
|
|
|
|
|
X
|
10.4*
|
|
Form of Restricted Stock Bonus Agreement and Grant Notice for Revance Therapeutics, Inc. 2014 Equity Incentive Plan
|
|
|
|
|
|
|
|
|
|
X
|
10.5*
|
|
Form of Stock Option Agreement and Grant Notice under Revance Therapeutics, Inc. 2014 Inducement Plan
|
|
|
|
|
|
|
|
|
|
X
|
10.6*
|
|
Form of Restricted Stock Agreement and Grant Notice under Revance Therapeutics, Inc. 2014 Inducement Plan
|
|
|
|
|
|
|
|
|
|
X
|
31.1
|
|
Certification of Principal Executive Officer pursuant to Rule 13a-14(a) and 15d-14(a) promulgated under the Exchange Act
|
|
|
|
|
|
|
|
|
|
X
|
31.2
|
|
Certification of Principal Financial Officer pursuant to Rule 13a-14(a) and 15d-14(a) promulgated under the Exchange Act
|
|
|
|
|
|
|
|
|
|
X
|
32.1†
|
|
Certification of the Chief Executive Officer pursuant to18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
|
|
|
|
|
|
X
|
32.2†
|
|
Certification of the Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
|
|
|
|
|
|
|
|
|
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 certain 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.
|
1)
|
Section 9.3
.
Section 9.3
, as modified by the First Amendment, is hereby replaced in its entirety with the following amended
Section 9.3
:
|
2)
|
Except as expressly amended herein, all other terms and conditions of the Agreement shall remain in full force and effect, and enforceable in accordance with its terms. The terms and conditions of this Amendment are hereby incorporated into and made a part of the Agreement.
|
3)
|
This Amendment may be executed in two (2) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one instrument. The parties may sign and deliver this Amendment by facsimile or sent by electronic mail in portable document format (PDF) and a reproduction of this Amendment made by facsimile or PDF will have the same effect as a signed and delivered original version.
|
HOSPIRA WORLDWIDE, INC.
|
REVANCE THERAPEUTICS, INC.
|
|
|
By:
/s/ Karen Blair
(Signature)
|
By:
/s/ L. Daniel Browne
(Signature)
|
|
|
Name: Karen Blair
|
Name: L. Daniel Browne
|
|
|
Title: President
One 2 One Contract Manufacturing Services
|
Title: President & CEO
|
|
|
|
|
|
|
|
Participant:
|
|
|
|
|
ID:
|
|
|
|
|
Date of Grant:
|
|
|
|
|
Grant Number:
|
|
|
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Vesting Commencement Date:
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Number of Restricted Stock Units/Shares:
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Vesting Schedule:
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Issuance Schedule:
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Subject to any change on a Capitalization Adjustment, one share of Common Stock will be issued for each Restricted Stock Unit that vests at the time set forth in Section 6 of the Award Agreement.
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REVANCE THERAPEUTICS, INC.
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By:
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Signature
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Title:
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Date:
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COMPANY:
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Revance Therapeutics, Inc.
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Attn: Stock Administrator
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7555 Gateway Boulevard
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Newark, CA 94560
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PARTICIPANT:
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Your address as on file with the Company
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at the time notice is given
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Optionholder:
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Date of Grant:
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Vesting Commencement Date:
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Number of Shares Subject to Option:
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Exercise Price (Per Share):
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Total Exercise Price:
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Expiration Date:
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Type of Grant
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Vesting Schedule
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REVANCE THERAPEUTICS, INC.
By:
_____________________________
Title:
___________________________
Date:
____________________________
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Participant:
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Date of Grant:
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Vesting Commencement Date:
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Number of Shares Subject to Award:
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Consideration:
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Participant’s Services
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REVANCE THERAPEUTICS, INC.
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By:
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Signature
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Title:
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Date:
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Very truly yours,
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REVANCE THERAPEUTICS, INC.
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By:
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RECIPIENT
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Name:
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ESCROW AGENT:
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Dated:
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Signature:
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[Participant's Name], Recipient
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Optionholder:
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Date of Grant:
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Vesting Commencement Date:
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Number of Shares Subject to Option:
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Exercise Price (Per Share):
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Total Exercise Price:
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Expiration Date:
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Type of Grant
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Nonstatutory Stock Option
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Vesting Schedule
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REVANCE THERAPEUTICS, INC.
By:
_______________________________
Title:
_____________________________
Date:
______________________________
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OPTIONHOLDER:
[NAME]
___________________________________
Signature
Date:
_______________________________
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Option Grant Date:
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Number of Shares as to which the Option is exercised:
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Certificates to be issued in name of:
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Total exercise price:
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$
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$
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Cash payment delivered herewith:
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$
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$
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[Value of ____ Shares delivered herewith:]
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$
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$
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[Value of ____ Shares pursuant to net exercise]
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$
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$
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Regulation T Program (cashless exercise):
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$
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$
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Very truly yours,
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Signature
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Print Name
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Participant:
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Date of Grant:
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Vesting Commencement Date:
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Number of Shares Subject to Award:
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Consideration:
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Participant’s Future Services
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Vesting Schedule
:
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[
____________]
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Very truly yours,
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REVANCE THERAPEUTICS, INC.
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By:
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RECIPIENT
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Name:
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ESCROW AGENT:
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Dated:
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Signature:
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[Participant's Name], Recipient
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1.
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I have reviewed this Form 10-Q of Revance Therapeutics, Inc.;
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2.
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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;
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3.
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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;
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4.
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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)) for the registrant and have:
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(a)
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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;
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(b)
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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
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(c)
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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
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5.
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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):
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(a)
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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
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(b)
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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.
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/s/ L. Daniel Browne
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L. Daniel Browne
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President and Chief Executive Officer
(Principal Executive Officer)
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1.
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I have reviewed this Form 10-Q of Revance Therapeutics, Inc.;
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2.
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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;
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3.
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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;
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4.
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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)) for the registrant and have:
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(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;
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(b)
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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
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(c)
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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
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5.
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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):
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(a)
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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
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(b)
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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.
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/s/ Lauren P. Silvernail
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Lauren P. Silvernail
|
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Chief Financial Officer and Executive Vice President of Corporate Development
(Principal Financial Officer)
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1.
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The Company’s Quarterly Report on Form 10-Q for the period ended
September 30, 2015
, 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
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2.
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The information contained in the Periodic Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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/s/ L. Daniel Browne
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L. Daniel Browne
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President and Chief Executive Officer
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1.
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The Company’s Quarterly Report on Form 10-Q for the period ended
September 30, 2015
, 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
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2.
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The information contained in the Periodic Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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/s/ Lauren P. Silvernail
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Lauren P. Silvernail
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Chief Financial Officer and Executive Vice President of Corporate Development
|