|
þ
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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¨
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
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Delaware
|
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27-4842691
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(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification No.)
|
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3721 Valley Centre Drive, Suite 200, San Diego, CA 92130
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(Address of Principal Executive Offices)
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|
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(760) 260-8600
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(Registrant’s Telephone number including area code)
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Large accelerated filer
|
þ
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Accelerated filer
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¨
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Non-accelerated filer
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¨
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Smaller reporting company
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¨
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|
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Emerging growth company
|
¨
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Page No.
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||
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||
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||
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||
|
||
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||
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March 31, 2018
|
|
December 31, 2017
|
||||
Assets
|
(unaudited)
|
|
|
|
|||
Current assets:
|
|
|
|
|
|
||
Cash and cash equivalents
|
$
|
61,117
|
|
|
$
|
99,394
|
|
Marketable securities
|
202,939
|
|
|
201,236
|
|
||
Accounts receivable, net
|
12,981
|
|
|
13,872
|
|
||
Inventory, net
|
5,142
|
|
|
5,351
|
|
||
Prepaid expenses and other current assets
|
2,011
|
|
|
3,112
|
|
||
Prepaid taxes
|
2,613
|
|
|
2,842
|
|
||
Total current assets
|
286,803
|
|
|
325,807
|
|
||
Property and equipment, net
|
3,042
|
|
|
3,230
|
|
||
Other assets
|
6,457
|
|
|
5,556
|
|
||
Investment-equity
|
15,000
|
|
|
—
|
|
||
Intangible assets, net
|
188,556
|
|
|
184,817
|
|
||
Goodwill
|
936
|
|
|
936
|
|
||
Total assets
|
$
|
500,794
|
|
|
$
|
520,346
|
|
Liabilities and Stockholders' Equity
|
|
|
|
|
|
||
Current liabilities:
|
|
|
|
|
|
||
Accounts payable
|
$
|
9,423
|
|
|
$
|
18,938
|
|
Accrued expenses
|
31,644
|
|
|
36,018
|
|
||
Guaranteed minimum royalty
|
2,000
|
|
|
2,000
|
|
||
Other current liabilities
|
3,958
|
|
|
3,902
|
|
||
Business combination-related contingent consideration
|
9,500
|
|
|
9,100
|
|
||
Derivative financial instruments, warrants
|
—
|
|
|
15,710
|
|
||
Total current liabilities
|
56,525
|
|
|
85,668
|
|
||
Convertible debt
|
45,238
|
|
|
45,077
|
|
||
Other non-current liabilities
|
4,617
|
|
|
2,472
|
|
||
Guaranteed minimum royalty, less current portion
|
12,939
|
|
|
13,095
|
|
||
Business combination-related contingent consideration, less current portion
|
82,000
|
|
|
80,900
|
|
||
Total liabilities
|
201,319
|
|
|
227,212
|
|
||
Stockholders' Equity:
|
|
|
|
|
|
||
Preferred stock $0.001 par value; 20,000,000 shares authorized; 0 issued and outstanding as of March 31, 2018 and December 31, 2017
|
—
|
|
|
—
|
|
||
Common stock $0.0001 par value; 100,000,000 shares authorized; 39,873,285 and 39,373,745 issued and outstanding as of March 31, 2018 and December 31, 2017, respectively
|
4
|
|
|
4
|
|
||
Additional paid-in capital
|
486,717
|
|
|
471,800
|
|
||
Accumulated deficit
|
(185,717
|
)
|
|
(177,655
|
)
|
||
Accumulated other comprehensive loss
|
(1,529
|
)
|
|
(1,015
|
)
|
||
Total stockholders' equity
|
299,475
|
|
|
293,134
|
|
||
Total liabilities and stockholders' equity
|
$
|
500,794
|
|
|
$
|
520,346
|
|
|
Three Months Ended March 31,
|
||||||
|
2018
|
|
2017
|
||||
Net product sales
|
$
|
38,432
|
|
|
$
|
33,620
|
|
Operating expenses:
|
|
|
|
|
|
||
Cost of goods sold
|
1,613
|
|
|
709
|
|
||
Research and development
|
24,636
|
|
|
20,860
|
|
||
Selling, general and administrative
|
26,468
|
|
|
23,115
|
|
||
Change in fair value of contingent consideration
|
3,627
|
|
|
3,344
|
|
||
Total operating expenses
|
56,344
|
|
|
48,028
|
|
||
Operating loss
|
(17,912
|
)
|
|
(14,408
|
)
|
||
Other income (expenses), net:
|
|
|
|
|
|
||
Other income, net
|
121
|
|
|
126
|
|
||
Interest expense, net
|
(358
|
)
|
|
(132
|
)
|
||
Change in fair value of derivative instruments
|
—
|
|
|
1,260
|
|
||
Total other income (expense), net
|
(237
|
)
|
|
1,254
|
|
||
Loss before provision for income taxes
|
(18,149
|
)
|
|
(13,154
|
)
|
||
Income tax benefit (expense)
|
(229
|
)
|
|
2,064
|
|
||
Net loss
|
$
|
(18,378
|
)
|
|
$
|
(11,090
|
)
|
|
|
|
|
||||
Net loss per common share:
|
|
|
|
|
|
||
Basic
|
$
|
(0.46
|
)
|
|
$
|
(0.29
|
)
|
Diluted
|
$
|
(0.46
|
)
|
|
$
|
(0.32
|
)
|
Weighted average common shares outstanding:
|
|
|
|
|
|
||
Basic
|
39,657,418
|
|
|
38,045,317
|
|
||
Diluted
|
39,657,418
|
|
|
39,158,922
|
|
||
|
|
|
|
||||
Comprehensive loss:
|
|
|
|
|
|
||
Net loss
|
$
|
(18,378
|
)
|
|
$
|
(11,090
|
)
|
Foreign currency translation
|
22
|
|
|
(76
|
)
|
||
Unrealized gain (loss) on marketable securities
|
(536
|
)
|
|
146
|
|
||
Comprehensive loss
|
$
|
(18,892
|
)
|
|
$
|
(11,020
|
)
|
|
For the Three Months Ended March 31,
|
||||||
|
2018
|
|
2017
|
||||
Cash Flows From Operating Activities:
|
|
|
|
||||
Net loss
|
$
|
(18,378
|
)
|
|
$
|
(11,090
|
)
|
Adjustments to reconcile net income to net cash provided by operating activities:
|
|
|
|
|
|
||
Depreciation and amortization
|
4,348
|
|
|
4,284
|
|
||
Deferred income tax benefit
|
—
|
|
|
(2,064
|
)
|
||
Interest income from notes receivable
|
—
|
|
|
(325
|
)
|
||
Non-cash interest expense
|
413
|
|
|
376
|
|
||
Amortization of premiums on marketable securities
|
356
|
|
|
287
|
|
||
Share based compensation
|
4,659
|
|
|
7,093
|
|
||
Change in fair value of liability classified warrants
|
—
|
|
|
(1,260
|
)
|
||
Change in fair value of contingent consideration
|
3,627
|
|
|
3,344
|
|
||
Payments related to change in fair value of contingent consideration
|
(4,245
|
)
|
|
(914
|
)
|
||
Inventory Reserve
|
816
|
|
|
25
|
|
||
Other
|
75
|
|
|
53
|
|
||
Changes in operating assets and liabilities, net of business acquisitions:
|
|
|
|
|
|
||
Accounts receivable
|
886
|
|
|
3,076
|
|
||
Inventory
|
(593
|
)
|
|
(574
|
)
|
||
Other current and non-current operating assets
|
421
|
|
|
(946
|
)
|
||
Accounts payable and accrued expenses
|
(9,330
|
)
|
|
(4,626
|
)
|
||
Other current and non-current operating liabilities
|
2,211
|
|
|
(146
|
)
|
||
Net cash used in operating activities
|
(14,734
|
)
|
|
(3,407
|
)
|
||
Cash Flows From Investing Activities:
|
|
|
|
|
|
||
Purchase of fixed assets
|
(39
|
)
|
|
(838
|
)
|
||
Cash paid for intangible assets
|
(8,217
|
)
|
|
(3,477
|
)
|
||
Proceeds from the sale/maturity of marketable securities
|
26,924
|
|
|
8,440
|
|
||
Purchase of marketable securities
|
(29,519
|
)
|
|
—
|
|
||
Cash paid for investments - equity
|
(10,000
|
)
|
|
—
|
|
||
Net cash provided by (used in) investing activities
|
(20,851
|
)
|
|
4,125
|
|
||
Cash Flows From Financing Activities:
|
|
|
|
|
|
||
Payment of acquisition-related contingent consideration
|
(7,066
|
)
|
|
(1,068
|
)
|
||
Payment of guaranteed minimum royalty
|
(500
|
)
|
|
(500
|
)
|
||
Payment of other liability
|
—
|
|
|
(250
|
)
|
||
Proceeds from exercise of warrants
|
608
|
|
|
—
|
|
||
Proceeds from exercise of stock options
|
4,256
|
|
|
1,964
|
|
||
Net cash provided by (used in) financing activities
|
(2,702
|
)
|
|
146
|
|
||
Effect of exchange rate changes on cash
|
10
|
|
|
4
|
|
||
Net change in cash
|
(38,277
|
)
|
|
868
|
|
||
Cash, beginning of year
|
99,394
|
|
|
41,002
|
|
||
Cash, end of period
|
$
|
61,117
|
|
|
$
|
41,870
|
|
▪
|
Focal segmental glomerulosclerosis ("FSGS")
, which is a leading cause of end-stage renal disease and nephrotic syndrome (“NS”). There are no U.S. Food and Drug Administration ("FDA") approved pharmacologic treatments for FSGS and off-label resources are limited to ACE/ARBs, steroids, and immunosuppressant agents, which are effective in only a subset of patients.
|
▪
|
Immunoglobulin A nephropathy ("IgAN
")
, which is characterized by hematuria, proteinuria, and variable rates of progressive renal failure. There is no FDA approved treatment for IgAN.
|
•
|
Chenodal® (chenodiol tablets) is approved in the United States for the treatment of patients suffering from gallstones in whom surgery poses an unacceptable health risk due to disease or advanced age. Chenodal has also been the standard of care for cerebrotendinous xanthomatosis ("CTX") patients for more than three decades and the Company is currently pursuing adding this indication to the label.
|
•
|
Cholbam® (cholic acid capsules) is approved in the United States (approved and marketed in Europe for select indications as Kolbam) for the treatment of bile acid synthesis disorders due to single enzyme defects and is further indicated for adjunctive treatment of patients with peroxisomal disorders.
|
•
|
Thiola® (tiopronin tablets) is approved in the United States for the prevention of cystine (kidney) stone formation in patients with severe homozygous cystinuria.
|
|
For the three months ended:
|
||||||
|
March 31, 2018
|
|
March 31, 2017
|
||||
Bile acid products
|
$
|
18,508
|
|
|
$
|
15,736
|
|
Thiola
|
19,924
|
|
|
17,884
|
|
||
Total net product revenue
|
$
|
38,432
|
|
|
$
|
33,620
|
|
|
March 31, 2018
|
|
December 31, 2017
|
||||
Marketable Securities:
|
|
|
|
||||
Commercial paper
|
$
|
10,339
|
|
|
$
|
6,897
|
|
Corporate debt securities
|
162,648
|
|
|
164,297
|
|
||
Securities of government sponsored entities
|
29,952
|
|
|
30,042
|
|
||
Total marketable securities:
|
$
|
202,939
|
|
|
$
|
201,236
|
|
|
Remaining Contractual Maturity
(in years) |
|
Amortized Cost
|
|
|
Unrealized Losses
|
|
Aggregate Estimated Fair Value
|
||||||
Marketable securities:
|
|
|
|
|
|
|
|
|
||||||
Commercial paper
|
Less than 1
|
|
$
|
10,384
|
|
|
|
$
|
(45
|
)
|
|
$
|
10,339
|
|
Corporate debt securities
|
Less than 1
|
|
88,525
|
|
|
|
(439
|
)
|
|
88,086
|
|
|||
Securities of government-sponsored entities
|
Less than 1
|
|
30,019
|
|
|
|
(67
|
)
|
|
29,952
|
|
|||
Total maturity less than 1 year
|
|
|
128,928
|
|
|
|
(551
|
)
|
|
128,377
|
|
|||
Corporate debt securities
|
1 to 2
|
|
75,276
|
|
|
|
(714
|
)
|
|
74,562
|
|
|||
Total maturity 1 to 2 years
|
|
|
75,276
|
|
|
|
(714
|
)
|
|
74,562
|
|
|||
Total available-for-sale securities
|
|
|
$
|
204,204
|
|
|
|
$
|
(1,265
|
)
|
|
$
|
202,939
|
|
|
Remaining Contractual Maturity
(in years)
|
|
Amortized Cost
|
|
|
Unrealized Losses
|
|
Aggregate Estimated Fair Value
|
||||||
Marketable securities:
|
|
|
|
|
|
|
|
|
||||||
Commercial paper
|
Less than 1
|
|
$
|
6,911
|
|
|
|
$
|
(14
|
)
|
|
$
|
6,897
|
|
Corporate debt securities
|
Less than 1
|
|
86,531
|
|
|
|
(198
|
)
|
|
86,333
|
|
|||
Securities of government-sponsored entities
|
Less than 1
|
|
30,132
|
|
|
|
(90
|
)
|
|
30,042
|
|
|||
Total maturity less than 1 year
|
|
|
123,574
|
|
|
|
(302
|
)
|
|
123,272
|
|
|||
Corporate debt securities
|
1 to 2
|
|
78,388
|
|
|
|
(424
|
)
|
|
77,964
|
|
|||
Total maturity 1 to 2 years
|
|
|
78,388
|
|
|
|
(424
|
)
|
|
77,964
|
|
|||
Total available-for-sale securities
|
|
|
$
|
201,962
|
|
|
|
$
|
(726
|
)
|
|
$
|
201,236
|
|
|
Common stock
|
Additional paid in capital
|
Accumulated other comprehensive loss
|
Accumulated deficit
|
Total stockholders' equity (deficit)
|
||||||||||
Balance–December 31, 2017
|
$
|
4
|
|
$
|
471,800
|
|
$
|
(1,015
|
)
|
$
|
(177,655
|
)
|
$
|
293,134
|
|
Balance-March 31, 2018 before effect of ASU 17-11
|
4
|
|
481,323
|
|
(1,529
|
)
|
(196,033
|
)
|
283,765
|
|
|||||
Effect of ASU 17-11
|
—
|
|
5,394
|
|
|
10,316
|
|
15,710
|
|
||||||
Balance–March 31, 2018
|
$
|
4
|
|
$
|
486,717
|
|
$
|
(1,529
|
)
|
$
|
(185,717
|
)
|
$
|
299,475
|
|
|
December 31, 2017
|
||
Fair value of common stock
|
$
|
21.07
|
|
Remaining life of the warrants (in years)
|
0.1 - 2.0 years
|
|
|
Risk-free interest rate*
|
1.39 - 1.89%
|
|
|
Expected volatility**
|
33 - 43%
|
|
|
Dividend yield
|
—
|
%
|
|
As of March 31, 2018
|
||||||||||||||
|
Total carrying and estimated fair value
|
|
Quoted prices in active markets
(Level 1) |
|
Significant other observable inputs (Level 2)
|
|
Significant unobservable inputs (Level 3)
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Cash and cash equivalents
|
$
|
61,117
|
|
|
$
|
61,117
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Marketable securities, available-for-sale
|
202,939
|
|
|
—
|
|
|
202,939
|
|
|
—
|
|
||||
Total
|
$
|
264,056
|
|
|
$
|
61,117
|
|
|
$
|
202,939
|
|
|
$
|
—
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Business combination-related contingent consideration
|
$
|
91,500
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
91,500
|
|
Total
|
$
|
91,500
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
91,500
|
|
|
As of December 31, 2017
|
||||||||||||||
|
Total carrying and estimated fair value
|
|
Quoted prices in active markets
(Level 1)
|
|
Significant other observable inputs (Level 2)
|
|
Significant unobservable inputs (Level 3)
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Cash and cash equivalents
|
$
|
99,394
|
|
|
$
|
92,726
|
|
|
$
|
6,668
|
|
|
$
|
—
|
|
Marketable securities, available-for-sale
|
201,236
|
|
|
—
|
|
|
201,236
|
|
|
—
|
|
||||
Total
|
$
|
300,630
|
|
|
$
|
92,726
|
|
|
$
|
207,904
|
|
|
$
|
—
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Derivative liability related to warrants
|
$
|
15,710
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
15,710
|
|
Business combination-related contingent consideration
|
90,000
|
|
|
—
|
|
|
—
|
|
|
90,000
|
|
||||
Total
|
$
|
105,710
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
105,710
|
|
|
Fair Value Measurements of Acquisition-Related Contingent Consideration
(Level 3) |
||
Balance at January 1, 2018
|
$
|
90,000
|
|
Increase from revaluation of contingent consideration
|
3,627
|
|
|
Contractual payments included in accrued liabilities at March 31, 2018
|
(2,127
|
)
|
|
Contractual payments
|
—
|
|
|
Balance at March 31, 2018
|
$
|
91,500
|
|
|
March 31, 2018
|
|
December 31, 2017
|
||||
Finite-lived intangible assets
|
$
|
243,865
|
|
|
$
|
235,863
|
|
Less: accumulated amortization
|
(55,309
|
)
|
|
(51,046
|
)
|
||
Net carrying value
|
$
|
188,556
|
|
|
$
|
184,817
|
|
|
Three Months Ended March 31,
|
||||||
|
2018
|
|
2017
|
||||
Research and development
|
$
|
103
|
|
|
$
|
81
|
|
Selling, general and administrative
|
4,096
|
|
|
4,090
|
|
||
Total amortization expense
|
$
|
4,199
|
|
|
$
|
4,171
|
|
|
March 31, 2018
|
|
December 31, 2017
|
||||
Government rebates payable
|
$
|
6,372
|
|
|
$
|
5,883
|
|
Compensation related costs
|
5,693
|
|
|
7,749
|
|
||
Accrued royalties and contingent consideration
|
5,870
|
|
|
6,429
|
|
||
Research and development
|
9,553
|
|
|
6,989
|
|
||
Selling, general and administrative
|
2,058
|
|
|
3,896
|
|
||
Restructuring expenses
|
42
|
|
|
3,549
|
|
||
Miscellaneous accrued
|
2,056
|
|
|
1,523
|
|
||
Total accrued expenses
|
$
|
31,644
|
|
|
$
|
36,018
|
|
|
Three Months Ended March 31,
|
||||||||||||||||||||
|
2018
|
|
2017
|
||||||||||||||||||
|
Shares
|
|
Net Loss
|
|
EPS
|
|
Shares
|
|
Net Loss
|
|
EPS
|
||||||||||
Basic loss per share
|
39,657,418
|
|
|
$
|
(18,378
|
)
|
|
$
|
(0.46
|
)
|
|
38,045,317
|
|
|
$
|
(11,090
|
)
|
|
$
|
(0.29
|
)
|
Dilutive shares related to warrants
|
—
|
|
|
—
|
|
|
|
|
|
1,113,605
|
|
|
—
|
|
|
|
|
||||
Change in fair value of derivative instruments
|
—
|
|
|
—
|
|
|
|
|
|
—
|
|
|
(1,260
|
)
|
|
|
|
||||
Dilutive loss per share
|
39,657,418
|
|
|
$
|
(18,378
|
)
|
|
$
|
(0.46
|
)
|
|
39,158,922
|
|
|
$
|
(12,350
|
)
|
|
$
|
(0.32
|
)
|
|
Three Months Ended March 31,
|
|
||||
|
2018
|
|
2017
|
|
||
Restricted stock units
|
139
|
|
|
332
|
|
|
Convertible debt
|
2,642
|
|
|
2,642
|
|
|
Options
|
7,025
|
|
|
6,405
|
|
|
Warrants
|
633
|
|
|
—
|
|
|
Total anti-dilutive shares
|
10,439
|
|
|
9,379
|
|
|
Facilities
|
|
Annual Base Rent
|
|
Lease Expiration
|
|
Comments
|
Occupied Locations
|
|
|
|
|
|
|
Corporate Headquarters
San Diego, CA
|
|
$2.1 million
|
|
July 2024
|
|
|
Vacated Locations
|
|
|
|
|
|
|
New York, NY
|
|
$0.5 million
|
|
November 2018
|
|
Sublet through expiration
|
|
Number of Restricted Stock Units
|
|
Weighted Average Grant Date Fair Value
|
|||
Unvested December 31, 2017
|
345,332
|
|
|
$
|
20.51
|
|
Granted
|
18,061
|
|
|
22.18
|
|
|
Vested
|
(11,377
|
)
|
|
18.33
|
|
|
Forfeited/canceled
|
(12,666
|
)
|
|
22.84
|
|
|
Unvested March 31, 2018
|
339,350
|
|
|
$
|
20.58
|
|
|
Shares Underlying Options
|
|
Weighted Average Exercise Price
|
|
Weighted Average Remaining Contractual Life (years)
|
|
Aggregate Intrinsic Value (in thousands)
|
|||||
Outstanding at December 31, 2017
|
7,153,668
|
|
|
$
|
17.16
|
|
|
6.95
|
|
$
|
39,010
|
|
Granted
|
136,500
|
|
|
24.08
|
|
|
|
|
|
|||
Exercised
|
(319,551
|
)
|
|
13.32
|
|
|
|
|
|
|||
Forfeited/canceled
|
(198,002
|
)
|
|
25.35
|
|
|
|
|
|
|||
Outstanding at March 31, 2018
|
6,772,615
|
|
|
$
|
17.25
|
|
|
7.02
|
|
$
|
43,054
|
|
|
Three Months Ended March 31,
|
|
||||||
|
2018
|
|
2017
|
|
||||
Research and development
|
$
|
1,407
|
|
|
$
|
2,656
|
|
|
Selling, general & administrative
|
3,202
|
|
|
4,437
|
|
|
||
Total
|
$
|
4,609
|
|
|
$
|
7,093
|
|
|
|
Three Months Ended March 31,
|
||||||
|
2018
|
|
2017
|
||||
Effective tax rate
|
(1.3
|
)%
|
|
15.7
|
%
|
||
Income tax benefit (expense)
|
$
|
(0.2
|
)
|
|
$
|
2.1
|
|
|
March 31, 2018
|
|
December 31, 2017
|
||||
Raw materials
|
$
|
3,743
|
|
|
$
|
3,435
|
|
Finished goods
|
1,399
|
|
|
1,916
|
|
||
Total inventory
|
$
|
5,142
|
|
|
$
|
5,351
|
|
•
|
Focal segmental glomerulosclerosis ("FSGS"), a leading cause of end-stage renal disease and nephrotic syndrome (“NS”). There are currently no FDA approved pharmacologic treatments for FSGS and off-label resources are limited to ACE/ARBs, steroids, and immunosuppressant agents, which are effective in only a subset of patients. Every year approximately 5,400 patients are diagnosed with FSGS and we estimate that there are up to 40,000 FSGS patients in the United States with approximately half of them being candidates for sparsentan. In 2015 and 2016 we received orphan drug designation in the United States and European Union and received positive data from our Phase 2 DUET study of sparsentan for the treatment of FSGS. In April 2018, we announced the initiation of the Phase 3 DUPLEX Study of sparsentan in FSGS. This pivotal DUPLEX Study is designed to include an interim analysis of modified partial remission of proteinuria. We expect that successful achievement of this endpoint will serve as the basis for Subpart H accelerated approval of sparsentan in the United States and Conditional Marketing Authorization (CMA) consideration in Europe. The confirmatory endpoint of the study will compare changes in slope of estimated glomerular filtration rate, or eGFR.
|
▪
|
Immunoglobulin A nephropathy ("IgAN
")
, which is characterized by hematuria, proteinuria, and variable rates of progressive renal failure. With an estimated prevalence of more than 100,000 in the United States and greater numbers in Europe and Asia, IgAN is the most common primary glomerular disease. Most patients are diagnosed between the ages of 16 and 35, with up to 40% progressing to end stage renal disease within 15 years. There are currently no FDA approved treatments for IgAN. The current standard of care is renin-angiotensin-aldosterone system (RAAS) blockade with immunosuppression also being commonly used for patients with significant proteinuria or rapidly progressive glomerulonephritis. Based on recent interactions we have had with the FDA and EMA, we are planning to initiate a single Phase 3 clinical trial designed to serve as the basis for an NDA filing for sparsentan for the treatment of IgAN. We are currently working to harmonize the protocol design for this Phase 3 study by incorporating the feedback to guide our clinical activity. We expect to initiate this study during the fourth quarter of 2018.
|
|
Three Months Ended March 31,
|
||||||||||
|
2018
|
|
2017
|
|
Change
|
||||||
Net product revenues by product:
|
|
|
|
|
|
||||||
Bile acid products
|
$
|
18,508
|
|
|
$
|
15,736
|
|
|
$
|
2,772
|
|
Thiola
|
19,924
|
|
|
17,884
|
|
|
2,040
|
|
|||
Total net product revenues
|
$
|
38,432
|
|
|
$
|
33,620
|
|
|
$
|
4,812
|
|
|
Three Months Ended March 31,
|
||||||||||
|
2018
|
|
2017
|
|
Change
|
||||||
Cost of goods sold
|
$
|
1,613
|
|
|
$
|
709
|
|
|
$
|
904
|
|
Research and development
|
24,636
|
|
|
20,860
|
|
|
3,776
|
|
|||
Selling, general and administrative
|
26,468
|
|
|
23,115
|
|
|
3,353
|
|
|||
Change in fair value of contingent consideration
|
3,627
|
|
|
3,344
|
|
|
283
|
|
|||
|
$
|
56,344
|
|
|
$
|
48,028
|
|
|
$
|
8,316
|
|
|
Three Months Ended March 31,
|
|
||||||||||
|
2018
|
|
2017
|
|
Change
|
|
||||||
Other income, net
|
$
|
121
|
|
|
$
|
126
|
|
|
$
|
(5
|
)
|
|
Interest expense, net
|
(358
|
)
|
|
(132
|
)
|
|
(226
|
)
|
|
|||
Change in fair value of derivative instruments
|
—
|
|
|
1,260
|
|
|
(1,260
|
)
|
|
|||
|
$
|
(237
|
)
|
|
$
|
1,254
|
|
|
$
|
(1,491
|
)
|
|
|
March 31, 2018
|
|
December 31, 2017
|
||||
Cash & Cash Equivalents
|
$
|
61,117
|
|
|
$
|
99,394
|
|
Marketable securities
|
202,939
|
|
|
201,236
|
|
||
Accumulated Deficit
|
(185,717
|
)
|
|
(177,655
|
)
|
||
Stockholders' Equity
|
299,475
|
|
|
293,134
|
|
||
|
|
|
|
||||
Net Working Capital*
|
$
|
230,278
|
|
|
$
|
240,139
|
|
Net Working Capital Ratio**
|
5.07
|
|
|
3.80
|
|
•
|
revenue growth of our marketed products;
|
•
|
the rate of progress and cost of our clinical trials, preclinical studies and other discovery and research and development activities;
|
•
|
the timing of, and costs involved in, seeking and obtaining marketing approvals for our products, and in maintaining quality systems standards for our products;
|
•
|
our ability to manufacture sufficient quantities of our products to meet expected demand;
|
•
|
the costs of preparing, filing, prosecuting, maintaining and enforcing any patent claims and other intellectual property rights, litigation costs and the results of litigation;
|
•
|
our ability to enter into collaboration, licensing or distribution arrangements and the terms and timing of these arrangements;
|
•
|
the potential need to expand our business, resulting in additional payroll and other overhead expenses;
|
•
|
the potential in-licensing of other products or technologies; and
|
•
|
the emergence of competing technologies or other adverse market or technological developments.
|
•
|
lower demonstrated efficacy, safety and/or tolerability compared to other drugs;
|
•
|
prevalence and severity of adverse side-effects;
|
•
|
lack of cost-effectiveness;
|
•
|
lack of coverage and adequate reimbursement availability from third-party payers;
|
•
|
a decision to wait for the approval of other therapies in development that have significant perceived advantages over our drug;
|
•
|
convenience and ease of administration;
|
•
|
other potential advantages of alternative treatment methods; and
|
•
|
ineffective marketing and/or distribution support.
|
•
|
our preclinical or nonclinical tests or clinical trials may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional preclinical testing or clinical trials or we may abandon projects that we expect to be promising;
|
•
|
regulators may require us to conduct studies of the long-term effects associated with the use of our product candidates;
|
•
|
regulators or institutional review boards may not authorize us to commence a clinical trial or conduct a clinical trial at a prospective trial site;
|
•
|
the FDA or any non-United States regulatory authority may impose conditions on us regarding the scope or design of our clinical trials or may require us to resubmit our clinical trial protocols to institutional review boards for re-inspection due to changes in the regulatory environment;
|
•
|
the number of patients required for our clinical trials may be larger than we anticipate or participants may drop out of our clinical trials at a higher rate than we anticipate;
|
•
|
our third-party contractors or clinical investigators may fail to comply with regulatory requirements or fail to meet their contractual obligations to us in a timely manner;
|
•
|
we might have to suspend or terminate one or more of our clinical trials if we, regulators or institutional review boards determine that the participants are being exposed to unacceptable health risks;
|
•
|
regulators or institutional review boards may require that we hold, suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements;
|
•
|
the cost of our clinical trials may be greater than we anticipate;
|
•
|
the supply or quality of our product candidates or other materials necessary to conduct our clinical trials may be insufficient or inadequate or we may not be able to reach agreements on acceptable terms with prospective clinical research organizations; and
|
•
|
the effects of our product candidates may not be the desired effects or may include undesirable side effects or the product candidates may have other unexpected characteristics.
|
•
|
be delayed in obtaining, or may not be able to obtain, marketing approval for one or more of our product candidates;
|
•
|
obtain approval for indications that are not as broad as intended or entirely different than those indications for which we sought approval; and
|
•
|
have the product removed from the market after obtaining marketing approval.
|
•
|
obtaining supplies of fosmetpantotenate, sparsentan, CNSA-001 and subsequent product candidates for completion of our clinical trials on a timely basis;
|
•
|
successful completion of pre-clinical and clinical studies;
|
•
|
with respect to L-UDCA, our ability to complete the activities necessary to submit an NDA;
|
•
|
obtaining marketing approvals from the FDA and similar regulatory authorities outside the United States;
|
•
|
establishing commercial-scale manufacturing arrangements with third-party manufacturers whose manufacturing facilities are operated in compliance with cGMP regulations;
|
•
|
launching commercial sales of the product, whether alone or in collaboration with others;
|
•
|
acceptance of the product by patients, the medical community and third-party payers;
|
•
|
reimbursement from medical, medicaid or private payers;
|
•
|
competition from other companies;
|
•
|
successful protection of our intellectual property rights from competing products in the United States and abroad; and
|
•
|
a continued acceptable safety and efficacy profile of our product candidates following approval.
|
•
|
regulatory authorities may require the addition of restrictive labeling statements;
|
•
|
regulatory authorities may withdraw their approval of the product; and
|
•
|
we may be required to change the way the product is administered or conduct additional clinical trials.
|
•
|
the prevalence and severity of any side effects, including any limitations or warnings contained in a product’s approved labeling;
|
•
|
the efficacy and potential advantages over alternative treatments;
|
•
|
the pricing of our product candidates;
|
•
|
relative convenience and ease of administration;
|
•
|
the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;
|
•
|
the strength of marketing and distribution support and timing of market introduction of competitive products;
|
•
|
publicity concerning our products or competing products and treatments; and
|
•
|
sufficient third-party insurance coverage or reimbursement.
|
•
|
we or our licensors were the first to make the inventions covered by each of our pending patent applications;
|
•
|
we or our licensors were the first to file patent applications for these inventions;
|
•
|
others will not independently develop similar or alternative technologies or duplicate any of our technologies;
|
•
|
any patents issued to us or our licensors that provide a basis for commercially viable products will provide us with any competitive advantages or will not be challenged by third parties;
|
•
|
we will develop additional proprietary technologies that are patentable;
|
•
|
we will file patent applications for new proprietary technologies promptly or at all;
|
•
|
the claims we make in our patents will be upheld by patent offices in the United States and elsewhere;
|
•
|
our patents will not expire prior to or shortly after commencing commercialization of a product; and
|
•
|
the patents of others will not have a negative effect on our ability to do business.
|
•
|
a covered benefit under its health plan;
|
•
|
safe, effective and medically necessary;
|
•
|
appropriate for the specific patient;
|
•
|
cost-effective; and
|
•
|
neither experimental nor investigational.
|
•
|
reliance on the third party for regulatory compliance and quality assurance;
|
•
|
limitations on supply availability resulting from capacity and scheduling constraints of the third parties;
|
•
|
impact on our reputation in the marketplace if manufacturers of our products fail to meet the demands of our customers;
|
•
|
the possible breach of the manufacturing agreement by the third party because of factors beyond our control; and
|
•
|
the possible termination or nonrenewal of the agreement by the third party, based on its own business priorities, at a time that is costly or inconvenient for us.
|
•
|
our inability to recruit and retain adequate numbers of effective sales and marketing personnel;
|
•
|
the inability of sales personnel to obtain access to or educate adequate numbers of physicians to prescribe our products;
|
•
|
the lack of complementary products to be offered by our sales personnel, which may put us at a competitive disadvantage against companies with broader product lines;
|
•
|
unforeseen costs associated with expanding our own sales and marketing team for new products or with entering into a partnering agreement with an independent sales and marketing organization; and
|
•
|
efforts by our competitors to commercialize competitive products.
|
•
|
continue our ongoing clinical development of fosmetpantotenate for the treatment of PKAN;
|
•
|
continue the open label portion of DUET and conduct the planned Phase 3 trials of sparsentan indications;
|
•
|
continue funding the clinical development of CNSA-001 for PKU;
|
•
|
complete requirements necessary for an NDA filing of L-UDCA and the next generation of Thiola;
|
•
|
continue the research and development of additional product candidates;
|
•
|
expand our sales and marketing infrastructure to commercialize our current products and any new products for which we may obtain regulatory approval; and
|
•
|
expand operational, financial, and management information systems and personnel, including personnel to support product development efforts and our obligations as a public company.
|
•
|
the progress and results of our pre-clinical and clinical studies of fosmetpantotenate, sparsentan, CNSA-001 and other drug candidates;
|
•
|
the costs, timing and outcome of regulatory review of our product candidates;
|
•
|
the number and development requirements of other product candidates that we pursue;
|
•
|
the costs of commercialization activities, including product marketing, sales and distribution;
|
•
|
the emergence of competing technologies and other adverse market developments;
|
•
|
the costs of preparing, filing and prosecuting patent applications and maintaining, enforcing and defending intellectual property related claims;
|
•
|
the extent to which we acquire or invest in businesses, products and technologies, including the extent to which we exercise our option to acquire Censa; and
|
•
|
our ability to establish collaborations and obtain milestone, royalty or other payments from any such collaborators.
|
•
|
results of clinical trials of our product candidates or those of our competitors;
|
•
|
our entry into or the loss of a significant collaboration;
|
•
|
regulatory or legal developments in the United States and other countries, including changes in the health care payment systems;
|
•
|
our ability to obtain and maintain marketing approvals from the FDA or similar regulatory authorities outside the United States;
|
•
|
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;
|
•
|
market conditions in the pharmaceutical and biotechnology sectors and issuance of new or changed securities analysts’ reports or recommendations;
|
•
|
general economic, industry and market conditions;
|
•
|
results of clinical trials conducted by others on drugs that would compete with our product candidates;
|
•
|
developments or disputes concerning patents or other proprietary rights;
|
•
|
public concern over our product candidates or any products approved in the future;
|
•
|
litigation;
|
•
|
communications from government officials regarding health care costs or pharmaceutical pricing;
|
•
|
future sales or anticipated sales of our common stock by us or our stockholders; and
|
•
|
the other factors described in this “Risk Factors” section.
|
•
|
integrating personnel, operations and systems, while maintaining focus on producing and delivering consistent, high quality products;
|
•
|
coordinating geographically dispersed organizations;
|
•
|
distracting employees from operations;
|
•
|
retaining existing customers and attracting new customers; and
|
•
|
managing inefficiencies associated with integrating the operations of the Company.
|
•
|
inability of sales personnel to obtain access to or convince adequate numbers of physicians to prescribe our products;
|
•
|
inability to recruit, retain and effectively manage adequate numbers of effective sales personnel;
|
•
|
lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies that have more extensive product lines; and
|
•
|
unforeseen delays, costs and expenses associated with maintaining our sales organization.
|
•
|
decreased demand for any product candidates or products that we may develop;
|
•
|
damage to our reputation;
|
•
|
regulatory investigations that could require costly recalls or product modifications;
|
•
|
withdrawal of clinical trial participants;
|
•
|
costs to defend the related litigation;
|
•
|
substantial monetary awards to trial participants or patients, including awards that substantially exceed our product liability insurance, which we would then be required to pay from other sources, if available, and would damage our ability to obtain liability insurance at reasonable costs, or at all, in the future;
|
•
|
loss of revenue;
|
•
|
the diversion of management’s attention from managing our business; and
|
•
|
the inability to commercialize any products that we may develop.
|
•
|
our failure to demonstrate to the satisfaction of the FDA or comparable regulatory authorities that a product candidate is safe and effective for a particular indication;
|
•
|
the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable regulatory authorities for approval;
|
•
|
our inability to demonstrate that a product candidate’s benefits outweigh its risks;
|
•
|
our inability to demonstrate that the product candidate presents an advantage over existing therapies;
|
•
|
the FDA’s or comparable regulatory authorities’ disagreement with the manner in which we interpret the data from preclinical studies or clinical trials;
|
•
|
failure of the third-party manufacturers with which we contract for clinical or commercial supplies to satisfactorily complete an FDA pre-approval inspection of the facility or facilities at which the product is manufactured to assess compliance with the FDA’s cGMP regulations to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity; and
|
•
|
a change in the approval policies or regulations of the FDA or comparable regulatory authorities or a change in the laws governing the approval process.
|
•
|
make it more difficult for us to satisfy our obligations with respect to any other debt we may incur in the future;
|
•
|
increase our vulnerability to general adverse economic and industry conditions;
|
•
|
require us to dedicate a substantial portion of our cash flow from operations to payments on our indebtedness and related interest, thereby reducing the availability of our cash flow to fund working capital, capital expenditures and other general corporate purposes;
|
•
|
limit our flexibility in planning for, or reacting to, changes in our business and the industry in which we operate;
|
•
|
increase our cost of borrowing;
|
•
|
place us at a competitive disadvantage compared to our competitors that may have less debt; and
|
•
|
limit our ability to obtain additional financing for working capital, capital expenditures, acquisitions, debt service requirements or general corporate purposes.
|
•
|
failure to pay (for more than 30 days) interest when due;
|
•
|
failure to pay principal when due;
|
•
|
failure to deliver shares of common stock upon conversion of a Note;
|
•
|
failure to provide notice of a fundamental change;
|
•
|
acceleration on our other indebtedness in excess of $10 million (other than indebtedness that is non-recourse to us); or
|
•
|
certain types of bankruptcy or insolvency involving us.
|
3.1
|
|
3.2
|
|
3.3
|
|
4.1
|
|
4.2
|
|
4.3
|
|
4.4
|
|
4.5
|
|
10.1
|
|
10.2+
|
|
10.3†
|
|
10.4†
|
|
10.5†
|
|
31.1
|
|
31.2
|
|
32.1
|
|
32.2
|
|
101.INS
|
XBRL Instance Document
|
101.SCH
|
XBRL Taxonomy Extension Schema Document
|
101.CAL
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
101.DEF
|
XBRL Taxonomy Extension Definition Linkbase Document
|
101.LAB
|
XBRL Taxonomy Extension Label Linkbase Document
|
101.PRE
|
Taxonomy Extension Presentation Linkbase Document
|
+
|
|
We have received confidential treatment of certain portions of this agreement, which have been omitted and filed separately with the SEC pursuant to Rule 406 under the Securities Act of 1933, as amended, or Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
|
†
|
|
Indicates management contract or compensatory plan.
|
Date: May 1, 2018
|
RETROPHIN, INC.
|
||
|
|
|
|
|
By:
|
/s/ Stephen Aselage
|
|
|
|
Name:
|
Stephen Aselage
|
|
|
Title:
|
Chief Executive Officer
|
|
|
|
|
|
By:
|
/s/ Laura Clague
|
|
|
|
Name:
|
Laura Clague
|
|
|
Title:
|
Chief Financial Officer
|
|
RETROPHIN, INC.
|
|
|
|
By: Name:
|
|
|
|
Title:
|
|
|
|
INDEMNITEE
|
|
|
|
Signature of Indemnitee
|
|
|
|
Print or Type Name of Indemnitee
|
1.
|
Capitalized Terms
. The capitalized terms used herein and not otherwise defined shall have the same definitions as provided in the Sublicense Agreement.
|
2.
|
Amendments
.
|
a)
|
Section 6.1.3 of the Sublicense Agreement is hereby amended to read as follows:
|
b)
|
Section 8.2.1 of the Sublicense Agreement is hereby amended to read as follows:
|
Milestone Event
|
Milestone Payment
|
Execution of Agreement
|
$1.15 million
|
The earlier of (a) December 31, 2012 or (b) initiation of the first Phase 2 Trial for a Licensed Product
|
$1.3 million (the “
Second Milestone
”); provided, that if the Second Milestone is received by Ligand (a) prior to or on January 31, 2012, Retrophin shall make an additional $50,000 payment simultaneously with the payment of the Second Milestone (for an aggregate payment of $1.35 million), (b) after January 31, 2013 but prior to or on February 28, 2013, Retrophin shall make an additional $100,000 payment simultaneously with the payment of the Second Milestone (for an aggregate payment of $1.4 million), and (c) after February 28, 2013 but prior to or on March 31, 2013, Retrophin shall make an additional $150,000 payment of the Second Milestone (for an aggregate payment of $1.45 million) (the additional payment, an “
Additional Payment
”)
1
|
Milestone Event
|
Milestone Payment
|
At or prior to Initiation of the first Phase 3 Trial for the first Licensed Product
|
$4.6 million
|
[...***...]
|
[...***...]
|
[...***...]
|
[...***...]
|
[...***...]
|
[...***...]
|
[...***...]
|
[...***...]
|
[...***...]
|
[...***...]
|
[...***...]
|
[...***...]
|
[...***...]
|
[...***...]
|
[...***...]
|
[...***...]
|
[...***...]
|
[...***...]
|
[...***...]
|
[...***...]
|
3.
|
No Other Amendments
. Except as provided herein, the Sublicense Agreement shall continue in full force and effect.
|
4.
|
Governing Law
. This Amendment shall be governed by, enforced, and shall be construed in accordance with the laws of the State of New York without regard to its conflicts of law provisions.
|
5.
|
Counterparts.
This Amendment may be executed in counter-parts with the same effect as if both Parties had signed the same document. All such counterparts shall be deemed an original, shall be construed together and shall constitute one and the same instrument.
|
EXECUTIVE
|
|
RETROPHIN, INC.
|
||
|
|
|
|
|
By:
|
/s/ William E. Rote
|
|
By:
|
/s/ Stephen Aselage
|
|
|
|
|
|
Date:
|
February 13, 2017
|
|
Date:
|
February 13, 2017
|
|
|
|
|
|
RETROPHIN, INC.:
|
|
EXECUTIVE
|
||
|
|
|
|
|
By:
|
|
|
By:
|
|
|
|
|
|
|
Date:
|
|
|
Date:
|
|
|
|
|
|
|
1.
|
Article 6, Section 6.8(a) of the Agreement shall be amended and restated in its entirety as follows:
|
2.
|
The Agreement and this Amendment represent the complete and entire understanding between the parties regarding the subject matter hereof and supersede all prior negotiations, representations or agreements, either written or oral, regarding this subject matter. No provisions of this Amendment may be modified, waived or discharged unless such waiver, modification or discharge is agreed to in writing signed by Executive and such officer as may be specifically designated by the Board of Directors of the Company.
|
3.
|
The validity, interpretation, construction and performance of this Amendment and the rights of the parties thereunder shall be interpreted and enforced under California law without reference to principles of conflicts of laws.
|
4.
|
This Amendment may be executed in multiple counterparts, each of which shall be deemed an original, but both of which together shall constitute one and the same instrument.
|
5.
|
Except for the matters set forth in this Amendment, all other terms of the Agreement shall remain unchanged and in full force and effect.
|
|
|
|
RETROPHIN, INC.
|
|
|
|
|
|
|
|
|
|
By:
|
/s/ Stephen Aselage
|
|
|
|
Name:
|
Stephen Aselage
|
|
|
|
Title:
|
Chief Executive Officer
|
|
Accepted and agreed:
|
|
|
|
|
/s/ William Rote
|
|
|
|
|
William Rote
|
|
|
|
EXECUTIVE
|
|
RETROPHIN, INC.
|
||
|
|
|
|
|
By:
|
/s/ Elizabeth Reed
|
|
By:
|
/s/ Stephen Aselage
|
|
|
|
|
|
Date:
|
February 6, 2017
|
|
Date:
|
February 6, 2017
|
|
|
|
|
|
RETROPHIN, INC.:
|
|
EXECUTIVE
|
||
|
|
|
|
|
By:
|
|
|
By:
|
|
|
|
|
|
|
Date:
|
|
|
Date:
|
|
|
|
|
|
|
1.
|
Article 6, Section 6.8(a) of the Agreement shall be amended and restated in its entirety as follows:
|
2.
|
The Agreement and this Amendment represent the complete and entire understanding between the parties regarding the subject matter hereof and supersede all prior negotiations, representations or agreements, either written or oral, regarding this subject matter. No provisions of this Amendment may be modified, waived or discharged unless such waiver, modification or discharge is agreed to in writing signed by Executive and such officer as may be specifically designated by the Board of Directors of the Company.
|
3.
|
The validity, interpretation, construction and performance of this Amendment and the rights of the parties thereunder shall be interpreted and enforced under California law without reference to principles of conflicts of laws.
|
4.
|
This Amendment may be executed in multiple counterparts, each of which shall be deemed an original, but both of which together shall constitute one and the same instrument.
|
5.
|
Except for the matters set forth in this Amendment, all other terms of the Agreement shall remain unchanged and in full force and effect.
|
|
|
|
RETROPHIN, INC.
|
|
|
|
|
|
|
|
|
|
By:
|
/s/ Stephen Aselage
|
|
|
|
Name:
|
Stephen Aselage
|
|
|
|
Title:
|
Chief Executive Officer
|
|
Accepted and agreed:
|
|
|
|
|
/s/ Elizabeth Reed
|
|
|
|
|
Elizabeth Reed
|
|
|
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of Retrophin, 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.
|
|
|
|
|
Date: May 1, 2018
|
|
|
|
|
|
|
|
|
|
|
/s/ Stephen Aselage
|
|
|
|
Stephen Aselage
|
|
|
|
Chief Executive Officer
|
|
|
|
(Principal Executive Officer)
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of Retrophin, 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.
|
|
|
|
|
Date: May 1, 2018
|
|
|
|
|
|
|
|
|
|
|
/s/ Laura Clague
|
|
|
|
Laura Clague
|
|
|
|
Chief Financial Officer
|
|
|
|
(Principle Financial Officer)
|
|
|
|
|
Date: May 1, 2018
|
|
|
|
|
|
|
|
|
|
|
/s/ Stephen Aselage
|
|
|
|
Stephen Aselage
|
|
|
|
Chief Executive Officer
|
|
|
|
(Principal Executive Officer)
|
|
|
|
|
Date: May 1, 2018
|
|
|
|
|
|
|
|
|
|
|
/s/ Laura Clague
|
|
|
|
Laura Clague
|
|
|
|
Chief Financial Officer
|
|
|
|
(Principal Financial Officer)
|