FORM 10-Q
|
ý
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
¨
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
|
EXELIXIS, INC.
(Exact name of registrant as specified in its charter)
|
Delaware
|
04-3257395
|
(State or other jurisdiction of incorporation or organization)
|
(I.R.S. Employer Identification Number)
|
Large accelerated filer
|
ý
|
|
Accelerated filer
|
¨
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|
Non-accelerated filer
|
¨
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|
Smaller reporting company
|
¨
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|
Emerging growth company
|
¨
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|
|
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Item 1.
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||
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||
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||
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||
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Item 2.
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Item 3.
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||
Item 4.
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||
Item 1.
|
||
Item 1A.
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||
Item 2.
|
||
Item 3.
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Item 4.
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Item 5.
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Item 6.
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September 30,
2018 |
|
December 31, 2017*
|
||||
ASSETS
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
353,623
|
|
|
$
|
183,164
|
|
Short-term investments
|
281,000
|
|
|
204,607
|
|
||
Short-term restricted cash and investments
|
504
|
|
|
504
|
|
||
Trade and other receivables, net
|
104,634
|
|
|
81,192
|
|
||
Inventory, net
|
10,433
|
|
|
6,657
|
|
||
Unbilled collaboration revenue
|
24,489
|
|
|
—
|
|
||
Prepaid expenses and other current assets
|
12,279
|
|
|
8,750
|
|
||
Total current assets
|
786,962
|
|
|
484,874
|
|
||
Long-term investments
|
114,093
|
|
|
64,255
|
|
||
Long-term restricted cash and investments
|
1,100
|
|
|
4,646
|
|
||
Property and equipment, net
|
51,046
|
|
|
25,743
|
|
||
Goodwill
|
63,684
|
|
|
63,684
|
|
||
Operating lease right-of-use assets
|
5,989
|
|
|
—
|
|
||
Other long-term assets
|
1,492
|
|
|
12,092
|
|
||
Total assets
|
$
|
1,024,366
|
|
|
$
|
655,294
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
8,679
|
|
|
$
|
9,575
|
|
Accrued compensation and benefits
|
27,283
|
|
|
21,073
|
|
||
Accrued clinical trial liabilities
|
18,958
|
|
|
19,849
|
|
||
Rebates and fees due to customers
|
11,689
|
|
|
7,565
|
|
||
Accrued collaboration liabilities
|
8,397
|
|
|
8,974
|
|
||
Current portion of deferred revenue
|
—
|
|
|
31,984
|
|
||
Other current liabilities
|
15,900
|
|
|
16,150
|
|
||
Total current liabilities
|
90,906
|
|
|
115,170
|
|
||
Long-term portion of deferred revenue
|
2,268
|
|
|
238,520
|
|
||
Long-term portion of lease liabilities
|
12,619
|
|
|
14,530
|
|
||
Other long-term liabilities
|
2,607
|
|
|
2,113
|
|
||
Total liabilities
|
108,400
|
|
|
370,333
|
|
||
Commitments
|
|
|
|
||||
Stockholders’ equity:
|
|
|
|
||||
Preferred stock, $0.001 par value, 10,000,000 shares authorized and no shares issued
|
—
|
|
|
—
|
|
||
Common stock, $0.001 par value; 400,000,000 shares authorized; issued and outstanding: 298,881,884 and 296,209,426 at September 30, 2018 and December 31, 2017, respectively
|
299
|
|
|
296
|
|
||
Additional paid-in capital
|
2,156,632
|
|
|
2,114,184
|
|
||
Accumulated other comprehensive loss
|
(513
|
)
|
|
(347
|
)
|
||
Accumulated deficit
|
(1,240,452
|
)
|
|
(1,829,172
|
)
|
||
Total stockholders’ equity
|
915,966
|
|
|
284,961
|
|
||
Total liabilities and stockholders’ equity
|
$
|
1,024,366
|
|
|
$
|
655,294
|
|
*
|
The Condensed Consolidated Balance Sheet as of December 31, 2017 has been derived from the audited financial statements as of that date.
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Revenues:
|
|
|
|
|
|
|
|
||||||||
Net product revenues
|
$
|
162,946
|
|
|
$
|
96,416
|
|
|
$
|
443,054
|
|
|
$
|
253,297
|
|
Collaboration revenues
|
62,451
|
|
|
56,094
|
|
|
182,170
|
|
|
79,108
|
|
||||
Total revenues
|
225,397
|
|
|
152,510
|
|
|
625,224
|
|
|
332,405
|
|
||||
Operating expenses:
|
|
|
|
|
|
|
|
||||||||
Cost of goods sold
|
7,360
|
|
|
4,658
|
|
|
18,996
|
|
|
10,875
|
|
||||
Research and development
|
44,741
|
|
|
28,543
|
|
|
124,986
|
|
|
79,967
|
|
||||
Selling, general and administrative
|
48,120
|
|
|
38,129
|
|
|
153,989
|
|
|
113,084
|
|
||||
Total operating expenses
|
100,221
|
|
|
71,330
|
|
|
297,971
|
|
|
203,926
|
|
||||
Income from operations
|
125,176
|
|
|
81,180
|
|
|
327,253
|
|
|
128,479
|
|
||||
Other income (expense), net:
|
|
|
|
|
|
|
|
||||||||
Interest income
|
3,507
|
|
|
1,133
|
|
|
8,099
|
|
|
3,497
|
|
||||
Interest expense
|
(1
|
)
|
|
—
|
|
|
(1
|
)
|
|
(8,679
|
)
|
||||
Other, net
|
272
|
|
|
2,275
|
|
|
369
|
|
|
(3,638
|
)
|
||||
Total other income (expense), net
|
3,778
|
|
|
3,408
|
|
|
8,467
|
|
|
(8,820
|
)
|
||||
Income before income taxes
|
128,954
|
|
|
84,588
|
|
|
335,720
|
|
|
119,659
|
|
||||
Provision for income taxes
|
2,324
|
|
|
3,206
|
|
|
5,739
|
|
|
3,921
|
|
||||
Net income
|
$
|
126,630
|
|
|
$
|
81,382
|
|
|
$
|
329,981
|
|
|
$
|
115,738
|
|
Net income per share, basic
|
$
|
0.42
|
|
|
$
|
0.28
|
|
|
$
|
1.11
|
|
|
$
|
0.39
|
|
Net income per share, diluted
|
$
|
0.41
|
|
|
$
|
0.26
|
|
|
$
|
1.05
|
|
|
$
|
0.37
|
|
Shares used in computing net income per share, basic
|
298,416
|
|
|
294,269
|
|
|
297,700
|
|
|
292,776
|
|
||||
Shares used in computing net income per share, diluted
|
312,346
|
|
|
312,940
|
|
|
313,200
|
|
|
311,555
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Net income
|
$
|
126,630
|
|
|
$
|
81,382
|
|
|
$
|
329,981
|
|
|
$
|
115,738
|
|
Other comprehensive income (loss)
(1)
|
218
|
|
|
67
|
|
|
(166
|
)
|
|
364
|
|
||||
Comprehensive income
|
$
|
126,848
|
|
|
$
|
81,449
|
|
|
$
|
329,815
|
|
|
$
|
116,102
|
|
(1)
|
Other comprehensive income (loss) consisted solely of unrealized gains or losses, net, on available-for-sale securities arising during the periods presented. Reclassification adjustments to net income resulting from realized gains or losses on the sale of securities were nominal and there was
no
income tax expense related to other comprehensive income during those periods.
|
|
Nine Months Ended September 30,
|
||||||
|
2018
|
|
2017
|
||||
Net income
|
$
|
329,981
|
|
|
$
|
115,738
|
|
Adjustments to reconcile net income to net cash provided by operating activities:
|
|
|
|
||||
Depreciation and amortization
|
2,876
|
|
|
842
|
|
||
Stock-based compensation
|
28,330
|
|
|
15,029
|
|
||
401(k) matching contributions made in common stock
|
3,232
|
|
|
1,373
|
|
||
Loss on extinguishment of debt
|
—
|
|
|
6,239
|
|
||
Amortization of debt discounts and debt issuance costs
|
—
|
|
|
182
|
|
||
Interest paid in kind
|
—
|
|
|
(11,825
|
)
|
||
Gain on other equity investments
|
(209
|
)
|
|
(2,980
|
)
|
||
Other
|
(1,423
|
)
|
|
157
|
|
||
Changes in assets and liabilities:
|
|
|
|
||||
Trade and other receivables, net
|
(15,645
|
)
|
|
(49,241
|
)
|
||
Inventory, net
|
(3,776
|
)
|
|
(2,468
|
)
|
||
Unbilled collaboration revenue
|
(32,673
|
)
|
|
—
|
|
||
Prepaid expenses and other current assets
|
(3,529
|
)
|
|
(2,530
|
)
|
||
Operating lease right-of-use assets
|
2,732
|
|
|
—
|
|
||
Other long-term assets
|
(542
|
)
|
|
689
|
|
||
Accounts payable
|
(1,248
|
)
|
|
(577
|
)
|
||
Accrued compensation and benefits
|
6,210
|
|
|
(420
|
)
|
||
Accrued clinical trial liabilities
|
(891
|
)
|
|
2,050
|
|
||
Rebates and fees due customers
|
4,124
|
|
|
1,723
|
|
||
Accrued collaboration liability
|
(577
|
)
|
|
7,091
|
|
||
Deferred revenue
|
(1,548
|
)
|
|
20,710
|
|
||
Long-term portion of lease liabilities
|
(974
|
)
|
|
—
|
|
||
Other current and long-term liabilities
|
(3,321
|
)
|
|
10,476
|
|
||
Net cash provided by operating activities
|
311,129
|
|
|
112,258
|
|
||
Cash flows from investing activities:
|
|
|
|
||||
Purchases of Property and equipment and other, net
|
(30,403
|
)
|
|
(3,449
|
)
|
||
Proceeds from sale of property and equipment
|
308
|
|
|
14
|
|
||
Purchases of investments
|
(368,304
|
)
|
|
(248,046
|
)
|
||
Proceeds from maturities of investments
|
231,204
|
|
|
266,335
|
|
||
Proceeds from sale of investments
|
11,935
|
|
|
37,294
|
|
||
Proceeds from other equity investments
|
209
|
|
|
2,980
|
|
||
Net cash (used in) provided by investing activities
|
(155,051
|
)
|
|
55,128
|
|
||
Cash flows from financing activities:
|
|
|
|
||||
Principal repayments of debt
|
—
|
|
|
(185,788
|
)
|
||
Proceeds from exercise of stock options
|
10,390
|
|
|
16,532
|
|
||
Proceeds from employee stock purchase plan
|
3,650
|
|
|
3,053
|
|
||
Taxes paid related to net share settlement of equity awards
|
(3,205
|
)
|
|
(3,012
|
)
|
||
Net cash provided by (used in) financing activities
|
10,835
|
|
|
(169,215
|
)
|
||
Net increase (decrease) in cash, cash equivalents and restricted cash
|
166,913
|
|
|
(1,829
|
)
|
||
Cash, cash equivalents and restricted cash at beginning of period
|
188,314
|
|
|
155,836
|
|
||
Cash, cash equivalents and restricted cash at end of period
|
$
|
355,227
|
|
|
$
|
154,007
|
|
|
Nine Months Ended September 30,
|
||||||
|
2018
|
|
2017
|
||||
Supplemental cash flow disclosure - non-cash investing and financing activity:
|
|
|
|
||||
Property and equipment deemed to have been acquired under build-to-suit lease
|
$
|
—
|
|
|
$
|
14,530
|
|
Right-of-use assets obtained in exchange for lease obligations
(1)
|
$
|
17,180
|
|
|
—
|
|
|
Unpaid liabilities incurred to acquire Property and equipment
|
$
|
1,281
|
|
|
$
|
245
|
|
(1)
|
Amounts for the
nine months ended
September 30, 2018
include the transition adjustment for the adoption of Accounting Standards Update (“ASU”) No. 2016-02,
Leases
(Topic 842) (“Topic 842”).
|
|
December 31, 2017
|
|
Adjustments Due to the Adoption of Topic 606
|
|
Adjustments Due to the Adoption of Topic 842
|
|
January 1, 2018
|
||||||||
Contract assets: unbilled collaboration revenue, gross:
|
|
|
|
|
|
|
|
||||||||
Current portion
|
$
|
—
|
|
|
$
|
9,588
|
|
|
$
|
—
|
|
|
$
|
9,588
|
|
Long-term portion
|
$
|
—
|
|
|
$
|
12,247
|
|
|
$
|
—
|
|
|
$
|
12,247
|
|
Trade and other receivables, net
|
$
|
81,192
|
|
|
$
|
—
|
|
|
$
|
7,743
|
|
|
$
|
88,935
|
|
Property and equipment, net
|
$
|
25,743
|
|
|
$
|
—
|
|
|
$
|
(14,530
|
)
|
|
$
|
11,213
|
|
Operating lease right-of-use assets
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
8,579
|
|
|
$
|
8,579
|
|
Contract liabilities: deferred revenue, gross:
|
|
|
|
|
|
|
|
||||||||
Current portion
|
$
|
31,984
|
|
|
$
|
(23,591
|
)
|
|
$
|
—
|
|
|
$
|
8,393
|
|
Long-term portion
|
$
|
238,520
|
|
|
$
|
(213,079
|
)
|
|
$
|
—
|
|
|
$
|
25,441
|
|
Operating lease liabilities:
|
|
|
|
|
|
|
|
||||||||
Other current liabilities
(1)
|
$
|
16,150
|
|
|
$
|
—
|
|
|
$
|
3,173
|
|
|
$
|
19,323
|
|
Long-term portion of lease liabilities
(2)
|
$
|
14,530
|
|
|
$
|
—
|
|
|
$
|
(1,206
|
)
|
|
$
|
13,324
|
|
Other long-term liabilities
|
$
|
2,113
|
|
|
$
|
—
|
|
|
$
|
(408
|
)
|
|
$
|
1,705
|
|
Accumulated deficit
|
$
|
(1,829,172
|
)
|
|
$
|
258,505
|
|
|
$
|
233
|
|
|
$
|
(1,570,434
|
)
|
|
Three Months Ended September 30, 2018
|
||||||||||||||
|
As Reported
|
|
Effect of Adoption of Topic 606 Higher / (Lower)
|
|
Effect of Adoption of Topic 842 Higher / (Lower)
|
|
Balances Without the Adoption of Topic 606 or 842
|
||||||||
Collaboration revenues
|
$
|
62,451
|
|
|
$
|
32,558
|
|
|
$
|
—
|
|
|
$
|
29,893
|
|
Total revenues
|
$
|
225,397
|
|
|
$
|
32,558
|
|
|
$
|
—
|
|
|
$
|
192,839
|
|
Selling, general and administrative expenses
|
$
|
48,120
|
|
|
$
|
—
|
|
|
$
|
936
|
|
|
$
|
47,184
|
|
Total operating expenses
|
$
|
100,221
|
|
|
$
|
—
|
|
|
$
|
936
|
|
|
$
|
99,285
|
|
Interest expense
|
$
|
(1
|
)
|
|
$
|
—
|
|
|
$
|
(348
|
)
|
|
$
|
(349
|
)
|
Total other income, net
|
$
|
3,778
|
|
|
$
|
—
|
|
|
$
|
348
|
|
|
$
|
3,430
|
|
Income before income taxes
|
$
|
128,954
|
|
|
$
|
32,558
|
|
|
$
|
(588
|
)
|
|
$
|
96,984
|
|
Provision for income taxes
|
$
|
2,324
|
|
|
$
|
680
|
|
|
$
|
(2
|
)
|
|
$
|
1,646
|
|
Net income
|
$
|
126,630
|
|
|
$
|
31,878
|
|
|
$
|
(586
|
)
|
|
$
|
95,338
|
|
Net income per share, basic
|
$
|
0.42
|
|
|
$
|
0.11
|
|
|
$
|
—
|
|
|
$
|
0.32
|
|
Net income per share, diluted
|
$
|
0.41
|
|
|
$
|
0.10
|
|
|
$
|
—
|
|
|
$
|
0.31
|
|
|
Nine Months Ended September 30, 2018
|
||||||||||||||
|
As Reported
|
|
Effect of Adoption of Topic 606 Higher / (Lower)
|
|
Effect of Adoption of Topic 842 Higher / (Lower)
|
|
Balances Without the Adoption of Topic 606 or 842
|
||||||||
Collaboration revenues
|
$
|
182,170
|
|
|
$
|
9,809
|
|
|
$
|
—
|
|
|
$
|
172,361
|
|
Total revenues
|
$
|
625,224
|
|
|
$
|
9,809
|
|
|
$
|
—
|
|
|
$
|
615,415
|
|
Selling, general and administrative expenses
|
$
|
153,989
|
|
|
$
|
—
|
|
|
$
|
936
|
|
|
$
|
153,053
|
|
Total operating expenses
|
$
|
297,971
|
|
|
$
|
—
|
|
|
$
|
936
|
|
|
$
|
297,035
|
|
Interest expense
|
$
|
(1
|
)
|
|
$
|
—
|
|
|
$
|
(348
|
)
|
|
$
|
(349
|
)
|
Total other income, net
|
$
|
8,467
|
|
|
$
|
—
|
|
|
$
|
348
|
|
|
$
|
8,119
|
|
Income before income taxes
|
$
|
335,720
|
|
|
$
|
9,809
|
|
|
$
|
(588
|
)
|
|
$
|
326,499
|
|
Provision for income taxes
|
$
|
5,739
|
|
|
$
|
566
|
|
|
$
|
(2
|
)
|
|
$
|
5,175
|
|
Net income
|
$
|
329,981
|
|
|
$
|
9,243
|
|
|
$
|
(586
|
)
|
|
$
|
321,324
|
|
Net income per share, basic
|
$
|
1.11
|
|
|
$
|
0.03
|
|
|
$
|
—
|
|
|
$
|
1.08
|
|
Net income per share, diluted
|
$
|
1.05
|
|
|
$
|
0.03
|
|
|
$
|
—
|
|
|
$
|
1.03
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Product revenues:
|
|
|
|
|
|
|
|
||||||||
Gross product revenues
|
$
|
193,356
|
|
|
$
|
111,148
|
|
|
$
|
525,438
|
|
|
$
|
289,365
|
|
Discounts and allowances
|
(30,410
|
)
|
|
(14,732
|
)
|
|
(82,384
|
)
|
|
(36,068
|
)
|
||||
Net product revenues
|
162,946
|
|
|
96,416
|
|
|
443,054
|
|
|
253,297
|
|
||||
Collaboration revenues:
|
|
|
|
|
|
|
|
||||||||
License revenues
(1)
|
51,323
|
|
|
54,335
|
|
|
152,261
|
|
|
74,706
|
|
||||
Research and development service revenues
(2)
|
10,560
|
|
|
2,316
|
|
|
27,464
|
|
|
5,623
|
|
||||
Other collaboration revenues
(3)
|
568
|
|
|
(557
|
)
|
|
2,445
|
|
|
(1,221
|
)
|
||||
Total collaboration revenues
|
62,451
|
|
|
56,094
|
|
|
182,170
|
|
|
79,108
|
|
||||
Total revenues
|
$
|
225,397
|
|
|
$
|
152,510
|
|
|
$
|
625,224
|
|
|
$
|
332,405
|
|
(1)
|
Upon the adoption of Topic 606, the allocation of proceeds from our collaboration partners, including upfront and milestone payments, between intellectual property licenses and research and development services as well as the resulting timing of recognition has changed. License revenues for the
three and nine months ended
September 30, 2018
included the immediate recognition of the portion of milestones that were allocated to the transfer of intellectual property licenses for those milestones for which it had become probable that a significant revenue reversal would not occur as well as royalty revenues from Ipsen and Genentech. License revenues for the
three and nine months ended
September 30, 2017
included the full recognition of substantive milestones achieved during the period, recognition of deferred revenues from upfront payments and a non-substantive milestone, which were being amortized over various periods, as well as royalty revenues from Ipsen and Genentech.
|
(2)
|
Research and development service revenues for the
three and nine months ended
September 30, 2018
included the recognition of deferred revenue for the portion of the upfront and milestone payments that have been allocated to the research and development service performance obligations which are being amortized through early 2030, as well as development cost reimbursements earned on our collaboration agreements. As described above, we did not allocate any of our upfront payments or milestones to research and development services prior to the adoption of Topic 606; therefore, Research and development service revenues for the
three and nine months ended
September 30, 2017
included only development cost reimbursements earned on our collaboration agreements.
|
(3)
|
Other collaboration revenues for the
three and nine months ended
September 30, 2018
included net losses on product supply services provided to Ipsen and Takeda and the profit on the U.S. commercialization of COTELLIC from Genentech. Other collaboration revenues for the
three and nine months ended
September 30, 2017
included only net losses on product supply services, since losses on the U.S. commercialization of COTELLIC for the period were instead included in Selling, general and administrative expenses.
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
CABOMETYX
|
$
|
158,262
|
|
|
$
|
90,362
|
|
|
$
|
428,317
|
|
|
$
|
233,582
|
|
COMETRIQ
|
4,684
|
|
|
6,054
|
|
|
14,737
|
|
|
19,715
|
|
||||
Net product revenues
|
$
|
162,946
|
|
|
$
|
96,416
|
|
|
$
|
443,054
|
|
|
$
|
253,297
|
|
|
Three Months Ended September 30,
|
||||||||||||
|
2018
|
|
2017
|
||||||||||
|
Dollars
|
|
Percent of total
|
|
Dollars
|
|
Percent of total
|
||||||
Ipsen
|
$
|
57,186
|
|
|
25
|
%
|
|
$
|
50,680
|
|
|
33
|
%
|
Caremark L.L.C.
|
30,707
|
|
|
14
|
%
|
|
20,272
|
|
|
13
|
%
|
||
Affiliates of McKesson Corporation
|
26,597
|
|
|
12
|
%
|
|
14,575
|
|
|
10
|
%
|
||
Diplomat Specialty Pharmacy
|
17,946
|
|
|
8
|
%
|
|
20,460
|
|
|
13
|
%
|
||
Accredo Health, Incorporated
|
20,677
|
|
|
9
|
%
|
|
13,445
|
|
|
9
|
%
|
||
Others, individually less than 10% of Total revenues for all periods presented
|
72,284
|
|
|
32
|
%
|
|
33,078
|
|
|
22
|
%
|
||
Total revenues
|
$
|
225,397
|
|
|
100
|
%
|
|
$
|
152,510
|
|
|
100
|
%
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2018
|
|
2017
|
||||||||||
|
Dollars
|
|
Percent of total
|
|
Dollars
|
|
Percent of total
|
||||||
Ipsen
|
$
|
145,038
|
|
|
23
|
%
|
|
$
|
60,704
|
|
|
18
|
%
|
Caremark L.L.C.
|
83,516
|
|
|
13
|
%
|
|
52,526
|
|
|
16
|
%
|
||
Affiliates of McKesson Corporation
|
71,249
|
|
|
11
|
%
|
|
38,699
|
|
|
12
|
%
|
||
Diplomat Specialty Pharmacy
|
56,568
|
|
|
9
|
%
|
|
62,909
|
|
|
19
|
%
|
||
Accredo Health, Incorporated
|
58,677
|
|
|
9
|
%
|
|
36,504
|
|
|
11
|
%
|
||
Others, individually less than 10% of Total revenues for all periods presented
|
210,176
|
|
|
35
|
%
|
|
81,063
|
|
|
24
|
%
|
||
Total revenues
|
$
|
625,224
|
|
|
100
|
%
|
|
$
|
332,405
|
|
|
100
|
%
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
U.S.
|
$
|
166,270
|
|
|
$
|
97,807
|
|
|
$
|
453,342
|
|
|
$
|
260,853
|
|
Europe
|
57,186
|
|
|
50,680
|
|
|
145,038
|
|
|
60,704
|
|
||||
Rest of the world
|
1,941
|
|
|
4,023
|
|
|
26,844
|
|
|
10,848
|
|
||||
Total revenues
|
$
|
225,397
|
|
|
$
|
152,510
|
|
|
$
|
625,224
|
|
|
$
|
332,405
|
|
|
Chargebacks and Discounts for Prompt Payment
|
|
Other Customer Credits/Fees and Co-pay Assistance
|
|
Rebates
|
|
Total
|
||||||||
Balance at December 31, 2017
|
$
|
1,928
|
|
|
$
|
1,795
|
|
|
$
|
5,770
|
|
|
$
|
9,493
|
|
Provision related to sales made in:
|
|
|
|
|
|
|
|
||||||||
Current period
|
52,296
|
|
|
9,208
|
|
|
21,192
|
|
|
82,696
|
|
||||
Prior periods
|
(520
|
)
|
|
156
|
|
|
50
|
|
|
(314
|
)
|
||||
Payments and customer credits issued
|
(50,726
|
)
|
|
(9,412
|
)
|
|
(17,070
|
)
|
|
(77,208
|
)
|
||||
Balance at September 30, 2018
|
$
|
2,978
|
|
|
$
|
1,747
|
|
|
$
|
9,942
|
|
|
$
|
14,667
|
|
|
Contract Assets: Unbilled Collaboration Revenue
|
|
Contract Liabilities: Deferred Revenue
|
||||||||||||
|
Current Portion
|
|
Long-term Portion
|
|
Current Portion
|
|
Long-term Portion
|
||||||||
Balance at December 31, 2017
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
31,984
|
|
|
$
|
238,520
|
|
Adoption of Topic 606
|
9,588
|
|
|
12,247
|
|
|
(23,591
|
)
|
|
(213,079
|
)
|
||||
Balance at January 1, 2018
|
9,588
|
|
|
12,247
|
|
|
8,393
|
|
|
25,441
|
|
||||
Increases as a result of a change in transaction price and recognition of revenues as services are performed
|
37,744
|
|
|
4,037
|
|
|
—
|
|
|
—
|
|
||||
Transfer to receivables from contract assets recognized at the beginning of the period
|
(9,109
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
Increases as a result of the deferral of milestones achieved in period, excluding amounts recognized as revenue
|
—
|
|
|
—
|
|
|
873
|
|
|
3,712
|
|
||||
Revenue recognized that was included in the contract liability balance at the beginning of the period
|
—
|
|
|
—
|
|
|
(6,114
|
)
|
|
—
|
|
||||
Other adjustments
(1)
|
(13,734
|
)
|
|
(16,284
|
)
|
|
(3,152
|
)
|
|
(26,885
|
)
|
||||
Balance at September 30, 2018
|
$
|
24,489
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2,268
|
|
(1)
|
Includes reclassification of deferred revenue from long-term to current and adjustments made due to netting of contract assets and liabilities by collaboration agreement.
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Ipsen collaboration revenues
|
$
|
57,186
|
|
|
$
|
50,679
|
|
|
$
|
145,038
|
|
|
$
|
60,703
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Takeda collaboration revenues
|
$
|
1,940
|
|
|
$
|
4,023
|
|
|
$
|
6,843
|
|
|
$
|
10,848
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Royalty revenues on ex-U.S. sales
|
$
|
1,390
|
|
|
$
|
1,392
|
|
|
$
|
4,285
|
|
|
$
|
5,057
|
|
Profits and losses on U.S. commercialization
|
$
|
1,935
|
|
|
$
|
(891
|
)
|
|
$
|
6,004
|
|
|
$
|
(2,298
|
)
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Royalties accruing to GSK
|
$
|
6,268
|
|
|
$
|
3,446
|
|
|
$
|
17,021
|
|
|
$
|
8,809
|
|
|
September 30, 2018
|
|
December 31, 2017
|
|
September 30, 2017
|
|
December 31, 2016
|
||||||||
Cash and cash equivalents
|
$
|
353,623
|
|
|
$
|
183,164
|
|
|
$
|
149,357
|
|
|
$
|
151,686
|
|
Restricted cash included in short-term restricted cash and investments
|
504
|
|
|
504
|
|
|
—
|
|
|
—
|
|
||||
Restricted cash included in long-term restricted cash and investments
|
1,100
|
|
|
4,646
|
|
|
4,650
|
|
|
4,150
|
|
||||
Cash, cash equivalents, and restricted cash as reported within the accompanying Condensed Consolidated Statements of Cash Flows
|
$
|
355,227
|
|
|
$
|
188,314
|
|
|
$
|
154,007
|
|
|
$
|
155,836
|
|
|
September 30, 2018
|
||||||||||||||
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Fair Value
|
||||||||
Money market funds
|
$
|
62,325
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
62,325
|
|
Certificates of deposit
|
19,098
|
|
|
—
|
|
|
—
|
|
|
19,098
|
|
||||
Commercial paper
|
355,720
|
|
|
—
|
|
|
—
|
|
|
355,720
|
|
||||
Corporate bonds
|
262,050
|
|
|
93
|
|
|
(549
|
)
|
|
261,594
|
|
||||
U.S. Treasury and government sponsored enterprises
|
50,621
|
|
|
1
|
|
|
(58
|
)
|
|
50,564
|
|
||||
Total
|
$
|
749,814
|
|
|
$
|
94
|
|
|
$
|
(607
|
)
|
|
$
|
749,301
|
|
|
December 31, 2017
|
||||||||||||||
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Fair Value
|
||||||||
Money market funds
|
$
|
45,478
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
45,478
|
|
Commercial paper
|
199,647
|
|
|
—
|
|
|
—
|
|
|
199,647
|
|
||||
Corporate bonds
|
179,336
|
|
|
18
|
|
|
(332
|
)
|
|
179,022
|
|
||||
U.S. Treasury and government sponsored enterprises
|
16,295
|
|
|
—
|
|
|
(32
|
)
|
|
16,263
|
|
||||
Total
|
$
|
440,756
|
|
|
$
|
18
|
|
|
$
|
(364
|
)
|
|
$
|
440,410
|
|
|
September 30, 2018
|
||||||||||||||||||||||
|
In an Unrealized Loss Position Less than 12 Months
|
|
In an Unrealized Loss Position 12 Months or Greater
|
|
Total
|
||||||||||||||||||
|
Fair Value
|
|
Gross
Unrealized Losses |
|
Fair Value
|
|
Gross
Unrealized Losses |
|
Fair Value
|
|
Gross
Unrealized Losses |
||||||||||||
Corporate bonds
|
$
|
175,380
|
|
|
$
|
(507
|
)
|
|
$
|
11,211
|
|
|
$
|
(42
|
)
|
|
$
|
186,591
|
|
|
$
|
(549
|
)
|
U.S. Treasury and government sponsored enterprises
|
42,669
|
|
|
(58
|
)
|
|
—
|
|
|
—
|
|
|
42,669
|
|
|
(58
|
)
|
||||||
Total
|
$
|
218,049
|
|
|
$
|
(565
|
)
|
|
$
|
11,211
|
|
|
$
|
(42
|
)
|
|
$
|
229,260
|
|
|
$
|
(607
|
)
|
|
December 31, 2017
|
||||||||||||||||||||||
|
In an Unrealized Loss Position Less than 12 Months
|
|
In an Unrealized Loss Position 12 Months or Greater
|
|
Total
|
||||||||||||||||||
|
Fair Value
|
|
Gross
Unrealized Losses |
|
Fair Value
|
|
Gross
Unrealized Losses |
|
Fair Value
|
|
Gross
Unrealized Losses |
||||||||||||
Corporate bonds
|
$
|
140,746
|
|
|
$
|
(296
|
)
|
|
$
|
20,047
|
|
|
$
|
(36
|
)
|
|
$
|
160,793
|
|
|
$
|
(332
|
)
|
U.S. Treasury and government sponsored enterprises
|
13,611
|
|
|
(23
|
)
|
|
2,651
|
|
|
(9
|
)
|
|
16,262
|
|
|
(32
|
)
|
||||||
Total
|
$
|
154,357
|
|
|
$
|
(319
|
)
|
|
$
|
22,698
|
|
|
$
|
(45
|
)
|
|
$
|
177,055
|
|
|
$
|
(364
|
)
|
|
September 30,
2018 |
|
December 31,
2017 |
||||
Maturing in one year or less
|
$
|
635,208
|
|
|
$
|
377,155
|
|
Maturing after one year through five years
|
114,093
|
|
|
63,255
|
|
||
Total
|
$
|
749,301
|
|
|
$
|
440,410
|
|
|
September 30,
2018 |
|
December 31, 2017
|
||||
Raw materials
|
$
|
2,344
|
|
|
$
|
498
|
|
Work in process
|
5,203
|
|
|
3,997
|
|
||
Finished goods
|
4,082
|
|
|
2,854
|
|
||
Total
|
$
|
11,629
|
|
|
$
|
7,349
|
|
|
|
|
|
||||
Balance Sheet classification:
|
|
|
|
||||
Inventory
|
$
|
10,433
|
|
|
$
|
6,657
|
|
Other long-term assets
|
1,196
|
|
|
692
|
|
||
Total
|
$
|
11,629
|
|
|
$
|
7,349
|
|
|
September 30,
2018 |
|
December 31,
2017 |
||||
Leasehold improvements
|
$
|
42,581
|
|
|
$
|
4,715
|
|
Computer equipment and software
|
15,533
|
|
|
14,146
|
|
||
Furniture and fixtures
|
3,780
|
|
|
1,609
|
|
||
Laboratory equipment
|
2,936
|
|
|
5,959
|
|
||
Construction in progress
|
2,071
|
|
|
22,114
|
|
||
|
66,901
|
|
|
48,543
|
|
||
Less: accumulated depreciation and amortization
|
(15,855
|
)
|
|
(22,800
|
)
|
||
Property and equipment, net
|
$
|
51,046
|
|
|
$
|
25,743
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Research and development
|
$
|
3,169
|
|
|
$
|
1,663
|
|
|
$
|
9,102
|
|
|
$
|
4,741
|
|
Selling, general and administrative
|
6,573
|
|
|
3,626
|
|
|
19,228
|
|
|
10,288
|
|
||||
Total stock-based compensation
|
$
|
9,742
|
|
|
$
|
5,289
|
|
|
$
|
28,330
|
|
|
$
|
15,029
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Stock options
|
$
|
8.67
|
|
|
$
|
11.75
|
|
|
$
|
9.13
|
|
|
$
|
10.32
|
|
ESPP
|
$
|
6.19
|
|
|
$
|
6.85
|
|
|
$
|
6.96
|
|
|
$
|
5.29
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||
Stock options:
|
|
|
|
|
|
|
|
||||
Risk-free interest rate
|
2.91
|
%
|
|
1.70
|
%
|
|
2.83
|
%
|
|
1.68
|
%
|
Dividend yield
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
Volatility
|
55
|
%
|
|
58
|
%
|
|
55
|
%
|
|
61
|
%
|
Expected life
|
4.4 years
|
|
|
4.0 years
|
|
|
4.4 years
|
|
|
4.1 years
|
|
ESPP:
|
|
|
|
|
|
|
|
||||
Risk-free interest rate
|
2.11
|
%
|
|
1.14
|
%
|
|
1.74
|
%
|
|
0.88
|
%
|
Dividend yield
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
Volatility
|
51
|
%
|
|
55
|
%
|
|
52
|
%
|
|
61
|
%
|
Expected life
|
6 months
|
|
|
6 months
|
|
|
6 months
|
|
|
6 months
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Provision for income taxes
|
$
|
2,324
|
|
|
$
|
3,206
|
|
|
$
|
5,739
|
|
|
$
|
3,921
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Numerator:
|
|
|
|
|
|
|
|
||||||||
Net income
|
$
|
126,630
|
|
|
$
|
81,382
|
|
|
$
|
329,981
|
|
|
$
|
115,738
|
|
Net income allocated to participating securities
|
—
|
|
|
(221
|
)
|
|
—
|
|
|
(368
|
)
|
||||
Net income allocable to common stock for basic net income per share
|
126,630
|
|
|
81,161
|
|
|
329,981
|
|
|
115,370
|
|
||||
Adjustment to net income allocated to participating securities
|
—
|
|
|
14
|
|
|
—
|
|
|
23
|
|
||||
Net income allocable to common stock for diluted net income per share
|
$
|
126,630
|
|
|
$
|
81,175
|
|
|
$
|
329,981
|
|
|
$
|
115,393
|
|
Denominator:
|
|
|
|
|
|
|
|
||||||||
Weighted-average shares of common stock outstanding used in computing basic net income per share
|
298,416
|
|
|
294,269
|
|
|
297,700
|
|
|
292,776
|
|
||||
Dilutive securities:
|
|
|
|
|
|
|
|
||||||||
Outstanding stock options, unvested RSUs and ESPP contributions
|
13,930
|
|
|
18,671
|
|
|
15,500
|
|
|
18,779
|
|
||||
Weighted-average shares of common stock outstanding and dilutive securities used in computing diluted net income per share
|
312,346
|
|
|
312,940
|
|
|
313,200
|
|
|
311,555
|
|
||||
|
|
|
|
|
|
|
|
||||||||
Net income per share, basic
|
$
|
0.42
|
|
|
$
|
0.28
|
|
|
$
|
1.11
|
|
|
$
|
0.39
|
|
Net income per share, diluted
|
$
|
0.41
|
|
|
$
|
0.26
|
|
|
$
|
1.05
|
|
|
$
|
0.37
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||
Outstanding stock options, unvested RSUs and ESPP contributions
|
5,687
|
|
|
583
|
|
|
2,938
|
|
|
1,108
|
|
Total
|
5,687
|
|
|
583
|
|
|
2,938
|
|
|
1,108
|
|
|
September 30, 2018
|
||||||||||
|
Level 1
|
|
Level 2
|
|
Total
|
||||||
Money market funds
|
$
|
62,325
|
|
|
$
|
—
|
|
|
$
|
62,325
|
|
Certificates of deposit
|
—
|
|
|
19,098
|
|
|
19,098
|
|
|||
Commercial paper
|
—
|
|
|
355,720
|
|
|
355,720
|
|
|||
Corporate bonds
|
—
|
|
|
261,594
|
|
|
261,594
|
|
|||
U.S. Treasury and government sponsored enterprises
|
—
|
|
|
50,564
|
|
|
50,564
|
|
|||
Total financial assets
|
$
|
62,325
|
|
|
$
|
686,976
|
|
|
$
|
749,301
|
|
|
December 31, 2017
|
||||||||||
|
Level 1
|
|
Level 2
|
|
Total
|
||||||
Money market funds
|
$
|
45,478
|
|
|
$
|
—
|
|
|
$
|
45,478
|
|
Commercial paper
|
—
|
|
|
199,647
|
|
|
199,647
|
|
|||
Corporate bonds
|
—
|
|
|
179,022
|
|
|
179,022
|
|
|||
U.S. Treasury and government sponsored enterprises
|
—
|
|
|
16,263
|
|
|
16,263
|
|
|||
Total financial assets
|
$
|
45,478
|
|
|
$
|
394,932
|
|
|
$
|
440,410
|
|
|
September 30,
2018 |
|
December 31, 2017
|
||||
Operating lease liabilities:
|
|
|
|
||||
Current portion included in Other current liabilities
|
$
|
2,315
|
|
|
$
|
—
|
|
Long-term portion of lease liabilities
|
12,529
|
|
|
—
|
|
||
Total operating lease liabilities
|
14,844
|
|
|
—
|
|
||
Financing lease liabilities:
|
|
|
|
||||
Financing obligation for build-to-suit lease
|
—
|
|
|
14,530
|
|
||
Current portion included in Other current liabilities
|
49
|
|
|
—
|
|
||
Long-term portion of lease liabilities
|
90
|
|
|
—
|
|
||
Total financing lease liabilities
|
139
|
|
|
14,530
|
|
||
Total lease liabilities
|
$
|
14,983
|
|
|
$
|
14,530
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Operating lease cost
|
$
|
1,614
|
|
|
$
|
986
|
|
|
$
|
3,587
|
|
|
$
|
4,292
|
|
Variable lease cost
|
363
|
|
|
229
|
|
|
1,366
|
|
|
705
|
|
||||
Sublease income
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,225
|
)
|
||||
Total lease costs
|
$
|
1,977
|
|
|
$
|
1,215
|
|
|
$
|
4,953
|
|
|
$
|
3,772
|
|
|
Operating leases
|
||
Remainder of 2018
|
$
|
403
|
|
Years ending December 31,
|
|
||
2019
|
2,654
|
|
|
2020
|
2,823
|
|
|
2021
|
2,904
|
|
|
2022
|
3,000
|
|
|
Thereafter
|
16,665
|
|
|
Total lease payments
|
28,449
|
|
|
Less:
|
|
||
Imputed interest
|
(5,435
|
)
|
|
Tenant improvement reimbursements
|
(8,170
|
)
|
|
Operating lease liabilities
|
$
|
14,844
|
|
•
|
In July 2018, we were added to Standard & Poor’s, or S&P’s, MidCap 400 index and are classified under S&P’s Global Industry Classification Standard Biotechnology Sub-Industry index.
|
•
|
In July 2018, the
NEJM
published results from CELESTIAL, our company-sponsored, global phase 3 pivotal trial comparing cabozantinib to placebo in patients with advanced HCC who had previously progressed on or were intolerant to sorafenib and up to one additional therapy. The data demonstrate that cabozantinib provided a statistically significant and clinically meaningful improvement in OS versus placebo.
|
•
|
In September 2018, we announced that the National Comprehensive Cancer Network, or NCCN, updated its Clinical Practice Guidelines to include favorable new recommendations for CABOMETYX as a treatment for patients with advanced RCC, regardless of patient risk status. In particular, NCCN designated CABOMETYX as the only preferred tyrosine kinase inhibitor treatment option for previously-untreated patients with poor- or intermediate-risk and for previously-treated patients.
|
•
|
In September 2018, Ipsen received regulatory approval from Health Canada for CABOMETYX as a treatment in Canada for adult patients with advanced RCC who have received prior VEGF targeted therapy.
|
•
|
In September 2018, Ipsen received a positive CHMP opinion for CABOMETYX as a treatment in the EU for adult patients with HCC who have been previously treated with sorafenib.
|
•
|
In October 2018, we announced the initiation of COSMIC-311, a phase 3 pivotal trial evaluating cabozantinib in patients with radioiodine refractory DTC who have progressed after up to two VEGFR-targeted therapies.
|
•
|
In October 2018, clinical data from cabozantinib were the subject of thirteen presentations at ESMO, including a poster presentation covering the results from the dose escalation stage of COSMIC-021, our phase 1b study evaluating the safety and tolerability of cabozantinib in combination with Roche’s atezolizumab in patients with locally advanced or metastatic solid tumors. Findings from the dose escalation phase of the trial demonstrate that the combination was well-tolerated and showed encouraging anti-tumor activity, including in patients with previously untreated advanced RCC. In another poster presentation at ESMO, data were presented from an analysis tha
t evaluated the effect of PD-L1 expression on clinical outcomes with cabozantinib in advanced RCC from the CABOSUN and METEOR trials. This analysis showed that cabozantinib’s activity was independent of PD-L1 expression. Additionally, a separate retrospective analysis of RCC patients found that cabozantinib was active following prior treatment with immune checkpoint inhibitor therapy either alone or in combination with VEGF-targeted or other prior therapy.
|
•
|
In October 2018, Ipsen received approvals from both the Agencia Nacional de Vigilancia Sanitaria in Brazil for CABOMETYX as a treatment for both previously-treated and previously-untreated advanced RCC and from the Taiwan
Food and Drug Administration
for CABOMETYX as a treatment for patients with advanced RCC who have received prior anti-angiogenic therapy.
|
•
|
Net income for the third quarter of 2018 was
$126.6 million
, or
$0.42
per share, basic and
$0.41
per share, diluted, compared to
$81.4 million
, or
$0.28
per share, basic and
$0.26
per share diluted, for the third quarter of 2017.
|
•
|
Total revenues for the third quarter of 2018 increased to
$225.4 million
, compared to
$152.5 million
for the third quarter of 2017.
|
•
|
Net product revenues for the third quarter of 2018 increased to
$162.9 million
, compared to
$96.4 million
for the third quarter of 2017.
|
•
|
Research and development expenses for the third quarter of 2018 increased to
$44.7 million
, compared to
$28.5 million
for the third quarter of 2017.
|
•
|
Selling, general and administrative expenses for the third quarter of 2018 increased to
$48.1 million
, compared to
$38.1 million
for the third quarter of 2017.
|
•
|
Cash and investments increased to
$750.3 million
at
September 30, 2018
, compared to
$457.2 million
at
December 31, 2017
.
|
|
Three Months Ended September 30,
|
|
Percentage Change -
Q3 2018 v. Q3 2017
|
|
Nine Months Ended September 30,
|
|
Percentage Change -
Year to Date 2018 v. 2017
|
||||||||||||||
|
2018
|
|
2017
|
|
|
2018
|
|
2017
|
|
||||||||||||
Net product revenues
|
$
|
162,946
|
|
|
$
|
96,416
|
|
|
69
|
%
|
|
$
|
443,054
|
|
|
$
|
253,297
|
|
|
75
|
%
|
Collaboration revenues
|
62,451
|
|
|
56,094
|
|
|
11
|
%
|
|
182,170
|
|
|
79,108
|
|
|
130
|
%
|
||||
Total revenues
|
$
|
225,397
|
|
|
$
|
152,510
|
|
|
48
|
%
|
|
$
|
625,224
|
|
|
$
|
332,405
|
|
|
88
|
%
|
|
Three Months Ended September 30,
|
|
Percentage Change -
Q3 2018 v. Q3 2017 |
|
Nine Months Ended September 30,
|
|
Percentage Change -
Year to Date 2018 v. 2017 |
||||||||||||||
|
2018
|
|
2017
|
|
|
2018
|
|
2017
|
|
||||||||||||
CABOMETYX
|
$
|
158,262
|
|
|
$
|
90,362
|
|
|
75
|
%
|
|
$
|
428,317
|
|
|
$
|
233,582
|
|
|
83
|
%
|
COMETRIQ
|
4,684
|
|
|
6,054
|
|
|
(23
|
)%
|
|
14,737
|
|
|
19,715
|
|
|
(25
|
)%
|
||||
Net product revenues
|
$
|
162,946
|
|
|
$
|
96,416
|
|
|
69
|
%
|
|
$
|
443,054
|
|
|
$
|
253,297
|
|
|
75
|
%
|
|
Three Months Ended September 30,
|
|
Percentage Change -
Q3 2018 v. Q3 2017 |
|
Nine Months Ended September 30,
|
|
Percentage Change -
Year to Date 2018 v. 2017 |
||||||||||||||
|
2018
|
|
2017
|
|
|
2018
|
|
2017
|
|
||||||||||||
Collaboration revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
License revenues
(1)
|
$
|
51,323
|
|
|
$
|
54,335
|
|
|
(6
|
)%
|
|
$
|
152,261
|
|
|
$
|
74,706
|
|
|
104
|
%
|
Research and development service revenues
(2)
|
10,560
|
|
|
2,316
|
|
|
356
|
%
|
|
27,464
|
|
|
5,623
|
|
|
388
|
%
|
||||
Other collaboration revenues
(3)
|
568
|
|
|
(557
|
)
|
|
n/m
|
|
|
2,445
|
|
|
(1,221
|
)
|
|
n/m
|
|
||||
Total collaboration revenues
|
$
|
62,451
|
|
|
$
|
56,094
|
|
|
11
|
%
|
|
$
|
182,170
|
|
|
$
|
79,108
|
|
|
130
|
%
|
(1)
|
Upon the adoption of Topic 606, the allocation of proceeds from our collaboration partners, including upfront and milestone payments, between intellectual property licenses and research and development services as well as the resulting timing of recognition has changed. License revenues for the
three and nine months ended
September 30, 2018
included the immediate recognition of the portion of milestones that were allocated to the transfer of intellectual property licenses for those milestones for which it had become probable that a significant revenue reversal would not occur as well as royalty revenues from Ipsen and Genentech. License revenues for the
three and nine months ended
September 30, 2017
included the full recognition of substantive milestones achieved during the period, recognition of deferred revenues from upfront payments and a non-substantive milestone, which were being amortized over various periods, as well as royalty revenues from Ipsen and Genentech.
|
(2)
|
Research and development service revenues for the
three and nine months ended
September 30, 2018
included the recognition of deferred revenue for the portion of the upfront and milestone payments that have been allocated to the research and development service performance obligations which are being amortized through early 2030, as well as development cost reimbursements earned on our collaboration agreements. As described above, we did not allocate any of our upfront payments or milestones to research and development services prior to the adoption of Topic 606; therefore, Research and development service revenues for the
three and nine months ended
September 30, 2017
included only development cost reimbursements earned on our collaboration agreements.
|
(3)
|
Other collaboration revenues for the
three and nine months ended
September 30, 2018
included net losses on product supply services provided to Ipsen and Takeda and the profit on the U.S. commercialization of COTELLIC from Genentech. Other collaboration revenues for the
three and nine months ended
September 30, 2017
included only net losses on product supply services, since losses on the U.S. commercialization of COTELLIC for the period were instead included in Selling, general and administrative expenses.
|
|
Three Months Ended September 30,
|
|
Percentage Change -
Q3 2018 v. Q3 2017 |
|
Nine Months Ended September 30,
|
|
Percentage Change -
Year to Date 2018 v. 2017 |
||||||||||||||
|
2018
|
|
2017
|
|
|
2018
|
|
2017
|
|
||||||||||||
Cost of goods sold
|
$
|
7,360
|
|
|
$
|
4,658
|
|
|
58
|
%
|
|
$
|
18,996
|
|
|
$
|
10,875
|
|
|
75
|
%
|
Gross margin
|
95
|
%
|
|
95
|
%
|
|
|
|
|
96
|
%
|
|
96
|
%
|
|
|
|
Three Months Ended September 30,
|
|
Percentage Change -
Q3 2018 v. Q3 2017 |
|
Nine Months Ended September 30,
|
|
Percentage Change -
2018 v. 2017 |
||||||||||||||
|
2018
|
|
2017
|
|
|
2018
|
|
2017
|
|
||||||||||||
Research and development expenses
|
$
|
44,741
|
|
|
$
|
28,543
|
|
|
57
|
%
|
|
$
|
124,986
|
|
|
$
|
79,967
|
|
|
56
|
%
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Research and development expenses:
|
|
|
|
|
|
|
|
||||||||
Development:
|
|
|
|
|
|
|
|
||||||||
Clinical trial costs
|
$
|
17,242
|
|
|
$
|
9,754
|
|
|
$
|
40,482
|
|
|
$
|
27,966
|
|
Personnel expenses
|
12,316
|
|
|
7,437
|
|
|
34,182
|
|
|
21,649
|
|
||||
Consulting and outside services
|
1,943
|
|
|
2,464
|
|
|
6,969
|
|
|
6,370
|
|
||||
Other development costs
|
2,925
|
|
|
3,771
|
|
|
10,257
|
|
|
10,318
|
|
||||
Total development
|
34,426
|
|
|
23,426
|
|
|
91,890
|
|
|
66,303
|
|
||||
Drug discovery
(1)
|
4,073
|
|
|
1,743
|
|
|
17,354
|
|
|
3,986
|
|
||||
Other
(2)
|
6,242
|
|
|
3,374
|
|
|
15,742
|
|
|
9,678
|
|
||||
Total research and development expenses
|
$
|
44,741
|
|
|
$
|
28,543
|
|
|
$
|
124,986
|
|
|
$
|
79,967
|
|
(1)
|
Primarily includes personnel expenses, consulting and outside services, laboratory supplies and license costs for our exclusive collaboration and license agreements with Invenra and StemSynergy.
|
(2)
|
Includes stock-based compensation and the allocation of general corporate costs to research and development.
|
|
Three Months Ended September 30,
|
|
Percentage Change -
Q3 2018 v. Q3 2017 |
|
Nine Months Ended September 30,
|
|
Percentage Change -
2018 v. 2017 |
||||||||||||||
|
2018
|
|
2017
|
|
|
2018
|
|
2017
|
|
||||||||||||
Selling, general and administrative expenses
|
$
|
48,120
|
|
|
$
|
38,129
|
|
|
26
|
%
|
|
$
|
153,989
|
|
|
$
|
113,084
|
|
|
36
|
%
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Interest income
|
$
|
3,507
|
|
|
$
|
1,133
|
|
|
$
|
8,099
|
|
|
$
|
3,497
|
|
Interest expense
|
(1
|
)
|
|
—
|
|
|
(1
|
)
|
|
(8,679
|
)
|
||||
Other, net
|
272
|
|
|
2,275
|
|
|
369
|
|
|
(3,638
|
)
|
||||
Total other income (expenses), net
|
$
|
3,778
|
|
|
$
|
3,408
|
|
|
$
|
8,467
|
|
|
$
|
(8,820
|
)
|
|
Three Months Ended September 30,
|
|
Percentage Change -
Q3 2018 v. Q3 2017 |
|
Nine Months Ended September 30,
|
|
Percentage Change -
2018 v. 2017 |
||||||||||||||
|
2018
|
|
2017
|
|
|
2018
|
|
2017
|
|
||||||||||||
Provision for income taxes
|
$
|
2,324
|
|
|
$
|
3,206
|
|
|
(28
|
)%
|
|
$
|
5,739
|
|
|
$
|
3,921
|
|
|
46
|
%
|
|
Nine Months Ended September 30,
|
||||||
|
2018
|
|
2017
|
||||
Net cash provided by operating activities:
|
|
|
|
||||
Net income
|
$
|
329,981
|
|
|
$
|
115,738
|
|
Adjustments to reconcile net income to net cash provided by operating activities
|
32,806
|
|
|
9,017
|
|
||
Changes in operating assets and liabilities
|
(51,658
|
)
|
|
(12,497
|
)
|
||
Net cash provided by operating activities
|
311,129
|
|
|
112,258
|
|
||
Net cash (used in) provided by investing activities
|
(155,051
|
)
|
|
55,128
|
|
||
Net cash provided by (used in) financing activities
|
10,835
|
|
|
(169,215
|
)
|
||
Net increase (decrease) in cash, cash equivalents and restricted cash
|
166,913
|
|
|
(1,829
|
)
|
||
Cash, cash equivalents and restricted cash at beginning of period
|
188,314
|
|
|
155,836
|
|
||
Cash, cash equivalents and restricted cash at end of period
|
$
|
355,227
|
|
|
$
|
154,007
|
|
•
|
the effectiveness, or perceived effectiveness, of CABOMETYX in comparison to competing products;
|
•
|
the safety of CABOMETYX, including the existence of serious side effects of CABOMETYX and their severity in comparison to those of competing products;
|
•
|
CABOMETYX’s relative convenience and ease of administration;
|
•
|
potential unexpected results connected with analysis of data from future or ongoing clinical trials of cabozantinib;
|
•
|
the timing of CABOMETYX label expansions for additional indications, if any, relative to competitive treatments;
|
•
|
the price of CABOMETYX relative to competitive therapies and any new government initiatives affecting pharmaceutical pricing;
|
•
|
the strength of CABOMETYX sales efforts, marketing, market access and product distribution support;
|
•
|
the sufficiency of commercial and government insurance coverage and adequacy of reimbursement for CABOMETYX; and
|
•
|
our ability to enforce our intellectual property rights with respect to CABOMETYX.
|
•
|
the federal Anti-Kickback Statute, or AKS, which governs our business activities, including our marketing practices, medical educational programs, pricing policies, and relationships with healthcare providers or other entities.
The AKS has been broadly interpreted to apply to manufacturer arrangements with prescribers,
|
•
|
the Federal Food, Drug, and Cosmetic Act, or FDCA, and its regulations, which prohibit, among other things, the introduction or delivery for introduction into interstate commerce of any drug that is adulterated or misbranded;
|
•
|
federal civil and criminal false claims laws, including the civil False Claims Act, and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payers that are false or fraudulent, or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;
|
•
|
federal criminal laws that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;
|
•
|
the Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and its implementing regulations, which impose certain requirements relating to the privacy, security and transmission of individually identifiable health information on covered entities and business associates that access such information on behalf of a covered entity;
|
•
|
state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payer, including commercial insurers, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts;
|
•
|
the Foreign Corrupt Practices Act, a U.S. law which regulates certain financial relationships with foreign government officials (which could include, for example, certain medical professionals) and its foreign equivalents;
|
•
|
federal and state consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers;
|
•
|
federal and state government price reporting laws, which require us to calculate and report complex pricing metrics to government agencies, where such reported prices are used in the calculation of reimbursement and/or discounts on our marketed drugs, as well as certain state and municipal government price reporting and transparency laws that require us to report certain information and/or provide justifications where drug prices exceed a certain price increase threshold. The landscape surrounding these state price reporting and transparency laws continues to evolve, and existing or future requirements may subject us to potentially significant discounts on our products, increased infrastructure costs, and could potentially affect our ability to offer certain marketplace discounts; and
|
•
|
state financial and drug pricing transparency laws, which generally require
that we track, and in certain cases, publicly report
certain types of expenditures in the U.S.
|
•
|
lack of efficacy or an effective safety profile;
|
•
|
negative or inconclusive clinical trial results may require us to conduct further testing or to abandon projects that we had expected to be promising;
|
•
|
discovery or commercialization by our competitors of other compounds or therapies that show significantly improved safety or efficacy compared to cabozantinib or our other product candidates;
|
•
|
our inability to identify and maintain a sufficient number of trial sites, many of which may already be engaged in other clinical trial programs;
|
•
|
lower-than-anticipated patient registration or enrollment in our clinical testing, resulting in the delay or cancellation of clinical testing;
|
•
|
failure by our collaborators to provide us on a timely basis with an adequate supply of product that complies with the applicable quality and regulatory requirements for a combination trial;
|
•
|
failure of our third-party contract research organizations or investigators to satisfy their contractual obligations, including deviating from any trial protocols; and
|
•
|
regulators or institutional review boards may withhold authorization to commence or conduct clinical trials of cabozantinib or another product candidate, or delay, suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or their determination that participating patients are being exposed to unacceptable health risks.
|
•
|
characteristics of the product candidate under investigation;
|
•
|
the number of patients who ultimately participate in the clinical trial;
|
•
|
the duration of patient follow-up that is appropriate in view of the results or required by regulatory authorities;
|
•
|
the number of clinical sites included in the trials; and
|
•
|
the length of time required to enroll suitable patient subjects.
|
•
|
the commercial success of both CABOMETYX and COMETRIQ and the revenues we generate from those approved products;
|
•
|
costs associated with maintaining our expanded sales, marketing, market access, medical affairs and product distribution capabilities for CABOMETYX and COMETRIQ;
|
•
|
the achievement of stated regulatory and commercial milestones under our collaboration agreements with Ipsen and Takeda;
|
•
|
the commercial success of COTELLIC and the revenues generated through our share of related profits and losses for the commercialization of COTELLIC in the U.S. and royalties from COTELLIC sales outside the U.S. under our collaboration with Genentech;
|
•
|
the potential regulatory approval of cabozantinib as a treatment for patients with previously-treated advanced HCC, and in other indications, both in the U.S. and abroad;
|
•
|
future clinical trial results;
|
•
|
our future investments in the expansion of our pipeline through drug discovery and corporate development activities;
|
•
|
our ability to control costs;
|
•
|
the cost of clinical drug supply for our clinical trials;
|
•
|
trends and developments in the pricing of oncologic therapeutics in the U.S. and abroad, especially in the EU;
|
•
|
scientific developments in the market for oncologic therapeutics and the timing of regulatory approvals for competing oncologic therapies; and
|
•
|
the filing, maintenance, prosecution, defense and enforcement of patent claims and other intellectual property rights.
|
•
|
we are not able to control the amount and timing of resources that our collaborators or potential future collaborators will devote to the development or commercialization of drug candidates or to their marketing and distribution;
|
•
|
we are not able to control the U.S. commercial resourcing decisions made and resulting costs incurred by Genentech for COTELLIC, which costs we are obligated to share, in part, under our collaboration agreement with Genentech;
|
•
|
collaborators may delay clinical trials, fail to supply us on a timely basis with the product required for a combination trial, deliver product that fails to meet appropriate quality and regulatory standards and results in a market recall or withdrawal, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a drug candidate, repeat or conduct new clinical trials or require a new formulation of a drug candidate for clinical testing;
|
•
|
disputes may arise between us and our collaborators that result in the delay or termination of the research, development or commercialization of our drug candidates, or that diminish or delay receipt of the economic benefits we are entitled to receive under the collaboration, or that result in costly litigation or arbitration that diverts management’s attention and resources;
|
•
|
collaborators may experience financial difficulties;
|
•
|
collaborators may not be successful in their efforts to obtain regulatory approvals in a timely manner, or at all;
|
•
|
collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our proprietary information or expose us to potential litigation;
|
•
|
collaborators may not comply with applicable healthcare regulatory laws;
|
•
|
business combinations or significant changes in a collaborator’s business strategy may adversely affect a collaborator’s willingness or ability to complete its obligations under any arrangement;
|
•
|
a collaborator could independently move forward with a competing drug candidate developed either independently or in collaboration with others, including our competitors;
|
•
|
we may be precluded from entering into additional collaboration arrangements with other parties in an area or field of exclusivity;
|
•
|
future collaborators may require us to relinquish some important rights, such as marketing and distribution rights; and
|
•
|
collaborations may be terminated or allowed to expire, which would delay, and may increase the cost of development of our drug candidates.
|
•
|
the commercial success of both CABOMETYX and COMETRIQ and the revenues we generate from those approved products;
|
•
|
customer ordering patterns for CABOMETYX and COMETRIQ, which may vary significantly from period to period;
|
•
|
the overall level of demand for CABOMETYX and COMETRIQ, including the impact of any competitive products and the duration of therapy for patients receiving CABOMETYX or COMETRIQ;
|
•
|
the commercial success of COTELLIC and the revenues generated through our share of related profits and losses for the commercialization of COTELLIC in the U.S. and royalties from COTELLIC sales outside the U.S. under our collaboration with Genentech;
|
•
|
changes in the amount of deductions from gross sales, including changes to the discount percentage of rebates and chargebacks mandated by the government programs in which we participate, including increases in the government discount percentage resulting from price increases we have taken or may take in the future, or due to different levels of utilization by entities entitled to government rebates and chargebacks and changes in patient demographics;
|
•
|
costs associated with maintaining our sales, marketing, market access, medical affairs and product distribution capabilities for CABOMETYX, COMETRIQ and COTELLIC;
|
•
|
our ability to obtain regulatory approval for cabozantinib as a treatment for patients with previously-treated advanced HCC;
|
•
|
the achievement of stated regulatory and commercial milestones under our collaboration agreements;
|
•
|
the progress and scope of other development and commercialization activities for cabozantinib and our other compounds;
|
•
|
future clinical trial results;
|
•
|
our future investments in the expansion of our pipeline through drug discovery and business development activities;
|
•
|
the inability to obtain adequate product supply for any approved drug product or inability to do so at acceptable prices;
|
•
|
recognition of upfront licensing or other fees or revenues;
|
•
|
payments of non-refundable upfront or licensing fees, or payment for cost-sharing expenses, to third parties;
|
•
|
the introduction of new technologies or products by our competitors;
|
•
|
the timing and willingness of collaborators to further develop or, if approved, commercialize our product candidates out-licensed to them;
|
•
|
the termination or non-renewal of existing collaborations or third-party vendor relationships;
|
•
|
regulatory actions with respect to our product candidates and any approved products or our competitors’ products;
|
•
|
disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;
|
•
|
the timing and amount of expenses incurred for clinical development and manufacturing of cabozantinib;
|
•
|
adjustments to expenses accrued in prior periods based on management’s estimates after the actual level of activity relating to such expenses becomes more certain;
|
•
|
the impairment of acquired goodwill and other assets;
|
•
|
additions and departures of key personnel;
|
•
|
significant fluctuations in interest rates or foreign currency exchange rates;
|
•
|
general and industry-specific economic conditions that may affect our or our collaborators’ research and development expenditures; and
|
•
|
other factors described in this “Risk Factors” section.
|
•
|
adverse or inconclusive results or announcements in our or our collaborators’ clinical trials or delays in those clinical trials;
|
•
|
the
announcement of FDA approval or non-approval, or delays in the FDA review process with respect to cabozantinib, our collaborators’ product candidates being developed in combination with cabozantinib, or our competitors’ product candidates
;
|
•
|
the commercial success of both CABOMETYX and COMETRIQ and the revenues we generate from those approved products;
|
•
|
the timing of achievement of our clinical, regulatory, partnering and other milestones, such as the commencement of clinical development, the completion of a clinical trial, the filing for regulatory approval or the establishment of collaborative arrangements for cabozantinib or any of our other programs or compounds;
|
•
|
actions taken by regulatory agencies, both in the U.S. and abroad, with respect to cabozantinib or our clinical trials for cabozantinib;
|
•
|
unanticipated regulatory actions taken by the FDA as a result of changing FDA standards and practices concerning the review of product candidates at earlier stages of clinical development or with lesser developed data sets and the speed with which the FDA is conducting regulatory reviews;
|
•
|
the announcement of new products
or clinical trial data
by our competitors;
|
•
|
the announcement of regulatory applications seeking a path to U.S. approval of generic versions of our marketed products;
|
•
|
quarterly variations in our or our competitors’ results of operations;
|
•
|
developments in our relationships with our collaborators, including the termination or modification of our agreements;
|
•
|
the announcement of an in-licensed product candidate or strategic acquisition;
|
•
|
conflicts or litigation with our collaborators;
|
•
|
litigation, including intellectual property infringement and product liability lawsuits, involving us;
|
•
|
failure to achieve operating results projected by securities analysts;
|
•
|
changes in earnings estimates or recommendations by securities analysts;
|
•
|
the entry into new financing arrangements;
|
•
|
developments in the biotechnology, biopharmaceutical or pharmaceutical industry;
|
•
|
sales of large blocks of our common stock or sales of our common stock by our executive officers, directors and significant stockholders;
|
•
|
departures of key personnel or board members;
|
•
|
the
extent to which coverage and reimbursement is available for both CABOMETYX and COMETRIQ from government and health administration authorities, private health insurers, managed care programs and other third-party payers
;
|
•
|
disposition of any of our technologies or compounds; and
|
•
|
general market, economic and political conditions and other factors, including factors unrelated to our operating performance or the operating performance of our competitors.
|
•
|
a classified Board of Directors;
|
•
|
a prohibition on actions by our stockholders by written consent;
|
•
|
the inability of our stockholders to call special meetings of stockholders;
|
•
|
the ability of our Board of Directors to issue preferred stock without stockholder approval, which could be used to institute a “poison pill” that would work to dilute the stock ownership of a potential hostile acquirer, effectively preventing acquisitions that have not been approved by our Board of Directors;
|
•
|
limitations on the removal of directors; and
|
•
|
advance notice requirements for director nominations and stockholder proposals.
|
Exhibit
Number
|
|
Exhibit Description
|
|
Incorporation by Reference
|
|
Filed
Herewith
|
||||||
Form
|
|
File Number
|
|
Exhibit/
Appendix
Reference
|
|
Filing Date
|
|
|||||
3.1
|
|
|
10-K
|
|
000-30235
|
|
3.1
|
|
3/10/2010
|
|
|
|
3.2
|
|
|
10-K
|
|
000-30235
|
|
3.2
|
|
3/10/2010
|
|
|
|
3.3
|
|
|
8-K
|
|
000-30235
|
|
3.1
|
|
5/25/2012
|
|
|
|
3.4
|
|
|
8-K
|
|
000-30235
|
|
3.1
|
|
10/15/2014
|
|
|
|
3.5
|
|
|
8-K
|
|
000-30235
|
|
3.2
|
|
10/15/2014
|
|
|
|
3.6
|
|
|
8-K
|
|
000-30235
|
|
3.1
|
|
12/5/2011
|
|
|
|
4.1
|
|
|
S-1,
as amended
|
|
333-96335
|
|
4.1
|
|
4/7/2000
|
|
|
|
10.1*
|
|
|
|
|
|
|
|
|
|
|
X
|
|
10.2*
|
|
|
|
|
|
|
|
|
|
|
X
|
|
10.3*
|
|
|
|
|
|
|
|
|
|
|
X
|
|
31.1
|
|
|
|
|
|
|
|
|
|
|
X
|
|
31.2
|
|
|
|
|
|
|
|
|
|
|
X
|
|
32.1‡
|
|
|
|
|
|
|
|
|
|
|
X
|
|
101.INS
|
|
XBRL Instance Document
|
|
|
|
|
|
|
|
|
|
X
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document
|
|
|
|
|
|
|
|
|
|
X
|
Exhibit
Number
|
|
Exhibit Description
|
|
Incorporation by Reference
|
|
Filed
Herewith
|
||||||
Form
|
|
File Number
|
|
Exhibit/
Appendix
Reference
|
|
Filing Date
|
|
|||||
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
|
*
|
Confidential treatment requested for certain portions of this exhibit.
|
‡
|
This certification accompanies this Quarterly Report on Form 10-Q, is not deemed filed with the SEC and is not to be incorporated by reference into any filing of Exelixis, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of this Quarterly Report on Form 10-Q), irrespective of any general incorporation language contained in such filing.
|
|
|
E
XELIXIS,
I
NC.
|
|
|
|
|
|
November 1, 2018
|
|
By:
|
/s/ C
HRISTOPHER
J. S
ENNER
|
Date
|
|
|
Christopher J. Senner
|
|
|
|
Executive Vice President and Chief Financial Officer
|
|
|
|
(Duly Authorized Officer and Principal Financial and Accounting Officer)
|
EXELIXIS, INC.
|
|
IPSEN PHARMA SAS
|
|
By: /s/ Michael M. Morrissey
|
|
By: /s/ François Garnier
|
|
Name: Michael M. Morrissey, Ph.D.
|
|
Name: François Garnier
|
|
Title: President & CEO
|
|
Title: Executive VP, General Counsel
|
|
|
|
|
|
BRISTOL-MYERS SQUIBB COMPANY
|
|
|
|
By: /s/ Fouad Namouni
|
|
|
|
Name: Fouad Namouni
|
|
|
|
Title: Head of Oncology Department
|
|
|
|
EXELIXIS, INC.
|
|
BRISTOL-MYERS SQUIBB COMPANY
|
|
By: /s/ Michael M. Morrissey
|
|
By: /s/ Fouad Namouni
|
|
Name: Michael M. Morrissey, Ph.D.
|
|
Name: Fouad Namouni
|
|
Title: President & CEO
|
|
Title: Head of Oncology Department
|
|
|
|
|
|
TAKEDA PHARMACEUTICAL COMPANY
LIMITED
|
|
|
|
By: /s/ Yukari Nishikata
|
|
|
|
Name: Yukari Nishikata
|
|
|
|
Title: Head of Oncology Therapeutic Area Unit for Japan and Asia
|
|
|
|
A.
|
Exelixis and Ipsen Pharma SAS (“
Ipsen
”) entered into a Collaboration and License Agreement dated February 29, 2016 (the “
Ipsen Agreement
”)
wherein Exelixis and Ipsen formed a collaboration for the continued development of and commercialization of Exelixis’s tyrosine kinase inhibitor known as “Cabozantinib”, and wherein Exelixis granted to Ipsen certain exclusive rights to develop and commercialize Cabozantinib worldwide, with the exception of the United States and Japan (the “
Ipsen Territory
”).
|
B.
|
Exelixis and Takeda Pharmaceutical Company Ltd. (“
Takeda
”) entered into a Collaboration and License Agreement dated January 30, 2017 (the “
Takeda Agreement
”)
wherein Exelixis and Takeda formed a collaboration for the continued development of and commercialization of Cabozantinib and wherein Exelixis granted to Takeda certain exclusive rights to develop and commercialize Cabozantinib in Japan (the “
Takeda Territory
”).
|
C.
|
Ono and BMS entered into those certain Collaboration Agreements between BMS and Ono dated September 20, 2011 and July 23, 2014, as amended from time to time (the “
BMS-Ono Agreements
”), wherein Ono and BMS formed a collaboration for the continued development of and commercialization of the human monoclonal antibody that binds PD-1 known as “Nivolumab” and wherein Ono has certain exclusive rights to develop and commercialize Nivolumab in Japan, South Korea and Taiwan (the
“Ono Territory
”) and BMS has certain exclusive rights to develop and commercialize Nivolumab in all other countries of the world.
|
D.
|
BMS and Exelixis entered into a Clinical Trial Collaboration Agreement (the “
Collaboration Agreement
”) dated February 24, 2017, relating to the conduct of one or more Combined Therapy Trials with Cabozantinib and Nivolumab, with or without BMS’s CTLA-4 monoclonal antibody known as “Ipilimumab”.
|
E.
|
BMS, Exelixis and Ipsen entered into a Supplement To The Clinical Trial Collaboration Agreement dated February 24, 2017 (the “
Ipsen Supplement Agreement
”) so that Combined Therapy Trials could be run under the Collaboration Agreement in any country of the Ipsen Territory except for South Korea or Taiwan and BMS could secure the necessary rights in the Ipsen Territory except for South Korea and Taiwan.
|
F.
|
The Collaboration Agreement, prior to the Supplemental Agreement Effective Date, excludes the conduct of Combined Therapy Trials in the Ono Territory, and otherwise excludes rights in the Ono Territory.
|
G.
|
The Parties now desire to enter into this Supplemental Agreement to supplement and amend the Collaboration Agreement to include Ono as a party for purposes of the conduct of Combined Therapy Trials in the Ono Territory and to otherwise expand the Collaboration Agreement to include the Ono Territory, in accordance with the Collaboration Agreement as supplemented and amended by this Supplemental Agreement.
|
H.
|
BMS, Exelixis and Ipsen are entering into an Amendment To The Supplement To The Clinical Trial Collaboration Agreement (the “
Ipsen Amendment
”) concurrently with this Supplemental Agreement so that Combined Therapy Trials can be run in South Korea and Taiwan and BMS can secure the necessary rights in South Korea and Taiwan for Ono and BMS.
|
I.
|
BMS, Exelixis and Takeda are entering into a Supplement To The Clinical Trial Collaboration Agreement (the “
Takeda Supplement Agreement
”) concurrently with this Supplemental Agreement so that Combined Therapy Trials can be run in Japan (i.e., the Takeda Territory) and BMS can secure the necessary rights in the Takeda Territory for Ono and BMS.
|
1.
|
DEFINITIONS AND REFERENCES TO CERTAIN DEFINED TERMS
|
2.
|
CONDUCT OF COMBINED THERAPY TRIALS IN THE ONO TERRITORY
|
3.
|
GOVERNANCE
|
4.
|
STUDY COSTS
|
5.
|
PHARMACOVIGILANCE
|
6.
|
INDEMNIFICATION
|
7.
|
MISCELLANEOUS
|
For Ono:
|
Ono Pharmaceutical Co., Ltd.
|
|
8-2, Kyutaromachi 1-Chome
|
|
Chuo-ku, Osaka 541-8564 Japan
|
|
Attention: Executive Director, Corporate Development & Strategy
|
|
|
With a copy to:
|
Ono Pharmaceutical Co., Ltd.
|
|
8-2, Kyutaromachi 1-Chome
|
|
Chuo-ku, Osaka 541-8564 Japan
|
|
Attention: Executive Director, Clinical Development
|
ONO PHARMACEUTICAL CO., LTD.
|
|
BRISTOL-MYERS SQUIBB COMPANY
|
|
By: /s/ Hiroshi Awata
|
|
By: /s/ Fouad Namouni
|
|
Name: Hiroshi Awata
|
|
Name: Fouad Namouni
|
|
Title: Member of the Board of Directors, Executive Vice President, Executive Director
|
|
Title: Head of Oncology Department
|
|
|
|
|
|
EXELIXIS, INC.
|
|
|
|
By: /s/ Michael M. Morrissey
|
|
|
|
Name: Michael M. Morrissey, Ph.D.
|
|
|
|
Title: President & CEO
|
|
|
|
/s/ M
ICHAEL
M. M
ORRISSEY
|
Michael M. Morrissey, Ph.D.
|
President and Chief Executive Officer
(Principal Executive Officer)
|
/s/ C
HRISTOPHER
J. S
ENNER
|
Christopher J. Senner
|
Executive Vice President and Chief Financial Officer
(Principal Financial Officer)
|
/s/ M
ICHAEL
M. M
ORRISSEY
|
|
|
|
/s/ C
HRISTOPHER
J. S
ENNER
|
Michael M. Morrissey, Ph.D.
|
|
|
|
Christopher J. Senner
|
President and Chief Executive Officer
(Principal Executive Officer)
|
|
|
|
Executive Vice President and Chief Financial Officer
(Principal Financial Officer)
|