|
x
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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
|
Virginia
|
|
26-0084895
|
(State or other jurisdiction of
incorporation or organization)
|
|
(I.R.S. Employer
Identification Number)
|
|
|
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20374 Seneca Meadows Parkway
Germantown, Maryland
|
|
20876
|
(Address of principal executive offices)
|
|
(Zip Code)
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Large accelerated filer
|
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x
|
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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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Emerging growth company
|
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¨
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Item No.
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Page
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1.
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2.
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3.
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||
4.
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|
||
1.
|
||
1A.
|
||
2.
|
||
3.
|
||
4.
|
||
5.
|
||
6.
|
||
|
•
|
our strategy and overall approach to our business model;
|
•
|
our ability to successfully enter new markets or develop additional products, whether with our collaborators or independently;
|
•
|
our ability to successfully enter into optimal strategic relationships with our subsidiaries and operating companies that we may form in the future;
|
•
|
competition from existing technologies and products or new technologies and products that may emerge;
|
•
|
actual or anticipated variations in our operating results;
|
•
|
our current and future joint ventures, or JVs, exclusive channel collaborations, or ECCs, license agreements and other collaborations;
|
•
|
developments concerning our collaborators and licensees;
|
•
|
actual or anticipated fluctuations in our competitors' or our collaborators' and licensees' operating results or changes in their respective growth rates;
|
•
|
our cash position;
|
•
|
market conditions in our industry;
|
•
|
our ability to protect our intellectual property and other proprietary rights and technologies;
|
•
|
our ability to adapt to changes in laws, regulations and policies;
|
•
|
the ability of our collaborators and licensees to adapt to changes in laws, regulations and policies and to secure any necessary regulatory approvals to commercialize any products developed under the ECCs, license agreements and JVs;
|
•
|
the ability of our collaborators and licensees to protect our intellectual property and other proprietary rights and technologies;
|
•
|
the ability of our collaborators and licensees to develop and successfully commercialize products enabled by our technologies;
|
•
|
the rate and degree of market acceptance of any products developed by our subsidiaries, a collaborator under an ECC, or through a JV or license under a license agreement;
|
•
|
our ability to retain and recruit key personnel;
|
•
|
the result of litigation proceedings or investigations that we face currently or may face in the future;
|
•
|
our expectations related to the use of proceeds from our public offerings and other financing efforts;
|
•
|
our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and
|
•
|
the impact of the Tax Cuts and Jobs Act of 2017 on our current and future operating results.
|
(Amounts in thousands, except share data)
|
September 30,
2018 |
|
December 31,
2017 |
||||
Assets
|
|
|
|
||||
Current assets
|
|
|
|
||||
Cash and cash equivalents
|
$
|
82,417
|
|
|
$
|
68,111
|
|
Restricted cash
|
6,987
|
|
|
6,987
|
|
||
Short-term investments
|
164,162
|
|
|
6,273
|
|
||
Equity securities
|
714
|
|
|
5,285
|
|
||
Receivables
|
|
|
|
||||
Trade, net
|
18,161
|
|
|
19,775
|
|
||
Related parties, net
|
8,841
|
|
|
17,913
|
|
||
Other
|
3,305
|
|
|
2,153
|
|
||
Inventory
|
18,294
|
|
|
20,493
|
|
||
Prepaid expenses and other
|
7,589
|
|
|
7,057
|
|
||
Total current assets
|
310,470
|
|
|
154,047
|
|
||
Equity securities, noncurrent
|
3,983
|
|
|
9,815
|
|
||
Investments in preferred stock
|
158,421
|
|
|
161,225
|
|
||
Property, plant and equipment, net
|
122,707
|
|
|
112,674
|
|
||
Intangible assets, net
|
213,244
|
|
|
232,877
|
|
||
Goodwill
|
151,276
|
|
|
153,289
|
|
||
Investments in affiliates
|
17,944
|
|
|
18,870
|
|
||
Other assets
|
2,370
|
|
|
4,054
|
|
||
Total assets
|
$
|
980,415
|
|
|
$
|
846,851
|
|
(Amounts in thousands, except share data)
|
September 30,
2018 |
|
December 31,
2017 |
||||
Liabilities and Total Equity
|
|
|
|
||||
Current liabilities
|
|
|
|
||||
Accounts payable
|
$
|
8,522
|
|
|
$
|
8,701
|
|
Accrued compensation and benefits
|
23,885
|
|
|
6,474
|
|
||
Other accrued liabilities
|
20,998
|
|
|
21,080
|
|
||
Deferred revenue, including $16,967 and $29,155 from related parties as of September 30, 2018 and December 31, 2017, respectively
|
38,036
|
|
|
42,870
|
|
||
Lines of credit
|
200
|
|
|
233
|
|
||
Current portion of long-term debt
|
546
|
|
|
502
|
|
||
Related party payables
|
143
|
|
|
313
|
|
||
Total current liabilities
|
92,330
|
|
|
80,173
|
|
||
Long-term debt, net of current portion, including $30,060 and $0 to related parties as of September 30, 2018 and December 31, 2017, respectively
|
183,133
|
|
|
7,535
|
|
||
Deferred revenue, net of current portion, including $115,885 and $157,628 from related parties as of September 30, 2018 and December 31, 2017, respectively
|
136,942
|
|
|
193,527
|
|
||
Deferred tax liabilities, net
|
9,363
|
|
|
15,620
|
|
||
Other long-term liabilities
|
3,204
|
|
|
3,451
|
|
||
Total liabilities
|
424,972
|
|
|
300,306
|
|
||
Commitments and contingencies (Note 16)
|
|
|
|
||||
Total equity
|
|
|
|
||||
Common stock, no par value, 200,000,000 shares authorized as of September 30, 2018 and December 31, 2017; 137,144,902 and 122,087,040 shares issued and outstanding as of September 30, 2018 and December 31, 2017, respectively
|
—
|
|
|
—
|
|
||
Additional paid-in capital
|
1,552,379
|
|
|
1,397,005
|
|
||
Accumulated deficit
|
(990,080
|
)
|
|
(847,820
|
)
|
||
Accumulated other comprehensive loss
|
(22,900
|
)
|
|
(15,554
|
)
|
||
Total Intrexon shareholders' equity
|
539,399
|
|
|
533,631
|
|
||
Noncontrolling interests
|
16,044
|
|
|
12,914
|
|
||
Total equity
|
555,443
|
|
|
546,545
|
|
||
Total liabilities and total equity
|
$
|
980,415
|
|
|
$
|
846,851
|
|
(Amounts in thousands, except share and per share data)
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
2018
|
|
2017
|
|
2018
|
|
2017
|
|||||||||
Revenues
|
|
|
|
|
|
|
|
||||||||
Collaboration and licensing revenues, including $11,952 and $24,492 from related parties during the three months ended September 30, 2018 and 2017, respectively, and $41,740 and $77,937 during the nine months ended September 30, 2018 and 2017, respectively
|
$
|
14,324
|
|
|
$
|
28,155
|
|
|
$
|
51,622
|
|
|
$
|
89,384
|
|
Product revenues
|
6,829
|
|
|
7,670
|
|
|
23,549
|
|
|
25,780
|
|
||||
Service revenues
|
10,414
|
|
|
9,975
|
|
|
40,379
|
|
|
37,890
|
|
||||
Other revenues
|
881
|
|
|
216
|
|
|
1,839
|
|
|
899
|
|
||||
Total revenues
|
32,448
|
|
|
46,016
|
|
|
117,389
|
|
|
153,953
|
|
||||
Operating Expenses
|
|
|
|
|
|
|
|
||||||||
Cost of products
|
8,877
|
|
|
8,001
|
|
|
28,046
|
|
|
25,625
|
|
||||
Cost of services
|
6,449
|
|
|
7,013
|
|
|
21,127
|
|
|
21,805
|
|
||||
Research and development
|
44,885
|
|
|
36,472
|
|
|
124,072
|
|
|
104,663
|
|
||||
Selling, general and administrative
|
38,708
|
|
|
39,277
|
|
|
112,872
|
|
|
113,258
|
|
||||
Total operating expenses
|
98,919
|
|
|
90,763
|
|
|
286,117
|
|
|
265,351
|
|
||||
Operating loss
|
(66,471
|
)
|
|
(44,747
|
)
|
|
(168,728
|
)
|
|
(111,398
|
)
|
||||
Other Income (Expense), Net
|
|
|
|
|
|
|
|
||||||||
Unrealized and realized appreciation (depreciation) in fair value of equity securities and preferred stock, net
|
(7,287
|
)
|
|
2,175
|
|
|
(27,565
|
)
|
|
9,240
|
|
||||
Interest expense
|
(3,999
|
)
|
|
(138
|
)
|
|
(4,240
|
)
|
|
(498
|
)
|
||||
Interest and dividend income
|
6,107
|
|
|
5,070
|
|
|
17,323
|
|
|
14,437
|
|
||||
Other income (expense), net
|
1,452
|
|
|
(1,021
|
)
|
|
571
|
|
|
4,453
|
|
||||
Total other income (expense), net
|
(3,727
|
)
|
|
6,086
|
|
|
(13,911
|
)
|
|
27,632
|
|
||||
Equity in net loss of affiliates
|
(2,870
|
)
|
|
(2,993
|
)
|
|
(9,880
|
)
|
|
(11,273
|
)
|
||||
Loss before income taxes
|
(73,068
|
)
|
|
(41,654
|
)
|
|
(192,519
|
)
|
|
(95,039
|
)
|
||||
Income tax benefit
|
14,322
|
|
|
818
|
|
|
19,535
|
|
|
2,164
|
|
||||
Net loss
|
$
|
(58,746
|
)
|
|
$
|
(40,836
|
)
|
|
$
|
(172,984
|
)
|
|
$
|
(92,875
|
)
|
Net loss attributable to the noncontrolling interests
|
1,422
|
|
|
1,147
|
|
|
4,113
|
|
|
3,123
|
|
||||
Net loss attributable to Intrexon
|
$
|
(57,324
|
)
|
|
$
|
(39,689
|
)
|
|
$
|
(168,871
|
)
|
|
$
|
(89,752
|
)
|
Net loss attributable to Intrexon per share, basic and diluted
|
$
|
(0.44
|
)
|
|
$
|
(0.33
|
)
|
|
$
|
(1.31
|
)
|
|
$
|
(0.75
|
)
|
Weighted average shares outstanding, basic and diluted
|
129,518,989
|
|
|
120,518,885
|
|
|
128,843,991
|
|
|
119,741,291
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
(Amounts in thousands)
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Net loss
|
$
|
(58,746
|
)
|
|
$
|
(40,836
|
)
|
|
$
|
(172,984
|
)
|
|
$
|
(92,875
|
)
|
Other comprehensive income (loss):
|
|
|
|
|
|
|
|
||||||||
Unrealized gain (loss) on investments
|
(96
|
)
|
|
79
|
|
|
(94
|
)
|
|
74
|
|
||||
Gain (loss) on foreign currency translation adjustments
|
(914
|
)
|
|
7,410
|
|
|
(7,207
|
)
|
|
19,405
|
|
||||
Comprehensive loss
|
(59,756
|
)
|
|
(33,347
|
)
|
|
(180,285
|
)
|
|
(73,396
|
)
|
||||
Comprehensive loss attributable to the noncontrolling interests
|
1,380
|
|
|
1,129
|
|
|
4,172
|
|
|
3,096
|
|
||||
Comprehensive loss attributable to Intrexon
|
$
|
(58,376
|
)
|
|
$
|
(32,218
|
)
|
|
$
|
(176,113
|
)
|
|
$
|
(70,300
|
)
|
(Amounts in thousands, except share data)
|
Common Stock
|
|
Additional
Paid-in
Capital
|
|
Accumulated
Other
Comprehensive
Loss
|
|
Accumulated
Deficit
|
|
Total
Intrexon
Shareholders'
Equity
|
|
Noncontrolling
Interests
|
|
Total
Equity
|
|||||||||||||||||
Shares
|
|
Amount
|
|
|
|
|
|
|
||||||||||||||||||||||
Balances at December 31, 2017
|
122,087,040
|
|
|
$
|
—
|
|
|
$
|
1,397,005
|
|
|
$
|
(15,554
|
)
|
|
$
|
(847,820
|
)
|
|
$
|
533,631
|
|
|
$
|
12,914
|
|
|
$
|
546,545
|
|
Cumulative effect of adoption of ASC 606
|
—
|
|
|
—
|
|
|
—
|
|
|
(104
|
)
|
|
26,611
|
|
|
26,507
|
|
|
—
|
|
|
26,507
|
|
|||||||
Stock-based compensation expense
|
—
|
|
|
—
|
|
|
28,251
|
|
|
—
|
|
|
—
|
|
|
28,251
|
|
|
89
|
|
|
28,340
|
|
|||||||
Shares issued upon vesting of restricted stock units and for exercises of stock options and warrants
|
66,314
|
|
|
—
|
|
|
262
|
|
|
—
|
|
|
—
|
|
|
262
|
|
|
812
|
|
|
1,074
|
|
|||||||
Shares issued as payment for services
|
612,117
|
|
|
—
|
|
|
8,404
|
|
|
—
|
|
|
—
|
|
|
8,404
|
|
|
—
|
|
|
8,404
|
|
|||||||
Shares and warrants issued in public offerings, net of issuance costs
|
6,900,000
|
|
|
—
|
|
|
82,374
|
|
|
—
|
|
|
—
|
|
|
82,374
|
|
|
5,616
|
|
|
87,990
|
|
|||||||
Equity component of convertible debt, net of issuance costs and deferred taxes
|
—
|
|
|
—
|
|
|
36,868
|
|
|
—
|
|
|
—
|
|
|
36,868
|
|
|
—
|
|
|
36,868
|
|
|||||||
Shares issued pursuant to share lending agreement
|
7,479,431
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||
Adjustments for noncontrolling interests
|
—
|
|
|
—
|
|
|
(785
|
)
|
|
—
|
|
|
—
|
|
|
(785
|
)
|
|
785
|
|
|
—
|
|
|||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(168,871
|
)
|
|
(168,871
|
)
|
|
(4,113
|
)
|
|
(172,984
|
)
|
|||||||
Other comprehensive loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(7,242
|
)
|
|
—
|
|
|
(7,242
|
)
|
|
(59
|
)
|
|
(7,301
|
)
|
|||||||
Balances at September 30, 2018
|
137,144,902
|
|
|
$
|
—
|
|
|
$
|
1,552,379
|
|
|
$
|
(22,900
|
)
|
|
$
|
(990,080
|
)
|
|
$
|
539,399
|
|
|
$
|
16,044
|
|
|
$
|
555,443
|
|
|
Nine Months Ended
September 30, |
||||||
(Amounts in thousands)
|
2018
|
|
2017
|
||||
Cash flows from operating activities
|
|
|
|
||||
Net loss
|
$
|
(172,984
|
)
|
|
$
|
(92,875
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
||||
Depreciation and amortization
|
25,184
|
|
|
22,881
|
|
||
Loss on disposal of assets, net
|
4,110
|
|
|
1,311
|
|
||
Write-off of in-process research and development acquired in asset acquisition
|
8,721
|
|
|
—
|
|
||
Unrealized and realized (appreciation) depreciation on equity securities and preferred stock,
net
|
27,565
|
|
|
(9,240
|
)
|
||
Noncash dividend income
|
(14,575
|
)
|
|
(12,303
|
)
|
||
Amortization of premiums (discounts) on investments, net
|
(275
|
)
|
|
411
|
|
||
Equity in net loss of affiliates
|
9,880
|
|
|
11,273
|
|
||
Stock-based compensation expense
|
28,340
|
|
|
31,949
|
|
||
Shares issued as payment for services
|
8,404
|
|
|
8,440
|
|
||
Provision for bad debts
|
1,597
|
|
|
1,093
|
|
||
Accretion of debt discount and amortization of deferred financing costs
|
2,116
|
|
|
—
|
|
||
Deferred income taxes
|
(19,335
|
)
|
|
(2,294
|
)
|
||
Other noncash items
|
635
|
|
|
(1,848
|
)
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Receivables:
|
|
|
|
||||
Trade
|
399
|
|
|
2,491
|
|
||
Related parties
|
6,085
|
|
|
(1,073
|
)
|
||
Other
|
(909
|
)
|
|
537
|
|
||
Inventory
|
2,577
|
|
|
3,418
|
|
||
Prepaid expenses and other
|
(511
|
)
|
|
(516
|
)
|
||
Other assets
|
584
|
|
|
(617
|
)
|
||
Accounts payable
|
(731
|
)
|
|
(3,756
|
)
|
||
Accrued compensation and benefits
|
17,561
|
|
|
3,291
|
|
||
Other accrued liabilities
|
1,591
|
|
|
1,554
|
|
||
Deferred revenue
|
(22,993
|
)
|
|
(35,281
|
)
|
||
Deferred consideration
|
—
|
|
|
(313
|
)
|
||
Related party payables
|
(167
|
)
|
|
356
|
|
||
Other long-term liabilities
|
253
|
|
|
1,271
|
|
||
Net cash used in operating activities
|
(86,878
|
)
|
|
(69,840
|
)
|
|
Nine Months Ended
September 30, |
||||||
(Amounts in thousands)
|
2018
|
|
2017
|
||||
Cash flows from investing activities
|
|
|
|
||||
Purchases of investments
|
(178,681
|
)
|
|
—
|
|
||
Maturities of investments
|
20,975
|
|
|
136,300
|
|
||
Purchases of preferred stock and warrants
|
—
|
|
|
(1,161
|
)
|
||
Proceeds from sales of equity securities
|
217
|
|
|
235
|
|
||
Cash acquired in business combination
|
—
|
|
|
2,054
|
|
||
Investments in affiliates
|
(14,139
|
)
|
|
(10,639
|
)
|
||
Return of investment in affiliate
|
2,598
|
|
|
—
|
|
||
Cash received (paid) in asset acquisition
|
15,500
|
|
|
(14,219
|
)
|
||
Purchases of property, plant and equipment
|
(30,354
|
)
|
|
(32,675
|
)
|
||
Proceeds from sale of assets
|
1,930
|
|
|
1,423
|
|
||
Issuances of notes receivable
|
—
|
|
|
(2,400
|
)
|
||
Proceeds from repayment of notes receivable
|
—
|
|
|
1,500
|
|
||
Net cash provided by (used in) investing activities
|
(181,954
|
)
|
|
80,418
|
|
||
Cash flows from financing activities
|
|
|
|
||||
Proceeds from issuance of shares and warrants in public offerings, net of issuance costs
|
87,990
|
|
|
—
|
|
||
Acquisitions of noncontrolling interests
|
—
|
|
|
(913
|
)
|
||
Advances from lines of credit
|
3,231
|
|
|
4,563
|
|
||
Repayments of advances from lines of credit
|
(3,264
|
)
|
|
(5,149
|
)
|
||
Proceeds from long-term debt, net of issuance costs
|
194,000
|
|
|
285
|
|
||
Payments of long-term debt
|
(485
|
)
|
|
(385
|
)
|
||
Payments of deferred consideration for acquisition
|
—
|
|
|
(8,678
|
)
|
||
Proceeds from stock option and warrant exercises
|
1,074
|
|
|
867
|
|
||
Payment of issuance costs
|
—
|
|
|
(10
|
)
|
||
Net cash provided by (used in) financing activities
|
282,546
|
|
|
(9,420
|
)
|
||
Effect of exchange rate changes on cash, cash equivalents, and restricted cash
|
578
|
|
|
892
|
|
||
Net increase in cash, cash equivalents, and restricted cash
|
14,292
|
|
|
2,050
|
|
||
Cash, cash equivalents, and restricted cash
|
|
|
|
||||
Beginning of period
|
75,545
|
|
|
69,594
|
|
||
End of period
|
$
|
89,837
|
|
|
$
|
71,644
|
|
|
Nine Months Ended
September 30, |
||||||
(Amounts in thousands)
|
2018
|
|
2017
|
||||
Supplemental disclosure of cash flow information
|
|
|
|
||||
Cash paid during the period for interest
|
$
|
360
|
|
|
$
|
534
|
|
Cash paid during the period for income taxes
|
193
|
|
|
497
|
|
||
Significant noncash financing and investing activities
|
|
|
|
||||
Stock and warrants issued in business combination
|
$
|
—
|
|
|
$
|
16,997
|
|
Stock issued to acquire noncontrolling interests
|
—
|
|
|
5,082
|
|
||
Long-term debt issued to a related party in an asset acquisition
|
30,000
|
|
|
—
|
|
||
Noncash dividend to shareholders
|
—
|
|
|
22,385
|
|
||
Purchases of property and equipment included in accounts payable and other accrued liabilities
|
2,088
|
|
|
2,137
|
|
||
Purchases of equipment financed through debt
|
193
|
|
|
—
|
|
|
September 30,
2018 |
|
December 31,
2017 |
||||
Cash and cash equivalents
|
$
|
82,417
|
|
|
$
|
68,111
|
|
Restricted cash
|
6,987
|
|
|
6,987
|
|
||
Restricted cash included in other assets
|
433
|
|
|
447
|
|
||
Cash, cash equivalents, and restricted cash
|
$
|
89,837
|
|
|
$
|
75,545
|
|
|
September 30,
2018 |
|
December 31,
2017 |
||||
Current assets
|
$
|
21,044
|
|
|
$
|
61,086
|
|
Noncurrent assets
|
27,827
|
|
|
13,598
|
|
||
Total assets
|
48,871
|
|
|
74,684
|
|
||
Current liabilities
|
5,324
|
|
|
6,213
|
|
||
Net assets
|
$
|
43,547
|
|
|
$
|
68,471
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Revenues
|
$
|
113
|
|
|
$
|
58
|
|
|
$
|
353
|
|
|
$
|
175
|
|
Operating expenses
|
11,621
|
|
|
9,693
|
|
|
30,762
|
|
|
33,128
|
|
||||
Operating loss
|
(11,508
|
)
|
|
(9,635
|
)
|
|
(30,409
|
)
|
|
(32,953
|
)
|
||||
Other, net
|
12
|
|
|
(145
|
)
|
|
33
|
|
|
37
|
|
||||
Net loss
|
$
|
(11,496
|
)
|
|
$
|
(9,780
|
)
|
|
$
|
(30,376
|
)
|
|
$
|
(32,916
|
)
|
•
|
As a period charge in the future period in which the tax arises; or
|
•
|
As part of deferred taxes related to the investment or subsidiary.
|
|
Three Months Ended
September 30, 2018 |
|
Nine Months Ended
September 30, 2018 |
||||||||||||||||||||
|
As Reported
|
|
Balances Without Adoption of ASC 606
|
|
Effect of Change
|
|
As Reported
|
|
Balances Without Adoption of ASC 606
|
|
Effect of Change
|
||||||||||||
Consolidated Statements of Operations
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Collaboration and licensing revenues
|
$
|
14,324
|
|
|
$
|
16,210
|
|
|
$
|
(1,886
|
)
|
|
$
|
51,622
|
|
|
$
|
58,305
|
|
|
$
|
(6,683
|
)
|
Net loss
|
(58,746
|
)
|
|
(56,860
|
)
|
|
(1,886
|
)
|
|
(172,984
|
)
|
|
(166,301
|
)
|
|
(6,683
|
)
|
||||||
Net loss attributable to Intrexon
|
(57,324
|
)
|
|
(55,438
|
)
|
|
(1,886
|
)
|
|
(168,871
|
)
|
|
(162,188
|
)
|
|
(6,683
|
)
|
|
September 30, 2018
|
||||||||||
|
As Reported
|
|
Balances Without Adoption of ASC 606
|
|
Effect of Change
|
||||||
Consolidated Balance Sheet
|
|
|
|
|
|
||||||
Liabilities
|
|
|
|
|
|
||||||
Deferred revenue, current
|
$
|
38,036
|
|
|
$
|
39,594
|
|
|
$
|
(1,558
|
)
|
Deferred revenue, net of current portion
|
136,942
|
|
|
156,803
|
|
|
(19,861
|
)
|
|||
Total equity
|
|
|
|
|
|
||||||
Accumulated deficit
|
(990,080
|
)
|
|
(1,010,007
|
)
|
|
19,927
|
|
|||
Accumulated other comprehensive loss
|
(22,900
|
)
|
|
(22,860
|
)
|
|
(40
|
)
|
Common shares
|
$
|
15,616
|
|
Warrants
|
1,381
|
|
|
Contingent consideration
|
585
|
|
|
|
$
|
17,582
|
|
Cash and cash equivalents
|
$
|
2,054
|
|
Short-term investments
|
542
|
|
|
Trade receivables
|
75
|
|
|
Other receivables
|
97
|
|
|
Prepaid expenses and other
|
227
|
|
|
Property and equipment
|
250
|
|
|
Intangible assets
|
14,000
|
|
|
Other noncurrent assets
|
58
|
|
|
Total assets acquired
|
17,303
|
|
|
Accounts payable
|
2,158
|
|
|
Accrued compensation and benefits
|
1,226
|
|
|
Other accrued expenses
|
856
|
|
|
Other long-term liabilities
|
92
|
|
|
Deferred tax liabilities
|
239
|
|
|
Total liabilities assumed
|
4,571
|
|
|
Net assets acquired
|
12,732
|
|
|
Goodwill
|
4,850
|
|
|
Total consideration
|
$
|
17,582
|
|
|
Nine Months Ended
September 30, |
||
|
2017
|
||
|
Pro forma
|
||
Revenues
|
$
|
154,185
|
|
Loss before income taxes
|
(102,305
|
)
|
|
Net loss
|
(100,330
|
)
|
|
Net loss attributable to the noncontrolling interests
|
3,123
|
|
|
Net loss attributable to Intrexon
|
(97,207
|
)
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
ZIOPHARM Oncology, Inc.
|
$
|
4,826
|
|
|
$
|
10,373
|
|
|
$
|
13,626
|
|
|
$
|
31,322
|
|
Oragenics, Inc.
|
705
|
|
|
475
|
|
|
867
|
|
|
1,519
|
|
||||
Fibrocell Science, Inc.
|
391
|
|
|
1,683
|
|
|
1,015
|
|
|
5,375
|
|
||||
Genopaver, LLC
|
689
|
|
|
1,422
|
|
|
3,076
|
|
|
4,615
|
|
||||
S & I Ophthalmic, LLC
|
—
|
|
|
376
|
|
|
—
|
|
|
751
|
|
||||
OvaXon, LLC
|
—
|
|
|
262
|
|
|
—
|
|
|
1,966
|
|
||||
Intrexon Energy Partners, LLC
|
1,329
|
|
|
1,903
|
|
|
3,345
|
|
|
8,909
|
|
||||
Persea Bio, LLC
|
199
|
|
|
266
|
|
|
714
|
|
|
821
|
|
||||
Ares Trading S.A.
|
1,576
|
|
|
2,356
|
|
|
7,525
|
|
|
8,474
|
|
||||
Intrexon Energy Partners II, LLC
|
754
|
|
|
816
|
|
|
1,685
|
|
|
2,921
|
|
||||
Intrexon T1D Partners, LLC
|
368
|
|
|
1,462
|
|
|
2,399
|
|
|
3,882
|
|
||||
Harvest start-up entities (1)
|
2,691
|
|
|
4,020
|
|
|
11,792
|
|
|
11,835
|
|
||||
Other
|
796
|
|
|
2,741
|
|
|
5,578
|
|
|
6,994
|
|
||||
Total
|
$
|
14,324
|
|
|
$
|
28,155
|
|
|
$
|
51,622
|
|
|
$
|
89,384
|
|
(1)
|
For the
three and nine
months ended
September 30, 2018
and
2017
, revenues recognized from collaborations with Harvest start-up entities include: Thrive Agrobiotics, Inc.; Exotech Bio, Inc.; and AD Skincare, Inc. For the
nine months ended September 30, 2018
and the
three and nine
months ended
September 30, 2017
, revenues recognized from collaborations with Harvest start-up entities also include Genten Therapeutics, Inc. and CRS Bio, Inc. For the
three and nine
months ended
September 30, 2017
, revenues recognized from collaborations with Harvest start-up entities also include Relieve Genetics, Inc.
|
|
September 30,
2018 |
|
December 31,
2017 |
||||
Collaboration and licensing agreements
|
$
|
170,356
|
|
|
$
|
231,583
|
|
Prepaid product and service revenues
|
3,119
|
|
|
4,681
|
|
||
Other
|
1,503
|
|
|
133
|
|
||
Total
|
$
|
174,978
|
|
|
$
|
236,397
|
|
Current portion of deferred revenue
|
$
|
38,036
|
|
|
$
|
42,870
|
|
Long-term portion of deferred revenue
|
136,942
|
|
|
193,527
|
|
||
Total
|
$
|
174,978
|
|
|
$
|
236,397
|
|
|
Average Remaining Performance Period (Years)
|
|
September 30,
2018 |
|
December 31,
2017 |
||||
ZIOPHARM Oncology, Inc.
|
5.3
|
|
$
|
51,084
|
|
|
$
|
90,496
|
|
Oragenics, Inc.
|
5.7
|
|
6,240
|
|
|
6,719
|
|
||
Fibrocell Science, Inc.
|
6.1
|
|
17,846
|
|
|
16,607
|
|
||
Genopaver, LLC
|
5.5
|
|
1,346
|
|
|
1,704
|
|
||
Intrexon Energy Partners, LLC
|
5.5
|
|
13,164
|
|
|
15,625
|
|
||
Persea Bio, LLC
|
6.3
|
|
2,802
|
|
|
3,500
|
|
||
Ares Trading S.A.
|
5.6
|
|
34,608
|
|
|
40,789
|
|
||
Intrexon Energy Partners II, LLC
|
6.2
|
|
14,910
|
|
|
13,833
|
|
||
Intrexon T1D Partners, LLC
|
6.5
|
|
8,760
|
|
|
8,435
|
|
||
Harvest start-up entities (1)
|
6.4
|
|
8,007
|
|
|
18,400
|
|
||
Other
|
4.5
|
|
10,721
|
|
|
14,423
|
|
||
Total
|
|
|
$
|
169,488
|
|
|
$
|
230,531
|
|
(1)
|
As of
September 30, 2018
and
December 31, 2017
, the balance of deferred revenue for collaborations with Harvest start-up entities includes: Thrive Agrobiotics, Inc.; Exotech Bio, Inc.; and AD Skincare, Inc. As of
December 31, 2017
, the balance of deferred revenue for collaborations with Harvest start-up entities also includes: Relieve Genetics, Inc.; Genten Therapeutics, Inc.; and CRS Bio, Inc. See Note
3
for further discussion of the asset acquisition of certain Harvest entities.
|
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Aggregate
Fair Value
|
||||||||
U.S. government debt securities
|
$
|
163,905
|
|
|
$
|
—
|
|
|
$
|
(96
|
)
|
|
$
|
163,809
|
|
Certificates of deposit
|
353
|
|
|
—
|
|
|
—
|
|
|
353
|
|
||||
Total
|
$
|
164,258
|
|
|
$
|
—
|
|
|
$
|
(96
|
)
|
|
$
|
164,162
|
|
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Aggregate
Fair Value
|
||||||||
U.S. government debt securities
|
$
|
6,000
|
|
|
$
|
—
|
|
|
$
|
(2
|
)
|
|
$
|
5,998
|
|
Certificates of deposit
|
275
|
|
|
—
|
|
|
—
|
|
|
275
|
|
||||
Total
|
$
|
6,275
|
|
|
$
|
—
|
|
|
$
|
(2
|
)
|
|
$
|
6,273
|
|
|
Nine Months Ended
September 30, 2018 |
||
Beginning balance
|
$
|
161,225
|
|
Dividend income from investments in preferred stock
|
14,575
|
|
|
Net unrealized depreciation in the fair value of the investments in preferred stock
|
(17,379
|
)
|
|
Ending balance
|
$
|
158,421
|
|
|
Quoted Prices in Active Markets
(Level 1)
|
|
Significant Other Observable Inputs
(Level 2)
|
|
Significant Unobservable Inputs
(Level 3)
|
|
September 30,
2018 |
||||||||
Assets
|
|
|
|
|
|
|
|
||||||||
U.S. government debt securities
|
$
|
—
|
|
|
$
|
163,809
|
|
|
$
|
—
|
|
|
$
|
163,809
|
|
Equity securities
|
3,591
|
|
|
1,106
|
|
|
—
|
|
|
4,697
|
|
||||
Preferred stock
|
—
|
|
|
—
|
|
|
158,421
|
|
|
158,421
|
|
||||
Other
|
—
|
|
|
653
|
|
|
—
|
|
|
653
|
|
||||
Total
|
$
|
3,591
|
|
|
$
|
165,568
|
|
|
$
|
158,421
|
|
|
$
|
327,580
|
|
|
Quoted Prices in Active Markets
(Level 1) |
|
Significant Other Observable Inputs
(Level 2) |
|
Significant Unobservable Inputs
(Level 3) |
|
December 31,
2017 |
||||||||
Assets
|
|
|
|
|
|
|
|
||||||||
U.S. government debt securities
|
$
|
—
|
|
|
$
|
5,998
|
|
|
$
|
—
|
|
|
$
|
5,998
|
|
Equity securities
|
10,537
|
|
|
4,563
|
|
|
—
|
|
|
15,100
|
|
||||
Preferred stock
|
—
|
|
|
—
|
|
|
161,225
|
|
|
161,225
|
|
||||
Other
|
—
|
|
|
850
|
|
|
—
|
|
|
850
|
|
||||
Total
|
$
|
10,537
|
|
|
$
|
11,411
|
|
|
$
|
161,225
|
|
|
$
|
183,173
|
|
|
September 30,
2018 |
|
December 31,
2017 |
||||
Supplies, embryos and other production materials
|
$
|
3,368
|
|
|
$
|
2,673
|
|
Work in process
|
4,578
|
|
|
4,767
|
|
||
Livestock
|
8,453
|
|
|
11,040
|
|
||
Feed
|
1,895
|
|
|
2,013
|
|
||
Total inventory
|
$
|
18,294
|
|
|
$
|
20,493
|
|
|
September 30,
2018 |
|
December 31,
2017 |
||||
Land and land improvements
|
$
|
12,373
|
|
|
$
|
11,767
|
|
Buildings and building improvements
|
18,533
|
|
|
18,183
|
|
||
Furniture and fixtures
|
1,716
|
|
|
2,515
|
|
||
Equipment
|
72,126
|
|
|
65,863
|
|
||
Leasehold improvements
|
25,281
|
|
|
25,277
|
|
||
Breeding stock
|
4,827
|
|
|
3,832
|
|
||
Computer hardware and software
|
11,490
|
|
|
10,128
|
|
||
Trees
|
10,635
|
|
|
6,642
|
|
||
Construction and other assets in progress
|
18,658
|
|
|
14,113
|
|
||
|
175,639
|
|
|
158,320
|
|
||
Less: Accumulated depreciation and amortization
|
(52,932
|
)
|
|
(45,646
|
)
|
||
Property, plant and equipment, net
|
$
|
122,707
|
|
|
$
|
112,674
|
|
Balance at December 31, 2017
|
$
|
153,289
|
|
Foreign currency translation adjustments
|
(2,013
|
)
|
|
Balance at September 30, 2018
|
$
|
151,276
|
|
|
Gross Carrying Amount
|
|
Accumulated Amortization
|
|
Net
|
||||||
Patents, developed technologies and know-how
|
$
|
257,318
|
|
|
$
|
(56,551
|
)
|
|
$
|
200,767
|
|
Customer relationships
|
10,700
|
|
|
(7,346
|
)
|
|
3,354
|
|
|||
Trademarks
|
6,800
|
|
|
(3,148
|
)
|
|
3,652
|
|
|||
In-process research and development
|
5,471
|
|
|
—
|
|
|
5,471
|
|
|||
Total
|
$
|
280,289
|
|
|
$
|
(67,045
|
)
|
|
$
|
213,244
|
|
|
Gross Carrying Amount
|
|
Accumulated Amortization
|
|
Net
|
||||||
Patents, developed technologies and know-how
|
$
|
263,615
|
|
|
$
|
(44,954
|
)
|
|
$
|
218,661
|
|
Customer relationships
|
10,700
|
|
|
(6,383
|
)
|
|
4,317
|
|
|||
Trademarks
|
6,800
|
|
|
(2,567
|
)
|
|
4,233
|
|
|||
In-process research and development
|
5,666
|
|
|
—
|
|
|
5,666
|
|
|||
Total
|
$
|
286,781
|
|
|
$
|
(53,904
|
)
|
|
$
|
232,877
|
|
|
September 30,
2018 |
|
December 31,
2017 |
||||
Convertible debt
|
$
|
175,899
|
|
|
$
|
—
|
|
Notes payable
|
4,667
|
|
|
5,010
|
|
||
Royalty-based financing
|
2,147
|
|
|
2,132
|
|
||
Other
|
966
|
|
|
895
|
|
||
Long-term debt
|
183,679
|
|
|
8,037
|
|
||
Less current portion
|
546
|
|
|
502
|
|
||
Long-term debt, less current portion
|
$
|
183,133
|
|
|
$
|
7,535
|
|
•
|
During any calendar quarter commencing after the calendar quarter ending on September 30, 2018, if the last reported sales price of Intrexon's common stock for at least
20
trading days (whether or not consecutive) during the last
30
consecutive trading days of the immediately preceding calendar quarter is greater than or equal to
130%
of the conversion price on each applicable trading day;
|
•
|
During the
five
business day period after any
five
consecutive trading day period in which the trading price, as defined in the Indenture, for the Convertible Notes is less than
98%
of the product of the last reported sales price of Intrexon's common stock and the conversion rate for the Convertible Notes on each such trading day; or
|
•
|
Upon the occurrence of specified corporate events as defined in the Indenture.
|
2018
|
$
|
210
|
|
2019
|
449
|
|
|
2020
|
30,463
|
|
|
2021
|
832
|
|
|
2022
|
375
|
|
|
2023
|
200,389
|
|
|
Thereafter
|
2,974
|
|
|
Total
|
$
|
235,692
|
|
|
September 30,
2018 |
|
December 31,
2017 |
||||
Unrealized loss on investments
|
$
|
(96
|
)
|
|
$
|
(2
|
)
|
Loss on foreign currency translation adjustments
|
(22,804
|
)
|
|
(15,552
|
)
|
||
Total accumulated other comprehensive loss
|
$
|
(22,900
|
)
|
|
$
|
(15,554
|
)
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Cost of products
|
$
|
14
|
|
|
$
|
30
|
|
|
$
|
64
|
|
|
$
|
86
|
|
Cost of services
|
51
|
|
|
82
|
|
|
207
|
|
|
242
|
|
||||
Research and development
|
1,681
|
|
|
2,383
|
|
|
7,315
|
|
|
7,018
|
|
||||
Selling, general and administrative
|
6,386
|
|
|
9,562
|
|
|
20,754
|
|
|
24,603
|
|
||||
Total
|
$
|
8,132
|
|
|
$
|
12,057
|
|
|
$
|
28,340
|
|
|
$
|
31,949
|
|
|
Number of Shares
|
|
Weighted Average Exercise Price
|
|
Weighted Average Remaining Contractual Term (Years)
|
|||
Balances at December 31, 2017
|
11,382,747
|
|
|
$
|
28.99
|
|
|
7.32
|
Granted
|
1,174,839
|
|
|
15.04
|
|
|
|
|
Exercised
|
(41,314
|
)
|
|
(6.33
|
)
|
|
|
|
Forfeited
|
(808,086
|
)
|
|
(21.41
|
)
|
|
|
|
Expired
|
(547,662
|
)
|
|
(27.40
|
)
|
|
|
|
Balances at September 30, 2018
|
11,160,524
|
|
|
28.23
|
|
|
6.79
|
|
Exercisable at September 30, 2018
|
7,177,315
|
|
|
30.15
|
|
|
6.02
|
2018
|
$
|
1,508
|
|
2019
|
9,417
|
|
|
2020
|
9,577
|
|
|
2021
|
8,904
|
|
|
2022
|
8,072
|
|
|
2023
|
7,009
|
|
|
Thereafter
|
31,330
|
|
|
Total
|
$
|
75,817
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Historical net loss per share:
|
|
|
|
|
|
|
|
||||||||
Numerator:
|
|
|
|
|
|
|
|
||||||||
Net loss attributable to Intrexon
|
$
|
(57,324
|
)
|
|
$
|
(39,689
|
)
|
|
$
|
(168,871
|
)
|
|
$
|
(89,752
|
)
|
Denominator:
|
|
|
|
|
|
|
|
||||||||
Weighted average shares outstanding, basic and diluted
|
129,518,989
|
|
|
120,518,885
|
|
|
128,843,991
|
|
|
119,741,291
|
|
||||
Net loss attributable to Intrexon per share, basic and diluted
|
$
|
(0.44
|
)
|
|
$
|
(0.33
|
)
|
|
$
|
(1.31
|
)
|
|
$
|
(0.75
|
)
|
|
September 30,
|
||||
|
2018
|
|
2017
|
||
Convertible debt
|
13,507,746
|
|
|
—
|
|
Options
|
11,160,524
|
|
|
12,641,770
|
|
Restricted stock units
|
980,758
|
|
|
—
|
|
Warrants
|
133,264
|
|
|
133,264
|
|
Total
|
25,782,292
|
|
|
12,775,034
|
|
•
|
salaries and benefits, including stock-based compensation expense, for personnel in research and development functions;
|
•
|
fees paid to consultants and contract research organizations who perform research on our behalf and under our direction;
|
•
|
costs related to laboratory supplies used in our research and development efforts;
|
•
|
costs related to certain in-licensed technology rights or reacquired in-process research and development;
|
•
|
depreciation of leasehold improvements and laboratory equipment;
|
•
|
amortization of patents and related technologies acquired in mergers and acquisitions; and
|
•
|
rent and utility costs for our research and development facilities.
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
|
(In thousands)
|
||||||||||||||
Expansion or improvement of our platform technologies
|
$
|
5,056
|
|
|
$
|
3,652
|
|
|
$
|
13,565
|
|
|
$
|
10,476
|
|
Specific applications of our technologies in support of current and prospective partners
|
18,676
|
|
|
19,363
|
|
|
55,440
|
|
|
56,369
|
|
||||
Expansion or improvement of our product and service offerings
|
6,027
|
|
|
6,917
|
|
|
21,729
|
|
|
20,030
|
|
||||
Other
|
15,126
|
|
|
6,540
|
|
|
33,338
|
|
|
17,788
|
|
||||
Total research and development expenses
|
$
|
44,885
|
|
|
$
|
36,472
|
|
|
$
|
124,072
|
|
|
$
|
104,663
|
|
|
Three Months Ended
September 30, |
|
Dollar
Change
|
|
Percent
Change
|
|||||||||
|
2018
|
|
2017
|
|
||||||||||
|
(In thousands)
|
|
|
|||||||||||
Revenues (1)
|
|
|
|
|
|
|
|
|||||||
Collaboration and licensing revenues (2)
|
$
|
14,324
|
|
|
$
|
28,155
|
|
|
$
|
(13,831
|
)
|
|
(49.1
|
)%
|
Product revenues
|
6,829
|
|
|
7,670
|
|
|
(841
|
)
|
|
(11.0
|
)%
|
|||
Service revenues
|
10,414
|
|
|
9,975
|
|
|
439
|
|
|
4.4
|
%
|
|||
Other revenues
|
881
|
|
|
216
|
|
|
665
|
|
|
>200%
|
|
|||
Total revenues
|
32,448
|
|
|
46,016
|
|
|
(13,568
|
)
|
|
(29.5
|
)%
|
|||
Operating expenses
|
|
|
|
|
|
|
|
|
||||||
Cost of products
|
8,877
|
|
|
8,001
|
|
|
876
|
|
|
10.9
|
%
|
|||
Cost of services
|
6,449
|
|
|
7,013
|
|
|
(564
|
)
|
|
(8.0
|
)%
|
|||
Research and development
|
44,885
|
|
|
36,472
|
|
|
8,413
|
|
|
23.1
|
%
|
|||
Selling, general and administrative
|
38,708
|
|
|
39,277
|
|
|
(569
|
)
|
|
(1.4
|
)%
|
|||
Total operating expenses
|
98,919
|
|
|
90,763
|
|
|
8,156
|
|
|
9.0
|
%
|
|||
Operating loss
|
(66,471
|
)
|
|
(44,747
|
)
|
|
(21,724
|
)
|
|
48.5
|
%
|
|||
Total other income (expense), net
|
(3,727
|
)
|
|
6,086
|
|
|
(9,813
|
)
|
|
(161.2
|
)%
|
|||
Equity in loss of affiliates
|
(2,870
|
)
|
|
(2,993
|
)
|
|
123
|
|
|
(4.1
|
)%
|
|||
Loss before income taxes
|
(73,068
|
)
|
|
(41,654
|
)
|
|
(31,414
|
)
|
|
75.4
|
%
|
|||
Income tax benefit
|
14,322
|
|
|
818
|
|
|
13,504
|
|
|
>200%
|
|
|||
Net loss
|
(58,746
|
)
|
|
(40,836
|
)
|
|
(17,910
|
)
|
|
43.9
|
%
|
|||
Net loss attributable to noncontrolling interests
|
1,422
|
|
|
1,147
|
|
|
275
|
|
|
24.0
|
%
|
|||
Net loss attributable to Intrexon
|
$
|
(57,324
|
)
|
|
$
|
(39,689
|
)
|
|
$
|
(17,635
|
)
|
|
44.4
|
%
|
(1)
|
Revenues in 2018 are accounted for under Accounting Standards Codification, or ASC, 606,
Revenue from Contracts with Customers
, or ASC 606, and revenues in 2017 are accounted for under ASC 605,
Revenue Recognition
, or ASC 605. We adopted ASC 606 on January 1, 2018 using the modified retrospective method, which applies the changes in accounting prospectively and does not restate prior periods.
|
(2)
|
Including
$11,952
and
$24,492
from related parties for the
three months ended September 30, 2018
and
2017
, respectively.
|
|
Three Months Ended
September 30, |
|
Dollar
Change |
||||||||
|
2018
|
|
2017
|
|
|||||||
|
(In thousands)
|
||||||||||
ZIOPHARM Oncology, Inc.
|
$
|
4,826
|
|
|
$
|
10,373
|
|
|
$
|
(5,547
|
)
|
Oragenics, Inc.
|
705
|
|
|
475
|
|
|
230
|
|
|||
Fibrocell Science, Inc.
|
391
|
|
|
1,683
|
|
|
(1,292
|
)
|
|||
Genopaver, LLC
|
689
|
|
|
1,422
|
|
|
(733
|
)
|
|||
S & I Ophthalmic, LLC
|
—
|
|
|
376
|
|
|
(376
|
)
|
|||
OvaXon, LLC
|
—
|
|
|
262
|
|
|
(262
|
)
|
|||
Intrexon Energy Partners, LLC
|
1,329
|
|
|
1,903
|
|
|
(574
|
)
|
|||
Persea Bio, LLC
|
199
|
|
|
266
|
|
|
(67
|
)
|
|||
Ares Trading S.A.
|
1,576
|
|
|
2,356
|
|
|
(780
|
)
|
|||
Intrexon Energy Partners II, LLC
|
754
|
|
|
816
|
|
|
(62
|
)
|
|||
Intrexon T1D Partners, LLC
|
368
|
|
|
1,462
|
|
|
(1,094
|
)
|
|||
Harvest Start-up Entities (1)
|
2,691
|
|
|
4,020
|
|
|
(1,329
|
)
|
|||
Other
|
796
|
|
|
2,741
|
|
|
(1,945
|
)
|
|||
Total
|
$
|
14,324
|
|
|
$
|
28,155
|
|
|
$
|
(13,831
|
)
|
(1)
|
For the
three months ended September 30, 2018
and
2017
, revenues recognized from collaborations with Harvest start-up entities include: Thrive Agrobiotics, Inc.; Exotech Bio, Inc.; and AD Skincare, Inc. For the
three months ended September 30, 2017
, revenues recognized from collaborations with Harvest start-up entities also include Relieve Genetics, Inc.; Genten Therapeutics, Inc.; and CRS Bio, Inc.
|
|
Nine Months Ended
September 30, |
|
Dollar
Change
|
|
Percent
Change
|
|||||||||
|
2018
|
|
2017
|
|
||||||||||
|
(In thousands)
|
|
|
|||||||||||
Revenues (1)
|
|
|
|
|
|
|
|
|||||||
Collaboration and licensing revenues (2)
|
$
|
51,622
|
|
|
$
|
89,384
|
|
|
$
|
(37,762
|
)
|
|
(42.2
|
)%
|
Product revenues
|
23,549
|
|
|
25,780
|
|
|
(2,231
|
)
|
|
(8.7
|
)%
|
|||
Service revenues
|
40,379
|
|
|
37,890
|
|
|
2,489
|
|
|
6.6
|
%
|
|||
Other revenues
|
1,839
|
|
|
899
|
|
|
940
|
|
|
104.6
|
%
|
|||
Total revenues
|
117,389
|
|
|
153,953
|
|
|
(36,564
|
)
|
|
(23.8
|
)%
|
|||
Operating expenses
|
|
|
|
|
|
|
|
|||||||
Cost of products
|
28,046
|
|
|
25,625
|
|
|
2,421
|
|
|
9.4
|
%
|
|||
Cost of services
|
21,127
|
|
|
21,805
|
|
|
(678
|
)
|
|
(3.1
|
)%
|
|||
Research and development
|
124,072
|
|
|
104,663
|
|
|
19,409
|
|
|
18.5
|
%
|
|||
Selling, general and administrative
|
112,872
|
|
|
113,258
|
|
|
(386
|
)
|
|
(0.3
|
)%
|
|||
Total operating expenses
|
286,117
|
|
|
265,351
|
|
|
20,766
|
|
|
7.8
|
%
|
|||
Operating loss
|
(168,728
|
)
|
|
(111,398
|
)
|
|
(57,330
|
)
|
|
51.5
|
%
|
|||
Total other income (expense), net
|
(13,911
|
)
|
|
27,632
|
|
|
(41,543
|
)
|
|
(150.3
|
)%
|
|||
Equity in loss of affiliates
|
(9,880
|
)
|
|
(11,273
|
)
|
|
1,393
|
|
|
(12.4
|
)%
|
|||
Loss before income taxes
|
(192,519
|
)
|
|
(95,039
|
)
|
|
(97,480
|
)
|
|
102.6
|
%
|
|||
Income tax benefit
|
19,535
|
|
|
2,164
|
|
|
17,371
|
|
|
>200%
|
|
|||
Net loss
|
(172,984
|
)
|
|
(92,875
|
)
|
|
(80,109
|
)
|
|
86.3
|
%
|
|||
Net loss attributable to noncontrolling interests
|
4,113
|
|
|
3,123
|
|
|
990
|
|
|
31.7
|
%
|
|||
Net loss attributable to Intrexon
|
$
|
(168,871
|
)
|
|
$
|
(89,752
|
)
|
|
$
|
(79,119
|
)
|
|
88.2
|
%
|
(1)
|
Revenues in 2018 are accounted for under ASC 606, and revenues in 2017 are accounted for under ASC 605. We adopted ASC 606 on January 1, 2018 using the modified retrospective method, which applies the changes in accounting prospectively and does not restate prior periods.
|
(2)
|
Including
$41,740
and
$77,937
from related parties for the
nine months ended September 30, 2018
and
2017
, respectively.
|
|
Nine Months Ended
September 30, |
|
Dollar
Change |
||||||||
|
2018
|
|
2017
|
|
|||||||
|
(In thousands)
|
||||||||||
ZIOPHARM Oncology, Inc.
|
$
|
13,626
|
|
|
$
|
31,322
|
|
|
$
|
(17,696
|
)
|
Oragenics, Inc.
|
867
|
|
|
1,519
|
|
|
(652
|
)
|
|||
Fibrocell Science, Inc.
|
1,015
|
|
|
5,375
|
|
|
(4,360
|
)
|
|||
Genopaver, LLC
|
3,076
|
|
|
4,615
|
|
|
(1,539
|
)
|
|||
S & I Ophthalmic, LLC
|
—
|
|
|
751
|
|
|
(751
|
)
|
|||
OvaXon, LLC
|
—
|
|
|
1,966
|
|
|
(1,966
|
)
|
|||
Intrexon Energy Partners, LLC
|
3,345
|
|
|
8,909
|
|
|
(5,564
|
)
|
|||
Persea Bio, LLC
|
714
|
|
|
821
|
|
|
(107
|
)
|
|||
Ares Trading S.A.
|
7,525
|
|
|
8,474
|
|
|
(949
|
)
|
|||
Intrexon Energy Partners II, LLC
|
1,685
|
|
|
2,921
|
|
|
(1,236
|
)
|
|||
Intrexon T1D Partners, LLC
|
2,399
|
|
|
3,882
|
|
|
(1,483
|
)
|
|||
Harvest Start-up Entities (1)
|
11,792
|
|
|
11,835
|
|
|
(43
|
)
|
|||
Other
|
5,578
|
|
|
6,994
|
|
|
(1,416
|
)
|
|||
Total
|
$
|
51,622
|
|
|
$
|
89,384
|
|
|
$
|
(37,762
|
)
|
(1)
|
For the
nine months ended September 30, 2018
and
2017
, revenues recognized from collaborations with Harvest start-up entities include: Thrive Agrobiotics, Inc.; Exotech Bio, Inc.; AD Skincare, Inc.; Genten Therapeutics, Inc.; and CRS Bio, Inc. For the
nine months ended September 30, 2017
, revenues recognized from collaborations with Harvest start-up entities also include Relieve Genetics, Inc.
|
|
Nine Months Ended
September 30, |
||||||
|
2018
|
|
2017
|
||||
|
(In thousands)
|
||||||
Net cash provided by (used in):
|
|
|
|
||||
Operating activities
|
$
|
(86,878
|
)
|
|
$
|
(69,840
|
)
|
Investing activities
|
(181,954
|
)
|
|
80,418
|
|
||
Financing activities
|
282,546
|
|
|
(9,420
|
)
|
||
Effect of exchange rate changes on cash, cash equivalents, and restricted cash
|
578
|
|
|
892
|
|
||
Net increase in cash, cash equivalents and restricted cash
|
$
|
14,292
|
|
|
$
|
2,050
|
|
•
|
progress in our research and development programs, as well as the magnitude of these programs;
|
•
|
the timing, receipt and amount of any payments received in connection with strategic transactions;
|
•
|
the timing, receipt and amount of upfront, milestone and other payments, if any, from present and future collaborators, if any;
|
•
|
the timing, receipt and amount of sales and royalties, if any, from our potential products;
|
•
|
our ability to maintain or improve the volume and pricing of our current product and service offerings and to develop new offerings, including those that may incorporate new technologies;
|
•
|
the timing and capital requirements to scale up our various product and service offerings and customer acceptance thereof;
|
•
|
our ability to maintain and establish additional collaborative arrangements and/or new strategic initiatives;
|
•
|
the timing of regulatory approval of products of our collaborations and operations;
|
•
|
the resources, time and cost required for the preparation, filing, prosecution, maintenance and enforcement of patent claims;
|
•
|
investments we may make in current and future collaborators, including JVs;
|
•
|
strategic mergers and acquisitions, including both the upfront acquisition cost as well as the cost to integrate, maintain, and expand the strategic target; and
|
•
|
the costs associated with legal activities, including litigation, arising in the course of our business activities and our ability to prevail in any such legal disputes.
|
|
Total
|
|
Less Than 1 Year
|
|
1 - 3 Years
|
|
3 - 5 Years
|
|
More Than 5 Years
|
||||||||||
|
(In thousands)
|
||||||||||||||||||
Operating Leases
|
$
|
75,817
|
|
|
$
|
8,418
|
|
|
$
|
18,844
|
|
|
$
|
15,384
|
|
|
$
|
33,171
|
|
Purchase commitments
|
8,826
|
|
|
4,048
|
|
|
4,778
|
|
|
—
|
|
|
—
|
|
|||||
Convertible debt
|
230,060
|
|
|
—
|
|
|
30,060
|
|
|
200,000
|
|
|
—
|
|
|||||
Cash interest payable on convertible debt
|
34,981
|
|
|
6,981
|
|
|
14,000
|
|
|
14,000
|
|
|
—
|
|
|||||
Long-term debt, excluding convertible debt
|
5,632
|
|
|
546
|
|
|
1,256
|
|
|
757
|
|
|
3,073
|
|
|||||
Contingent consideration
|
585
|
|
|
—
|
|
|
585
|
|
|
—
|
|
|
—
|
|
|||||
Total
|
$
|
355,901
|
|
|
$
|
19,993
|
|
|
$
|
69,523
|
|
|
$
|
230,141
|
|
|
$
|
36,244
|
|
Exhibit
No.
|
|
Description
|
4.1*
|
|
Base Indenture, dated July 3, 2018, by and between Intrexon Corporation and The Bank of New York Mellon Trust Company, N.A.
(incorporated by reference to Exhibit 4.1 to Intrexon Corporation's Current Report on Form 8-K filed on July 3, 2018 with the Securities and Exchange Commission).
|
|
|
|
4.2*
|
|
First Supplemental Indenture (including the form of 3.50% convertible senior notes due 2023), dated July 3, 2018, by and between Intrexon Corporation and The Bank of New York Mellon Trust Company, N.A.
(incorporated by reference to Exhibit 4.2 to Intrexon Corporation's Current Report on Form 8-K filed on July 3, 2018 with the Securities and Exchange Commission).
|
|
|
|
10.1**#
|
|
|
|
|
|
31.1
|
|
|
|
|
|
31.2
|
|
|
|
|
|
32.1**
|
|
|
|
|
|
32.2**
|
|
|
|
|
|
101.0
|
|
Interactive Data File (Quarterly Report on Form 10-Q, for the quarterly period ended September 30, 2018, formatted in XBRL (eXtensible Business Reporting Language)).
Attached as Exhibit 101.0 to this Quarterly Report on Form 10-Q are the following documents formatted in XBRL: (i) the Consolidated Balance Sheets as of September 30, 2018 and December 31, 2017, (ii) the Consolidated Statements of Operations for the three and nine months ended September 30, 2018 and 2017, (iii) the Consolidated Statements of Comprehensive Loss for the three and nine months ended September 30, 2018 and 2017, (iv) the Consolidated Statements of Shareholders' and Total Equity for the nine months ended September 30, 2018, (v) the Consolidated Statements of Cash Flows for the nine months ended September 30, 2018 and 2017, and (vi) the Notes to Consolidated Financial Statements.
|
**
|
Furnished herewith.
|
#
|
Portions of the exhibit (indicated by asterisks) have been omitted pursuant to a confidential treatment order granted by the Securities and Exchange Commission.
|
|
|
Intrexon Corporation
|
||
|
|
(Registrant)
|
||
|
|
|
||
Date: November 8, 2018
|
|
By:
|
|
/s/ Rick L. Sterling
|
|
|
|
|
Rick L. Sterling
|
|
|
|
|
Chief Financial Officer
|
|
|
|
|
(Principal Financial and Accounting Officer)
|
Development Milestone Event
|
Milestone Payment
|
Initiation of the first [*****] Clinical Trial
|
[*****] Dollars ($[*****])
|
First Regulatory Approval in [*****]
|
[*****] Dollars ($[*****])
|
First Regulatory Approval by [*****]
|
[*****] Dollars ($[*****])
|
First Regulatory Approval in [*****]
|
[*****] Dollars ($[*****])
|
Total
|
Fifty-two million five hundred thousand Dollars ($52,500,000)
|
Royalty Tier
|
Annual Net Sales of each Exclusive Royalty-Bearing Product
in the Territory
|
Royalty Rate
|
1
|
For that portion of annual aggregate Net Sales of each Exclusive Royalty-Bearing Product less than or equal to [*****] Dollars ($[*****])
|
[*****]%
|
2
|
For that portion of annual aggregate Net Sales of Exclusive Royalty-Bearing Product greater than [*****] Dollars ($[*****]) and less than or equal to [*****] Dollars ($[*****])
|
[*****]%
|
3
|
For that portion of annual aggregate Net Sales of Exclusive Royalty-Bearing Product greater than [*****] Dollars ($[*****])
|
[*****]%
|
Royalty Tier
|
Annual Net Sales of each Non-Exclusive Product and TCR Product
in the Territory
|
Royalty Rate
|
1
|
For that portion of annual aggregate Net Sales of each Non-Exclusive Product and TCR Product less than or equal to [*****] Dollars ($[*****])
|
[*****]%
|
2
|
For that portion of annual aggregate Net Sales of each Non-Exclusive Product and TCR Product greater than [*****] Dollars ($[*****])and less than or equal to [*****] Dollars ($[*****])
|
[*****]%
|
3
|
For that portion of annual aggregate Net Sales of each Non-Exclusive Product and TCR Product greater than [*****] Dollars ($[*****])
|
[*****]%
|
Ziopharm Oncology, Inc.
By: /s/ Laurence J.N. Cooper
Name: Laurence J.N. Cooper
Title: Chief Executive Officer
|
Precigen, Inc.
By: /s/ Donald P. Lehr
Name: Donald P. Lehr
Title: Director
Solely for the purposes of the Recitals, Section 2.2, Section 3.4, Article 13 and Section 14.13:
Intrexon Corporation
By: /s/ Donald P. Lehr
Name: Donald P. Lehr
Title: Chief Legal Officer
|
INTREXON
DOCKET NO
|
TITLE
|
PRIORITY DATE
|
COUNTRY
|
SERIAL NO
|
FILE DATE
|
PATENT NO
|
ISSUE DATE
|
GENERAL DESCRIPTION
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
|
||||||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
|
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
|
||||||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
|
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
|
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
[*****]
|
[*****]
|
[*****]
|
|
|
||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
[*****]
|
[*****]
|
[*****]
|
|
|
||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
[*****]
|
[*****]
|
[*****]
|
|
|
||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
[*****]
|
[*****]
|
[*****]
|
|
|
||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
[*****]
|
[*****]
|
[*****]
|
|
|
||||
[*****]
|
[*****]
|
[*****]
|
|
|
||||
[*****]
|
[*****]
|
[*****]
|
|
|
||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
[*****]
|
[*****]
|
[*****]
|
|
|
||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
[*****]
|
[*****]
|
[*****]
|
|
|
||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
||||
[*****]
|
[*****]
|
[*****]
|
|
|
||||
[*****]
|
[*****]
|
[*****]
|
|
|
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|
||||
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|
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INTREXON
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Ziopharm Oncology Contacts:
David Connolly
Vice President, Corporate Communications/Investor Relations
Tel: +1 (617) 502-1881
Email:
dconnolly@ziopharm.com
|
Mike Moyer
Vice President, Portfolio Strategy
Tel : +1 (617) 765-3770
Email : mmoyer@ziopharm.com
|
Intrexon Investor Contact:
Steven Harasym
Vice President, Investor Relations
Tel: +1 (214) 721-0607
investors@dna.com
|
Intrexon Corporate Contact:
Marie Rossi, Ph.D.
Vice President, Communications
Tel: +1 (301) 556-9850
publicrelations@dna.com
|
INTREXON CORPORATION
|
||
|
|
|
By:
|
|
|
Name:
|
||
Title:
|
•
|
Exclusive License Agreement by and between the University of Pittsburgh - Of the commonwealth System of Higher Education and Intrexon Corporation, effective as of February 1, 2008, as amended August 29, 2008, April 3, 2009 and October 25, 2012.
|
1.
|
I have reviewed this quarterly report on Form 10-Q of Intrexon Corporation;
|
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 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 and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
|
/s/ RANDAL J. KIRK
|
Randal J. Kirk
|
Chairman and Chief Executive Officer
|
(Principal Executive Officer)
|
1.
|
I have reviewed this quarterly report on Form 10-Q of Intrexon Corporation;
|
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 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 and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
|
/s/ RICK L. STERLING
|
Rick L. Sterling
|
Chief Financial Officer
|
(Principal Financial Officer)
|
•
|
the Quarterly Report on Form 10-Q of the Company for the quarter ended
September 30, 2018
(the "Report") fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
•
|
the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
/s/ RANDAL J. KIRK
|
Randal J. Kirk
|
Chairman and Chief Executive Officer
|
(Principal Executive Officer)
|
•
|
the Quarterly Report on Form 10-Q of the Company for the quarter ended
September 30, 2018
(the "Report") fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
•
|
the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
/s/ RICK L. STERLING
|
Rick L. Sterling
|
Chief Financial Officer
|
(Principal Financial Officer)
|