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Delaware
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04-3561634
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(State or Other Jurisdiction of
Incorporation or Organization)
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(I.R.S. Employer Identification No.)
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675 West Kendall Street, Cambridge, MA
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02142
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(Address of Principal Executive Offices)
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(Zip Code)
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Large accelerated filer
x
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Accelerated filer
¨
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Non-accelerated filer
¨
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Smaller reporting company
¨
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(Do not check if a smaller reporting company)
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Emerging growth company
¨
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Page
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|
|
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Condensed Consolidated Balance Sheets as of
September 30, 2017 and December 31, 2016
|
|
|
|
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Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three
and Nine Months Ended September 30, 2017 and 2016
|
|
|
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Condensed Consolidated Statements of Cash Flows for the
Nine Months Ended September 30, 2017 and 2016
|
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||
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September 30, 2017
|
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December 31, 2016
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||||
Assets
|
|
|
|
|
|
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Current assets:
|
|
|
|
|
|
||
Cash and cash equivalents
|
$
|
172,838
|
|
|
$
|
150,738
|
|
Marketable securities
|
245,948
|
|
|
202,413
|
|
||
Collaboration receivable
|
14,333
|
|
|
70,242
|
|
||
Restricted cash
|
2,412
|
|
|
—
|
|
||
Prepaid expenses and other current assets
|
6,958
|
|
|
4,607
|
|
||
Total current assets
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442,489
|
|
|
428,000
|
|
||
Marketable securities, long-term
|
4,292
|
|
|
—
|
|
||
Property and equipment, net
|
29,948
|
|
|
20,847
|
|
||
Intangible assets, net
|
4,324
|
|
|
5,189
|
|
||
Other long-term assets
|
21,489
|
|
|
23,701
|
|
||
Total assets
|
$
|
502,542
|
|
|
$
|
477,737
|
|
|
|
|
|
||||
Liabilities and Stockholders’ Equity
|
|
|
|
|
|
||
Current liabilities:
|
|
|
|
|
|
||
Accounts payable
|
$
|
12,652
|
|
|
$
|
3,632
|
|
Accrued expenses
|
25,152
|
|
|
26,866
|
|
||
Collaboration advance, net
|
13,888
|
|
|
32,895
|
|
||
Deferred revenue
|
54,487
|
|
|
7,272
|
|
||
Other current liabilities
|
80
|
|
|
11
|
|
||
Total current liabilities
|
106,259
|
|
|
70,676
|
|
||
Deferred revenue, net of current portion
|
29,845
|
|
|
31,360
|
|
||
Other long-term liabilities
|
5,924
|
|
|
3,793
|
|
||
Total liabilities
|
142,028
|
|
|
105,829
|
|
||
Commitments and contingencies (Note 6)
|
|
|
|
|
|
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Stockholders’ Equity:
|
|
|
|
|
|
||
Common stock, $0.0001 par value per share; 100,000 shares authorized, 76,623 shares issued and 76,394 shares outstanding at September 30, 2017 and 71,305 shares issued and 71,076 outstanding at December 31, 2016
|
8
|
|
|
7
|
|
||
Additional paid-in capital
|
939,586
|
|
|
848,304
|
|
||
Accumulated other comprehensive income
|
47
|
|
|
86
|
|
||
Accumulated deficit
|
(576,013
|
)
|
|
(473,375
|
)
|
||
Treasury stock, at cost, 229 shares
|
(3,114
|
)
|
|
(3,114
|
)
|
||
|
|
|
|
||||
Total stockholders’ equity
|
360,514
|
|
|
371,908
|
|
||
|
|
|
|
||||
Total liabilities and stockholders’ equity
|
$
|
502,542
|
|
|
$
|
477,737
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2017
|
|
2016
|
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2017
|
|
2016
|
||||||||
Collaboration revenues:
|
|
|
|
|
|
|
|
|
|
||||||
Product revenue
|
$
|
10,890
|
|
|
$
|
23,339
|
|
|
$
|
53,434
|
|
|
$
|
58,831
|
|
Research and development revenue
|
13,200
|
|
|
5,805
|
|
|
20,840
|
|
|
16,593
|
|
||||
Total collaboration revenue
|
24,090
|
|
|
29,144
|
|
|
74,274
|
|
|
75,424
|
|
||||
|
|
|
|
|
|
|
|
||||||||
Operating expenses:
|
|
|
|
|
|
|
|
|
|
||||||
Research and development
|
37,914
|
|
|
31,568
|
|
|
113,078
|
|
|
93,498
|
|
||||
General and administrative
|
20,703
|
|
|
15,758
|
|
|
66,380
|
|
|
46,301
|
|
||||
Total operating expenses
|
58,617
|
|
|
47,326
|
|
|
179,458
|
|
|
139,799
|
|
||||
|
|
|
|
|
|
|
|
||||||||
Operating loss
|
(34,527
|
)
|
|
(18,182
|
)
|
|
(105,184
|
)
|
|
(64,375
|
)
|
||||
|
|
|
|
|
|
|
|
||||||||
Other income, net
|
1,339
|
|
|
638
|
|
|
3,329
|
|
|
1,833
|
|
||||
|
|
|
|
|
|
|
|
||||||||
Net loss
|
$
|
(33,188
|
)
|
|
$
|
(17,544
|
)
|
|
$
|
(101,855
|
)
|
|
$
|
(62,542
|
)
|
|
|
|
|
|
|
|
|
||||||||
Basic and diluted net loss per share
|
$
|
(0.44
|
)
|
|
$
|
(0.26
|
)
|
|
$
|
(1.40
|
)
|
|
$
|
(0.91
|
)
|
|
|
|
|
|
|
|
|
||||||||
Weighted average shares used in computing basic and diluted net loss per share
|
74,611
|
|
|
68,799
|
|
|
72,585
|
|
|
68,540
|
|
||||
|
|
|
|
|
|
|
|
||||||||
Comprehensive loss:
|
|
|
|
|
|
|
|
|
|
||||||
Net loss
|
$
|
(33,188
|
)
|
|
$
|
(17,544
|
)
|
|
$
|
(101,855
|
)
|
|
$
|
(62,542
|
)
|
Net unrealized holding gains (losses) on available-for-sale marketable securities
|
52
|
|
|
(36
|
)
|
|
(39
|
)
|
|
246
|
|
||||
Comprehensive loss
|
$
|
(33,136
|
)
|
|
$
|
(17,580
|
)
|
|
$
|
(101,894
|
)
|
|
$
|
(62,296
|
)
|
|
Nine Months Ended September 30,
|
||||||
|
2017
|
|
2016
|
||||
Cash Flows from Operating Activities:
|
|
|
|
|
|
||
Net loss
|
$
|
(101,855
|
)
|
|
$
|
(62,542
|
)
|
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
|
|
|
|
|
|
||
Depreciation and amortization of property and equipment
|
4,719
|
|
|
5,726
|
|
||
Share-based compensation expense
|
16,309
|
|
|
14,756
|
|
||
Amortization of premium on investments
|
248
|
|
|
524
|
|
||
Amortization of intangibles
|
865
|
|
|
1,240
|
|
||
Changes in working capital
|
87,567
|
|
|
4,141
|
|
||
|
|
|
|
||||
Net cash provided by (used in) operating activities
|
7,853
|
|
|
(36,155
|
)
|
||
|
|
|
|
||||
Cash Flows from Investing Activities:
|
|
|
|
|
|
||
Purchases of property and equipment
|
(11,213
|
)
|
|
(4,806
|
)
|
||
Purchases of marketable securities
|
(366,292
|
)
|
|
(264,905
|
)
|
||
Proceeds from maturities of marketable securities
|
318,178
|
|
|
350,531
|
|
||
|
|
|
|
||||
Net cash (used in) provided by investing activities
|
(59,327
|
)
|
|
80,820
|
|
||
|
|
|
|
||||
Cash Flows from Financing Activities:
|
|
|
|
|
|
||
Net proceeds from issuance of common stock under ATM facility
|
64,090
|
|
|
—
|
|
||
Proceeds from issuance of common stock under stock plans
|
9,484
|
|
|
1,218
|
|
||
Repurchase of common stock pursuant to share surrender
|
—
|
|
|
(1,065
|
)
|
||
|
|
|
|
||||
Net cash provided by financing activities
|
73,574
|
|
|
153
|
|
||
|
|
|
|
||||
Net increase in cash and cash equivalents
|
22,100
|
|
|
44,818
|
|
||
Cash and cash equivalents, beginning of period
|
150,738
|
|
|
61,461
|
|
||
Cash and cash equivalents, end of period
|
$
|
172,838
|
|
|
$
|
106,279
|
|
|
|
|
|
||||
Non-Cash Investing/Financing Activities:
|
|
|
|
||||
Purchases of property and equipment included in accounts payable and accrued expenses
|
$
|
3,542
|
|
|
$
|
267
|
|
Common shares issued to Parivid to settle milestone payment
|
$
|
—
|
|
|
$
|
3,190
|
|
Receivable due from stock option exercises
|
$
|
617
|
|
|
$
|
—
|
|
As of September 30, 2017
|
|
Total
|
|
Quoted
Prices in
Active
Markets
(Level 1)
|
|
Significant
Other
Observable
Inputs
(Level 2)
|
|
Significant
Other
Unobservable
Inputs
(Level 3)
|
||||||||
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash equivalents:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Money market funds
|
|
$
|
131,428
|
|
|
$
|
131,428
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Overnight repurchase agreements
|
|
29,000
|
|
|
—
|
|
|
29,000
|
|
|
—
|
|
||||
Marketable securities:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
U.S. government-sponsored enterprise securities
|
|
2,187
|
|
|
—
|
|
|
2,187
|
|
|
—
|
|
||||
Corporate debt securities
|
|
95,780
|
|
|
—
|
|
|
95,780
|
|
|
—
|
|
||||
Commercial paper obligations
|
|
102,668
|
|
|
—
|
|
|
102,668
|
|
|
—
|
|
||||
Asset-backed securities
|
|
49,605
|
|
|
—
|
|
|
49,605
|
|
|
—
|
|
||||
|
|
|
|
|
|
|
|
|
||||||||
Total
|
|
$
|
410,668
|
|
|
$
|
131,428
|
|
|
$
|
279,240
|
|
|
$
|
—
|
|
As of December 31, 2016
|
|
Total
|
|
Quoted
Prices in
Active
Markets
(Level 1)
|
|
Significant
Other
Observable
Inputs
(Level 2)
|
|
Significant
Other
Unobservable
Inputs
(Level 3)
|
||||||||
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash equivalents:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Money market funds
|
|
$
|
121,510
|
|
|
$
|
121,510
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Overnight repurchase agreements
|
|
24,000
|
|
|
—
|
|
|
24,000
|
|
|
—
|
|
||||
Marketable securities:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Corporate debt securities
|
|
47,906
|
|
|
—
|
|
|
47,906
|
|
|
—
|
|
||||
Commercial paper obligations
|
|
84,436
|
|
|
—
|
|
|
84,436
|
|
|
—
|
|
||||
Asset-backed securities
|
|
70,071
|
|
|
—
|
|
|
70,071
|
|
|
—
|
|
||||
|
|
|
|
|
|
|
|
|
||||||||
Total
|
|
$
|
347,923
|
|
|
$
|
121,510
|
|
|
$
|
226,413
|
|
|
$
|
—
|
|
As of September 30, 2017
|
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Fair
Value
|
||||||||
Cash, money market funds and overnight repurchase agreements
|
|
$
|
172,838
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
172,838
|
|
U.S. government-sponsored enterprise securities due in one year or less
|
|
2,188
|
|
|
—
|
|
|
(1
|
)
|
|
2,187
|
|
||||
Corporate debt securities due in one year or less
|
|
95,806
|
|
|
2
|
|
|
(28
|
)
|
|
95,780
|
|
||||
Commercial paper obligations due in one year or less
|
|
102,584
|
|
|
84
|
|
|
—
|
|
|
102,668
|
|
||||
Asset-backed securities due in one year or less
|
|
45,318
|
|
|
—
|
|
|
(5
|
)
|
|
45,313
|
|
||||
Asset-backed securities due in more than one year
|
|
4,297
|
|
|
—
|
|
|
(5
|
)
|
|
4,292
|
|
||||
|
|
|
|
|
|
|
|
|
||||||||
Total
|
|
$
|
423,031
|
|
|
$
|
86
|
|
|
$
|
(39
|
)
|
|
$
|
423,078
|
|
|
|
|
|
|
|
|
|
|
||||||||
Reported as:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash and cash equivalents
|
|
$
|
172,838
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
172,838
|
|
Marketable securities
|
|
250,193
|
|
|
86
|
|
|
(39
|
)
|
|
250,240
|
|
||||
|
|
|
|
|
|
|
|
|
||||||||
Total
|
|
$
|
423,031
|
|
|
$
|
86
|
|
|
$
|
(39
|
)
|
|
$
|
423,078
|
|
As of December 31, 2016
|
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Fair
Value
|
||||||||
Cash, money market funds and overnight repurchase agreements
|
|
$
|
150,738
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
150,738
|
|
Corporate debt securities due in one year or less
|
|
47,942
|
|
|
—
|
|
|
(36
|
)
|
|
47,906
|
|
||||
Commercial paper obligations due in one year or less
|
|
84,301
|
|
|
135
|
|
|
—
|
|
|
84,436
|
|
||||
Asset-backed securities due in one year or less
|
|
70,084
|
|
|
1
|
|
|
(14
|
)
|
|
70,071
|
|
||||
|
|
|
|
|
|
|
|
|
||||||||
Total
|
|
$
|
353,065
|
|
|
$
|
136
|
|
|
$
|
(50
|
)
|
|
$
|
353,151
|
|
|
|
|
|
|
|
|
|
|
||||||||
Reported as:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash and cash equivalents
|
|
$
|
150,738
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
150,738
|
|
Marketable securities
|
|
202,327
|
|
|
136
|
|
|
(50
|
)
|
|
202,413
|
|
||||
|
|
|
|
|
|
|
|
|
||||||||
Total
|
|
$
|
353,065
|
|
|
$
|
136
|
|
|
$
|
(50
|
)
|
|
$
|
353,151
|
|
Property Location
|
Approximate Square Footage
|
Lease Expiration Date
|
Letter of Credit Amount
|
Balance Sheet Classification
|
|||
675 West Kendall Street
|
78,500
|
|
4/30/2018
|
$
|
2,412
|
|
Current Asset
|
320 Bent Street
|
105,000
|
|
2/28/2027
|
748
|
|
Non-Current Asset
|
|
301 Binney Street, Fifth Floor
|
80,000
|
|
6/29/2025
|
1,101
|
|
Non-Current Asset
|
|
301 Binney Street, Fourth Floor
|
53,000
|
|
3/31/2028
|
1,271
|
|
Non-Current Asset
|
|
Total
|
|
|
$
|
5,532
|
|
|
|
|
For the Three Months Ended September 30, 2017
|
||||||||||||||||||
|
|
2003 Sandoz
Collaboration
Agreement
|
|
2006 Sandoz
Collaboration
Agreement
|
|
Mylan
Collaboration
Agreement
|
|
CSL License Agreement
|
|
Total
Collaborations
|
||||||||||
Collaboration revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
Product revenue
|
|
$
|
—
|
|
|
$
|
10,890
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
10,890
|
|
Research and development revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Milestone
|
|
—
|
|
|
10,000
|
|
|
—
|
|
|
—
|
|
|
10,000
|
|
|||||
Recognition of upfront payments
|
|
—
|
|
|
—
|
|
|
1,122
|
|
|
—
|
|
|
1,122
|
|
|||||
Research and development services and external costs
|
|
60
|
|
|
673
|
|
|
—
|
|
|
1,345
|
|
|
2,078
|
|
|||||
Total research and development revenue
|
|
60
|
|
|
10,673
|
|
|
1,122
|
|
|
1,345
|
|
|
13,200
|
|
|||||
Total collaboration revenues
|
|
$
|
60
|
|
|
$
|
21,563
|
|
|
$
|
1,122
|
|
|
$
|
1,345
|
|
|
$
|
24,090
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Research and development expense
|
|
$
|
21
|
|
|
$
|
422
|
|
|
$
|
14,709
|
|
|
$
|
2,544
|
|
|
$
|
17,696
|
|
General and administrative expense
|
|
3,780
|
|
|
119
|
|
|
1,004
|
|
|
36
|
|
|
4,939
|
|
|||||
Less: net recoverable amount from collaboration partner
|
|
—
|
|
|
—
|
|
|
(7,046
|
)
|
|
(837
|
)
|
|
(7,883
|
)
|
|||||
Total operating expenses
|
|
$
|
3,801
|
|
|
$
|
541
|
|
|
$
|
8,667
|
|
|
$
|
1,743
|
|
|
$
|
14,752
|
|
|
|
For the Three Months Ended September 30, 2016
|
||||||||||||||||||
|
|
2003 Sandoz
Collaboration
Agreement
|
|
2006 Sandoz
Collaboration
Agreement
|
|
Mylan
Collaboration
Agreement
|
|
Baxalta
Collaboration
Agreement (1)
|
|
Total
Collaborations
|
||||||||||
Collaboration revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Product revenue
|
|
$
|
—
|
|
|
$
|
23,339
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
23,339
|
|
Research and development revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Recognition of upfront payments
|
|
—
|
|
|
—
|
|
|
1,785
|
|
|
2,498
|
|
|
4,283
|
|
|||||
Research and development services and external costs
|
|
128
|
|
|
494
|
|
|
—
|
|
|
900
|
|
|
1,522
|
|
|||||
Total research and development revenue
|
|
128
|
|
|
494
|
|
|
1,785
|
|
|
3,398
|
|
|
5,805
|
|
|||||
Total collaboration revenues
|
|
$
|
128
|
|
|
$
|
23,833
|
|
|
$
|
1,785
|
|
|
$
|
3,398
|
|
|
$
|
29,144
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Research and development expense
|
|
$
|
1
|
|
|
$
|
349
|
|
|
$
|
16,481
|
|
|
$
|
402
|
|
|
$
|
17,233
|
|
General and administrative expense
|
|
332
|
|
|
66
|
|
|
1,289
|
|
|
—
|
|
|
1,687
|
|
|||||
Less: net recoverable amount from collaboration partner
|
|
—
|
|
|
—
|
|
|
(8,114
|
)
|
|
—
|
|
|
(8,114
|
)
|
|||||
Total operating expenses
|
|
$
|
333
|
|
|
$
|
415
|
|
|
$
|
9,656
|
|
|
$
|
402
|
|
|
$
|
10,806
|
|
|
|
For the Nine Months Ended September 30, 2017
|
|||||||||||||||||||
|
|
2003 Sandoz
Collaboration
Agreement
|
|
2006 Sandoz
Collaboration
Agreement
|
|
Mylan
Collaboration
Agreement
|
|
CSL License Agreement
|
|
Total
Collaborations
|
|||||||||||
Collaboration revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Product revenue
|
|
$
|
—
|
|
|
$
|
53,434
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
53,434
|
|
|
Research and development revenue:
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
Milestone
|
|
—
|
|
|
10,000
|
|
|
—
|
|
|
—
|
|
—
|
|
10,000
|
|
|||||
Recognition of upfront payments
|
|
—
|
|
|
—
|
|
|
4,299
|
|
|
—
|
|
|
4,299
|
|
||||||
Research and development services and external costs
|
|
2,822
|
|
|
1,653
|
|
|
—
|
|
|
2,066
|
|
|
6,541
|
|
||||||
Total research and development revenue
|
|
2,822
|
|
|
11,653
|
|
|
4,299
|
|
|
2,066
|
|
|
20,840
|
|
||||||
Total collaboration revenues
|
|
$
|
2,822
|
|
|
$
|
65,087
|
|
|
$
|
4,299
|
|
|
$
|
2,066
|
|
|
$
|
74,274
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
Research and development expense
|
|
$
|
1,958
|
|
|
$
|
1,575
|
|
|
$
|
44,381
|
|
|
$
|
7,115
|
|
|
$
|
55,029
|
|
|
General and administrative expense
|
|
13,410
|
|
|
356
|
|
|
2,496
|
|
|
98
|
|
|
16,360
|
|
||||||
Less: net recoverable amount from collaboration partner
|
|
—
|
|
|
—
|
|
|
(19,982
|
)
|
|
(4,333
|
)
|
|
(24,315
|
)
|
||||||
Total operating expenses
|
|
$
|
15,368
|
|
|
$
|
1,931
|
|
|
$
|
26,895
|
|
|
$
|
2,880
|
|
|
$
|
47,074
|
|
|
|
For the Nine Months Ended September 30, 2016
|
||||||||||||||||||
|
|
2003 Sandoz
Collaboration
Agreement
|
|
2006 Sandoz
Collaboration
Agreement
|
|
Mylan
Collaboration
Agreement
|
|
Baxalta
Collaboration
Agreement (1)
|
|
Total
Collaborations
|
||||||||||
Collaboration revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
Product revenue
|
|
$
|
—
|
|
|
$
|
58,831
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
58,831
|
|
Research and development revenue:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Recognition of upfront payments
|
|
—
|
|
|
—
|
|
|
4,550
|
|
|
7,382
|
|
|
11,932
|
|
|||||
Research and development services and external costs
|
|
266
|
|
|
1,878
|
|
|
—
|
|
|
2,517
|
|
|
4,661
|
|
|||||
Total research and development revenue
|
|
266
|
|
|
1,878
|
|
|
4,550
|
|
|
9,899
|
|
|
16,593
|
|
|||||
Total collaboration revenues
|
|
$
|
266
|
|
|
$
|
60,709
|
|
|
$
|
4,550
|
|
|
$
|
9,899
|
|
|
$
|
75,424
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Research and development expense
|
|
$
|
1
|
|
|
$
|
1,643
|
|
|
$
|
40,658
|
|
|
$
|
880
|
|
|
$
|
43,182
|
|
General and administrative expense
|
|
1,865
|
|
|
341
|
|
|
2,416
|
|
|
316
|
|
|
4,938
|
|
|||||
Less: net recoverable amount from collaboration partner
|
|
—
|
|
|
—
|
|
|
(20,766
|
)
|
|
—
|
|
|
(20,766
|
)
|
|||||
Total operating expenses
|
|
$
|
1,866
|
|
|
$
|
1,984
|
|
|
$
|
22,308
|
|
|
$
|
1,196
|
|
|
$
|
27,354
|
|
|
|
For the Three Months Ended
September 30, 2017 |
|
For the Three Months Ended
September 30, 2016 |
|
For the Nine Months Ended
September 30, 2017 |
|
For the Nine Months Ended
September 30, 2016 |
||||||||
Research and development
|
|
$
|
1,860
|
|
|
$
|
2,042
|
|
|
$
|
6,083
|
|
|
$
|
6,426
|
|
General and administrative
|
|
3,056
|
|
|
2,897
|
|
|
10,226
|
|
|
8,330
|
|
||||
Total share-based compensation expense
|
|
$
|
4,916
|
|
|
$
|
4,939
|
|
|
$
|
16,309
|
|
|
$
|
14,756
|
|
|
|
For the Three Months Ended
September 30, 2017 |
|
For the Three Months Ended
September 30, 2016 |
|
For the Nine Months Ended
September 30, 2017 |
|
For the Nine Months Ended
September 30, 2016 |
||||||||
Stock options
|
|
$
|
2,494
|
|
|
$
|
2,149
|
|
|
$
|
7,819
|
|
|
$
|
7,278
|
|
Restricted stock awards and units
|
|
2,289
|
|
|
2,688
|
|
|
8,120
|
|
|
7,161
|
|
||||
Employee stock purchase plan
|
|
133
|
|
|
102
|
|
|
370
|
|
|
317
|
|
||||
Total share-based compensation expense
|
|
$
|
4,916
|
|
|
$
|
4,939
|
|
|
$
|
16,309
|
|
|
$
|
14,756
|
|
|
|
Weighted Average Assumptions
|
||||||||||
|
|
Stock Options
|
|
Employee Stock Purchase Plan
|
||||||||
|
|
For the Three Months Ended September 30, 2017
|
|
For the Three Months Ended September 30, 2016
|
|
For the Three Months Ended September 30, 2017
|
|
For the Three Months Ended September 30, 2016
|
||||
Expected volatility
|
|
50
|
%
|
|
60
|
%
|
|
52
|
%
|
|
58
|
%
|
Expected dividends
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Expected life (years)
|
|
6.2
|
|
|
6.1
|
|
|
0.5
|
|
|
0.5
|
|
Risk-free interest rate
|
|
2.0
|
%
|
|
1.4
|
%
|
|
0.9
|
%
|
|
0.4
|
%
|
|
|
Weighted Average Assumptions
|
||||||||||
|
|
Stock Options
|
|
Employee Stock Purchase Plan
|
||||||||
|
|
For the Nine Months Ended September 30, 2017
|
|
For the Nine Months Ended September 30, 2016
|
|
For the Nine Months Ended September 30, 2017
|
|
For the Nine Months Ended September 30, 2016
|
||||
Expected volatility
|
|
53
|
%
|
|
58
|
%
|
|
55
|
%
|
|
57
|
%
|
Expected dividends
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Expected life (years)
|
|
5.8
|
|
|
6.1
|
|
|
0.5
|
|
|
0.5
|
|
Risk-free interest rate
|
|
2.1
|
%
|
|
1.5
|
%
|
|
0.7
|
%
|
|
0.4
|
%
|
Operating lease commitments
|
Total
|
||
October 1 to December 31, 2017
|
$
|
3,310
|
|
2018
|
19,013
|
|
|
2019
|
18,848
|
|
|
2020
|
19,380
|
|
|
2021
|
19,856
|
|
|
2022 and beyond
|
102,860
|
|
|
Total future minimum lease payments
|
$
|
183,267
|
|
•
|
expenses incurred under agreements with consultants, third-party contract research organizations, or CROs, and investigative sites where all of our nonclinical studies and clinical trials are conducted;
|
•
|
costs of acquiring reference comparator materials and manufacturing nonclinical study and clinical trial supplies and other materials from contract manufacturing organizations, or CMOs, and related costs associated with release and stability testing; and
|
•
|
costs associated with process development activities.
|
•
|
personnel-related expenses, which include salaries, benefits and share-based compensation; and
|
•
|
facilities and other allocated expenses, which include direct and allocated expenses for rent and maintenance of facilities, depreciation and amortization of leasehold improvements and equipment and laboratory and other supplies.
|
|
Phase of Development as of
|
|
Three Months Ended September 30,
|
|
Project
Inception to
|
||||||||
|
September 30, 2017
|
|
2017
|
|
2016
|
|
September 30, 2017
|
||||||
External Costs Incurred by Product Area:
|
|
|
|
|
|
|
|
|
|
|
|||
Complex Generics(1)
|
ANDAs filed(2)
|
|
$
|
443
|
|
|
$
|
349
|
|
|
$
|
107,987
|
|
Biosimilars
|
Various(3)
|
|
14,581
|
|
|
2,413
|
|
|
154,811
|
|
|||
Novel Therapeutics
|
Various(4)
|
|
2,995
|
|
|
9,663
|
|
|
102,371
|
|
|||
Internal Costs
|
|
|
19,895
|
|
|
19,143
|
|
|
|
|
|||
Total Research and Development Expenses
|
|
|
$
|
37,914
|
|
|
$
|
31,568
|
|
|
|
|
(1)
|
Includes external costs for GLATOPA and Enoxaparin Sodium Injection.
|
(2)
|
In July 2010, the first ANDA for Enoxaparin Sodium Injection was approved by the FDA, and Sandoz launched the product. In April 2015, the FDA approved the ANDA for once-daily GLATOPA 20 mg/mL. Sandoz launched GLATOPA 20 mg/mL in June 2015. The ANDA for GLATOPA 40 mg/mL is under FDA review. For more information on GLATOPA 40 mg/mL, see "
—Overview—Complex Generics—GLATOPA
®
40 mg/mL—Generic Three-times-weekly COPAXONE
®
(glatiramer acetate injection) 40 mg/mL.
"
|
(3)
|
Biosimilars include M923, a biosimilar candidate of HUMIRA
®
(adalimumab), M834, a biosimilar candidate of ORENCIA
®
(abatacept), as well as
five
other biosimilar candidates, including our undisclosed biosimilar candidate, M710. In April 2016, enrollment in the pivotal clinical trial for M923 was completed and in November 2016, following an interim analysis, we announced top-line Phase III results including that M923 met its primary endpoint in
|
(4)
|
Our novel therapeutic programs include M281, for which the multiple ascending dose portion of a Phase 1 study was initiated in January 2017; M230, which our licensee, CSL, has informed us that it plans to advance with a goal of beginning clinical development in late
2017
, subject to regulatory feedback; M254, which is currently in preclinical development and for which we are planning to initiate an IND-enabling toxicology study in
2017
; costs related to our necuparanib program, which was discontinued in August 2016; as well as other discovery and nonclinical stage programs.
|
|
Phase of Development as of
|
|
Nine Months Ended September 30,
|
|
Project
Inception to
|
||||||||
|
September 30, 2017
|
|
2017
|
|
2016
|
|
September 30, 2017
|
||||||
External Costs Incurred by Product Area:
|
|
|
|
|
|
|
|
|
|
|
|||
Complex Generics(1)
|
ANDAs filed(2)
|
|
$
|
3,533
|
|
|
$
|
1,643
|
|
|
$
|
107,987
|
|
Biosimilars
|
Various(3)
|
|
41,091
|
|
|
8,625
|
|
|
154,811
|
|
|||
Novel Therapeutics
|
Various(4)
|
|
9,106
|
|
|
24,816
|
|
|
102,371
|
|
|||
Internal Costs
|
|
|
59,348
|
|
|
58,414
|
|
|
|
|
|||
Total Research and Development Expenses
|
|
|
$
|
113,078
|
|
|
$
|
93,498
|
|
|
|
|
(1)
|
Includes external costs for GLATOPA and Enoxaparin Sodium Injection.
|
(2)
|
In July 2010, the first ANDA for Enoxaparin Sodium Injection was approved by the FDA, and Sandoz launched the product. In April 2015, the FDA approved the ANDA for once-daily GLATOPA 20 mg/mL. Sandoz launched GLATOPA 20 mg/mL in June 2015. The ANDA for GLATOPA 40 mg/mL is under FDA review. For more information on GLATOPA 40 mg/mL, see "
—Overview—Complex Generics—GLATOPA
®
40 mg/mL—Generic Three-times-weekly COPAXONE
®
(glatiramer acetate injection) 40 mg/mL.
"
|
(3)
|
Biosimilars include M923, a biosimilar candidate of HUMIRA
®
(adalimumab), M834, a biosimilar candidate of ORENCIA
®
(abatacept), as well as
five
other biosimilar candidates, including our undisclosed biosimilar candidate, M710. In April 2016, enrollment in the pivotal clinical trial for M923 was completed and in November 2016, following an interim analysis, we announced top-line Phase III results including that M923 met its primary endpoint in the study. We completed a Phase 1 clinical trial of M834. Our other biosimilar candidates are in the discovery and process development phase. As a result of the cost-sharing provisions of the Mylan Collaboration Agreement, we offset approximately
$18.9 million
and
$19.8 million
against research and development costs during the
nine months ended September 30, 2017
and
2016
, respectively.
|
(4)
|
Our novel therapeutic programs include M281, for which the multiple ascending dose portion of a Phase 1 study was initiated in January 2017; M230, which our licensee, CSL, has informed us that it plans to advance with a goal of beginning clinical development in
2017
, subject to regulatory feedback; M254, which is currently in preclinical development and for which we are planning to initiate an IND-enabling toxicology study in
2017
; costs related to our necuparanib program, which was discontinued in August 2016; as well as other discovery and nonclinical stage programs.
|
|
|
Nine Months Ended September 30,
|
||||||
|
|
2017
|
|
2016
|
||||
|
|
(in thousands)
|
||||||
Net cash provided by (used in) operating activities
|
|
$
|
7,853
|
|
|
$
|
(36,155
|
)
|
Net cash (used in) provided by investing activities
|
|
$
|
(59,327
|
)
|
|
$
|
80,820
|
|
Net cash provided by financing activities
|
|
$
|
73,574
|
|
|
$
|
153
|
|
Net increase in cash and cash equivalents
|
|
$
|
22,100
|
|
|
$
|
44,818
|
|
•
|
settling patent lawsuits with generic or biosimilar companies, resulting in such patents remaining an obstacle for generic or biosimilar approval by others;
|
•
|
seeking to restrict biosimilar commercialization options by restricting access by biosimilar and generic applicants by litigation or legislative action to the use of inter partes patent review proceedings at the U.S. Patent Office to challenge invalid biologic patent rights;
|
•
|
settling paragraph IV patent litigation with generic companies to prevent the expiration of the 180-day generic marketing exclusivity period or to delay the triggering of such exclusivity period;
|
•
|
submitting Citizen Petitions to request the FDA Commissioner to take administrative action with respect to prospective and submitted generic drug or biosimilar applications or to influence the adoption of policy with regard to the submission of biosimilar applications;
|
•
|
appealing denials of Citizen Petitions in United States federal district courts and seeking injunctive relief to reverse approval of generic drug or biosimilar applications;
|
•
|
restricting access to reference products for equivalence and biosimilarity testing that interfere with timely generic and biosimilar development plans, respectively;
|
•
|
conducting medical education with physicians, payers and regulators that claim that generic or biosimilar products are too complex for generic or biosimilar approval and influence potential market share;
|
•
|
seeking state law restrictions on the substitution of generic and biosimilar products at the pharmacy without the intervention of a physician or through other restrictive means such as excessive recordkeeping requirements or patient and physician notification;
|
•
|
seeking federal or state regulatory restrictions on the use of the same non-proprietary name as the reference brand product for a biosimilar or interchangeable biologic;
|
•
|
seeking federal reimbursement policies that do not promote adoption of biosimilars and interchangeable biologics;
|
•
|
seeking changes to the United States Pharmacopeia, an industry recognized compilation of drug and biologic standards;
|
•
|
pursuing new patents for existing products or processes which could extend patent protection for a number of years or otherwise delay the launch of generic drugs or biosimilars; and
|
•
|
influencing legislatures so that they attach special regulatory exclusivity or patent extension amendments to unrelated federal legislation.
|
•
|
significantly greater financial, technical and human resources than we have at every stage of the discovery, development, manufacturing and commercialization process;
|
•
|
more extensive experience in commercializing generic drugs, biosimilars and novel therapeutics, conducting nonclinical studies, conducting clinical trials, obtaining regulatory approvals, challenging patents and manufacturing and marketing pharmaceutical products;
|
•
|
products that have been approved or are in late stages of development; and
|
•
|
collaborative arrangements in our target markets with leading companies and/or research institutions.
|
•
|
the safety and effectiveness of our products;
|
•
|
with regard to our generic products and our generic and biosimilar product candidates, the differential availability of clinical data and experience and willingness of physicians, payers and formularies to rely on biosimilarity data;
|
•
|
the timing and scope of regulatory approvals for these products and regulatory opposition to any product approvals;
|
•
|
the availability and cost of manufacturing, marketing, distribution and sales capabilities;
|
•
|
the effectiveness of our marketing, distribution and sales capabilities;
|
•
|
the price of our products;
|
•
|
the availability and amount of discounts, rebates and third-party reimbursement for our products; and
|
•
|
the strength of our patent positions.
|
•
|
the timing of our receipt of any marketing approvals, the terms of any approval and the countries in which approvals are obtained;
|
•
|
the safety, efficacy and ease of administration of our products;
|
•
|
the competitive landscape for our products, including but not limited to competitive pricing of our products;
|
•
|
physician confidence in the safety and efficacy of complex generic products or biosimilars;
|
•
|
the absence of, or limited clinical data available from, sameness testing of our complex generic products and biosimilarity or interchangeability testing of our biosimilar products;
|
•
|
the success and extent of our physician education and marketing programs;
|
•
|
the clinical, medical affairs, sales, distribution and marketing efforts of competitors; and
|
•
|
the availability and amount of government and third-party payer reimbursement.
|
•
|
we may find that the acquired company or assets does not further our business strategy, or that we overpaid for the company or assets, or that economic conditions change, all of which may generate a future impairment charge;
|
•
|
difficulty integrating the operations and personnel of the acquired business, and difficulty retaining the key personnel of the acquired business;
|
•
|
difficulty incorporating the acquired technologies;
|
•
|
difficulties or failures with the performance of the acquired technologies or products;
|
•
|
we may face product liability risks associated with the sale of the acquired company’s products;
|
•
|
disruption or diversion of management’s attention by transition or integration issues and the complexity of managing diverse locations;
|
•
|
difficulty maintaining uniform standards, internal controls, procedures and policies;
|
•
|
the acquisition may result in litigation from terminated employees or third parties; and
|
•
|
we may experience significant problems or liabilities associated with product quality, technology and legal contingencies.
|
•
|
the level of sales of GLATOPA 20 mg/mL;
|
•
|
the successful commercialization of GLATOPA 40 mg/mL and our other product candidates;
|
•
|
the impact of prior or contemporaneous competition on our products and product candidates, such as Mylan N.V.'s generic equivalents of COPAXONE 20 mg/mL and 40 mg/mL on GLATOPA 20 mg/mL and, if approved and launched, GLATOPA 40 mg/mL;
|
•
|
the cost of advancing our product candidates and funding our development programs, including the costs of nonclinical and clinical studies, obtaining reference product for nonclinical and clinical studies, manufacturing nonclinical and clinical supply material, and obtaining regulatory approvals;
|
•
|
the receipt of contingent milestone payments under our Mylan Collaboration Agreement;
|
•
|
the receipt of milestone payments under our CSL License Agreement;
|
•
|
the continuation without disruption of development and manufacturing activities of M923 following Baxalta’s termination of the Baxalta Collaboration Agreement, which was effective on December 31, 2016;
|
•
|
the timing of FDA approval of the products of our competitors;
|
•
|
the cost of litigation, including with Amphastar relating to Enoxaparin Sodium Injection, that is not otherwise covered by our collaboration agreements, or potential patent litigation with others, as well as any damages, including possibly treble damages, that may be owed to third parties should we be unsuccessful in such litigation;
|
•
|
the ability to enter into additional strategic alliances for our non-partnered programs, such as M923, as well as the terms and timing of any milestone, royalty or profit share payments thereunder;
|
•
|
whether we opt out of the cost-and-profit sharing arrangement under the CSL License Agreement;
|
•
|
the continued progress in our research and development programs, including completion of our nonclinical studies and clinical trials;
|
•
|
the cost of acquiring and/or in-licensing other technologies, products or assets; and
|
•
|
the cost of manufacturing, marketing and sales activities, if any.
|
•
|
contains the same active ingredients as COPAXONE 40 mg/mL;
|
•
|
is of the same dosage form, strength and route of administration as COPAXONE 40 mg/mL, and has the same labeling as the approved labeling for COPAXONE 40 mg/mL, with certain exceptions; and
|
•
|
meets compendia or other applicable standards for strength, quality, purity and identity, including potency.
|
•
|
a requirement for the applicant, as a condition to using the pre-approval patent exchange and clearance process, to share, in confidence, the information in its abbreviated pathway application with the reference product company’s and patent owner’s counsel;
|
•
|
the inclusion of multiple potential patent rights in the patent clearance process; and
|
•
|
a grant to each reference product company of 12 years of marketing exclusivity following the reference product approval.
|
•
|
regulators or institutional review boards may not authorize us to commence a clinical trial or conduct a clinical trial at a prospective trial site;
|
•
|
our nonclinical studies or clinical trials may produce negative or inconclusive results, and we may be required to conduct additional nonclinical studies or clinical trials or we may abandon projects that we previously expected to be promising;
|
•
|
enrollment in our clinical trials may be slower than we anticipate, resulting in significant delays, and participants may drop out of our clinical trials at a higher rate than we anticipate;
|
•
|
we might have to suspend or terminate our clinical trials if the participants are being exposed to unacceptable health risks;
|
•
|
regulators or institutional review boards may require that we hold, suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or if, in their opinion, participants are being exposed to unacceptable health risks;
|
•
|
the cost of our clinical trials may be greater than we anticipate;
|
•
|
the effects of our product candidates may not be the desired effects or may include undesirable side effects or our product candidates may have other unexpected characteristics; and
|
•
|
we may decide to modify or expand the clinical trials we are undertaking if new agents are introduced that influence current standard of care and medical practice, warranting a revision to our clinical development plan.
|
•
|
a covered benefit under its health plan;
|
•
|
safe, effective and medically necessary;
|
•
|
appropriate for the specific patient;
|
•
|
cost-effective; and
|
•
|
neither experimental nor investigational.
|
•
|
competition in seeking appropriate collaborators;
|
•
|
restrictions on future strategic alliances in existing strategic alliance agreements;
|
•
|
a reduced number of potential collaborators due to recent business combinations of large pharmaceutical companies;
|
•
|
inability to negotiate strategic alliances on a timely basis; and
|
•
|
inability to negotiate strategic alliances on acceptable terms.
|
•
|
a classified board of directors;
|
•
|
a prohibition on actions by our stockholders by written consent; and
|
•
|
limitations on the removal of directors.
|
•
|
delays in achievement of, or failure to achieve, program milestones that are associated with the valuation of our company or significant milestone revenue;
|
•
|
failure of GLATOPA 20 mg/mL to sustain profitable sales or market share that meet expectations of securities analysts;
|
•
|
adverse FDA decisions relating to our GLATOPA programs, including any FDA decision to delay approval of the GLATOPA 40 mg/mL ANDA until satisfactory resolution of the compliance observations in the FDA's February 2017 warning letter to Pfizer, Sandoz’ third party fill/finish manufacturer for GLATOPA, and an FDA decision to require additional data, including requiring clinical trials, as a condition to the GLATOPA 40 mg/mL ANDA approval;
|
•
|
litigation involving our company or our general industry or both, including litigation pertaining to the launch of our collaborators’ or our competitors’ products, including without limitation, a decision in the GLATOPA 40 mg/mL patent litigation or a competitors’ related patent litigation that prevents the launch or delays the launch of our GLATOPA 40 mg/mL product;
|
•
|
a decision in favor of, or against, Amphastar in our patent litigation suits, a settlement related to any case, or a decision in favor of third parties in antitrust litigation filed against us;
|
•
|
announcements by other companies regarding the status of their ANDAs for generic versions of COPAXONE;
|
•
|
FDA approval of other companies’ ANDAs for generic versions of COPAXONE;
|
•
|
marketing and/or launch of other companies’ generic versions of COPAXONE, such as Mylan N.V.'s October 2017 launch of its generic equivalents of COPAXONE 20 mg/mL and 40 mg/mL;
|
•
|
adverse FDA decisions regarding the development requirements for one of our biosimilar product candidates or failure of our other product applications to meet the requirements for regulatory review and/or approval;
|
•
|
results or delays in our or our competitors’ clinical trials or regulatory filings;
|
•
|
enactment of legislation that repeals the law enacting the biosimilar regulatory approval pathway or amends the law in a manner that is adverse to our biosimilar development strategy;
|
•
|
failure to demonstrate therapeutic equivalence with respect to our technology-enabled generic product candidate, GLATOPA 40 mg/mL, or biosimilarity or interchangeability with respect to our biosimilar product candidates such as M923 or M834;
|
•
|
demonstration of or failure to demonstrate the safety and efficacy for our novel product candidates;
|
•
|
our inability to manufacture any products in conformance with cGMP or in sufficient quantities to meet the requirements for the commercial sale of the product or to meet market demand;
|
•
|
failure of any of our product candidates, if approved, to achieve commercial success;
|
•
|
the discovery of unexpected or increased incidence in patients’ adverse reactions to the use of our products or product candidates or indications of other safety concerns;
|
•
|
developments or disputes concerning our patents or other proprietary rights;
|
•
|
changes in estimates of our financial results or recommendations by securities analysts;
|
•
|
termination of any of our product development and commercialization collaborations;
|
•
|
significant acquisitions, strategic partnerships, joint ventures or capital commitments by us or our competitors;
|
•
|
investors’ general perception of our company, our products, the economy and general market conditions;
|
•
|
rapid or disorderly sales of stock by holders of significant amounts of our stock; or
|
•
|
significant fluctuations in the price of securities generally or biotechnology company securities specifically.
|
|
*
|
Filed herewith.
|
**
|
Furnished herewith.
|
+
|
Confidential treatment requested as to certain portions, which portions are omitted and filed separately with the Securities and Exchange Commission.
|
|
Momenta Pharmaceuticals, Inc.
|
|
|
|
|
Date: November 1, 2017
|
By:
|
/s/ Craig A. Wheeler
|
|
|
Craig A. Wheeler, President and Chief Executive Officer
|
|
|
(Principal Executive Officer)
|
|
|
|
|
|
|
Date: November 1, 2017
|
By:
|
/s/ Scott M. Storer
|
|
|
Scott M. Storer, Senior Vice President and Chief Financial Officer
|
|
|
(Principal Financial and Accounting Officer)
|
Definition or Provision
|
Means the Following (As of the Binney Term Commencement Date)
|
Approximate Rentable Area of Binney Premises
|
52,252 square feet
|
Approximate Rentable Area of Binney Building
|
417,290 square feet
|
Tenant’s Pro Rata Share of Binney Building
|
12.52%
|
Dates
|
Square Feet of Rentable Area
|
Base Rent per Square Foot of Rentable Area
|
Monthly Base Rent*
|
Annual Base Rent*
|
|
Binney Rent Commencement Date – Month 12 after Binney Rent Commencement Date
|
52,252
|
$73.00
|
$317,866.33
|
$3,814,396
|
Dates
|
Square Feet of Rentable Area
|
Base Rent per Square Foot of Rentable Area
|
Monthly Base Rent
|
Annual Base Rent
|
9/1/2017 – 8/31/2018
|
104,678
|
$77.52 annually
|
$676,219.88
|
$8,114,638.56
|
9/1/2018 - 8/31/2019
|
104,678
|
$79.62 annually
|
$694,538.53
|
$8,334,462.36
|
9/1/2019 - 8/31/2020
|
104,678
|
$81.78 annually
|
$713,380.57
|
$8,560,566.84
|
9/1/2020 - 8/31/2021
|
104,678
|
$84.01 annually
|
$732,833.23
|
$8,793,998.78
|
9/1/2021 - 8/31/2022
|
104,678
|
$86.31 annually
|
$752,896.52
|
$9,034,758.18
|
9/1/2022 - 8/31/2023
|
104,678
|
$88.67 annually
|
$773,483.19
|
$9,281,798.26
|
9/1/2023 - 8/31/2024
|
104,678
|
$91.11 annually
|
$794,767.72
|
$9,537,212.58
|
9/1/2024 - 8/31/2025
|
104,678
|
$93.62 annually
|
$816,662.86
|
$9,799,954.36
|
9/1/2025 - 8/31/2026
|
104,678
|
$96.20 annually
|
$839,168.63
|
$10,070,023.60
|
9/1/2026 - 2/28/2027
|
104,678
|
$98.86 annually
|
$862,372.26
|
$10,348,467.08*
|
Dates
|
Square Feet of Rentable Area
|
Base Rent per Square Foot of Rentable Area
|
Monthly Base Rent
|
Annual Base Rent
|
9/1/2017 - 8/31/2018
|
104,678
|
$70.04 annually
|
$610,970.59
|
$7,331,647.12
|
9/1/2018 - 8/31/2019
|
104,678
|
$72.14 annually
|
$629,289.24
|
$7,551,470.92
|
9/1/2019 - 8/31/2020
|
104,678
|
$74.30 annually
|
$648,131.28
|
$7,777,575.40
|
9/1/2020 - 8/31/2021
|
104,678
|
$76.53 annually
|
$667,583.95
|
$8,011,007.34
|
9/1/2021 - 8/31/2022
|
104,678
|
$78.83 annually
|
$687,647.23
|
$8,251,766.74
|
9/1/2022 - 8/31/2023
|
104,678
|
$81.19 annually
|
$708,233.90
|
$8,498,806.82
|
9/1/2023 - 8/31/2024
|
104,678
|
$83.63 annually
|
$729,518.43
|
$8,754,221.14
|
9/1/2024 - 8/31/2025
|
104,678
|
$86.14 annually
|
$751,413.58
|
$9,016,962.92
|
9/1/2025 - 8/31/2026
|
104,678
|
$88.72 annually
|
$773,919.35
|
$9,287,032.16
|
9/1/2026 - 2/28/2027
|
104,678
|
$91.38 annually
|
$797,122.97
|
$9,565,475.64*
|
d. Commercial General Liability:
Bodily Injury and Property Damage
|
Commercially reasonable amounts, but in any event no less than $1,000,000 per occurrence and $2,000,000 general aggregate, with $2,000,000 products and completed operations aggregate.
|
b. Commercial Automobile Liability:
Bodily Injury and Property Damage
|
$1,000,000 per accident
|
c. Employer’s Liability:
Each Accident
Disease – Policy Limit
Disease – Each Employee
|
$500,000
$500,000
$500,000
|
d. Umbrella Liability:
Bodily Injury and Property Damage
|
Commercially reasonable amounts (excess of coverages a, b and c above), but in any event no less than $5,000,000 per occurrence / aggregate.
|
Dates
|
Approximate Square Feet of Rentable Area
|
Base Rent per Square Foot of Rentable Area
|
Monthly Base Rent
|
Annual Base Rent
|
[__]/[__]/[__]-[__]/[__]/[__]
|
[ ]
|
$[_______]
|
[ ]
|
[ ]
|
Re:
|
Collaboration and License Agreement dated June 13, 2007, as amended/Write-Off Amount
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of Momenta Pharmaceuticals, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer 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:
|
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):
|
Dated: November 1, 2017
|
/s/ Craig A. Wheeler
|
|
Craig A. Wheeler
|
|
President and Chief Executive Officer
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of Momenta Pharmaceuticals, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer 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:
|
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):
|
Dated: November 1, 2017
|
/s/ Scott M. Storer
|
|
Scott M. Storer
|
|
Senior Vice President and Chief Financial Officer
|
Dated: November 1, 2017
|
/s/ Craig A. Wheeler
|
|
Craig A. Wheeler
|
|
President and Chief Executive Officer
|
|
|
Dated: November 1, 2017
|
/s/ Scott M. Storer
|
|
Scott M. Storer
|
|
Senior Vice President and Chief Financial Officer
|