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☒
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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☐
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
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06-1591613
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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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9704 Medical Center Drive
Rockville, Maryland
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20850
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(Address of principal executive offices)
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(Zip code)
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Large accelerated filer
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☒
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Accelerated filer
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☐
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Non-accelerated filer
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☐ (Do not check if a smaller reporting company)
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Smaller reporting company
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☐
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Emerging growth company ☐
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PART I.
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Item 1.
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Item 2.
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Item 3.
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Item 4.
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PART II.
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Item 1A.
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Item 6.
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•
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our plans to develop and commercialize our product candidates;
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•
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the outcomes of our ongoing and planned clinical trials, including when clinical trials will be initiated and completed and when data will be reported or regulatory filings made;
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•
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the timing of and our ability to obtain and maintain regulatory approvals for our product candidates;
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•
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our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;
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•
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our ability to enter into new collaborations or to identify additional products or product candidates with significant commercial potential that are consistent with our commercial objectives;
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•
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our ability to recover the investment in our manufacturing capabilities;
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•
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the rate and degree of market acceptance and clinical utility of our products;
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•
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our commercialization, marketing and manufacturing capabilities and strategy;
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•
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significant competition in our industry;
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•
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costs of litigation and the failure to successfully defend lawsuits and other claims against us;
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•
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economic, political and other risks associated with our international operations;
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•
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our ability to receive research funding and achieve anticipated milestones under our collaborations;
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•
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our ability to protect and enforce patents and other intellectual property;
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•
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costs of compliance and our failure to comply with new and existing governmental regulations including, but not limited to, tax regulations;
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•
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loss or retirement of key members of management;
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•
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failure to successfully execute our growth strategy, including any delays in our planned future growth; and
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•
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our failure to maintain effective internal controls.
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March 31, 2018
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December 31, 2017
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||||
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(unaudited)
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||||
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Assets
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||||
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Current assets:
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||||
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Cash and cash equivalents
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$
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200,448
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$
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211,727
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Marketable securities
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59,633
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93,394
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Accounts receivable
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7,281
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13,643
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|
||
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Prepaid expenses
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3,328
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|
|
3,151
|
|
||
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Other current assets
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349
|
|
|
383
|
|
||
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Total current assets
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271,039
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|
|
322,298
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|
||
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Property and equipment, net
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53,443
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|
|
49,983
|
|
||
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Other assets
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1,596
|
|
|
1,602
|
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Total assets
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$
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326,078
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$
|
373,883
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||||
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Liabilities and stockholders' equity
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||||
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Current liabilities:
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||||
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Accounts payable
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$
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10,266
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$
|
2,451
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Accrued expenses
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30,489
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38,581
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Deferred revenue
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8,121
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7,202
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Deferred rent
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905
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1,048
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Lease exit liability
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—
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298
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Other liabilities
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175
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175
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Total current liabilities
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49,956
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49,755
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Deferred revenue, net of current portion
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17,762
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13,637
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Deferred rent, net of current portion
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11,084
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11,253
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Total liabilities
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78,802
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74,645
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Stockholders' equity:
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|
||||
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Common stock, $0.01 par value – 125,000,000 shares authorized, 37,024,623 and 36,859,077 shares outstanding at March 31, 2018 and December 31, 2017, respectively
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370
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|
|
369
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|
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Additional paid-in capital
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615,284
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611,270
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Accumulated deficit
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(368,355
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)
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(312,340
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)
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Accumulated other comprehensive loss
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(23
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)
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(61
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)
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Total stockholders' equity
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247,276
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299,238
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Total liabilities and stockholders' equity
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$
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326,078
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$
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373,883
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Three Months Ended March 31,
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||||||
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2018
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2017
|
||||
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Revenues:
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Revenue from collaborative agreements
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$
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4,501
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$
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1,278
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Revenue from government agreements
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194
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777
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Total revenues
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4,695
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2,055
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Costs and expenses:
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Research and development
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45,670
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32,801
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General and administrative
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9,235
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7,462
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Total costs and expenses
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54,905
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40,263
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Loss from operations
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(50,210
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)
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(38,208
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)
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Other income
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674
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553
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Net loss
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(49,536
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)
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(37,655
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)
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Other comprehensive loss:
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||||
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Unrealized gain (loss) on investments
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39
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(26
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)
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Comprehensive loss
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$
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(49,497
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)
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$
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(37,681
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)
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||||
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||||
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Basic and diluted net loss per common share
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$
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(1.34
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)
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$
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(1.08
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)
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Basic and diluted weighted average common shares outstanding
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36,936,560
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34,958,228
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Three Months Ended March 31,
|
||||||
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2018
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2017
|
||||
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Cash flows from operating activities
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|
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|
||||
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Net loss
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$
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(49,536
|
)
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$
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(37,655
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)
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Adjustments to reconcile net loss to net cash used in operating activities:
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|
||||
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Depreciation and amortization expense
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1,338
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1,978
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Stock-based compensation
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3,432
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3,461
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|
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Changes in operating assets and liabilities:
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|
||||
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Accounts receivable
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6,361
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|
|
671
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|
||
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Prepaid expenses
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(177
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)
|
|
(1,535
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)
|
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Other assets
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40
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|
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(81
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)
|
||
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Accounts payable and other liabilities
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7,815
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(2,223
|
)
|
||
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Accrued expenses
|
1,477
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|
|
1,823
|
|
||
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Lease exit liability
|
(298
|
)
|
|
(379
|
)
|
||
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Deferred revenue
|
(1,435
|
)
|
|
(1,065
|
)
|
||
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Deferred rent
|
(312
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)
|
|
(326
|
)
|
||
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Net cash used in operating activities
|
(31,295
|
)
|
|
(35,331
|
)
|
||
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Cash flows from investing activities
|
|
|
|
||||
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Purchases of marketable securities
|
(24,452
|
)
|
|
(56,937
|
)
|
||
|
Proceeds from sale and maturities of marketable securities
|
58,358
|
|
|
50,072
|
|
||
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Purchases of property and equipment
|
(14,519
|
)
|
|
(1,492
|
)
|
||
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Net cash provided by (used in) investing activities
|
19,387
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|
|
(8,357
|
)
|
||
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Cash flows from financing activities
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|
|
|
||||
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Proceeds from stock option exercises and ESPP purchases
|
629
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|
|
108
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|
||
|
Net cash provided by financing activities
|
629
|
|
|
108
|
|
||
|
Net change in cash and cash equivalents
|
(11,279
|
)
|
|
(43,580
|
)
|
||
|
Cash and cash equivalents at beginning of period
|
211,727
|
|
|
84,098
|
|
||
|
Cash and cash equivalents at end of period
|
$
|
200,448
|
|
|
$
|
40,518
|
|
|
|
Pre-Adoption
|
|
ASC 606 Adjustment
|
|
Post-Adoption
|
||||||
|
Deferred revenue, current
|
$
|
7,202
|
|
|
$
|
540
|
|
|
$
|
7,742
|
|
|
Deferred revenue, net of current portion
|
13,637
|
|
|
5,939
|
|
|
19,576
|
|
|||
|
Accumulated deficit
|
(312,340
|
)
|
|
(6,479
|
)
|
|
(318,819
|
)
|
|||
|
Three Months Ended March 31, 2018
|
As Reported
|
|
Balances without adoption of ASC 606
|
|
Effect of Change Higher/(Lower)
|
||||||
|
Revenue from collaborative agreements
|
$
|
4,501
|
|
|
$
|
4,366
|
|
|
$
|
135
|
|
|
Net loss
|
(49,536
|
)
|
|
(49,671
|
)
|
|
(135
|
)
|
|||
|
Basic and diluted net loss per common share
|
$
|
(1.34
|
)
|
|
$
|
(1.35
|
)
|
|
$
|
0.01
|
|
|
|
|
|
|
|
|
||||||
|
|
|
||||||||||
|
As of March 31, 2018
|
As Reported
|
|
Balances without adoption of ASC 606
|
|
Effect of Change Higher/(Lower)
|
||||||
|
Deferred revenue, current
|
$
|
8,121
|
|
|
$
|
7,417
|
|
|
$
|
704
|
|
|
Deferred revenue, net of current portion
|
17,762
|
|
|
12,122
|
|
|
5,640
|
|
|||
|
Accumulated deficit
|
(368,355
|
)
|
|
(362,011
|
)
|
|
6,344
|
|
|||
|
|
Balance at Beginning of Period
|
|
Additions
|
|
Deductions
|
|
Balance at End of Period
|
||||||||
|
Deferred revenue
|
$
|
27,318
|
|
|
$
|
500
|
|
|
$
|
(1,935
|
)
|
|
$
|
25,883
|
|
|
•
|
Level 1 - Fair value is determined by using unadjusted quoted prices that are available in active markets for identical assets and liabilities.
|
|
•
|
Level 2 - Fair value is determined by using inputs other than Level 1 quoted prices that are directly or indirectly observable. Inputs can include quoted prices for similar assets and liabilities in active markets or quoted prices for identical assets and liabilities in inactive markets. Related inputs can also include those used in valuation or other pricing models, such as interest rates and yield curves that can be corroborated by observable market data.
|
|
•
|
Level 3 - Fair value is determined by inputs that are unobservable and not corroborated by market data. Use of these inputs involves significant and subjective judgments to be made by a reporting entity - e.g., determining an appropriate adjustment to a discount factor for illiquidity associated with a given security.
|
|
|
Fair Value Measurements at March 31, 2018
|
||||||||||||||
|
|
|
|
Quoted Prices in Active Markets for Identical Assets
|
|
Significant Other Observable Inputs
|
|
Significant Unobservable Inputs
|
||||||||
|
|
Total
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||
|
Assets:
|
|
|
|
|
|
|
|
||||||||
|
Money market funds
|
$
|
96,851
|
|
|
$
|
96,851
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
U.S. Treasury securities
|
3,997
|
|
|
—
|
|
|
3,997
|
|
|
—
|
|
||||
|
Corporate debt securities
|
55,636
|
|
|
—
|
|
|
55,636
|
|
|
—
|
|
||||
|
Total assets measured at fair value
(a)
|
$
|
156,484
|
|
|
$
|
96,851
|
|
|
$
|
59,633
|
|
|
$
|
—
|
|
|
|
Fair Value Measurements at December 31, 2017
|
||||||||||||||
|
|
|
|
Quoted Prices in Active Markets for Identical Assets
|
|
Significant Other Observable Inputs
|
|
Significant Unobservable Inputs
|
||||||||
|
|
Total
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||
|
Assets:
|
|
|
|
|
|
|
|
||||||||
|
Money market funds
|
$
|
61,512
|
|
|
$
|
61,512
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
U.S. Treasury securities
|
3,990
|
|
|
—
|
|
|
3,990
|
|
|
—
|
|
||||
|
Government-sponsored enterprises
|
11,990
|
|
|
—
|
|
|
11,990
|
|
|
—
|
|
||||
|
Corporate debt securities
|
78,418
|
|
|
—
|
|
|
78,418
|
|
|
—
|
|
||||
|
Total assets measured at fair value
(a)
|
$
|
155,910
|
|
|
$
|
61,512
|
|
|
$
|
94,398
|
|
|
$
|
—
|
|
|
|
March 31, 2018
|
||||||||||||||
|
|
Amortized
Cost |
|
Gross
Unrealized Gains |
|
Gross
Unrealized Losses |
|
Fair
Value |
||||||||
|
U.S. Treasury securities
|
$
|
3,999
|
|
|
$
|
—
|
|
|
$
|
(2
|
)
|
|
$
|
3,997
|
|
|
Corporate debt securities
|
55,657
|
|
|
4
|
|
|
(25
|
)
|
|
55,636
|
|
||||
|
Total
|
$
|
59,656
|
|
|
$
|
4
|
|
|
$
|
(27
|
)
|
|
$
|
59,633
|
|
|
|
December 31, 2017
|
||||||||||||||
|
|
Amortized
Cost |
|
Gross
Unrealized Gains |
|
Gross
Unrealized Losses |
|
Fair
Value |
||||||||
|
U.S. Treasury securities
|
$
|
3,995
|
|
|
$
|
—
|
|
|
$
|
(6
|
)
|
|
$
|
3,989
|
|
|
Government-sponsored enterprises
|
11,998
|
|
|
—
|
|
|
(7
|
)
|
|
11,991
|
|
||||
|
Corporate debt securities
|
77,462
|
|
|
2
|
|
|
(50
|
)
|
|
77,414
|
|
||||
|
Total
|
$
|
93,455
|
|
|
$
|
2
|
|
|
$
|
(63
|
)
|
|
$
|
93,394
|
|
|
Accrual balance at December 31, 2017
|
$
|
298
|
|
|
Principal payments
|
(298
|
)
|
|
|
Accrual balance at March 31, 2018
|
$
|
—
|
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2018
|
|
2017
|
||||
|
Research and development
|
$
|
1,700
|
|
|
$
|
1,673
|
|
|
General and administrative
|
1,732
|
|
|
1,788
|
|
||
|
Total stock-based compensation expense
|
$
|
3,432
|
|
|
$
|
3,461
|
|
|
|
Three Months Ended March 31,
|
||
|
|
2018
|
|
2017
|
|
Expected dividend yield
|
0%
|
|
0%
|
|
Expected volatility
|
68% - 71%
|
|
67%
|
|
Risk-free interest rate
|
2.4% - 2.8%
|
|
2.3%
|
|
Expected term
|
6.25 years
|
|
6.25 years
|
|
|
Shares
|
|
Weighted-
Average Exercise Price |
|
Weighted-Average
Remaining Contractual Term (Years) |
|
Aggregate
Intrinsic Value (in thousands) |
|||||
|
Outstanding, December 31, 2017
|
4,504,642
|
|
|
$
|
19.79
|
|
|
7.0
|
|
|
||
|
Granted
|
1,038,874
|
|
|
28.49
|
|
|
|
|
|
|||
|
Exercised
|
(176,616
|
)
|
|
5.03
|
|
|
|
|
|
|||
|
Forfeited or expired
|
(51,423
|
)
|
|
20.90
|
|
|
|
|
|
|||
|
Outstanding, March 31, 2018
|
5,315,477
|
|
|
21.97
|
|
|
7.4
|
|
$
|
29,749
|
|
|
|
As of March 31, 2018:
|
|
|
|
|
|
|
|
|
|
|
||
|
Exercisable
|
2,940,789
|
|
|
18.61
|
|
|
6.1
|
|
25,431
|
|
||
|
Vested and expected to vest
|
5,074,332
|
|
|
21.76
|
|
|
7.4
|
|
29,334
|
|
||
|
|
Three Months Ended March 31,
|
||||||
|
|
2018
|
|
2017
|
||||
|
Numerator:
|
|
|
|
||||
|
Net loss used for calculation of basic and diluted EPS
|
$
|
(49,536
|
)
|
|
$
|
(37,655
|
)
|
|
|
|
|
|
||||
|
Denominator:
|
|
|
|
||||
|
Weighted average shares outstanding, basic
|
36,936,560
|
|
|
34,958,228
|
|
||
|
Effect of dilutive securities:
|
|
|
|
||||
|
Stock options and restricted stock units
|
—
|
|
|
—
|
|
||
|
Weighted average shares outstanding, diluted
|
36,936,560
|
|
|
34,958,228
|
|
||
|
|
|
|
|
||||
|
Net loss per share, basic and diluted
|
$
|
(1.34
|
)
|
|
$
|
(1.08
|
)
|
|
ITEM 2.
|
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
|
•
|
Incyte.
In October 2017, we entered into an exclusive global collaboration and license agreement with Incyte Corporation (Incyte) for INCMGA0012 (also known as MGA012), an investigational monoclonal antibody that inhibits programmed cell death protein 1 (PD-1). Incyte has obtained exclusive worldwide rights for the development and commercialization of INCMGA0012 in all indications, while we retain the right to develop our pipeline assets in combination with INCMGA0012. The transaction closed in the fourth quarter of 2017 and we received a $150.0 million upfront payment from Incyte upon the closing.
|
|
•
|
Servier.
In September 2012, we entered into an agreement with Les Laboratoires Servier and Institut de Recherches Servier (Servier) to develop and commercialize three DART® molecules in all countries other than the United States, Canada, Mexico, Japan, South Korea and India. We received a $20.0 million upfront option fee. In addition, we will be eligible to receive up to approximately $700 million in additional license fees and clinical, development, regulatory and sales milestone payments if Servier exercises its remaining options and successfully develops, obtains regulatory approval for, and commercializes a product under each license. Additionally, assuming exercise of its options, Servier may share Phase 2 and Phase 3 development costs and would be obligated to pay us low double-digit to mid-teen royalties on product sales in its territories.
|
|
|
Three Months Ended March 31,
|
|
Increase/(Decrease)
|
|||||||||||
|
|
2018
|
|
2017
|
|
|
|
|
|||||||
|
|
|
|
(dollars in millions)
|
|
|
|
|
|||||||
|
Revenue from collaborative agreements
|
$
|
4.5
|
|
|
$
|
1.3
|
|
|
$
|
3.2
|
|
|
252
|
%
|
|
Revenue from government agreements
|
0.2
|
|
|
0.8
|
|
|
(0.6
|
)
|
|
(75
|
)%
|
|||
|
Total revenue
|
$
|
4.7
|
|
|
$
|
2.1
|
|
|
$
|
2.6
|
|
|
128
|
%
|
|
|
Three Months Ended March 31,
|
|
Increase/(Decrease)
|
|||||||||||
|
|
2018
|
|
2017
|
|
|
|
|
|||||||
|
|
(dollars in millions)
|
|
|
|||||||||||
|
Margetuximab
|
$
|
18.5
|
|
|
$
|
10.7
|
|
|
$
|
7.8
|
|
|
73
|
%
|
|
Enoblituzumab
|
4.8
|
|
|
4.0
|
|
|
0.8
|
|
|
20
|
%
|
|||
|
Flotetuzumab
|
2.1
|
|
|
1.1
|
|
|
1.0
|
|
|
91
|
%
|
|||
|
MGA012
|
7.4
|
|
|
2.4
|
|
|
5.0
|
|
|
208
|
%
|
|||
|
MGD013
|
1.1
|
|
|
1.9
|
|
|
(0.8
|
)
|
|
(42
|
)%
|
|||
|
MGD009
|
2.2
|
|
|
1.1
|
|
|
1.1
|
|
|
100
|
%
|
|||
|
MGC018
|
1.6
|
|
|
3.2
|
|
|
(1.6
|
)
|
|
(50
|
)%
|
|||
|
MGD007
|
1.9
|
|
|
1.2
|
|
|
0.7
|
|
|
58
|
%
|
|||
|
Preclinical immune checkpoint programs
|
2.4
|
|
|
3.0
|
|
|
(0.6
|
)
|
|
(20
|
)%
|
|||
|
Other preclinical and clinical programs, collectively
|
3.7
|
|
|
4.2
|
|
|
(0.5
|
)
|
|
(12
|
)%
|
|||
|
Total research and development expense
|
$
|
45.7
|
|
|
$
|
32.8
|
|
|
$
|
12.9
|
|
|
39
|
%
|
|
|
Three Months Ended March 31,
|
|
Increase
|
|||||||||||
|
|
2018
|
|
2017
|
|
|
|
|
|||||||
|
|
|
|
(dollars in millions)
|
|
|
|
|
|||||||
|
General and administrative expense
|
$
|
9.2
|
|
|
$
|
7.5
|
|
|
$
|
1.7
|
|
|
23
|
%
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2018
|
|
2017
|
||||
|
|
(dollars in millions)
|
||||||
|
Net cash provided by (used in):
|
|
|
|
||||
|
Operating activities
|
$
|
(31.3
|
)
|
|
$
|
(35.3
|
)
|
|
Investing activities
|
19.4
|
|
|
(8.4
|
)
|
||
|
Financing activities
|
0.6
|
|
|
0.1
|
|
||
|
Net decrease in cash and cash equivalents
|
$
|
(11.3
|
)
|
|
$
|
(43.6
|
)
|
|
ITEM 3.
|
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
|
|
ITEM 4.
|
CONTROLS AND PROCEDURES
|
|
Item 1A.
|
Risk Factors
|
|
Item 6.
|
Exhibits
|
|
10.1+
|
|
|
|
|
|
31.1
|
|
|
|
|
|
31.2
|
|
|
|
|
|
32.1
|
|
|
|
|
|
32.2
|
|
|
|
|
|
101.INS
|
XBRL Instance Document
|
|
|
|
|
101.SCH
|
XBRL Schema Document
|
|
|
|
|
101.CAL
|
XBRL Calculation Linkbase Document
|
|
|
|
|
101.DEF
|
XBRL Definition Linkbase Document
|
|
|
|
|
101.LAB
|
XBRL Labels Linkbase Document
|
|
|
|
|
101.PRE
|
XBRL Presentation Linkbase Document
|
|
|
|
|
+ Portions of this exhibit (indicated by asterisks) have been omitted pursuant to a request for confidential treatment submitted separately to the SEC.
|
|
|
|
MACROGENICS, INC.
|
|
|
|
BY:
|
/s/ Scott Koenig
|
|
|
|
Scott Koenig, M.D., Ph.D.
|
|
|
|
President and Chief Executive Officer
|
|
|
|
(Principal Executive Officer)
|
|
|
BY:
|
/s/ James Karrels
|
|
|
|
James Karrels
|
|
|
|
Senior Vice President and Chief Financial Officer
|
|
|
|
(Principal Financial Officer)
|
|
Dated: May 7, 2018
|
|
|
|
Exhibit Page Number
|
|
|
10.1+
|
|
|
|
|
|
31.1
|
|
|
|
|
|
31.2
|
|
|
|
|
|
32.1
|
|
|
|
|
|
32.2
|
|
|
|
|
|
101.INS
|
XBRL Instance Document
|
|
|
|
|
101.SCH
|
XBRL Schema Document
|
|
|
|
|
101.CAL
|
XBRL Calculation Linkbase Document
|
|
|
|
|
101.DEF
|
XBRL Definition Linkbase Document
|
|
|
|
|
101.LAB
|
XBRL Labels Linkbase Document
|
|
|
|
|
101.PRE
|
XBRL Presentation Linkbase Document
|
|
|
|
|
+ Portions of this exhibit (indicated by asterisks) have been omitted pursuant to a request for confidential treatment submitted separately to the SEC.
|
|
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|