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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Vericel Corporation | NASDAQ:VCEL | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
1.21 | 2.64% | 47.08 | 46.10 | 48.84 | 48.645 | 45.46 | 46.04 | 471,942 | 23:09:00 |
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Michigan
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94-3096597
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(State or other jurisdiction of
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(I.R.S. employer
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incorporation or organization)
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identification no.)
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64 Sidney Street
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Cambridge, MA 02139
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(Address of principal executive offices, including zip code)
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Large accelerated filer -
o
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Accelerated filer -
x
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Non-accelerated filer -
o
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Smaller reporting company -
o
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(Do not check if a smaller reporting company)
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COMMON STOCK, NO PAR VALUE
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23,995,116
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(Class)
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Outstanding at August 5, 2016
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PART I — FINANCIAL INFORMATION
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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 — OTHER INFORMATION
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Item 1.
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Item 1A.
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Item 2.
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Item 6.
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June 30,
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December 31,
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2016
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2015
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||||
ASSETS
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Current assets:
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|
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|
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Cash
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$
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9,835
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$
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14,581
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Accounts receivable (net of allowance for doubtful accounts of $54 and $68, respectively)
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9,031
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10,919
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Inventory
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2,393
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1,379
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Other current assets
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1,046
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464
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Total current assets
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22,305
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27,343
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Property and equipment, net
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4,351
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4,049
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Intangible assets, net
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2,778
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2,917
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Total assets
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$
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29,434
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$
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34,309
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LIABILITIES AND SHAREHOLDERS’ EQUITY
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Current liabilities:
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Accounts payable
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$
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5,305
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$
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7,588
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Accrued expenses
|
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2,892
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|
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3,603
|
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Revolving credit agreement, net of deferred costs of $96
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2,304
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—
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Warrant liabilities
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455
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757
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Short-term deferred rent
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460
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118
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Other
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39
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42
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Total current liabilities
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11,455
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12,108
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Long-term deferred rent
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820
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—
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Long term debt
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52
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71
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Total liabilities
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12,327
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12,179
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COMMITMENTS AND CONTINGENCIES (Note 13)
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Shareholders’ equity:
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Series A non-voting convertible preferred stock, no par value: shares authorized and reserved — 1; shares issued and outstanding — 1
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3,150
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3,150
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Series B-2 voting convertible preferred stock, no par value: shares authorized and reserved — 39, shares issued and outstanding — 12
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38,389
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38,389
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Common stock, no par value; shares authorized — 75,000; shares issued and outstanding — 22,684 and 23,789, respectively
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309,437
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307,766
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Treasury stock — 1,250 shares
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(3,150
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)
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(3,150
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)
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Accumulated deficit
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(330,719
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)
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(324,025
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)
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Total shareholders’ equity
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17,107
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22,130
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Total liabilities and shareholders’ equity
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$
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29,434
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$
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34,309
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Three Months Ended June 30,
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Six Months Ended June 30,
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2016
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2015
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2016
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2015
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Revenues:
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Product sales
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$
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12,823
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$
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13,590
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$
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26,931
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$
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24,439
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Total revenues
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12,823
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13,590
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26,931
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24,439
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Costs and expenses:
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Cost of product sales
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7,300
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6,901
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13,860
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12,469
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Gross profit
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5,523
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6,689
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13,071
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11,970
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Research and development
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4,058
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3,369
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7,594
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7,746
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Selling, general and administrative
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6,449
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5,585
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12,453
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11,061
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Total operating expenses
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10,507
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8,954
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20,047
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18,807
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Loss from operations
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(4,984
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)
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(2,265
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)
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(6,976
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)
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(6,837
|
)
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Other income (expense):
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0
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Decrease (increase) in fair value of warrants
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1,942
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112
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302
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(205
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)
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Foreign currency translation (loss) gain
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(1
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)
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(6
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)
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(11
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)
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10
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Interest income
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2
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9
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7
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22
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Interest expense
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(3
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)
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(2
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)
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(6
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)
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(4
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)
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Other expense
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—
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—
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(10
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)
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—
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Total other income (expense)
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1,940
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113
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282
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(177
|
)
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Net loss
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$
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(3,044
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)
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$
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(2,152
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)
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$
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(6,694
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)
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$
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(7,014
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)
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Net loss per share attributable to common shareholders (Basic and Diluted) (see note 11)
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$
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(0.22
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)
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$
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(0.16
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)
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$
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(0.46
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)
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$
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(0.43
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)
|
Weighted average number of common shares outstanding (Basic and Diluted)
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22,684
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23,786
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22,644
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23,786
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Six Months Ended June 30,
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2016
|
|
2015
|
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Operating activities:
|
|
|
|
|
|
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Net loss
|
|
$
|
(6,694
|
)
|
|
$
|
(7,014
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)
|
Adjustments to reconcile net loss to net cash used for operating activities:
|
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|
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|
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Depreciation and amortization
|
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923
|
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|
672
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|
||
Stock compensation expense
|
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1,319
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1,614
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Change in fair value of warrants
|
|
(302
|
)
|
|
205
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|
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Inventory provision
|
|
86
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|
|
—
|
|
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Deferred rent expense
|
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260
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|
|
—
|
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Tenant improvement reimbursement
|
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607
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|
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—
|
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Foreign currency translation loss
|
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11
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|
10
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Gain on sales of fixed assets
|
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—
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|
(35
|
)
|
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Changes in operating assets and liabilities:
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Inventory
|
|
(1,099
|
)
|
|
(157
|
)
|
||
Accounts receivable
|
|
1,888
|
|
|
(789
|
)
|
||
Other current assets
|
|
(385
|
)
|
|
(1,235
|
)
|
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Accounts payable
|
|
(2,305
|
)
|
|
(412
|
)
|
||
Accrued expenses
|
|
(711
|
)
|
|
(1,458
|
)
|
||
Other non-current assets and liabilities, net
|
|
—
|
|
|
8
|
|
||
Net cash used for operating activities
|
|
(6,402
|
)
|
|
(8,591
|
)
|
||
Investing activities:
|
|
|
|
|
|
|
||
Expenditures for property, plant and equipment
|
|
(1,074
|
)
|
|
(1,555
|
)
|
||
Other
|
|
93
|
|
|
35
|
|
||
Net cash used in investing activities
|
|
(981
|
)
|
|
(1,520
|
)
|
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Financing activities:
|
|
|
|
|
|
|
||
Net proceeds from issuance of common stock
|
|
352
|
|
|
3
|
|
||
Borrowings under revolving credit agreement
|
|
2,400
|
|
|
—
|
|
||
Deferred financing costs
|
|
(96
|
)
|
|
—
|
|
||
Payments on long-term debt
|
|
(19
|
)
|
|
(17
|
)
|
||
Net cash provided by (used in) financing activities
|
|
2,637
|
|
|
(14
|
)
|
||
Net decrease in cash
|
|
(4,746
|
)
|
|
(10,125
|
)
|
||
Cash at beginning of period
|
|
14,581
|
|
|
30,343
|
|
||
Cash at end of period
|
|
$
|
9,835
|
|
|
$
|
20,218
|
|
|
|
|
|
|
||||
Supplemental cash flow information (non-cash):
|
|
|
|
|
|
|
||
Additions to equipment in process included in accounts payable
|
|
$
|
11
|
|
|
$
|
700
|
|
1.
|
Organization
|
2.
|
Basis of Presentation
|
3.
|
Recent Accounting Pronouncements
|
4.
|
Selected Balance Sheet Components
|
(In thousands)
|
June 30, 2016
|
|
December 31, 2015
|
||||
Raw materials
|
$
|
2,089
|
|
|
$
|
1,228
|
|
Work-in-process
|
276
|
|
|
131
|
|
||
Finished goods
|
28
|
|
|
20
|
|
||
Inventory
|
$
|
2,393
|
|
|
$
|
1,379
|
|
(In thousands)
|
June 30, 2016
|
|
December 31, 2015
|
||||
Machinery and equipment
|
$
|
3,200
|
|
|
$
|
3,280
|
|
Furniture, fixtures and office equipment
|
931
|
|
|
931
|
|
||
Computer equipment and software
|
2,662
|
|
|
2,662
|
|
||
Leasehold improvements
|
3,291
|
|
|
2,393
|
|
||
Construction in process
|
593
|
|
|
421
|
|
||
Total property and equipment, gross
|
10,677
|
|
|
9,687
|
|
||
Less: Accumulated depreciation
|
(6,326
|
)
|
|
(5,638
|
)
|
||
|
$
|
4,351
|
|
|
$
|
4,049
|
|
(In thousands)
|
June 30, 2016
|
|
December 31, 2015
|
||||
Commercial rights
|
$
|
3,360
|
|
|
$
|
3,360
|
|
Less: accumulated amortization
|
$
|
(582
|
)
|
|
$
|
(443
|
)
|
|
$
|
2,778
|
|
|
$
|
2,917
|
|
Calendar Years Ending December 31, (In thousands)
|
|
||
2016
|
$
|
141
|
|
2017
|
280
|
|
|
2018
|
280
|
|
|
2019
|
280
|
|
|
2020
|
280
|
|
|
Thereafter
|
1,517
|
|
|
Total
|
$
|
2,778
|
|
(In thousands)
|
June 30, 2016
|
|
December 31, 2015
|
||||
Bonus related compensation
|
$
|
1,325
|
|
|
$
|
1,956
|
|
Employee related accruals
|
1,485
|
|
|
1,341
|
|
||
Accrued expenses
|
82
|
|
|
306
|
|
||
|
$
|
2,892
|
|
|
$
|
3,603
|
|
5.
|
Stock Purchase Warrants
|
|
|
August 2013
Warrants |
Exercise price
|
|
$4.80
|
Expiration date
|
|
August 16, 2018
|
Total shares issuable on exercise
|
|
724,950
|
August 2013 Warrants
|
|
June 30, 2016
|
|
December 31, 2015
|
||||
Closing stock price
|
|
$
|
2.25
|
|
|
$
|
2.58
|
|
Expected dividend rate
|
|
—
|
%
|
|
—
|
%
|
||
Expected stock price volatility
|
|
85.9
|
%
|
|
91.4
|
%
|
||
Risk-free interest rate
|
|
0.6
|
%
|
|
1.3
|
%
|
||
Expected life (years)
|
|
2.13
|
|
|
2.63
|
|
6.
|
Debt
|
7.
|
Stock-based Compensation
|
|
|
Six Months Ended June 30,
|
||||
Service-Based Stock Options
|
|
2016
|
|
2015
|
||
Expected dividend rate
|
|
—
|
%
|
|
—
|
%
|
Expected stock price volatility
|
|
78.7 – 92.2%
|
|
|
78.8 – 88.1%
|
|
Risk-free interest rate
|
|
1.2 – 1.8%
|
|
|
1.5 – 2.0%
|
|
Expected life (years)
|
|
5.5 – 6.3
|
|
|
5.5 – 6.3
|
|
Service-Based Stock Options
|
|
Options
|
|
Weighted
Average
Exercise Price
|
|
Weighted Average
Remaining
Contractual Term
(Years)
|
|
Aggregate
Intrinsic Value
|
|||||
Outstanding at December 31, 2015
|
|
2,523,400
|
|
|
$
|
6.36
|
|
|
8.7
|
|
$
|
5,000
|
|
Granted
|
|
1,072,230
|
|
|
$
|
3.03
|
|
|
|
|
|
|
|
Exercised
|
|
39,231
|
|
|
$
|
3.06
|
|
|
|
|
$
|
76,827
|
|
Expired
|
|
72,375
|
|
|
$
|
37.79
|
|
|
|
|
|
|
|
Forfeited
|
|
113,686
|
|
|
$
|
3.81
|
|
|
|
|
|
|
|
Outstanding at June 30, 2016
|
|
3,370,338
|
|
|
$
|
4.75
|
|
|
7.8
|
|
$
|
150,224
|
|
Exercisable at June 30, 2016
|
|
900,364
|
|
|
$
|
8.93
|
|
|
8.6
|
|
$
|
8,439
|
|
8.
|
Fair Value Measurements
|
•
|
Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities;
|
•
|
Level 2: Quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability; and
|
•
|
Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity).
|
|
|
June 30, 2016
|
|
December 31, 2015
|
||||||||||||||||||||||||||||
|
|
|
|
Fair value measurement category
|
|
|
|
Fair value measurement category
|
||||||||||||||||||||||||
(In thousands)
|
|
Total
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||||||||||
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Warrant liabilities
|
|
$
|
455
|
|
|
$
|
—
|
|
|
$
|
455
|
|
|
$
|
—
|
|
|
$
|
757
|
|
|
$
|
—
|
|
|
$
|
757
|
|
|
$
|
—
|
|
9.
|
Shareholders' Equity
|
10.
|
Preferred Stock
|
11.
|
Net Loss Per Common Share
|
|
|
Three months ended June 30,
|
|
Six months ended June 30,
|
||||||||||||
(Amounts In thousands except per share amounts)
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Numerator:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss
|
|
$
|
(3,044
|
)
|
|
$
|
(2,152
|
)
|
|
$
|
(6,694
|
)
|
|
$
|
(7,014
|
)
|
Dividends accumulated on convertible preferred stock
|
|
(1,856
|
)
|
|
(1,654
|
)
|
|
(3,660
|
)
|
|
(3,244
|
)
|
||||
Net loss attributable to common shareholders
|
|
$
|
(4,900
|
)
|
|
$
|
(3,806
|
)
|
|
$
|
(10,354
|
)
|
|
$
|
(10,258
|
)
|
Denominator:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Denominator for basic and diluted EPS:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Weighted-average common shares outstanding
|
|
22,684
|
|
|
23,786
|
|
|
22,644
|
|
|
23,786
|
|
||||
Net loss per share attributable to common shareholders (basic and diluted)
|
|
$
|
(0.22
|
)
|
|
$
|
(0.16
|
)
|
|
$
|
(0.46
|
)
|
|
$
|
(0.43
|
)
|
(In thousands)
|
|
Total
|
|
2016
|
|
2017
|
|
2018
|
|
2019
|
|
2020
|
|
More than 5 Years
|
||||||||||||||
Operating leases
|
|
$
|
25,538
|
|
|
$
|
2,123
|
|
|
$
|
4,897
|
|
|
$
|
4,590
|
|
|
$
|
4,267
|
|
|
$
|
4,386
|
|
|
$
|
5,275
|
|
Purchase commitments
|
|
450
|
|
|
450
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||
Capital leases
|
|
97
|
|
|
22
|
|
|
43
|
|
|
32
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||
Total
|
|
$
|
26,085
|
|
|
$
|
2,595
|
|
|
$
|
4,940
|
|
|
$
|
4,622
|
|
|
$
|
4,267
|
|
|
$
|
4,386
|
|
|
$
|
5,275
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
(In thousands)
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Total revenues
|
|
$
|
12,823
|
|
|
$
|
13,590
|
|
|
$
|
26,931
|
|
|
$
|
24,439
|
|
Cost of product sales
|
|
7,300
|
|
|
6,901
|
|
|
13,860
|
|
|
12,469
|
|
||||
Gross profit
|
|
5,523
|
|
|
6,689
|
|
|
13,071
|
|
|
11,970
|
|
||||
Total operating expenses
|
|
10,507
|
|
|
8,954
|
|
|
20,047
|
|
|
18,807
|
|
||||
Loss from operations
|
|
(4,984
|
)
|
|
(2,265
|
)
|
|
(6,976
|
)
|
|
(6,837
|
)
|
||||
Other expense
|
|
1,940
|
|
|
113
|
|
|
282
|
|
|
(177
|
)
|
||||
Net loss
|
|
$
|
(3,044
|
)
|
|
$
|
(2,152
|
)
|
|
$
|
(6,694
|
)
|
|
$
|
(7,014
|
)
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
Revenue by product (in thousands)
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Carticel
|
|
$
|
8,987
|
|
|
$
|
9,063
|
|
|
$
|
17,798
|
|
|
$
|
16,181
|
|
Epicel
|
|
3,836
|
|
|
4,274
|
|
|
9,133
|
|
|
7,913
|
|
||||
Bone Marrow
|
|
—
|
|
|
253
|
|
|
—
|
|
|
345
|
|
||||
|
|
$
|
12,823
|
|
|
$
|
13,590
|
|
|
$
|
26,931
|
|
|
$
|
24,439
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
(In thousands)
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Gross profit
|
|
$
|
5,523
|
|
|
$
|
6,689
|
|
|
$
|
13,071
|
|
|
$
|
11,970
|
|
Gross profit %
|
|
43
|
%
|
|
49
|
%
|
|
49
|
%
|
|
49
|
%
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||
(In thousands)
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||
Research and development costs
|
|
4,058
|
|
|
3,369
|
|
|
7,594
|
|
|
7,746
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
(In thousands)
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Dilated Cardiomyopathy
|
|
$
|
2,038
|
|
|
$
|
1,866
|
|
|
$
|
3,857
|
|
|
$
|
5,298
|
|
MACI
|
|
728
|
|
|
417
|
|
|
1,280
|
|
|
607
|
|
||||
Carticel
|
|
719
|
|
|
522
|
|
|
1,366
|
|
|
1,000
|
|
||||
Epicel
|
|
573
|
|
|
564
|
|
|
1,091
|
|
|
841
|
|
||||
Total research and development expenses
|
|
$
|
4,058
|
|
|
$
|
3,369
|
|
|
$
|
7,594
|
|
|
$
|
7,746
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
(In thousands)
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Selling, general and administrative costs
|
|
$
|
6,449
|
|
|
$
|
5,585
|
|
|
$
|
12,453
|
|
|
$
|
11,061
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
(In thousands)
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Increase in fair value of warrants
|
|
$
|
1,942
|
|
|
$
|
112
|
|
|
$
|
302
|
|
|
$
|
(205
|
)
|
Foreign currency translation (loss) gain
|
|
(1
|
)
|
|
(6
|
)
|
|
(11
|
)
|
|
10
|
|
||||
Other income
|
|
—
|
|
|
—
|
|
|
(10
|
)
|
|
—
|
|
||||
Net interest income
|
|
(1
|
)
|
|
7
|
|
|
1
|
|
|
18
|
|
||||
Total other income (expense)
|
|
$
|
1,940
|
|
|
$
|
113
|
|
|
$
|
282
|
|
|
$
|
(177
|
)
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
(In thousands)
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Cost of goods sold
|
|
$
|
131
|
|
|
$
|
67
|
|
|
$
|
214
|
|
|
$
|
187
|
|
Research and development
|
|
179
|
|
|
145
|
|
|
$
|
258
|
|
|
$
|
357
|
|
||
Selling, general and administrative
|
|
521
|
|
|
480
|
|
|
847
|
|
|
1,070
|
|
||||
Total non-cash stock-based compensation expense
|
|
$
|
831
|
|
|
$
|
692
|
|
|
$
|
1,319
|
|
|
$
|
1,614
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
(Amounts In thousands except per share amounts)
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Numerator:
|
|
|
|
|
|
|
|
|
||||||||
Numerator of basic and diluted EPS
|
|
$
|
(4,900
|
)
|
|
$
|
(3,806
|
)
|
|
$
|
(10,354
|
)
|
|
$
|
(10,258
|
)
|
Add: (Decrease) increase in fair value of warrants
|
|
(1,942
|
)
|
|
(112
|
)
|
|
(302
|
)
|
|
205
|
|
||||
Add: Dividends accumulated on convertible preferred stock
|
|
1,856
|
|
|
1,654
|
|
|
3,660
|
|
|
3,244
|
|
||||
Adjusted net loss - Non-GAAP
|
|
$
|
(4,986
|
)
|
|
$
|
(2,264
|
)
|
|
$
|
(6,996
|
)
|
|
$
|
(6,809
|
)
|
Denominator:
|
|
|
|
|
|
|
|
|
||||||||
Denominator for basic and diluted EPS:
|
|
|
|
|
|
|
|
|
||||||||
Weighted-average common shares outstanding
|
|
22,684
|
|
|
23,786
|
|
|
22,644
|
|
|
23,786
|
|
||||
Add: Treasury stock
|
|
1,250
|
|
|
—
|
|
|
1,250
|
|
|
—
|
|
||||
Adjusted denominator for basic and diluted EPS - Non-GAAP
|
|
23,934
|
|
|
23,786
|
|
|
23,894
|
|
|
23,786
|
|
||||
Adjusted net loss per share (basic and diluted) - Non-GAAP
|
|
$
|
(0.21
|
)
|
|
$
|
(0.10
|
)
|
|
$
|
(0.29
|
)
|
|
$
|
(0.29
|
)
|
1)
|
Removed inappropriate permissions. Information Technology staff responsible for the maintenance of Active Directory Group assignments made changes to the Controller’s permissions and the Controller’s permissions were corrected to remove the incompatible access.
|
2)
|
Enabled and designed a reporting functionality that provides an audit trail for journal entries, module access and other relevant user actions.
|
3)
|
Reviewed remaining conflicts and permissions and documented the appropriate control that effectively mitigate the risk associated with the conflicts and/or permissions. In addition, we implemented a new control to review changes to personnel access in the financial reporting system.
|
|
VERICEL CORPORATION
|
|
|
|
|
|
/s/ DOMINICK C. COLANGELO
|
|
Dominick C. Colangelo
|
|
President and Chief Executive Officer
|
|
(Principal Executive Officer)
|
|
|
|
|
|
/s/ GERARD MICHEL
|
|
Gerard Michel
|
|
Chief Financial Officer and Vice President, Corporate Development
|
|
(Principal Financial Officer)
|
Exhibit No.
|
|
Description
|
|
|
|
10.1†**
|
|
Amended and Restated Contract Manufacturing and Supply Agreement, dated April 20, 2016 between the Company and Vention Medical Inc. (formerly ATEK Medical, LLC).
|
|
|
|
10.2**
|
|
First Amendment to the Services Agreement, dated April 5, 2016 between the Company and Dohmen Life Science Services, LLC, dated May 31, 2016.
|
|
|
|
10.3†**
|
|
Second Amendment to the Services Agreement, dated April 5, 2016 between the Company and Dohmen Life Science Services, LLC, dated July 1, 2016.
|
|
|
|
10.4**
|
|
Seventh Amendment to Transition Services Agreement, dated as of May 28, 2016, by and between the Company and Genzyme Corporation.
|
|
|
|
31.1**
|
|
Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
31.2**
|
|
Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
32.1**
|
|
Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
32.2**
|
|
Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
|
|
|
101.INS**
|
|
XBRL Instance Document
|
|
|
|
101.SCH**
|
|
XBRL Taxonomy Extension Schema Document
|
|
|
|
101.CAL**
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
|
|
101.LAB**
|
|
XBRL Taxonomy Extension Label Linkbase Document
|
|
|
|
101.PRE**
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
|
|
101 DEF**
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
TERM
|
|
DEFINITION
|
Adverse Event
|
|
Any adverse change in health or “side-effect” that occurs in a person participating in a clinical trial, from the time they consent to joining the trial until a pre-specified period of time after their treatment has been completed.
|
Autologous (Patient Specific)
|
|
Originating from the patient receiving treatment. (Vericel uses only autologous cells).
|
BLA — Biologics License Application
|
|
An application containing product safety, efficacy and manufacturing information required by the FDA to market biologics products in the U.S.
|
CLI — Critical Limb Ischemia
|
|
An atherosclerotic vascular disease characterized by insufficient blood flow in the lower extremities that causes severe pain, tissue loss or both.
|
Controlled Clinical Trial
|
|
A clinical study that compares patients receiving a specific treatment to patients receiving an alternate treatment for the condition of interest. The alternate treatment may be another active treatment, standard of care for the condition and/or a placebo (inactive) treatment.
|
DCM — Dilated Cardiomyopathy
|
|
A chronic cardiac disease where expansion of the patient’s heart reduces the pumping function to a point that the normal circulation of blood cannot be maintained.
|
Double-Blind Clinical Trial
|
|
Clinical trials in which neither the patient nor the physician know if the patient received the experimental treatment or a control/placebo.
|
FDA — Food & Drug Administration
|
|
The U.S. FDA ensures that medicines, medical devices, and radiation-emitting consumer products are safe and effective. Authorized by Congress to enforce the Federal Food, Drug, and Cosmetic Act and several other public health laws, the agency monitors the manufacture, import, transport, storage, and sale of $1 trillion worth of goods annually.
|
GMP — Good Manufacturing Practice
|
|
GMP regulations require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups, and errors.
|
Hematopoietic Cells
|
|
All of the cells in the blood system including myeloid (monocytes and macrophages, neutrophils, basophils, eosinophils, erythrocytes, megakaryocytes/platelets, dendritic cells), and lymphoid lineages (T-cells, B-cells, NK-cells).
|
Ischemia
|
|
A shortage or inadequate flow of blood to a body part (commonly an organ or tissue) caused by a constriction or obstruction of the blood vessels supplying it.
|
LVEF — Left Ventricular Ejection Fraction
|
|
The fraction of blood pumped out of the left ventricle with each heartbeat.
|
Mesenchymal stromal cells
|
|
Connective tissue cells that, in the case of bone marrow derived MSCs, function to support blood forming cells and secrete anti-inflammatory factors.
|
M2 anti-inflammatory macrophages
|
|
Specialized blood cells that remove damaged tissue and bacteria and secrete anti-inflammatory factors.
|
Open-label Clinical Trial
|
|
A trial in which both the treating physician and the patient know whether they are receiving the experimental treatment or control/placebo treatment.
|
Orphan Drug Designation
|
|
“Orphan drug” refers to a drug or biologic that is intended for use in the treatment of a rare disease or condition. Orphan drug designation from the U.S. Food and Drug Association (FDA) qualifies the sponsor to receive certain benefits from the Government in exchange for developing the drug for a rare disease or condition. The drug must then go through the FDA marketing approval process like any other drug or biologic which evaluates for safety and efficacy. Usually a sponsor receives a quicker review time and lower application fees for an orphan product.
|
Phase 1 Clinical Trial
|
|
A Phase 1 trial represents an initial study in a small group of patients to test for safety and other relevant factors.
|
Phase 2 Clinical Trial
|
|
A Phase 2 trial represents a study in a moderate number of patients to assess the safety and efficacy of a product.
|
Phase 2b Clinical Trial
|
|
A Phase 2b trial is a moderately-sized Phase 2 trial that is more specifically designed assess the efficacy of a product than a Phase 2a trial.
|
Phase 3 Clinical Trial
|
|
Phase 3 studies are initiated to establish safety and efficacy in an expanded patient population at multiple clinical trial sites and are generally larger than trials in earlier phases of development.
|
Prospective Clinical Trial
|
|
A clinical trial in which participants are identified and then followed throughout the study going forward in time.
|
Randomized Clinical Trial
|
|
A clinical trial in which the participants are assigned randomly to different treatment groups.
|
1 Year Vericel Chart |
1 Month Vericel Chart |
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