InVivo Therapeutics Holdings Corp. (NVIV), a life sciences
company focused on the development and commercialization of novel drug
delivery technologies as well as biopolymer devices for the treatment of
spinal cord injuries and other nervous system conditions, today reported
financial results for the year ended December 31, 2013.
Mark Perrin, the CEO of InVivo, said, “In the first ten weeks of this
year, key leadership additions were made including the appointments of
Tamara Joseph as Senior Vice President, General Counsel and Chief
Compliance Officer, Thomas Ulich, MD as Chief Scientific Officer, and
Louis Vaickus, MD as Chief Medical Officer. Operationally, we continue
to focus our efforts to initiate the first-in-man study of our novel
scaffolding device to treat acute spinal cord injuries. Lastly, we have
significantly increased our business development activities to leverage
the opportunities with our scaffold and hydrogel platforms.”
The Company also provided an update with respect to the clinical study
of its scaffold device. One clinical site has now received Institutional
Review Board approval and finalized its contract and a second site is
nearing completion of these steps. Additional sites are progressing
through this process. As a result of manufacturing issues with respect
to the scaffold, the company expects that its first clinical study site
will receive product and be ready to enroll subjects in the second
quarter of 2014. The Company also announced that, as a result of
ongoing discussions with clinical experts, we are reviewing
non-traumatic spinal cord impairment indications that could benefit from
our device. This effort could result in additional uses of the scaffold
and may expand the entire development program.
Financial Results
For the year ended December 31, 2013, the Company reported a net loss of
approximately $38,756,000 or $.52 per diluted share, compared to net
income of $4,664,000 or $.06 per diluted share, for the year ended
December 31, 2012. Included in results for the years ended December 31,
2013 and 2012 were non-cash gains (losses) from modification of warrants
and derivatives of $(18,871,000), and $17,479,000, respectively,
reflecting changes in the fair market value of the derivative warrant
liability. Exclusive of these non-cash items, the adjusted net loss for
the year ended December 31, 2013, was $19,120,000, or $.26 per diluted
share, compared to an adjusted net loss of $12,816,000, or $.18 per
diluted share for 2012. The Company ended the year with $13,980,000 of
cash and cash equivalents. Adjusted net loss and adjusted net loss per
share are non-GAAP financial measures that exclude the items noted. A
reconciliation of these measures to the comparable GAAP measure is
included with the tables contained in this release. The Company believes
a presentation of these non-GAAP measures provides useful information to
investors to better understand, on a period-to-period comparable basis,
financial amounts both including and excluding these identified items,
the Company's operations.
About InVivo Therapeutics
InVivo Therapeutics Holdings Corp. is a pioneering biomaterials company
with unique technologies for drug delivery with a focus on treatment of
spinal cord injuries. The Company was founded in 2005 with proprietary
technology co-invented by Robert Langer, ScD., Professor at
Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who
is affiliated with Massachusetts General Hospital. In 2011 the Company
earned the David S. Apple Award from the American Spinal Injury
Association for its outstanding contribution to spinal cord injury
medicine. The publicly traded company is headquartered in Cambridge, MA.
For more details, visit, www.invivotherapeutics.com.
Safe Harbor Statement
Any statements contained in this press release that do not describe
historical facts may constitute forward-looking statements within the
meaning of the federal securities laws. Any forward-looking
statements contained herein are based on current expectations, and
include statements regarding the Company’s expectations with respect to
the commencement of human clinical trials for the scaffold product,
increased business development activities, and future uses and
indications for its scaffold product. These statements are
subject to a number of risks and uncertainties that could cause actual
future results to differ materially from current expectations including,
but not limited to, risks and uncertainties relating to the Company’s
limited operating history and history of net losses, its ability to
raise substantial additional capital to finance planned operations, its
ability to successfully commercialize current and future product
candidates and to successfully complete clinical trials and obtain and
maintain regulatory approval of its product candidates, its ability to
protect and maintain its intellectual property, and other risks
associated with the Company’s business and strategies identified and
described in more detail in our filings with the SEC, including our
Annual Report on Form 10-K for the year ended December 31, 2013 and
subsequent filings with the Securities and Exchange Commission. We do
not undertake to update these forward-looking statements made by us.
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InVivo Therapeutics Holdings Corp.
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(A Development Stage Company)
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Consolidated Balance Sheets
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December 31,
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2013
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2012
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ASSETS:
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Current assets:
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Cash and cash equivalents
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$
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13,980,321
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$
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12,825,090
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Restricted cash
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601,471
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601,351
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Prepaid expenses and other current assets
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20,087
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143,867
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Total current assets
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14,601,879
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13,570,308
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Property and equipment, net
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2,337,210
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2,311,942
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Other assets
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157,355
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179,415
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Total assets
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$
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17,096,444
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$
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16,061,665
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LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT):
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Current liabilities:
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Accounts payable
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$
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899,260
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$
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1,152,550
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Note payable-current portion
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73,987
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—
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Capital lease payable-current portion
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2,799
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32,606
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Derivative warrant liability
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—
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14,584,818
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Accrued expenses
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1,292,185
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1,021,275
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Total current liabilities
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2,268,231
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16,791,249
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Loan payable
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1,920,000
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1,578,000
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Note payable-less current portion
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18,497
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—
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Capital lease payable-less current portion
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—
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2,799
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Total liabilities
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4,206,728
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18,372,048
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Commitments and contingencies
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Stockholders’ equity (deficit):
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Common stock, $0.00001 par value, authorized 200,000,000 shares;
issued and outstanding 78,773,736 and 65,881,122 shares at
December 31 2013 and 2012, respectively
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788
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659
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Additional paid-in capital
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94,798,231
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40,842,339
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Deficit accumulated during the development stage
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(81,909,303
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)
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(43,153,381
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Total stockholders’ equity (deficit)
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12,889,716
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(2,310,383
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)
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Total liabilities and stockholders’ equity (deficit)
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$
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17,096,444
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$
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16,061,665
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InVivo Therapeutics Holdings Corp.
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(A Development Stage Company)
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Consolidated Statements of Operations
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Years Ended December 31,
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Period from November 28, 2005 (inception)
to December 31, 2013
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2013
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2012
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2011
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Operating expenses:
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Research and development
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$
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10,533,004
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$
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6,375,795
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$
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4,102,847
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$
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25,792,663
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General and administrative
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8,472,197
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6,403,656
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4,555,872
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23,127,390
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Total operating expenses
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19,005,201
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12,779,451
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8,658,719
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48,920,023
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Operating loss
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(19,005,201
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(12,779,451
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(8,658,719
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(48,920,023
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Other income (expense):
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Other income
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—
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—
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—
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383,000
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Interest income
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15,279
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35,184
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8,759
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70,512
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Interest expense
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(129,902
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(71,726
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(12,676
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(1,267,959
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Modification of warrants
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(764,769
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—
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—
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(764,769
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Derivatives gain (loss)
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(18,871,329
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17,479,674
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(26,065,579
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(31,409,816
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Other income (expense), net
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(19,750,721
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17,443,132
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(26,069,496
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(32,989,032
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Net income (loss)
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$
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(38,755,922
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$
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4,663,681
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$
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(34,728,215
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$
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(81,909,055
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Net income (loss) per share, basic
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$
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(0.52
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$
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0.07
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$
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(0.67
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$
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(2.04
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Net income (loss) per share, diluted
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$
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(0.52
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$
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0.06
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$
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(0.67
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$
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(2.04
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Weighted average number of common shares outstanding, basic
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73,991,686
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63,226,899
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51,894,871
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40,121,647
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Weighted average number of common shares outstanding, diluted
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73,991,686
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71,919,419
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51,894,871
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40,121,647
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Reconciliation of GAAP to non-GAAP measures
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InVivo Therapeutics Holdings Corp.
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(A Development Stage Company)
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Years Ended
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December 31,
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2013
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2012
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Reported GAAP net income (loss)
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$
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(38,755,922
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$
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4,663,681
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Add Back: Derivative gain (loss)
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(18,871,329
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17,443,132
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Add Back: Modification of Warrants
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(764,769
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Pro Forma Net Loss
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$
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(19,119,824
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$
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(12,815,993
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Reported GAAP net income (loss) per diluted share
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$
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(0.52
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$
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0.06
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Derivative gain (loss) per diluted share
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(0.25
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)
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0.24
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Modification of Warrants gain (loss) per diluted share
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(0.01
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Pro-Forma net income (loss) per diluted share
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$
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(0.26
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$
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(0.18
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Copyright Business Wire 2014