InVivo Therapeutics Holdings Corp. (NVIV) today reported
financial results for the quarter ended June 30, 2015.
Mark Perrin, Chief Executive Officer and Chairman, said, “InVivo made
significant advancements across all fronts during the second quarter.
The three patients in our ongoing clinical trial continued to make
meaningful motor and sensory improvements. We added two new clinical
sites, one of which is a federally designated Spinal Cord Injury Model
Systems center. We expanded our communications efforts by exhibiting at
two major neurological conferences and were highlighted in InVivo
Co-founder Dr. Robert Langer’s closing keynote address at the
International Society for Stem Cell Research Annual Meeting. We added a
wealth of spinal cord injury and neurosurgical knowledge to our
scientific advisory board by adding Jim Guest, M.D., Ph.D., and we
strengthened our Board structure by appointing Ann Merrifield as Lead
Director.
“Further, these significant advancements were likely being monitored by
a broader set of financial institutions with our uplisting to the Nasdaq
and our inclusion in various Russell Indexes. It was a great quarter and
we reiterate our previous cash forecast: we anticipate our cash position
will last us into the fourth quarter of 2016.”
Financial Results
For the quarter ended June 30, 2015, the Company reported a net loss of
approximately $10,443,000 or $.39 per diluted share, compared to a net
loss of $3,646,000 or $.17 per diluted share, for the quarter ended June
30, 2014. The 2015 results were impacted by a loss in the derivative
warrant liability of $4,653,000 reflecting changes in the fair market
value of the derivative warrant liability. The results for the three
months ended June 30, 2014 were impacted by a gain in the deferred
warrant liability of $1,127,000 and partly offset by a charge of
$309,000 related to the re-alignment of resources completed in the
second quarter of 2014. Excluding these charges, for the quarters ended
June 30, 2015 and June 30, 2014, adjusted earnings loss per diluted
share were $.21 and $.21, respectively.
The Company ended the quarter with $25,114,000 of cash and cash
equivalents. During the second quarter, the Company received $4.0
Million from the exercise of warrants issued in the Company’s May 2014
public offering.
For the six months ended June 30, 2015, the Company reported a net loss
of approximately $26,273,000 or $1.02 per diluted share, compared to a
net loss of $8,749,000 or $.45 per diluted share, for the six months
ended June 30, 2014. The 2015 results were impacted by a loss in the
derivative warrant liability of $14,940,000 reflecting changes in the
fair market value of the derivative warrant liability. The results for
the six months ended June 30, 2014 were impacted by a gain in the
derivative warrant liability of $1,127,000. This gain was partly offset
by a charge related to the re-alignment of resources, completed in the
second quarter of 2014, of $309,000. Exclusive of these items, for the
six months ended June 30, 2015 and June 30, 2014, adjusted earnings per
diluted share losses were $.44 and $.48, respectively.
Through the first six months of 2015, the Company received $6.9 Million
from warrant exercises, representing approximately 69% of the warrants
issued in the Company’s May 2014 public offering.
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 research and clinical-stage
biomaterials and biotechnology company with a focus on treatment of
spinal cord injuries. The company was founded in 2005 with proprietary
technology co-invented by Robert Langer, Sc.D., Professor at
Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who
then was at Boston Children’s Hospital and who now 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. In 2015, the
company’s investigational Neuro-Spinal Scaffold received the 2015
Becker’s Healthcare Spine Device Award. 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. These statements can be
identified by words such as "believe," "anticipate," "intend,"
"estimate," "will," "may," "should," "expect" and
similar expressions, and include statements regarding the Company’s
forecasted cash position . Any forward-looking statements contained
herein are based on current expectations, and are subject to a number of
risks and uncertainties. Factors that could cause actual future results
to differ materially from current expectations include, but are not
limited to, risks and uncertainties relating to the volatility of the
trading price of the Company’s common stock; the Company’s ability to
successfully open additional clinical sites for enrollment and to enroll
additional patients; the timing of the Institutional Review Board
process; the Company’s ability to obtain FDA approval to commercialize
its products; the Company’s ability to develop, market and sell products
based on its technology; the expected benefits and efficacy of the
Company’s products and technology in connection with the treatment of
spinal cord injuries; the availability of substantial additional funding
for the Company to continue its operations and to conduct research and
development, clinical studies and future product commercialization; and
other risks associated with the Company’s business, research, product
development, regulatory approval, marketing and distribution plans and
strategies identified and described in more detail in the Company’s
Annual Report on Form 10-K for the year ended December 31, 2014 , and
its other filings with the SEC, including the Company’s Form 10-Qs and
current reports on Form 8-K. The Company does not undertake to update
these forward-looking statements.
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InVivo Therapeutics Holdings Corp. Consolidated
Balance Sheets (In thousands, except share and
per-share data) (Unaudited)
|
|
|
|
|
|
|
|
|
|
As of
|
|
|
|
June 30, 2015
|
|
December 31, 2014
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ASSETS:
|
|
|
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
$
|
25,114
|
|
|
$
|
13,459
|
|
Restricted cash
|
|
|
|
361
|
|
|
|
422
|
|
Prepaid expenses and other current assets
|
|
|
|
397
|
|
|
|
1,072
|
|
Total current assets
|
|
|
|
25,872
|
|
|
|
14,953
|
|
|
|
|
|
|
|
Property, equipment and leasehold improvements, net
|
|
|
|
1,261
|
|
|
|
1,605
|
|
Other assets
|
|
|
|
124
|
|
|
|
135
|
|
Total assets
|
|
|
$
|
27,257
|
|
|
$
|
16,693
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY:
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
Accounts payable
|
|
|
$
|
953
|
|
|
$
|
569
|
|
Loan payable-current portion
|
|
|
|
259
|
|
|
|
320
|
|
Note payable-current portion
|
|
|
|
—
|
|
|
|
18
|
|
Derivative warrant liability
|
|
|
|
7,722
|
|
|
|
7,224
|
|
Accrued expenses
|
|
|
|
1,409
|
|
|
|
1,044
|
|
Total current liabilities
|
|
|
|
10,343
|
|
|
|
9,175
|
|
|
|
|
|
|
|
Loan payable, net of current portion
|
|
|
|
1,600
|
|
|
|
1,600
|
|
Total liabilities
|
|
|
|
11,943
|
|
|
|
10,775
|
|
|
|
|
|
|
|
Commitments and contingencies
|
|
|
|
|
|
|
|
|
|
|
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Stockholders’ equity:
|
|
|
|
|
|
Common stock, $0.00001 par value, authorized 50,000,000 shares; issued
and outstanding 26,856,177 and 23,453,000 shares at June 30,
2015 and December 31, 2014, respectively.
|
|
|
|
1
|
|
|
|
1
|
|
Additional paid-in capital
|
|
|
|
141,841
|
|
|
|
106,172
|
|
Accumulated deficit
|
|
|
|
(126,528
|
)
|
|
|
(100,255
|
)
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Total stockholders’ equity
|
|
|
|
15,314
|
|
|
|
5,918
|
|
|
|
|
|
|
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Total liabilities and stockholders’ equity
|
|
|
$
|
27,257
|
|
|
$
|
16,693
|
|
|
|
|
|
|
|
|
InVivo Therapeutics Holdings Corp. Consolidated
Statements of Operations (In thousands, except share
and per-share data) (Unaudited)
|
|
|
|
|
|
|
|
|
|
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Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
$
|
2,546
|
|
|
$
|
3,051
|
|
$
|
4,848
|
|
|
$
|
6,293
|
|
General and administrative
|
|
|
|
3,214
|
|
|
|
1,688
|
|
6,422
|
|
|
3,517
|
|
Total operating expenses
|
|
|
|
5,760
|
|
|
|
4,739
|
|
11,270
|
|
|
9,810
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss
|
|
|
|
(5,760
|
)
|
|
|
(4,739
|
)
|
(11,270
|
)
|
|
(9,810
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
|
2
|
|
|
|
1
|
|
3
|
|
|
2
|
|
Interest expense
|
|
|
|
(32
|
)
|
|
|
(35
|
)
|
(66
|
)
|
|
(68
|
)
|
Derivatives gain (loss)
|
|
|
|
(4,653
|
)
|
|
|
1,127
|
|
(14,940
|
)
|
|
1,127
|
|
Other income (expense), net
|
|
|
|
(4,683
|
)
|
|
|
1,093
|
|
(15,003
|
)
|
|
1,061
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
(10,443
|
)
|
|
$
|
(3,646
|
)
|
$
|
(26,273
|
)
|
|
$
|
(8,749
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic
|
|
|
$
|
(0.39
|
)
|
|
$
|
(0.17
|
)
|
$
|
(1.02
|
)
|
|
$
|
(0.45
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share, diluted
|
|
|
$
|
(0.39
|
)
|
|
$
|
(0.17
|
)
|
$
|
(1.02
|
)
|
|
$
|
(0.45
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares outstanding, basic
|
|
|
|
26,508,170
|
|
|
|
21,821,355
|
|
25,713,438
|
|
|
19,561,455
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares outstanding, diluted
|
|
|
|
26,508,170
|
|
|
|
21,821,355
|
|
25,713,438
|
|
|
19,561,455
|
|
|
|
|
|
|
|
|
|
|
|
|
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InVivo Therapeutics Holdings Corp. Reconciliation of
GAAP to non-GAAP measures (In thousands, except share
and per-share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
Reported GAAP net income /(loss)
|
|
|
(10,443)
|
|
(3,646)
|
|
(26,273)
|
|
(8,749)
|
Add Back: Derivative gain/(loss)
|
|
|
(4,653)
|
|
1,127
|
|
(14,940)
|
|
1,127
|
Add Back: Restructuring costs
|
|
|
-
|
|
(309)
|
|
-
|
|
(309)
|
Adjusted Net Loss
|
|
|
(5,790)
|
|
(4,464)
|
|
(11,333)
|
|
(9,567)
|
|
|
|
|
|
|
|
|
|
|
Reported GAAP net loss per diluted share
|
|
|
(0.39)
|
|
(0.17)
|
|
(1.02)
|
|
(0.45)
|
Derivative loss per diluted share
|
|
|
(0.18)
|
|
0.05
|
|
(0.58)
|
|
0.05
|
Restructuring costs per diluted share
|
|
|
-
|
|
(.01)
|
|
-
|
|
(.02)
|
Adjusted net loss per diluted share
|
|
|
(0.21)
|
|
(0.21)
|
|
(0.44)
|
|
(0.48)
|
|
|
|
|
|
|
|
|
|
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