CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp. (NVIV) today reported financial results for the quarter ended June 30, 2014.
Mark Perrin, the CEO of InVivo, said, “Given the accomplishments of the first half year, I am tremendously excited that as we enter the second half of 2014, we will be able to successfully leverage and build on the major strengths and capabilities that have been established. Our new highly-experienced leadership team represents the best people to drive the development of our two major products: the Neuro-Spinal Scaffold and the Neuro-Spinal Scaffold plus stem cells programs. These two major assets form the foundational core of our newly focused mission, which is to lead as the experts in the field of spinal cord injury.”
Financial Results
For the quarter ended June 30, 2014, the Company reported a net loss of approximately $3,646,000, or $0.04 per diluted share, compared to a net loss of $14,286,000 or $0.20 per diluted share, for the quarter ended June 30, 2013. The 2014 results were impacted by two items. First, a gain in the derivative warrant liability of $1,127,000, and second, an unfavorable impact of $309,000 related to the realignment of resources completed in the quarter. The results for the quarter ended June 30, 2013 were adversely impacted by non-cash gains (losses) from the modification of warrants and derivatives of ($9,187,000), reflecting changes in the fair market value of the derivative warrant liability. Exclusive of these items, for the quarter ended June 30, 2014 and 2013, earnings loss per diluted share was $0.05 and $0.07, respectively.
For the six months ended June 30, 2014, the Company reported a net loss of approximately $8,749,000, or $0.11 per diluted share, compared to a net loss of $27,612,000 or $0.40 per diluted share, for the six months ended June 30, 2013. The 2014 results were impacted by two items. First, a gain in the derivative warrant liability of $1,127,000 and second, an unfavorable impact of $309,000 related to the realignment of resources completed in the second quarter. The results for the six months ended June 30, 2013 were adversely impacted by non-cash gains (losses) from modification of warrants and derivatives of ($19,636,000), reflecting changes in the fair market value of the derivative warrant liability. Exclusive of these items, for the six months ended June 30, 2014 and 2013, earnings loss per diluted share was $0.12 and $0.12 respectively.
The Company ended the second quarter of 2014 with $20,850,000 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 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, ScD, Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, MD, 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. 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 expectations with respect to results in the second half of 2014 and the development of its programs focused on the treatment of spinal cord injuries and its ability to become a leader in the related industry. 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 Company’s ability to successfully open additional clinical sites for enrollment; 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 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, 2013, as amended, 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. |
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(A Development Stage Company) |
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Consolidated Balance Sheets |
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(In thousands, except share and per share data) |
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(Unaudited) |
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| As of | ||||||||||
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June 30, 2014 |
December 31, 2013 |
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| ASSETS: | ||||||||||
| Current assets: | ||||||||||
| Cash and cash equivalents | $ | 20,850 | $ | 13,980 | ||||||
| Restricted cash | 371 | 602 | ||||||||
| Prepaid expenses | 378 | 20 | ||||||||
| Total current assets | 21,599 | 14,602 | ||||||||
| Property, equipment and leasehold improvements, net | 1,973 | 2,337 | ||||||||
| Other assets | 146 | 157 | ||||||||
| Total assets | $ | 23,718 | $ | 17,096 | ||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY: | ||||||||||
| Current liabilities: | ||||||||||
| Accounts payable | $ | 592 | $ | 899 | ||||||
| Note payable-current portion | 55 | 74 | ||||||||
| Capital lease payable | — | 3 | ||||||||
| Derivative warrant liability | 5,721 | — | ||||||||
| Accrued expenses | 1,415 | 1,292 | ||||||||
| Total current liabilities | 7,783 | 2,268 | ||||||||
| Loan payable | 1,920 | 1,920 | ||||||||
| Note payable-less current portion | — | 18 | ||||||||
| Total liabilities | 9,703 | 4,206 | ||||||||
| Commitments and Contingencies | ||||||||||
| Stockholders’ equity: | ||||||||||
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Common stock, $0.00001 par value, authorized 200,000,000 shares at
June 30, 2014 |
1 | 1 | ||||||||
| Additional paid-in capital | 104,672 | 94,798 | ||||||||
| Deficit accumulated during the development stage | (90,658 | ) | (81,909 | ) | ||||||
| Total stockholders’ equity | 14,015 | 12,890 | ||||||||
| Total liabilities and stockholders’ equity | $ | 23,718 | $ | 17,096 | ||||||
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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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(Unaudited) |
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Three Months Ended June 30, |
Six Months Ended June 30, |
November 28, 2005 (inception) to June 30, |
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| 2014 | 2013 | 2014 | 2013 | 2014 | |||||||||||||||||||||
| Operating expenses: | |||||||||||||||||||||||||
| Research and development | $ | 3,051 | $ | 2,591 | $ | 6,293 | $ | 3,804 | $ | 32,086 | |||||||||||||||
| General and administrative | 1,688 | 2,481 | 3,517 | 4,119 | 26,644 | ||||||||||||||||||||
| Total operating expenses | 4,739 | 5,072 | 9,810 | 7,923 | 58,730 | ||||||||||||||||||||
| Operating loss | (4,739 | ) | (5,072 | ) | (9,810 | ) | (7,923 | ) | (58,730 | ) | |||||||||||||||
| Other income (expense): | |||||||||||||||||||||||||
| Other income | — | — | — | — | 383 | ||||||||||||||||||||
| Interest income | 1 | 6 | 2 | 9 | 73 | ||||||||||||||||||||
| Interest expense | (35 | ) | (33 | ) | (68 | ) | (62 | ) | (1,336 | ) | |||||||||||||||
| Modification of warrants | — | (765 | ) | — | (765 | ) | (765 | ) | |||||||||||||||||
| Derivatives gain (loss) | 1,127 | (8,422 | ) | 1,127 | (18,871 | ) | (30,283 | ) | |||||||||||||||||
| Other income (expense), net | 1,093 | (9,214 | ) | 1,061 | (19,689 | ) | (31,928 | ) | |||||||||||||||||
| Net income (loss) | $ | (3,646 | ) | $ | (14,286 | ) | $ | (8,749 | ) | $ | (27,612 | ) | $ | (90,658 | ) | ||||||||||
| Net income (loss) per share, basic | $ | (0.04 | ) | $ | (0.20 | ) | $ | (0.11 | ) | $ | (0.40 | ) | $ | (2.13 | ) | ||||||||||
| Net income (loss) per share, diluted | $ | (0.04 | ) | $ | (0.20 | ) | $ | (0.11 | ) | $ | (0.40 | ) | $ | (2.13 | ) | ||||||||||
| Weighted average number of common shares outstanding, basic | 87,285,418 | 72,389,679 | 78,245,818 | 69,234,059 | 42,598,059 | ||||||||||||||||||||
| Weighted average number of common shares outstanding, diluted | 87,285,418 | 72,389,769 | 78,245,818 | 69,234,059 | 42,598,059 | ||||||||||||||||||||
| Reconciliation of GAAP to non-GAAP measures | ||||||||||||||||
| InVivo Therapeutics Holdings Corp. | ||||||||||||||||
| (A Development Stage Company) | ||||||||||||||||
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, |
June 30, |
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| 2014 | 2013 | 2014 | 2013 | |||||||||||||
| Reported GAAP net income (loss) | (3,646 | ) | (14,286 | ) | (8,749 | ) | (27,612 | ) | ||||||||
| Add Back: Derivative gain (Loss) | 1,127 | (8,422 | ) | 1,127 | (18,871 | ) | ||||||||||
| Add Back: Modification of Warrants | - | (765 | ) | - | (765 | ) | ||||||||||
| Add Back: Restructuring Costs | (309 | ) | - | (309 | ) | - | ||||||||||
| Pro Forma Net Loss | (4,464 | ) | (5,099 | ) | (9,567 | ) | (7,976 | ) | ||||||||
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| Reported GAAP net loss per diluted share | (0.04 | ) | (0.20 | ) | (0.11 | ) | (0.40 | ) | ||||||||
| Derivative gain (loss) per diluted share | 0.01 | (0.12 | ) | 0.01 | (0.27 | ) | ||||||||||
| Modification of Warrants gain (loss) per diluted share | - | (0.01 | ) | - | (0.01 | ) | ||||||||||
| Restructuring Costs per diluted share | - | - | - | - | ||||||||||||
| Pro Forma net income (loss) per diluted share | (0.05 | ) | (0.07 | ) | (0.12 | ) | (0.12 | ) | ||||||||
