2017 Q2 Form 10-Q Financial Statement

#000119312517254439 Filed on August 10, 2017

View on sec.gov

Income Statement

Concept 2017 Q2 2016 Q2
Revenue $0.00 $0.00
YoY Change
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $2.170M $2.160M
YoY Change 0.46% 24.14%
% of Gross Profit
Research & Development $4.208M $5.794M
YoY Change -27.37% -1.09%
% of Gross Profit
Depreciation & Amortization $400.0K $432.0K
YoY Change -7.41% 8.82%
% of Gross Profit
Operating Expenses $6.374M $7.955M
YoY Change -19.87% 4.77%
Operating Profit -$6.374M -$7.955M
YoY Change -19.87% 4.77%
Interest Expense $40.00K $17.00K
YoY Change 135.29% -34.62%
% of Operating Profit
Other Income/Expense, Net -$168.0K -$83.00K
YoY Change 102.41% 107.5%
Pretax Income -$6.540M -$8.040M
YoY Change -18.66% 5.37%
Income Tax
% Of Pretax Income
Net Earnings -$6.542M -$8.038M
YoY Change -18.61% 5.31%
Net Earnings / Revenue
Basic Earnings Per Share
Diluted Earnings Per Share -$17.68M -$36.55M
COMMON SHARES
Basic Shares Outstanding 21.17M shares 13.27M shares
Diluted Shares Outstanding

Balance Sheet

Concept 2017 Q2 2016 Q2
SHORT-TERM ASSETS
Cash & Short-Term Investments $18.54M $15.93M
YoY Change 16.38% -64.77%
Cash & Equivalents $10.56M $15.93M
Short-Term Investments $7.978M
Other Short-Term Assets $300.0K $350.0K
YoY Change -14.29% -61.11%
Inventory
Prepaid Expenses
Receivables
Other Receivables
Total Short-Term Assets $18.84M $16.28M
YoY Change 15.78% -64.71%
LONG-TERM ASSETS
Property, Plant & Equipment $3.146M $4.665M
YoY Change -32.56% -14.06%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $140.0K $140.0K
YoY Change 0.0% -88.14%
Total Long-Term Assets $3.283M $5.002M
YoY Change -34.37% -29.74%
TOTAL ASSETS
Total Short-Term Assets $18.84M $16.28M
Total Long-Term Assets $3.283M $5.002M
Total Assets $22.13M $21.28M
YoY Change 3.99% -60.03%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $1.618M $1.769M
YoY Change -8.54% -24.3%
Accrued Expenses $1.394M $3.560M
YoY Change -60.84% 70.09%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00
YoY Change
Long-Term Debt Due $470.0K $580.0K
YoY Change -18.97% 0.0%
Total Short-Term Liabilities $3.827M $6.721M
YoY Change -43.06% 0.51%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $470.0K
YoY Change -100.0% -55.24%
Other Long-Term Liabilities $17.49M $1.200M
YoY Change 1357.5% -26.38%
Total Long-Term Liabilities $17.49M $1.670M
YoY Change 947.31% -37.69%
TOTAL LIABILITIES
Total Short-Term Liabilities $3.827M $6.721M
Total Long-Term Liabilities $17.49M $1.670M
Total Liabilities $21.32M $8.389M
YoY Change 154.15% -10.5%
SHAREHOLDERS EQUITY
Retained Earnings -$195.4M -$181.5M
YoY Change 7.64% 21.71%
Common Stock $196.2M $194.4M
YoY Change 0.92% 0.73%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $806.0K $12.89M
YoY Change
Total Liabilities & Shareholders Equity $22.13M $21.28M
YoY Change 3.99% -60.03%

Cashflow Statement

Concept 2017 Q2 2016 Q2
OPERATING ACTIVITIES
Net Income -$6.542M -$8.038M
YoY Change -18.61% 5.31%
Depreciation, Depletion And Amortization $400.0K $432.0K
YoY Change -7.41% 8.82%
Cash From Operating Activities -$5.620M -$6.540M
YoY Change -14.07% -12.45%
INVESTING ACTIVITIES
Capital Expenditures -$40.00K -$280.0K
YoY Change -85.71% -30.0%
Acquisitions
YoY Change
Other Investing Activities $0.00
YoY Change
Cash From Investing Activities -$40.00K -$280.0K
YoY Change -85.71% -30.0%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities -140.0K -140.0K
YoY Change 0.0% 55.56%
NET CHANGE
Cash From Operating Activities -5.620M -6.540M
Cash From Investing Activities -40.00K -280.0K
Cash From Financing Activities -140.0K -140.0K
Net Change In Cash -5.800M -6.960M
YoY Change -16.67% -12.56%
FREE CASH FLOW
Cash From Operating Activities -$5.620M -$6.540M
Capital Expenditures -$40.00K -$280.0K
Free Cash Flow -$5.580M -$6.260M
YoY Change -10.86% -11.46%

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<div> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt"> <b>1. NATURE OF BUSINESS</b></p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 6pt"> <b>Organization</b></p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 6pt"> Histogenics Corporation (the &#x201C;Company&#x201D;) was incorporated under the laws of the Commonwealth of Massachusetts on June&#xA0;28, 2000 and has its principal operations in Waltham, Massachusetts. In 2006, the Company&#x2019;s board of directors approved a corporate reorganization pursuant to which the Company incorporated as a Delaware corporation. The Company is a regenerative medicine company engaged in developing and commercializing products in the musculoskeletal segment of the marketplace. The Company combines cell therapy and tissue engineering technologies to develop products for tissue repair and regeneration and is initially focused on patients suffering from cartilage-derived pain and immobility. The Company&#x2019;s most advanced product, NeoCart, is currently in a Phase 3 clinical trial in the United States (the &#x201C;U.S.&#x201D;) under a special protocol assessment with the U.S. Food and Drug Administration (&#x201C;FDA&#x201D;) for the treatment of knee cartilage damage. In June 2017, the Company announced that it had completed enrollment in the NeoCart Phase 3 clinical trial. The Company expects to report <font style="WHITE-SPACE: nowrap">top-line</font> data in the third quarter of 2018 and file a Biologics License Application (&#x201C;BLA&#x201D;) with the FDA in the same quarter subject to successful Phase 3 clinical trial results.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt"> On May&#xA0;13, 2011, the Company completed the acquisition of ProChon Biotech Ltd. (&#x201C;ProChon&#x201D;), a privately-held biotechnology company focused on modulating the fibroblast growth factor system for consideration of $2.2&#xA0;million to enable it to create more effective solutions for tissue regeneration. ProChon&#x2019;s products combine cell regeneration technologies with proprietary growth factors and biocompatible scaffolds to restore injured or chronically damaged tissues. The acquisition of ProChon provided the Company with access to a significant portfolio of intellectual property, including proprietary cell growth factors, in addition to furthering opportunities for the use of biomaterials to create more effective solutions for regenerating human tissue. The acquisition led to the initial recognition of goodwill, which was subsequently written off in 2011, and intangible assets including IPR&amp;D and a licensing agreement which have been fully-impaired.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt"> On December&#xA0;18, 2014, the Company formed a wholly owned subsidiary, Histogenics Securities Corporation, under the laws of the Commonwealth of Massachusetts.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt"> On September&#xA0;29, 2016, the Company closed a private placement of common stock, preferred stock and warrants, contemplated by a securities purchase agreement dated September&#xA0;15, 2016, with certain institutional and accredited investors. The net proceeds after deducting placement agent fees and other transaction-related expenses was $27.6&#xA0;million. See Note 6, Capital Stock, for further discussion of the private placement.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt"> Since its inception, the Company has devoted substantially all of its efforts to product development, recruiting management and technical staff, raising capital, starting up production and building infrastructure and has not yet generated revenues from its planned principal operations. Expenses have primarily been for research and development and related administrative costs.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt"> The Company is subject to a number of risks. The developmental nature of its activities is such that significant inherent risks exist in the Company&#x2019;s operations. Principal among these risks are the successful development of therapeutics, successfully enrolling patients in its clinical trials in a timely manner, ability to obtain adequate financing, obtaining regulatory approval for any of its product candidates in any jurisdiction, obtaining adequate reimbursement rates for any of its approved product candidates, compliance with government regulations, protection of proprietary therapeutics, fluctuations in operating results, dependence on key personnel and collaborative partners, adoption of the Company&#x2019;s products by the physician community, rapid technological changes inherent in the markets targeted, and substitute products and competition from larger companies.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 18pt"> <b>Liquidity</b></p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 6pt"> The consolidated financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As shown in the accompanying consolidated financial statements, the Company had an accumulated deficit at June&#xA0;30, 2017 of $195.4&#xA0;million and has incurred losses and cash flow deficits from operations for the six months ended June&#xA0;30, 2017 and 2016. The Company has financed operations to date primarily through private placements of equity securities, including the sales of common stock and preferred stock, and the related issuance of warrants in September 2016, the issuance of common stock in the initial public offering completed in December 2014, and borrowings under debt agreements. The Company anticipates that it will continue to incur net losses for the next&#xA0;several years and will require additional capital to complete the filing of a BLA with the FDA and commercialize NeoCart, if approved, and for the future development of its existing product candidates. However, the Company expects that total operating expenses will be lower over the next four quarters than the previous four quarters. As of June&#xA0;30, 2017, the Company had approximately $18.5&#xA0;million of cash and cash equivalents and marketable securities. Given the Company&#x2019;s current development plans, it anticipates that its existing cash and cash equivalents and marketable securities will be not be sufficient to fund its operations beyond the middle of 2018.&#xA0;Accordingly, these factors, among others, raise substantial doubt about the Company&#x2019;s ability to continue as a going concern.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 10pt"> To meet its capital needs, the Company intends to raise additional capital through debt or equity financing or other strategic transactions. However, there can be no assurance that the Company will be able to complete any such transaction on acceptable terms or otherwise. The failure of the Company to obtain sufficient funds on commercially acceptable terms when needed could have a material adverse effect on the Company&#x2019;s business, results of operations and financial condition. The forecast of cash resources is forward-looking information that involves risks and uncertainties, and the actual amount of our expenses could vary materially and adversely as a result of a number of factors. The Company has based its estimates on assumptions that may prove to be wrong, and the Company&#x2019;s expenses could prove to be significantly higher than it currently anticipates.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 18pt"> <b>Basis of Accounting</b></p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 6pt"> The consolidated financial statements are unaudited and have been prepared in conformity with accounting principles generally accepted in the United States of America (&#x201C;U.S. GAAP&#x201D;). However, they do not include all of the information and footnotes required by GAAP for complete financial statements. These interim consolidated financial statements, in the opinion of the Company&#x2019;s management, reflect all normal recurring adjustments necessary for a fair presentation of the Company&#x2019;s financial position and results of operations for the interim periods ended June&#xA0;30, 2017 and 2016. The results of operations for the interim periods are not necessarily indicative of the results of operations to be expected for the full year. These interim financial statements should be read in conjunction with the audited financial statements as of and for the year ended December&#xA0;31, 2016, and the notes thereto, which are included in the Company&#x2019;s Annual Report on Form <font style="WHITE-SPACE: nowrap">10-K,</font> filed with the Securities and Exchange Commission (the &#x201C;SEC&#x201D;) on March&#xA0;16, 2017.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 10pt"> The consolidated financial statements include the accounts of Histogenics Corporation and its wholly-owned subsidiaries, ProChon and Histogenics Securities Corporation. All significant intercompany accounts and transactions are eliminated in consolidation.</p> </div>
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