2017 Q4 Form 10-Q Financial Statement

#000119312517338756 Filed on November 09, 2017

View on sec.gov

Income Statement

Concept 2017 Q4 2017 Q3 2016 Q3
Revenue $0.00 $0.00 $0.00
YoY Change
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $2.670M $2.230M $1.770M
YoY Change 11.72% 25.99% -19.18%
% of Gross Profit
Research & Development $3.370M $3.488M $4.880M
YoY Change -36.65% -28.52% -16.55%
% of Gross Profit
Depreciation & Amortization $350.0K $400.0K $404.0K
YoY Change -12.5% -0.99% -2.42%
% of Gross Profit
Operating Expenses $6.030M $5.713M $6.648M
YoY Change -21.79% -14.06% -17.3%
Operating Profit -$5.713M -$6.648M
YoY Change -14.06% -17.3%
Interest Expense -$790.0K $39.00K $20.00K
YoY Change -104.67% 95.0% -13.04%
% of Operating Profit
Other Income/Expense, Net $30.00K -$282.0K -$2.667M
YoY Change -40.0% -89.43% 6738.46%
Pretax Income -$6.800M -$6.000M -$9.320M
YoY Change -175.06% -35.62% 15.35%
Income Tax
% Of Pretax Income
Net Earnings -$6.800M -$5.995M -$9.315M
YoY Change -175.06% -35.64% 15.31%
Net Earnings / Revenue
Basic Earnings Per Share -$0.23
Diluted Earnings Per Share -$17.00M -$0.23 -$42.36M
COMMON SHARES
Basic Shares Outstanding 24.07M shares 22.55M 13.27M shares
Diluted Shares Outstanding 22.55M

Balance Sheet

Concept 2017 Q4 2017 Q3 2016 Q3
SHORT-TERM ASSETS
Cash & Short-Term Investments $7.981M $12.62M $37.99M
YoY Change -74.99% -66.78% 0.72%
Cash & Equivalents $7.081M $10.80M $37.99M
Short-Term Investments $900.0K $1.821M
Other Short-Term Assets $122.0K $260.0K $200.0K
YoY Change 79.41% 30.0% -45.95%
Inventory
Prepaid Expenses
Receivables
Other Receivables
Total Short-Term Assets $8.175M $12.88M $38.20M
YoY Change -74.52% -66.29% 0.28%
LONG-TERM ASSETS
Property, Plant & Equipment $2.723M $2.814M $4.263M
YoY Change -29.46% -33.99% -22.67%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $140.0K $140.0K $140.0K
YoY Change 0.0% 0.0% -88.24%
Total Long-Term Assets $2.860M $2.951M $4.600M
YoY Change -28.45% -35.85% -36.23%
TOTAL ASSETS
Total Short-Term Assets $8.175M $12.88M $38.20M
Total Long-Term Assets $2.860M $2.951M $4.600M
Total Assets $11.04M $15.83M $42.80M
YoY Change -69.41% -63.01% -5.53%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $776.0K $827.0K $1.665M
YoY Change -51.13% -50.33% -16.79%
Accrued Expenses $2.705M $1.518M $4.290M
YoY Change 28.99% -64.62% 75.17%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due $180.0K $320.0K $580.0K
YoY Change -68.97% -44.83% 0.0%
Total Short-Term Liabilities $3.805M $2.914M $7.209M
YoY Change -26.42% -59.58% 7.76%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00 $320.0K
YoY Change -100.0% -100.0% -64.84%
Other Long-Term Liabilities $18.50M $17.73M $31.23M
YoY Change 7.81% -43.23% 1941.18%
Total Long-Term Liabilities $18.50M $17.73M $31.55M
YoY Change 6.69% -43.8% 1193.03%
TOTAL LIABILITIES
Total Short-Term Liabilities $3.805M $2.914M $7.209M
Total Long-Term Liabilities $18.50M $17.73M $31.55M
Total Liabilities $22.30M $20.64M $38.76M
YoY Change -0.92% -46.75% 324.76%
SHAREHOLDERS EQUITY
Retained Earnings -$208.2M -$201.4M -$190.8M
YoY Change 14.53% 5.53% 21.38%
Common Stock $196.9M $196.6M $194.9M
YoY Change 0.81% 0.88% 0.77%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $4.435M -$4.813M $4.036M
YoY Change
Total Liabilities & Shareholders Equity $11.04M $15.83M $42.80M
YoY Change -69.41% -63.01% -5.53%

Cashflow Statement

Concept 2017 Q4 2017 Q3 2016 Q3
OPERATING ACTIVITIES
Net Income -$6.800M -$5.995M -$9.315M
YoY Change -175.06% -35.64% 15.31%
Depreciation, Depletion And Amortization $350.0K $400.0K $404.0K
YoY Change -12.5% -0.99% -2.42%
Cash From Operating Activities -$4.320M -$5.730M -$5.460M
YoY Change -26.78% 4.95% -20.64%
INVESTING ACTIVITIES
Capital Expenditures -$150.0K -$50.00K -$10.00K
YoY Change 400.0% -98.0%
Acquisitions
YoY Change
Other Investing Activities $900.0K $6.160M
YoY Change
Cash From Investing Activities $750.0K $6.100M -$10.00K
YoY Change -61100.0% -98.0%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities -150.0K -140.0K 27.53M
YoY Change -21.05% -100.51% -23041.67%
NET CHANGE
Cash From Operating Activities -4.320M -5.730M -5.460M
Cash From Investing Activities 750.0K 6.100M -10.00K
Cash From Financing Activities -150.0K -140.0K 27.53M
Net Change In Cash -3.720M 230.0K 22.06M
YoY Change -38.92% -98.96% -394.13%
FREE CASH FLOW
Cash From Operating Activities -$4.320M -$5.730M -$5.460M
Capital Expenditures -$150.0K -$50.00K -$10.00K
Free Cash Flow -$4.170M -$5.680M -$5.450M
YoY Change -29.32% 4.22% -14.58%

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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 cell therapy 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<sup style="FONT-SIZE: 85%; VERTICAL-ALIGN: top">&#xAE;</sup>, 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 top-line 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. 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, the introduction of 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 September&#xA0;30, 2017 of $201.4&#xA0;million and has incurred losses and cash flow deficits from operations for the nine months ended September&#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 September&#xA0;30, 2017, the Company had approximately $12.6&#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: 0px; FONT-SIZE: 1px; MARGIN-TOP: 12px"> &#xA0;</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 0pt"> 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 September&#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 10-K, 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: 12pt"> 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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