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Report of Independent Registered Public Accounting Firm To the Board of Directors and Stockholders Organogenesis Inc., Opinion on the Financial Statements We have audited the accompanying consolidated balance sheets of O

Key Takeaway: Report of Independent Registered Public Accounting Firm To the Board of Directors and Stockholders Opinion on the Financial Statements We have audited the accompanying consolidated balance sheets of Organogenesis Inc. (the Company) as of December 31, 2017 and 2016, the related

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Report of Independent Registered Public Accounting Firm
To the Board of Directors and Stockholders
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Organogenesis Inc. (the Company) as of December 31, 2017 and 2016, the related consolidated statements of operations and comprehensive loss, redeemable common stock and stockholders equity (deficit) and cash flows for each of the three years in the period ended December 31, 2017, and the related notes to the consolidated financial statements (collectively, the financial statements). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2017 and 2016, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2017, in conformity with accounting principles generally accepted in the United States of America.
These financial statements are the responsibility of the Company s management. Our responsibility is to express an opinion on the Company s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB and in accordance with auditing standards generally accepted in the United States of America. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
We have served as the Company s auditor since 2004.
Boston, Massachusetts
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share amounts)
December 31,
2016 2017
Assets
Current assets:
Cash (VIE restricted 2016: $267) $ 1,778 $ 2,309
Restricted cash 80 49
Accounts receivable, net 19,149 28,124
Due from affiliates (VIE restricted 2016: $4,433) 4,433
Inventory 13,220 14,270
Prepaid expenses and other current assets (VIE restricted 2016: $183) 1,820 4,399
Contingent consideration forfeiture rights 589
Total current assets 40,480 49,740
Property and equipment, net (VIE restricted 2016: $10,042) 45,474 42,112
Notes receivable from related parties 415 413
Intangible assets, net 11,386 29,759
Goodwill 6,093 25,539
Deferred tax assets 424
Other assets 10 735
Total assets $ 103,858 $ 148,722
Liabilities, Redeemable Common Stock and Stockholders Equity (Deficit)
Current liabilities:
Deferred acquisition consideration $ $ 5,000
Current portion of line of credit 4,869
Current portion of notes payable 6,139
Current portion of capital lease obligations 189 1,525
Accounts payable 11,771 19,053
Accrued expenses and other current liabilities (VIE non-recourse 2016: $167) 17,644 26,395
Total current liabilities 40,612 51,973
Line of credit, net of current portion 17,618
Notes payable, net of current portion (VIE non-recourse 2016: $19,909) 19,909 14,816
Long-term debt affiliates 53,076 52,142
Due to affiliates 400 4,500
Warrant liability 1,201 2,238
Deferred rent, net of current portion 74
Capital lease obligations, net of current portion 3,213 12,390
Other liabilities 1,426 1,526
Total liabilities 119,837 157,277
Commitments and contingencies (Notes 19, 21)
Redeemable common stock, $0.001 par value; 0 and 358,891 shares issued and outstanding at December 31, 2016 and 2017, respectively 6,762
Stockholders equity (deficit):
Common stock, $0.001 par value; 40,000,000 shares authorized at December 31, 2016 and 2017, respectively, 31,464,067 and 32,996,612 shares issued and outstanding at December 31, 2016 and 2017, respectively 31 33
Additional paid-in capital 33,538 50,059
Accumulated deficit (VIE restricted 2016: $3,297) (55,647 ) (65,409 )
Total Organogenesis Inc. stockholders deficit (22,078 ) (15,317 )
Non-controlling interest in affiliates 6,099
Total stockholders deficit (15,979 ) (15,317 )
Total liabilities, redeemable common stock and stockholders equity $ 103,858 $ 148,722
The accompanying notes are an integral part of these consolidated financial statements
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share amounts)
Year Ended December 31,
2015 2016 2017
Net revenue $ 98,975 $ 138,732 $ 198,508
Cost of goods sold 46,450 48,201 61,220
Gross profit 52,525 90,531 137,288
Operating expenses:
Selling, general and administrative 68,174 93,029 133,717
Research and development 3,882 6,277 9,065
Total operating expenses 72,056 99,306 142,782
Loss from operations (19,531 ) (8,775 ) (5,494 )
Other income (expense), net:
Interest expense (3,487 ) (5,627 ) (8,139 )
Interest income 139 153 129
Change in fair value of warrants (737 ) (1,037 )
Other income (expense), net 277 285 (9 )
Total other income (expense), net (3,071 ) (5,926 ) (9,056 )
Net loss before income taxes (22,602 ) (14,701 ) (14,550 )
Income tax (expense) benefit 177 (65 ) 7,025
Net loss and comprehensive loss (22,425 ) (14,766 ) (7,525 )
Net income attributable to non-controlling interest in affiliates 1,836 2,221 863
Net loss attributable to Organogenesis Inc. $ (24,261 ) $ (16,987 ) $ (8,388 )
Net loss per share attributable to Organogenesis Inc. basic and diluted $ (0.78 ) $ (0.55 ) $ (0.28 )
Weighted average common shares outstanding basic and diluted 30,966,451 31,131,067 31,466,384
The accompanying notes are an integral part of these consolidated financial statements
CONSOLIDATED STATEMENTS OF REDEEMABLE COMMON STOCK AND STOCKHOLDERS
(in thousands, except share amounts)
Redeemable Common Stock Common Stock Additional Paid-in Accumulated Total Organogenesis Inc. Stockholders Equity Non- controlling Interest in Total Stockholders Equity
Shares Amount Shares Amount Capital Deficit (Deficit) Affiliates (Deficit)
Balances as of December 31, 2014 30,546,726 $ 31 $ 30,770 $ (14,399 ) $ 16,402 $ 7,242 $ 23,644
Exercise of stock options 917,341 1,836 1,836 1,836
Stock-based compensation expense 459 459 459
Net income (loss) (24,261 ) (24,261 ) 1,836 (22,425 )
Balances as of December 31, 2015 31,464,067 31 33,065 (38,660 ) (5,564 ) 9,078 3,514
Stock-based compensation expense 473 473 473
Distributions to non-controlling interests (5,200 ) (5,200 )
Net income (loss) (16,987 ) (16,987 ) 2,221 (14,766 )
Balances as of December 31, 2016 31,464,067 31 33,538 (55,647 ) (22,078 ) 6,099 (15,979 )
Shares issued in connection with NuTech Medical acquisition 358,891 6,339 1,435,564 2 10,268 10,270 10,270
VIE deconsolidation (1,374 ) (1,374 ) (7,962 ) (9,336 )
Extinguishment of subordinated notes affiliates 4,577 4,577 4,577
Exercise of stock options 96,981 221 221 221
Warrants issued in connection with notes payable 959 959 959
Cash contributions from members of affiliates 1,000 1,000
Stock-based compensation expense 919 919 919
Accretion of redeemable common shares 423 (423 ) (423 ) (423 )
Net income (loss) (8,388 ) (8,388 ) 863 (7,525 )
Balance as of December 31, 2017 358,891 $ 6,762 32,996,612 $ 33 $ 50,059 $ (65,409 ) $ (15,317 ) $ $ (15,317 )
The accompanying notes are an integral part of these consolidated financial statements
CONSOLIDATED STATEMENTS OF CASH FLOWS
Year Ended December 31,
2015 2016 2017
Cash flows from operating activities:
Net loss $ (22,425 ) $ (14,766 ) $ (7,525 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation 6,063 5,702 3,591
Amortization of intangible assets 1,622 1,617 2,037
Non-cash interest expense 1,151 1,662 2,415
Non-cash interest income (105 ) (108 ) (111 )
Non-cash rent expense 30 (26 ) 70
Deferred tax benefit (7,301 )
Loss (gain) on disposal of property and equipment 72 (9 ) (8 )
Impairment of notes receivable 113
Provision (benefit) recorded for sales returns and doubtful accounts (112 ) 25 1,166
Provision recorded for inventory reserve 6,903 7,472 5,497
Stock-based compensation 459 473 919
Change in fair value of warrant liability 737 1,037
Reduction in contingent earn-out (3,300 )
Change in fair value of interest rate swap 5 (253 ) 6
Impairment of intangible assets 240
Change in fair value of forfeiture rights (212 )
Changes in operating assets and liabilities:
Accounts receivable 1,406 (6,556 ) (7,010 )
Inventory (8,198 ) (5,367 ) (3,817 )
Prepaid expenses and other current assets 308 1,009 (2,680 )
Other assets 799
Accounts payable 2,116 33 3,967
Accrued expenses and other current liabilities 2,363 1,110 982
Accrued interest affiliate debt 407 2,339 3,190
Deferred revenue (25 )
Other liabilities 28 35 100
Net cash used in operating activities (10,193 ) (4,871 ) (3,574 )
Cash flows from investing activities:
Purchases of property and equipment (510 ) (1,361 ) (2,426 )
Proceeds from disposal of property and equipment 121 115 8
Acquisition of NuTech Medical, net of cash acquired (11,790 )
VIE deconsolidation (666 )
Net cash used in investing activities (389 ) (1,246 ) (14,874 )
Cash flows from financing activities:
Line of credit borrowings (repayment), net 2,056 (2,399 ) 12,749
Notes payable related party borrowings (repayment), net (2,494 ) 2,398 (1,335 )
Repayment on equipment loan (1,916 )
Repayment of notes payable (5,250 ) (6,325 )
Proceeds from long-term debt affiliates 11,095 17,204
Distributions to non-controlling interests (5,200 )
Borrowings from affiliates 209 23
Proceeds from the exercise of stock options 1,836 221
Cash contributions from members of affiliates 1,000
Proceeds from capital lease 16,000
Payments of deferred acquisition consideration (2,500 )
Payment of debt issuance costs (862 )
Net cash provided by financing activities 10,786 6,776 18,948
Change in cash and restricted cash 204 659 500
Cash and restricted cash, beginning of year 995 1,199 1,858
Cash and restricted cash, end of year $ 1,199 $ 1,858 $ 2,358
Supplemental disclosure of cash flow information:
Cash paid for interest $ 1,160 $ 3,965 $ 5,715
Cash paid for taxes $ 529 $ 29 $ 96
Supplemental disclosure of non-cash investing and financing activities:
Fair value of warrant issued in connection with Subordinated Notes $ $ 464 $
Debt issuance costs included in other liabilities $ $ 680 $
Purchases of property and equipment in accrued expenses $ $ 63 $ 764
Deferred capital lease obligations $ 1,000 $ 1,100 $ 2,743
Fair value of warrant issued in connection with notes payable $ $ $ 959
Extinguishment of Subordinated Notes affiliates $ $ $ 4,577
Accretion of redeemable common stock $ $ $ 423
Shares issued in connection with NuTech Medical acquisition $ $ $ 16,609
Deconsolidation of variable interest entities, net of cash $ $ $ 9,052
Issuance of deferred acquisition consideration $ $ $ 7,500
Issuance of contingent consideration forfeiture rights $ $ $ 377
The accompanying notes are an integral part of these consolidated financial statements
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
1. Nature of Business
Organogenesis Inc. ( Organogenesis or the Company ) is a leading regenerative medicine company focused on the development, manufacture, and commercialization of solutions for the Advanced Wound Care and Surgical & Sports Medicine markets. The Company s products have been shown through clinical and scientific studies to support and in some cases accelerate tissue healing and improve patient outcomes. The Company is advancing the standard of care in each phase of the healing process through multiple breakthroughs in tissue engineering and cell therapy. The Company s solutions address large and growing markets driven by aging demographics and increases in comorbidities such as diabetes, obesity, cardiovascular and peripheral vascular disease and smoking. The Company offers differentiated products and in-house customer support to a wide range of health care customers including hospitals, wound care centers, government facilities, ambulatory service centers (ASCs) and physician offices. The Company s mission is to provide integrated healing solutions that substantially improve medical outcomes and the lives of patients while lowering the overall cost of care.
The Company offers a comprehensive portfolio of products in the markets it serves that address patient needs across the continuum of care. The Company has and intends to continue to generate data from clinical trials, real world outcomes and health economics research that validate the clinical efficacy and value proposition offered by the Company s products. The majority of the existing and pipeline products in the Company s portfolio have Premarket Application approval, Business License Applicant approval or Premarket Notification 510(k) clearance from the United States Food and Drug Administration ( FDA ). Given the extensive time and cost required to conduct clinical trials and receive FDA approvals, we believe our data and regulatory approvals provide us a strong competitive advantage. The Company s product development expertise and multiple technology platforms provide a robust product pipeline which the Company believes will drive future growth.
In March 2017, the Company purchased Nutech Medical, Inc. ( NuTech Medical ) pursuant to an Agreement of Plan of Merger ( Merger ) dated March 18, 2017. As a result of this transaction, NuTech Medical is now a wholly-owned subsidiary of the Company. Under the terms of the Merger, the Company transferred $12,000 in cash, $7,500 of deferred acquisition consideration, 67,555 fully vested common stock options and 1,794,455 shares of the Company s common stock, of which 358,891 shares are redeemable. Results of operations for NuTech Medical are included in the Company s consolidated financial statements from the date of acquisition (See Note 4).
The Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company s ability to continue as a going concern within one year after the date that the consolidated financial statements are issued.
Through December 31, 2017, the Company has funded its operations primarily with cash flow from product sales and proceeds from loans from affiliates and entities controlled by its affiliates and third-party debt. The Company has incurred recurring losses since inception, including net losses of $24,261, $16,987 and $8,388 for the years ended December 31, 2015, 2016 and 2017, respectively. In addition, as of December 31, 2017, the Company had an accumulated deficit of $65,409 and working capital deficit of $2,233. The Company expects to continue to generate operating losses for the foreseeable future. As of March 23, 2018, the issuance date of the consolidated financial statements for the year ended December 31, 2017, the Company expects that its cash of $2,309 as of December 31, 2017, plus cash flows from product sales, availability under the existing line of credit and available proceeds from additional financing raised subsequent to year end (see Note 26), will be sufficient to fund its operating expenses, capital expenditure requirements and debt service payments through at least March 31, 2019.
The Company is seeking to raise additional funding through public and/or private equity financings, debt financings or other strategic transactions. The Company may not be able to obtain funding on acceptable terms, or at all. The terms of any financing may adversely affect the holdings or the rights of the Company s stockholders.
The Company expects to continue investing in product development, sales and marketing and customer support for its products. The long-term continuation of the Company s business plan is dependent upon the generation of sufficient revenues from its products to offset expenses, capital expenditures, debt service payments and contingent payment obligations. In the event that the Company does not generate sufficient revenues and is unable to obtain funding, the Company will be forced to delay, reduce or eliminate some or all of its research and development programs, product portfolio expansion, commercialization efforts or capital expenditures, which could adversely affect the Company s business prospects, ability to meet long-term liquidity needs or the Company may be unable to continue operations.
The accompanying consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. Accordingly, the consolidated financial statements have been prepared on a basis that assumes the Company will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business.
2. Significant Accounting Policies
The preparation of financial statements in conformity with accounting principles generally accepted in the United States ( GAAP ) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported consolidated statements of operations during the reporting period. Actual results could differ from those estimates.
Principles of Consolidation
The consolidated financial statements include the accounts of Organogenesis (a Delaware corporation), its wholly owned subsidiary, Organogenesis GmbH (a Switzerland corporation) NuTech Medical from the acquisition date of March 24, 2017, and the accounts of Dan Road Associates, LLC ( Dan Road Associates ), 85 Dan Road Associates, LLC ( 85 Dan Road Associates ) and Canton 65 Dan Road Associates, LLC ( 65 Dan Road Associates ) which were variable interest entities requiring consolidation (each a Real Estate Entity, collectively the Real Estate Entities ) are included in the consolidated financial statements through the deconsolidation date of June 1, 2017, as discussed below.
Dan Road Equity I, LLC, a wholly owned subsidiary of Dan Road Associates, and 65 Dan Road SPE, LLC, a wholly owned subsidiary of 65 Dan Road Associates, were each formed in 2011. Dan Road Equity I, LLC and 65 Dan Road, LLC were formed as special purpose entities ( SPEs ) solely to own the real property of its respective parent. As such, in connection with the formation of the SPEs, Dan Road Associates and 65 Dan Road Associates transferred title to the real property held by them, along with the related mortgages and operations, to Dan Road Equity I and 65 Dan Road, LLC respectively.
On June 1, 2017, the Real Estate Entities entered into amendments to their respective mortgage notes which resulted in the removal of the requirement that the Company s affiliates provide personal guarantees for the mortgages. As a result, the Company determined that the Real Estate Entities no longer met the definition of a variable interest entity, and accordingly, the Company determined that the Real Estate Entities were no longer required to be consolidated under the variable interest entity model. The Real Estate Entities were deconsolidated and the financial statements as of June 1, 2017 derecognized all assets and liabilities of the Real Estate Entities (See Note 3). The results of operations for the year ended December 31, 2017 include the operations of the Real Estate Entities through the date of deconsolidation. The consolidated balance sheet as of December 31, 2017 does not include the accounts of the Real Estate Entities.
All significant intercompany balances and transactions have been eliminated in consolidation.
Consolidated Variable Interest Entities
The Company is required to evaluate its relationships with certain entities which meet the definition of a variable interest entity to determine whether consolidation is required under GAAP, as there exists a controlling financial interest. The Company has considered its relationships with certain entities, some of which are wholly-owned by affiliates of the Company, to determine whether it had a variable interest in these entities and, if so, whether the Company is the primary beneficiary of the relationship.
In making the determination that an entity meets the definition of a variable interest entity, the Company assesses various factors including voting rights, right to receive residual gain and losses as well as the ability of the entity s equity at risk to finance the future operations of the entity. Significant judgement is required when evaluating the sufficiency of the equity at risk and the Company considers all relevant relationships the entities have related to financing the operations including but not limited to equity investment, debt financing and personal guarantees of equity holders to secure debt financing.
In evaluating whether or not the Company has a controlling financial interest and would be considered the primary beneficiary of the entity, the Company must determine if it has the ability to control the activities that most significantly impact the economic performance of an entity determined to be a variable interest entity and also if the Company has the obligation to absorb losses or the right to receive residual returns which could be significant to a variable interest entity. The Company considers the following factors in determining if it has the right to control activities of the entity: the purpose and the design of the entity, all relationships the Company has with the entity, as we well as relationships affiliates may have with each entity, to determine who has the power to direct the activities that most significantly impact the economic performance of the entity. This evaluation requires consideration of all facts and circumstances relevant to decision-making that affects the entity s future performance and the exercise of professional judgment in deciding which decision making rights are most important. This analysis takes into account power through related parties who also have the ability to assert significant influence on the Company s decision making ability. The Company evaluates all of its economic relationships with variable interest entities to determine the significance of its obligation to absorb losses or right to receive returns including leasing arrangements, residual value guarantees and amounts due to or from the variable interest entities. The Company assesses its determination as the primary beneficiary on an ongoing basis at each balance sheet date.
The Company is the primary tenant in each of the facilities owned by the Real Estate Entities under long-term leases which were determined to be capital leases which would effectively act as a residual guaranty on the value of the assets of the Real Estate Entities. Furthermore, the Company has made substantial improvements to each of the buildings, all of which transfer residual value to the Company.
As a result, the accounts and transactions of the Real Estate Entities are consolidated, for financial reporting purposes, until derecognized. The non-controlling interest in the Real Estate Entities are reported as non-controlling interest in affiliates in the equity section of the consolidated balance sheets, and the non-controlling interest in earnings are reported as net income attributable to non-controlling interest in affiliates in the consolidated statements of operations and comprehensive loss. Losses generated by the Real Estate Entities prior to 2008, which occurred prior to the adoption of FIN 46 and subsequently ASU 810 were recorded in the Company s retained earnings and remained constant until the Real Estate Entities were deconsolidated on June 1, 2017.
Although the Company consolidated all of the assets and liabilities of the Real Estate Entities, the assets of the Real Estate Entities were not available to settle obligations of the Company and the creditors of the Real Estate Entities did not have recourse against the assets of the Company, except as provided for contractually.
Operating segments are defined as components of an enterprise about which discrete financial information is available that is evaluated regularly by the chief operating decision maker, or decision making group, in making decisions on how to allocate resources and assess performance for the organization. The Company s chief decision maker is the Chief Executive Officer. The Company s chief decision maker reviews consolidated operating results to make decisions about allocating resources and assessing performance for the entire Company. Accordingly, the Company has determined that it has a single operating segment regenerative medicine.
The Company manages its operations as a single operating segment for the purposes of assessing performance and making operating decisions. The Company s portfolio includes regenerative medicine products in various stages, ranging from preclinical to late stage development, and commercialized advanced wound care and surgical and sports medicine products which support healing across a wide variety of wound types at many different types of facilities.
The Company primarily maintains its cash in bank deposit accounts in the United States which, at times, may exceed the federally insured limits. The Company has not experienced losses in such accounts and believes it is not exposed to significant credit risk on cash. For purposes of reporting cash flows, the Company considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. The Company had no cash equivalents as of December 31, 2016 or 2017.
The Company had restricted cash of $80 and $49 as of December 31, 2016 and 2017, respectively. Restricted cash represents employee deposits in connection with the Company s health benefit plan.
Accounts receivable are stated at invoice value less estimated allowances for sales returns and doubtful accounts. The Company estimates the allowance for sales returns based on a historical percentage of returns over a twelve-month trailing average of sales. The Company continually monitors customer payments and maintains a reserve for estimated losses resulting from its customers inability to make required payments. The Company considers factors when estimating the allowance for doubtful accounts such as historical experience, credit quality, age of the accounts receivable balances, geographic related risks and economic conditions that may affect a customer s ability to pay. In cases where there are circumstances that may impair a specific customer s ability to meet its financial obligations, a specific allowance is recorded against amounts due, thereby reducing the net recognized receivable to the amount reasonably believed to be collectible. Accounts receivables are written off when deemed uncollectible. Recoveries of accounts receivable previously written off are recorded when received.
Inventories are stated at the lower of cost or net realizable value. Cost is recorded on the first-in, first-out method. Work in process and finished goods include materials, labor and allocated overhead. Inventory also includes cell banks and the cost of tests mandated by regulatory agencies of the materials to qualify them for production.
The Company regularly reviews inventory quantities on hand and records a provision to write down excess and obsolete inventory to its estimated net realizable value based upon management s assumptions of future material usage, yields and obsolescence, which are a result of future demand and market conditions and the effective life of certain inventory items.
The Company also tests other components of its inventory for future growth projections. The Company determines the average yield of the component and compares it to projected revenue to ensure it is properly reserved.
Property and Equipment, Net
Property and equipment are recorded at cost and depreciated over the estimated useful lives of the respective asset on a straight-line basis. As of December 31, 2016 and 2017, the Company s property and equipment consisted of buildings, building and land improvements, furniture and computers, and equipment. Property and equipment estimated useful lives are as follows:
Buildings 39 years
Leasehold improvements Lesser of the life of the lease or the economic life of the asset
Furniture and computers 3 - 5 years
Equipment 5 - 10 years
Upon retirement or sale, the cost of assets disposed and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is included in the consolidated statement of operations and comprehensive loss. Expenditures for repairs and maintenance are charged to expense as incurred. Expenditures for major improvements that extend the useful lives of the related asset are capitalized and depreciated over their remaining estimated useful lives. Construction in progress costs are capitalized when incurred until the assets are placed in service, at which time the costs will be transferred to the related property and equipment accounts, and depreciated over their respective useful lives.
Business combinations are accounted for under the acquisition method. The total cost of an acquisition is allocated to the underlying identifiable net assets, based on their respective estimated fair values as of the acquisition date. Determining the fair value of assets acquired and liabilities assumed requires management s judgment and often involves the use of significant estimates and assumptions, including assumptions with respect to future cash inflows and outflows, discount rates, asset lives and market multiples, among other items. Assets acquired and liabilities assumed are recorded at their estimated fair values. The excess of the purchase price over the estimated fair values of the net assets acquired is recorded as goodwill.
Goodwill is tested for impairment annually as of December 31, or more frequently when events or changes in circumstances indicate that the asset might be impaired. Examples of such events or circumstances include, but are not limited to, a significant adverse change in legal or business climate, an adverse regulatory action or unanticipated competition.
The Company first assesses qualitative factors to determine whether the existence of events or circumstances would indicate that it is more likely than not that the fair value of the reporting unit was less than its carrying amount. If after assessing the totality of events or circumstances, the Company were to determine that it is more likely than not that the fair value of the reporting unit is less than its carrying amount, then the Company would perform a quantitative impairment test.
The Company compares the fair value of the reporting unit to its carrying value. If the fair value of the reporting unit exceeds the carrying value of the net assets, goodwill is not impaired. If the implied fair value of the reporting unit s goodwill is less than the carrying value, the difference is recorded as an impairment loss.
There was no impairment of goodwill identified during the years ended December 31, 2015, 2016 or 2017.
Intangible Assets Subject to Amortization
Intangible assets include intellectual property either owned by the Company or for which the Company has a license. Intangible assets acquired in a business combination are recognized at fair value using generally accepted valuation methods deemed appropriate for the type of intangible asset acquired and reported net of accumulated amortization, separately from goodwill. Intangible assets with finite lives are amortized over their estimated useful lives. Intangible assets include developed technology and patents, trade names, trademarks, independent sales agency networks and non-compete agreements obtained through business acquisitions. Amortization of intangible assets subject to amortization is calculated on the straight-line method based on the following estimated useful lives:
Trade names and trademarks 10 - 12 years
Developed technology 10 - 12 years
Independent sales agency network 3 years
Non-compete agreements 5 years
Impairment of Long-Lived Assets
Long-lived assets consist primarily of property and equipment and intangible assets. The Company reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset or asset group may not be recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or economic trends and significant changes or planned changes in the use of the assets. When such an event occurs, management determines whether there has been impairment by comparing the anticipated undiscounted future net cash flows to the related asset group s carrying value. If an asset is determined to be impaired, the asset is written down to fair value, which is determined based either on discounted cash flows or appraised value, depending on the nature of the asset. As of December 31, 2015, the undiscounted cash flows of the patents was determined to be zero which is below the carrying value of the patents, and as a result the Company recognized an impairment charge in the amount of $240 within selling general and administrative expenses in the consolidated statements of operations and comprehensive loss to write the fair value of the patents to zero. The Company did not record any impairment on long-lived assets during the years ended December 31, 2016 or 2017.
Deferred Financing Costs
The Company adopted the provisions of ASU 2015-15, Presentation and Subsequent Measurement of Debt Issuance Costs Associated with Line-of-Credit Arrangements, issued by the FASB in August 2015, which allows debt issuance costs associated with line-of-credit arrangements to be classified as an asset. Accordingly, the Company capitalized certain third-party fees that are directly associated with the Credit Agreement. Deferred financing costs included in the other assets on the consolidated balance sheet were $463 as of December 31, 2017 and are amortized over the term of the agreement.
The Company early adopted the provisions of ASU 2015-03, Simplifying the Presentation of Debt Issuance Costs, issued by the FASB in April 2015, which simplifies the presentation of debt issuance costs. Accordingly, the Company presents debt issuance costs as a direct reduction from the carrying amount of the associated debt on the consolidated balance sheet. As of December 31, 2016, debt issuance costs totaled $195 as a direct reduction from the carrying amount of note payable affiliates on the consolidated balance sheet. As of December 31, 2017, debt issuance costs totaled $6,424, with $1,079 as a direct reduction from the carrying amount of note payable, and $5,345 as a direct reduction from the carrying amount of the long-term debt affiliates, on the consolidated balance sheet.
Deferred Offering Costs
The Company capitalizes certain legal, professional accounting and other third-party fees that are directly associated with in-process equity financings as deferred offering costs until such financings are consummated. After consummation of the equity financing, these costs are recorded in stockholders equity (deficit) as a reduction of proceeds generated as a result of the offering. Should the planned equity financing be abandoned, the deferred offering costs will be expensed immediately as a charge to operating expenses in the consolidated statement of operations. The Company recorded $0 and $2,724 of deferred offering costs as of December 31, 2016 and 2017, respectively, to prepaid expenses and other current assets within the consolidated balance sheets.
The Real Estate Entities utilize interest rate swaps to manage the economic impact of fluctuations in interest rates. The Real Estate Entities do not use interest rate swaps for speculative or trading purposes. Periodically, the Real Estate Entities enter into interest rate swap agreements to modify the interest characteristics of the outstanding debt. The Real Estate Entities interest rate swaps have not been designated as hedging instruments, and as such, the fair value of these instruments is recorded as an asset or liability on the consolidated balance sheet with change in the fair value of the instruments recognized as income or expense in the current period as a component of other income (expense), net in the consolidated statements of operations and comprehensive loss.
All interest rate swaps are recorded on the balance sheet at fair value. The fair values of the Company s interest rate swaps are determined based on inputs that are readily available in public markets or can be derived from information available in publicly quoted markets, which represent level 2 inputs as defined by GAAP.
In connection with entering into the subordinated notes agreement (see Note 13), the Company agreed to issue warrants to purchase common stock to the debtors under the agreement. The Company classifies the warrants as a liability on its consolidated balance sheet because each warrant provides for down-round protection which causes the exercise price of the warrants to be adjusted if future equity issuances are below the current exercise price of the warrants. The price of the warrant will also be adjusted any time the price of another equity-linked instrument changes. The warrant liability was initially recorded at fair value upon entering into the Subordinated Notes agreement and is subsequently remeasured to fair value at each reporting date. Changes in the fair value of the warrant liability are recognized as a component of other income (expense), net in the consolidated statement of operations and comprehensive loss. Changes in the fair value of the warrant liability will continue to be recognized until the warrants are exercised, expire or qualify for equity classification. The Company has and will continue to reassess the warrant classification at each balance sheet date.
Revenue from product sales is recognized upon delivery, after risk of ownership passes to the customer in accordance with a purchase order which includes a fixed price, collection is probable, and no performance obligations exist. Product shipped to customers in advance of the receipt of a purchase order is not recognized as revenue or cost of goods sold until the purchase order is received. Revenue is recorded net of a provision for estimated sales returns and early payment discounts, which are accrued at the time revenue is recognized, based upon historical experience and specific circumstances.
Shipping and Handling
The Company records amounts incurred related to shipping and handling costs as a cost of goods sold.
Each of the Company s products carry product warranties, which generally provide customers the right to return defective product during the specified warranty period for replacement at no cost to the customer. The Company did not record any reserves for product warranties as of December 31, 2016 or 2017.
Stock-Based Compensation
The Company measures stock-based awards granted to employees based on the fair value of the awards on the date of grant and recognizes compensation expense for those awards over the requisite service period, which is generally the vesting period of the respective award. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Generally, the Company issues stock-based awards with only service-based vesting conditions and records the expense for these awards using the straight-line method.
The Company recognizes stock-based compensation expense within the consolidated financial statements for all share-based payments based upon the estimated grant-date fair value for the awards expected to ultimately vest.
The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option pricing model. The Company historically has been a private company and lacks company-specific historical and implied volatility information for its stock. Therefore, it estimates its expected stock price volatility based on the historical volatility of publicly traded peer companies and expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own traded stock price. The expected term of the Company s stock options has been determined utilizing the simplified method for awards that qualify as plain-vanilla options. The expected term of stock options granted to non-employees is equal to the contractual term of the option award. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company has never paid cash dividends on its common stock and does not expect to pay any cash dividends in the foreseeable future.
From 2010 through 2013, the Company had a loan program that permitted certain officers of the Company to borrow funds secured by their individual equity holdings in Company stock and options (see Note 10).
Advertising costs are expensed as incurred and are included in selling, general and administrative expense in the consolidated statements of operations and comprehensive loss. Advertising costs were approximately $1,281, $1,196 and $947 for the years ended December 31, 2015, 2016 and 2017, respectively.
Research and Development Costs
Research and development expenses relate to the Company s investments in improvements to manufacturing processes, product enhancements to currently available products, and additional investments in the Company s product pipeline and platforms. Research and development costs also include expenses such as clinical trial and regulatory costs. The Company expenses research and development costs as incurred.
Interest income is primarily recognized by the Company for interest earned on Employee Loans (see Note 10) and interest earned by the Real Estate Entities on loans entered into by the entities through the date of deconsolidation on June 1, 2017.
The Company s functional currency, including the Company s Swiss subsidiary, Organogenesis GmbH, is the U.S. dollar. Foreign currency gains and losses resulting from re-measurement of assets and liabilities held in foreign currencies and transactions settled in a currency other than the functional currency are included separately as non-operating income or expense in the consolidated statements of operations and comprehensive loss as a component of other income (expense), net. The foreign currency amounts recorded for all periods presented were insignificant.
The Company accounts for income taxes using the asset and liability method which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the consolidated financial statements or in the Company s tax returns. Deferred tax assets and liabilities are determined on the basis of the differences between the consolidated financial statement and the tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. The Company annually assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent it believes, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established through a charge to income tax expense. Potential for recovery of deferred tax assets is evaluated by estimating the future taxable profits expected and considering prudent and feasible tax planning strategies.
The Company accounts for uncertain income tax positions recognized in the consolidated financial statements by applying a two-step process to determine the amount of tax benefit to be recognized. First, the tax position must be evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities. If the tax position is deemed more-likely-than-not to be sustained, the tax position is then assessed to determine the amount of benefit to recognize in the consolidated financial statements. The amount of the benefit that may be recognized is the largest amount that has a greater than 50% likelihood of being realized upon ultimate settlement. The provision for income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate as well as the related net interest and penalties.
Fair value of financial instruments
Certain assets and liabilities of the Company are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:
Level 1 Quoted prices in active markets for identical assets or liabilities.
Level 2 Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.
Level 3 Unobservable inputs that are supported by little or no market activity that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.
Last updated: Dec 11, 2018