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1. Organization and Basis of Presentation
MAKO Surgical Corp. (the "Company" or "MAKO") is an emerging medical device company that markets its advanced robotic arm solution and orthopedic implants for orthopedic procedures called MAKOplasty®. The Company was incorporated in the State of Delaware on November 12, 2004 and is headquartered in Fort Lauderdale, Florida. The Company's common stock trades on The NASDAQ Global Select Market under the ticker symbol "MAKO."
Basis of Presentation and Use of Estimates
The financial statements have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The accounting estimates that require management's most significant, difficult and subjective judgments include revenue recognition, allowance for doubtful accounts, inventory valuation, valuation allowance for deferred income tax assets, impairment of long-lived assets and the determination of stock-based compensation. Actual results could differ significantly from these estimates.
Liquidity and Operations
In executing its current business plan, the Company believes its existing cash, cash equivalents and investment balances will be sufficient to meet its anticipated cash requirements for at least the next twelve months. To the extent the Company's available cash, cash equivalents and investment balances are insufficient to satisfy its operating requirements, the Company will need to seek additional sources of funds, including selling additional equity, debt or other securities or entering into a credit facility, or modifying its current business plan. The sale of additional equity or convertible debt securities may result in dilution to the Company's current stockholders. If the Company raises additional funds through the issuance of debt securities, these securities may have rights senior to those of its common stock and could contain covenants that could restrict the Company's operations and ability to issue dividends. The Company may also require additional capital beyond its currently forecasted amounts. Any required additional capital, whether forecasted or not, may not be available on reasonable terms, or at all. If the Company is unable to obtain additional financing, the Company may be required to reduce the scope of, delay or eliminate some or all of its planned research, development and commercialization activities, which could materially harm its business and results of operations.
Concentrations of Credit Risk and Other Risks and Uncertainties
Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents, investments, and accounts receivable. The Company's cash and cash equivalents are held in demand and money market accounts at four large financial institutions. The Company's investments are held in a variety of interest bearing instruments, including notes and bonds from U.S. government agencies and certificates of deposit at three large financial institutions. Such deposits are generally in excess of insured limits. The Company has not experienced any historical losses on its deposits of cash and cash equivalents.
The Company may perform credit evaluations of its customers' financial condition and, generally, requires no collateral from its customers. The Company provides an allowance for doubtful accounts when collections become doubtful but has not experienced any significant credit losses to date.
The Company is subject to risks common to emerging companies in the medical device industry including, but not limited to: new technological innovations, dependence on key personnel, dependence on key suppliers, changes in general economic conditions and interest rates, protection of proprietary technology, compliance with new and established domestic and foreign government regulations and taxes, uncertainty of widespread market acceptance of products, access to credit for capital purchases by our customers, product liability and the need to obtain additional financing. The Company's products include components subject to rapid technological change. Certain components used in manufacturing have relatively few alternative sources of supply and establishing additional or replacement suppliers for such components cannot be accomplished quickly. The inability of any of these suppliers to fulfill the Company's supply requirements may negatively impact future operating results. While the Company has ongoing programs to minimize the adverse effect of such uncertainty and considers technological change in estimating the net realizable value of its inventory, uncertainty continues to exist.
The Company expects to derive most of its revenue from capital sales of its RIO® Robotic Arm Interactive Orthopedic ("RIO") system, current and future MAKOplasty applications to the RIO system, recurring sales of implants and disposable products required for each MAKOplasty procedure, and service plans that are sold with the RIO system. If the Company is unable to achieve broad commercial acceptance of MAKOplasty or obtain regulatory clearances or approvals for future products, including other orthopedic products, its revenue would be adversely affected and the Company would not become profitable.
The Company's current versions of its RIO system, its MAKOplasty partial knee and total hip arthroplasty applications, and its RESTORIS® MCK multicompartmental knee implant systems and RESTORIS total hip implant systems have been cleared by the U.S. Food and Drug Administration ("FDA"). Certain products currently under development by the Company will require clearance or approval by the FDA or other international regulatory agencies prior to commercial sale. There can be no assurance that the Company's products will receive the necessary clearances or approvals. If the Company were to be denied any such clearance or approval or such clearance or approval were delayed, it could have a material adverse impact on the Company.
Financial Accounting Standards Board ("FASB") Accounting Standards Codification ("ASC") 280, Segment Reporting, establishes standards for reporting information about operating segments. Operating segments are defined as components of an enterprise about which separate financial information is available that is evaluated regularly by the chief operating decision maker, or decision making group, in deciding how to allocate resources and in assessing performance. The Company's chief operating decision maker is its CEO. The Company's CEO reviews financial information presented on an aggregate basis for purposes of allocating resources and evaluating financial performance. The Company has one business activity and there are no segment managers who are held accountable for operations, operating results and plans for products or components below the aggregate Company level. Accordingly, the Company reports as a single operating segment. No single hospital customer accounted for more than 10% of the Company's total revenue for the years ended December 31, 2011, 2010 and 2009. During the years ended December 31, 2011, 2010 and 2009, domestic revenue accounted for 96% or greater of total revenue, while international revenue accounted for 4% or less of total revenue, for each of the years.
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2. Summary of Significant Accounting Policies
Cash and Cash Equivalents
The Company considers all highly liquid investments with an original maturity at date of purchase of 90 days or less to be cash equivalents.
Fair Value of Financial Instruments
Carrying amounts of certain of the Company's financial instruments, including cash and cash equivalents, investments, accounts receivable and other accrued liabilities approximate fair value due to their short maturities or market rates of interest.
Allowance for Doubtful Accounts
The Company regularly reviews customer balances by considering factors such as historical experience, credit quality, the age of the accounts receivable balances and current economic conditions that may affect a customer's ability to pay. The Company provides an allowance for doubtful accounts when collections become doubtful but has not experienced any significant credit losses to date.
Inventory
Inventory is stated at the lower of cost or market value on a first-in, first-out basis. Inventory costs include direct materials, direct labor and manufacturing overhead. The Company reviews its inventory periodically to determine net realizable value and considers product upgrades in its periodic review of realizability. The Company writes down inventory, if required, based on forecasted demand and technological obsolescence. These factors are impacted by market and economic conditions, technology changes and new product introductions and require estimates that may include uncertain elements.
Property and Equipment
Property and equipment are stated at cost, net of accumulated depreciation. Depreciation of property and equipment is computed using the straight-line method over their estimated useful lives of three to seven years. Leasehold improvements are amortized on a straight-line basis over the lesser of their useful life or the term of the lease and are included in depreciation expense in the accompanying statements of operations. Upon retirement or sale, the cost and related accumulated depreciation are removed from the balance sheet and the resulting gain or loss is reflected in operations. Maintenance and repairs are charged to operations as incurred.
The Company loans instrumentation to its customers, who use the instrumentation to perform MAKOplasty procedures in conjunction with using the RIO system. These loaned instrument sets are comprised of tools and equipment that facilitate the implantation of the Company's implants ("Implant Instruments"). Implant Instruments loaned to customers are not part of the tangible product sold and title of Implant Instruments remains with the Company. Accordingly, Implant Instruments are classified as a long-lived asset and included as a component of property and equipment. Undeployed Implant Instruments are carried at cost, net of allowances for excess and obsolete instruments. Implant Instruments in the field are carried at cost less accumulated depreciation. Depreciation is computed using the straight-line method based on an estimated useful life of five years. The Company reviews instruments for impairment whenever events or changes in circumstances indicate that the carrying value of an instrument may not be recoverable. To better reflect the economics of the Implant Instruments and enhance comparability with other companies in our industry, depreciation expense on Implant Instruments has been reclassified from cost of revenue – procedures to selling, general and administrative expense beginning in the first quarter of 2010. Depreciation expense for implant instruments was $1.1 million, $464,000 and $250,000 for the years ended December 31, 2011, 2010 and 2009, respectively.
The Company also enters into RIO system consignment arrangements for clinical evaluation or clinical research purposes with terms ranging from sixty days to three years. Under the terms of such arrangements, the Company installs a RIO system at the evaluation or research site and retains title to the RIO system, while the evaluation or research site has use of the RIO system and purchases the Company's implants and disposables products. Depreciation expense on consigned RIO systems and instruments is classified in selling, general and administrative expense and is computed using the straight-line method based on the estimated useful life of three years. As of December 31, 2011, the Company had one consigned RIO system, which is being utilized for clinical research purposes.
Service and demonstration RIO systems and instruments consist of RIO systems, associated instrumentation, service tools and equipment, and MAKOplasty procedure models used for sales demonstrations, surgeon training, and temporary RIO system placements at customer sites under warranty and extended warranty agreements. Service and demonstration RIO systems and instruments are classified as a long-lived asset and
included as a component of property and equipment. Depreciation expense on service and demonstration RIO systems and instruments is classified in selling, general and administrative expense and is computed using the straight-line method based on an estimated useful life of three years.
Intangible Assets
The Company's intangible assets are comprised of patents, patent applications and licenses to intellectual property rights. These intangible assets are carried at cost, net of accumulated amortization. Amortization is recorded using the straight-line method over their respective useful lives, which range from 3 to 13 years based on the respective anticipated lives of the underlying patents and patent applications.
Impairment of Long-Lived Assets
The Company evaluates its long-lived assets for indicators of impairment by comparison of the carrying amounts to future net undiscounted cash flows expected to be generated by such assets when events or changes in circumstances indicate the carrying amount of an asset may not be recoverable. Should an impairment exist, the impairment loss would be measured based on the excess carrying value of the asset over the asset's fair value or estimated discounted future cash flows.
Revenue Recognition
Revenue is generated: from (1) unit sales of the Company's RIO system and MAKOplasty applications (collectively, the "RIO system"), including associated instrumentation, installation services and training; (2) sales of implants and disposable products utilized in MAKOplasty procedures; and (3) sales of warranty and maintenance services. The Company recognizes revenue in accordance with ASC 605-10, Revenue Recognition, when persuasive evidence of an arrangement exists, the fee is fixed or determinable, collection of the fee is probable and delivery has occurred. For all sales, the Company uses either a signed agreement or a binding purchase order as evidence of an arrangement.
The Company's multiple-element arrangements are generally comprised of the following elements that qualify as separate units of accounting: (1) RIO system sales; (2) sales of implants and disposable products; and (3) warranty and maintenance services on the RIO system hardware. The Company's revenue recognition policies generally result in revenue recognition at the following points:
|
|
|
|
|
|
1. |
RIO system sales: Revenues related to RIO system sales are recognized upon installation of the system, training of at least one surgeon, which typically occurs prior to or concurrent with the RIO system installation, and customer acceptance, if required. |
|
|
|
|
|
|
2. |
Procedure revenue: Revenues from the sale of implants and disposable products utilized in MAKOplasty procedures are recognized at the time of sale (i.e., at the time of the related surgical procedure). |
|
|
|
|
|
|
3. |
Service revenue: Revenues from warranty and maintenance services, including extended warranty services, on the RIO system hardware are deferred and recognized ratably over the service period until no further obligation exists. Sales of the Company's RIO system generally include a one-year warranty and maintenance obligation for services. Costs associated with providing warranty and maintenance services are expensed to cost of revenue as incurred. |
Provisions for discounts and rebates to customers are established as a reduction to revenue in the same period as the related sales are recorded.
A portion of the Company's end-user customers acquire the RIO system through a leasing arrangement with qualified third-party leasing companies. In these instances, the Company sells the RIO system to the third-party leasing company, and the end-user customer enters into an independent leasing arrangement with the third-party leasing company. The Company recognizes RIO system revenue for a RIO system sale to a third-party leasing company on the same basis as a RIO system sale directly to an end-user customer. The Company sells implants and disposable products utilized in MAKOplasty procedures directly to end-user customers under a separate agreement.
The Company's domestic sales contracts generally do not provide the customer with a right of return. If such a right is provided, all related revenues would be deferred until such right expires or is waived. In a limited number of RIO system sales, the Company's agreement with the customer provides for a customer acceptance period, which typically does not exceed three months, following which the customer may either accept or return the RIO system. No system revenue is recognized for these RIO system sales until the customer has unconditionally accepted the RIO system.
Sales of implants and disposable products to independent international distributors generally provide for a right of return. Accordingly, no revenue is recognized for these sales until the right of return expires or is waived. Sales of the Company's RIO system to international distributors generally do not provide the distributor with a right of return. If such a right is provided, all related revenues would be deferred until such right expires or is waived. The one-year warranty for RIO system sales to international distributors is limited to replacing parts within the warranty period and does not provide for maintenance services. The Company accrues for the estimated costs of providing the one-year warranty for RIO system sales to international distributors upon installation as a component of cost of revenue - systems in the statements of operations.
The Company's RIO system includes software that is essential to the functionality of the product. Since the RIO system's software and non-software components function together to deliver the RIO system's essential functionality, they are considered one deliverable that is excluded from the software revenue recognition guidance.
The Company allocates arrangement consideration to the RIO systems and associated instrumentation, its implants and disposables and its warranty and maintenance services based upon the relative selling-price method. Under this method, revenue is allocated at the time of sale to all deliverables based on their relative selling price using a specific hierarchy. The hierarchy is as follows: vendor-specific objective evidence ("VSOE") of fair value of the respective elements, third-party evidence of selling price, or best estimate of selling price ("ESP").
The Company allocates arrangement consideration using ESP for its RIO system, ESP for its implants and disposables and VSOE of fair value for its warranty and maintenance services. VSOE of fair value is based on the price charged when the element is sold separately. ESP is established by determining the price at which the Company would transact a sale if the product was sold on a stand-alone basis. The Company determines ESP for its products by considering multiple factors including, but not limited to, geographies, type of customer, and market conditions. The Company regularly reviews ESP and maintains internal controls over the establishment and updates of these estimates.
Subsequent to December 31, 2008, the Company no longer manufactures its Tactile Guidance System™ ("TGS™"), to which associated TGS sales arrangements required it to provide upgrades and enhancements, through and including the delivery of the RIO system. The Company commercially released the RIO system in the first quarter of 2009. Sales arrangements for RIO systems do not require the Company to provide upgrades and enhancements. As a result, revenues related to RIO system sales are generally recognized upon installation of the system and training of at least one surgeon.
Prior to delivery of the RIO system, sales of TGS units were recorded as deferred revenue and the direct cost of revenue associated with the sale of TGS units was recorded as deferred cost of revenue. Revenue for all previously deferred TGS sales was recognized in the Company's statement of operations during the year ended December 31, 2009, upon delivery of the RIO system. As of December 31, 2011, the deferred revenue balance consists primarily of deferred service revenue as discussed below.
Costs associated with establishing an accrual for royalties covered by licensing arrangements related to the sale of RIO systems are expensed upon installation and are included in cost of revenue - systems, in the statements of operations.
Deferred Revenue and Deferred Cost of Revenue
Deferred revenue consists of deferred service revenue, deferred system revenue and deferred procedure revenue. Deferred service revenue results from the advance payment for services to be delivered over a period of time, usually in one-year increments. Deferred system revenue arises from timing differences between the installation of RIO systems and satisfaction of all revenue recognition criteria consistent with the Company's revenue recognition policy. Deferred procedure revenue arises from sales to independent international distributors which provide for a right of return. No revenue is recognized for these sales until the right of return expires or is waived. Deferred revenue expected to be realized within one year is classified as a current liability. Deferred cost of revenue consists of the direct costs associated with the manufacture of RIO systems and implants and disposable products for which the revenue has been deferred in accordance with the Company's revenue recognition policy. The deferred revenue balance as of December 31, 2011 consisted primarily of deferred service revenue for warranty and maintenance services on the RIO system hardware.
Foreign Currency Transactions
Gains or losses from foreign currency transactions are included in other income, net. To date, realized gains and losses recognized from foreign currency transactions were not significant.
Research and Development Costs
Costs related to research, design and development of products are charged to research and development expense as incurred. These costs include direct salary costs for research and development personnel, costs for materials used in research and development activities and costs for outside services.
Shipping and Handling Costs
Costs incurred for shipping and handling are included in cost of revenue at the time the expense is incurred.
Software Development Costs
Software development costs are included in research and development and are expensed as incurred. After technological feasibility is established, material software development costs are capitalized. The capitalized cost is then amortized on a straight-line basis over the estimated product life, or on the ratio of current revenue to total projected product revenue, whichever is greater. To date, the period between achieving technological feasibility, which the Company has defined as the establishment of a working model which typically occurs when the verification and validation testing is complete, and the general availability of such software has been short and software development costs qualifying for capitalization have been insignificant. Accordingly, the Company has not capitalized any software development costs to date.
Stock-Based Compensation
The Company recognizes compensation expense for its stock-based awards in accordance with ASC 718, Compensation-Stock Compensation. ASC 718 requires the recognition of compensation expense, using a fair value based method, for costs related to all stock-based payments including stock options. ASC 718 requires companies to estimate the fair value of stock-based payment awards on the date of grant using an option-pricing model.
The Company accounts for stock-based compensation arrangements with non-employees in accordance with the ASC 505-50, Equity-Based Payments to Non-Employees. The Company records the expense of such services based on the estimated fair value of the equity instrument using the Black-Scholes pricing model. The value of the equity instrument is charged to expense over the term of the service agreement.
See Note 8 for a detailed discussion of the various stock option plans and related stock-based compensation.
Advertising Costs
Advertising costs are expensed as incurred. Advertising costs were approximately $2.4 million, $1.6 million and $1.3 million for the years ended December 31, 2011, 2010 and 2009, respectively.
Income Taxes
The Company accounts for income taxes under ASC 740, Income Taxes. Deferred income taxes are determined based upon differences between financial reporting and income tax bases of assets and liabilities and are measured using the enacted income tax rates and laws that will be in effect when the differences are expected to reverse. The Company recognizes any interest and penalties related to unrecognized tax benefits as a component of income tax expense.
Due to uncertainty surrounding realization of the deferred income tax assets in future periods, the Company has recorded a 100% valuation allowance against its net deferred tax assets. If it is determined in the future that it is more likely than not that the deferred income tax assets are realizable, the valuation allowance will be reduced.
Operating Leases
Rental payments and incentives are recognized on a straight-line basis over the life of a lease. See Note 7 for further discussion of operating leases.
Net Loss Per Share
The Company calculated net loss per share in accordance with ASC 260, Earnings per Share. Basic earnings per share ("EPS") is calculated by dividing the net income or loss by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted EPS is computed by dividing the net income or loss by the weighted average number of common shares outstanding for the period and the weighted average number of dilutive common stock equivalents outstanding for the period determined using the treasury stock method. The following table sets forth potential shares of common stock that are not included in the calculation of diluted net loss per share because to do so would be anti-dilutive as of the end of each period presented:
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
|
|
|
December 31, |
|
|
|
| |
|
|
|
2011 |
|
2010 |
|
2009 |
| |||
|
Stock options outstanding |
|
|
4,753 |
|
|
4,405 |
|
|
3,478 |
|
|
Warrants to purchase common stock |
|
|
1,503 |
|
|
2,039 |
|
|
2,065 |
|
|
Unvested restricted stock |
|
|
469 |
|
|
503 |
|
|
222 |
|
Recent Accounting Pronouncements
In June 2011, the Financial Accounting Standards Board issued new accounting guidance related to the presentation of comprehensive income that increases comparability between U.S. generally accepted accounting principles and International Financial Reporting Standards. This guidance will require companies to present the components of net income and other comprehensive income ("OCI") either as one continuous statement or as two consecutive statements, eliminating the option to present components of other comprehensive income as part of the statement of changes in stockholders' equity. This guidance is effective for the Company's interim and annual periods beginning January 1, 2012. The Company early adopted this guidance in 2011 and reports OCI in a separate statement. The adoption did not have a material impact on the Company's results of operations or financial position.
|
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3. Investments
The Company's investments are classified as available-for-sale. Available-for-sale securities are carried at fair value, with the unrealized gains and losses included in other comprehensive income within stockholders' equity. Realized gains and losses, interest and dividends, amortization of premium and discount on investment securities and declines in value determined to be other-than-temporary on available-for-sale securities are included in other income, net. During the years ended December 31, 2011, 2010 and 2009, realized gains and losses recognized on the sale of investments were not significant. The cost of securities sold is based on the specific identification method.
The amortized cost and fair value of short and long-term investments, with gross unrealized gains and losses, were as follows:
As of December 31, 2011
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
Amortized |
|
Gross |
|
Gross |
|
Fair |
| ||||
|
Short-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government agencies |
|
$ |
19,733 |
|
$ |
23 |
|
$ |
(3 |
) |
$ |
19,753 |
|
|
Certificates of deposit |
|
|
16,588 |
|
|
24 |
|
|
(11 |
) |
|
16,601 |
|
|
Long-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government agencies |
|
|
3,761 |
|
|
21 |
|
|
― |
|
|
3,782 |
|
|
Certificates of deposit |
|
|
5,104 |
|
|
18 |
|
|
(2 |
) |
|
5,120 |
|
|
Total investments |
|
$ |
45,186 |
|
$ |
86 |
|
$ |
(16 |
) |
$ |
45,256 |
|
As of December 31, 2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
Amortized |
|
Gross |
|
Gross |
|
Fair |
| ||||
|
Short-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government agencies |
|
$ |
34,483 |
|
$ |
4 |
|
$ |
(16 |
) |
$ |
34,471 |
|
|
Certificates of deposit |
|
|
10,453 |
|
|
1 |
|
|
(28 |
) |
|
10,426 |
|
|
U.S. corporate debt |
|
|
1,501 |
|
|
3 |
|
|
― |
|
|
1,504 |
|
|
Long-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government agencies |
|
|
17,251 |
|
|
2 |
|
|
(8 |
) |
|
17,245 |
|
|
Certificates of deposit |
|
|
6,095 |
|
|
― |
|
|
(57 |
) |
|
6,038 |
|
|
Total investments |
|
$ |
69,783 |
|
$ |
10 |
|
$ |
(109 |
) |
$ |
69,684 |
|
As of December 31, 2011 and December 31, 2010, all short-term investments had maturity dates of less than one year. As of December 31, 2011 and December 31, 2010, all long-term investments had maturity dates between one and three years.
The fair values of the Company's investments based on the level of inputs are summarized below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
Fair Value Measurements at the Reporting Date Using |
| ||||||||||
|
|
|
December |
|
Quoted |
|
Significant |
|
Significant |
| ||||
|
Short-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government agencies |
|
$ |
19,753 |
|
$ |
756 |
|
$ |
18,997 |
|
$ |
― |
|
|
Certificates of deposit |
|
|
16,601 |
|
|
― |
|
|
16,601 |
|
|
― |
|
|
Long-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government agencies |
|
|
3,782 |
|
|
1,522 |
|
|
2,260 |
|
|
― |
|
|
Certificates of deposit |
|
|
5,120 |
|
|
― |
|
|
5,120 |
|
|
― |
|
|
Total investments |
|
$ |
45,256 |
|
$ |
2,278 |
|
$ |
42,978 |
|
$ |
― |
|
Level 2 securities are priced using quoted market prices for similar instruments or discounted cash flow techniques. Prior to January 1, 2011, the Company classified certain investments as Level 1 and, upon further review, has subsequently determined to classify them as Level 2. In the first quarter of 2011, the Company transferred $61.2 million of assets previously classified within Level 1 to Level 2. It was determined that the fair value of such investments is based off Level 2 valuation techniques, and not identical assets in active markets, as defined within Level 1 valuation techniques. This transfer had no impact on the fair value of the Company's investments as stated in any of the periods presented. No investments measured at fair value on a recurring basis used Level 3 or significant unobservable inputs for the year ended December 31, 2011.
Carrying amounts of certain of the Company's financial instruments, including cash and cash equivalents, investments, accounts receivable and other accrued liabilities approximate fair value due to their short maturities or market rates of interest.
|
|||
4. Selected Balance Sheet Components
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
December 31, |
| ||||
|
|
|
2011 |
|
2010 |
| ||
|
Inventory: |
|
|
|
|
|
|
|
|
Raw materials |
|
$ |
3,051 |
|
$ |
2,522 |
|
|
Work-in-process |
|
|
866 |
|
|
972 |
|
|
Finished goods |
|
|
15,612 |
|
|
7,010 |
|
|
Total inventory |
|
$ |
19,529 |
|
$ |
10,504 |
|
The Company incurred inventory write-offs totaling approximately $256,000 and $1.7 million during the years ended December 31, 2011 and 2010, respectively. Inventory write-offs in 2010 primarily related to the write-off of excess RESTORIS unicompartmental knee implant system implants necessitated by the rapid adoption of the RESTORIS MCK multicompartmental knee implant system ("RESTORIS MCK") and the corresponding decline in the usage of RESTORIS Classic.
The Company reviews its inventory periodically to determine net realizable value and considers product upgrades in its periodic review of realizability. Depending on demand for the Company's products and technical obsolescence, additional future write-offs of the Company's inventory may occur.
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
December 31, |
|
Estimated |
| |||||
|
|
|
2011 |
|
2010 |
|
| ||||
|
Property and equipment: |
|
|
|
|
|
|
|
|
|
|
|
Consigned instruments and RIO systems |
|
$ |
8,200 |
|
$ |
3,287 |
|
|
3-5 years |
|
|
Service and demo RIO systems and instruments |
|
|
5,587 |
|
|
4,029 |
|
|
3 years |
|
|
Computer equipment and software |
|
|
4,775 |
|
|
2,960 |
|
|
3 years |
|
|
Manufacturing and laboratory equipment |
|
|
2,657 |
|
|
1,945 |
|
|
3-5 years |
|
|
Undeployed implant instruments |
|
|
4,525 |
|
|
1,226 |
|
|
See Note 2 |
|
|
Office furniture and equipment |
|
|
1,306 |
|
|
1,038 |
|
|
7 years |
|
|
Leasehold improvements |
|
|
1,782 |
|
|
738 |
|
|
Lesser of 5-10 years or lease term |
|
|
|
|
|
28,832 |
|
|
15,223 |
|
|
|
|
|
Less accumulated depreciation and amortization |
|
|
(9,443 |
) |
|
(6,011 |
) |
|
|
|
|
Total property and equipment, net |
|
$ |
19,389 |
|
$ |
9,212 |
|
|
| |
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
December 31, |
| ||||
|
|
|
2011 |
|
2010 |
| ||
|
Other accrued liabilities: |
|
|
|
|
|
|
|
|
Accrued royalties |
|
$ |
1,580 |
|
$ |
833 |
|
|
Accrued consulting fees |
|
|
548 |
|
|
792 |
|
|
Other |
|
|
8,494 |
|
|
3,439 |
|
|
|
|
$ |
10,622 |
|
$ |
5,064 | |
|
|||
5. Related Party Transactions
Asset Purchase Agreement
In February 2010, the Company completed the acquisition of substantially all of the intellectual property portfolio of Z-Kat, Inc. ("Z-Kat"). The terms of the Asset Purchase Agreement between the Company and Z-Kat (the "Asset Purchase Agreement") terminated the Company's prior licenses with Z-Kat, including Z-Kat's nonexclusive sublicense to the Company's intellectual property portfolio, and transferred to the Company ownership rights to certain intellectual property assets for core technologies in computer assisted surgery ("CAS"), haptics and robotics, including U.S. and foreign patents and patent applications, proprietary software and documentation, trade secrets and trademarks owned by Z-Kat, and certain contractual and other rights to patents, patent applications and other intellectual property licensed to Z-Kat under licenses. Certain of the Company's rights under the Asset Purchase Agreement remain subject to any prior license granted by Z-Kat, including a license to Biomet Manufacturing Corp. In consideration for consummation of the transactions contemplated by the Asset Purchase Agreement and License Agreement, the Company issued 230,458 shares of its unregistered common stock to Z-Kat in a private placement, which was treated as a related party transaction because certain directors and executive officers of the Company had a material interest in Z-Kat by virtue of their ownership of Z-Kat stock. The Company and Z-Kat are not entities under common control. The Asset Purchase Agreement and License Agreement were approved by the independent members of the board of directors and audit committee of the Company. The value of the intellectual property acquired under the Asset Purchase Agreement of $3.1 million was based on the closing price per share of $13.25 of the Company's common stock on February 25, 2010, the date the transaction was closed, and was recorded as an intangible asset and is being amortized over its estimated useful life of eight years.
License Agreement
In August 2009, the Company entered into a License Agreement (the "Sensor Agreement") with a third-party sensor company associated with the potential future development of intellectual property and technology related to sensing devices in orthopedics. The Sensor Agreement required an initial payment of $50,000 and required future payments in the event that the Company decided to enter into a licensing and supply agreement with the third-party sensor company following the end of the research and development period. In August 2010, the Company exercised its option to enter into a non-exclusive license and supply agreement for an upfront payment of $250,000 (the "Non-Exclusive License Payment"). The Non-Exclusive License Payment was recorded as an intangible asset and is being amortized over its estimated useful life of ten years. In October 2010, the Company exercised its option to enter into an exclusive license and supply agreement which required additional payments of $750,000 (the "Exclusive License Payments"). The Exclusive License Payments were recorded as an intangible asset and are being amortized over the estimated useful life of approximately five years. The Sensor Agreement was treated as a related party transaction because certain directors of the Company had a material interest in the third-party sensor company by virtue of their ownership of the third-party sensor company's outstanding stock. The Company and the third-party sensor company are not entities under common control.
|
|||
6. Intangible Assets
The Company's intangible assets are comprised of purchased patents, patent applications and licenses to intellectual property rights (the "Licenses"). The Licenses are amortized on a straight line basis over their estimated useful lives which range from approximately 3 to 13 years. See Note 7 for additional discussion of Licenses.
The following tables present details of MAKO's intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
| ||||||||||
|
(in thousands) |
|
2011 |
|
2010 |
| ||||||||
|
|
|
Amount |
|
Weighted |
|
Amount |
|
Weighted |
| ||||
|
Licenses |
|
$ |
9,080 |
|
|
8.6 |
|
$ |
7,880 |
|
|
9.4 |
|
|
Z-Kat intellectual property (see Note 5) |
|
|
3,166 |
|
|
8.0 |
|
|
3,166 |
|
|
8.0 |
|
|
|
|
|
12,246 |
|
|
8.4 |
|
|
11,046 |
|
|
9.0 |
|
|
Less: accumulated amortization |
|
|
(4,962 |
) |
|
|
|
|
(3,516 |
) |
|
|
|
|
Intangible assets, net |
|
$ |
7,284 |
|
|
|
$ |
7,530 |
|
|
| ||
Amortization expense related to intangible assets was approximately $1.4 million, $1.1 million and $682,000 for the years ended December 31, 2011, 2010 and 2009, respectively.
The estimated future amortization expense of intangible assets for the next five years as of December 31, 2011 is as follows:
|
|
|
|
|
|
|
(in thousands) |
|
|
|
|
|
2012 |
|
$ |
1,679 |
|
|
2013 |
|
|
1,673 |
|
|
2014 |
|
|
1,479 |
|
|
2015 |
|
|
1,198 |
|
|
2016 |
|
|
595 |
|
|
Total |
|
$ |
6,624 |
|
|||
7. Commitments and Contingencies
Operating Leases
In September 2010, the Company entered into an expanded ten year operating lease for the Company's existing headquarters in Fort Lauderdale, Florida, to allow for expansion to support anticipated growth, and terminated the previous lease. Under the new lease, the Company has the option to renew its facility lease for two consecutive five year periods. The lease provides for periodic rent increases and requires the Company to pay the operating costs including taxes, insurance and maintenance. Rent expense on a straight-line basis was $850,000, $624,000 and $613,000 for the years ended December 31, 2011, 2010 and 2009, respectively. The rent expense for the years ended December 31, 2011, 2010 and 2009 included the Company's monthly variable operating costs of the facility.
Future minimum lease commitments, excluding monthly variable operating costs, under the Company's operating lease as of December 31, 2011 are as follows:
|
|
|
|
|
|
|
(in thousands) |
|
|
|
|
|
2012 |
|
$ |
337 |
|
|
2013 |
|
|
352 |
|
|
2014 |
|
|
504 |
|
|
2015 |
|
|
657 |
|
|
2016 |
|
|
673 |
|
|
Thereafter |
|
|
3,010 |
|
|
Total |
|
$ |
5,533 |
|
Purchase Commitments
At December 31, 2011, the Company was committed to make future purchases for purchase orders that occur in the ordinary course of business under various purchase arrangements with fixed purchase provisions aggregating $15.7 million. Other commitments include sponsored research and license agreement obligations under contractual arrangements of $4.7 million as of December 31, 2011.
License and Development Agreements
The Company has license agreements and development agreements related to current product offerings and research and development projects. Royalty payments related to these agreements are anticipated to range between 3% and 11% of future sales of the Company's RIO system and components thereof and/or products. These royalty payments are subject to certain minimum annual royalty payments as shown in the schedule below. The terms of these license agreements continue until the terms expire or the related licensed patents and intellectual property rights expire, which is expected to range between 3 and 16 years. The net expense related to the Company's license and royalty agreements was approximately $3.3 million, $2.0 million and $1.5 million for the years ended December 31, 2011, 2010 and 2009, respectively.
As of December 31, 2011, future annual minimum royalty payments under licenses and development agreements are anticipated to be as follows:
|
|
|
|
|
|
|
(in thousands) |
|
|
|
|
|
2012 |
|
$ |
1,994 |
|
|
2013 |
|
|
2,147 |
|
|
2014 |
|
|
2,030 |
|
|
2015 |
|
|
1,775 |
|
|
2016 |
|
|
1,757 |
|
|
Thereafter |
|
|
3,451 |
|
|
|
|
$ |
13,154 |
|
Development Agreement
In October 2010, the Company entered into a Strategic Alliance Agreement (the Pipeline Agreement") with Pipeline Biomedical Holdings, LLC ("Pipeline") to develop and supply potential future advanced implant technologies for use with the Company's RIO system, including the development of a MAKO-branded RESTORIS family of hip implant systems for use with the MAKOplasty total hip arthroplasty application. Upon execution of the Pipeline Agreement on October 1, 2010, the Company issued and delivered to Pipeline 203,417 unregistered restricted shares of its common stock (the "Pipeline Shares") as consideration for the rights granted to MAKO under the Pipeline Agreement. The Pipeline Shares vested in the first quarter of 2011 upon achievement of certain performance conditions (the "Performance Conditions"). If the Performance Conditions were not achieved, the Company could have terminated the Pipeline Agreement at its option subject to a breakup fee not to exceed $800,000 (the "Breakup Fee"). Although the Company believed Pipeline would achieve the Performance Conditions, as of December 31, 2010, the Company accrued $400,000 in expense for its obligation under the Breakup Fee.
The total value of $4.0 million to be recognized for the value of the Pipeline Shares was determined in the first quarter of 2011 on the date the performance conditions were achieved and the Pipeline Shares vested. The value of the Pipeline Shares is being recognized as a component of research and development expense on a straight line basis over 45 months from the effective date of the Pipeline Agreement through June 30, 2014 - the period over which Pipeline is expected to perform development services under the Pipeline Agreement. In accordance with ASC 505-50, however, no research and development expense associated with the services under the Pipeline Agreement was to be recognized for the Pipeline Shares until achievement of the Performance Conditions.
Upon achievement of the Performance Conditions, the Company recognized $320,000 in expense in the first quarter of 2011, which represented the difference between the amount accrued in 2010 for the Breakup Fee obligation and the ratable portion of the expense to be recognized for the Pipeline Shares from the effective date of the Pipeline Agreement through March 31, 2011. The remaining value of the Pipeline Shares is being recognized on a straight line basis through June 30, 2014. Pursuant to an amendment to the Pipeline Agreement dated October 21, 2011, the expected development period was extended 12 months from the effective date of the Pipeline Agreement through June 30, 2014. As of December 31, 2011, the Company had recognized $1.7 million of expense related to the Pipeline Shares. The Company has no further obligation beyond the previously issued Pipeline Shares to fund Pipeline's research of implant technologies under the Pipeline Agreement. The Pipeline Agreement contains provisions under which Pipeline will supply the Company implants developed under the Pipeline Agreement.
Contingencies
The Company is a party to legal contingencies or claims arising in the normal course of business, none of which the Company believes is material to its financial position, results of operations or cash flows.
|
|||
8. Stockholders' Equity
Preferred Stock
As of December 31, 2011 and 2010, the Company was authorized to issue 27,000,000 shares of $0.001 par value preferred stock. As of December 31, 2011 and 2010, there were no shares of preferred stock issued or outstanding.
Common Stock
As of December 31, 2011 and 2010, the Company was authorized to issue 135,000,000 shares of $0.001 par value common stock. Common stockholders are entitled to dividends as and if declared by the Board of Directors, subject to the rights of holders of all classes of stock outstanding having priority rights as to dividends. There have been no dividends declared to date on the common stock. The holder of each share of common stock is entitled to one vote.
401K Plan
The Company maintains a qualified deferred compensation plan under Section 401K of the Internal Revenue Code, covering substantially all full-time employees, which permits employees to contribute up to 84% of pre-tax annual compensation up to annual statutory limitations. The discretionary company match for employee contributions to the plan is 25% of up to the first 6% of the participant's earnings contributed to the plan. The discretionary company match for the years ended December 31, 2011, 2010 and 2009 was $261,000, $190,000 and $141,000, respectively.
Employee Stock Purchase Plan
The Company's 2008 Employee Stock Purchase Plan authorizes the issuance of 625,000 shares of the Company's common stock for purchase by eligible employees of the Company or any of its participating affiliates. The shares of common stock issuable under the 2008 Employee Stock Purchase Plan may be authorized but unissued shares, treasury shares or shares purchased on the open market. The purchase price for a purchase period may not be less than 85% of the fair market value of the Company's common stock on the first trading day of the applicable purchase period or the last trading day of such purchase period, whichever is lower. During the year ended December 31, 2011, the Company issued approximately 77,000 shares under the 2008 Employee Stock Purchase Plan. As of December 31, 2011, there were approximately 390,000 shares reserved for future grant under the 2008 Employee Stock Purchase Plan.
Stock Option Plans and Stock-Based Compensation
The Company recognizes compensation expense for its stock-based awards in accordance with ASC 718, Compensation-Stock Compensation. ASC 718 requires the recognition of compensation expense, using a fair value based method, for costs related to all stock-based payments including stock options. ASC 718 requires companies to estimate the fair value of stock-based payment awards on the date of grant using an option-pricing model.
During the years ended December 31, 2011, 2010 and 2009, stock-based compensation expense was $9.9 million, $6.4 million and $4.0 million, respectively. Included within stock-based compensation expense for the year ended December 31, 2011 were $7.5 million related to stock option grants, $1.9 million related to restricted stock granted to the Company's CEO at various dates from 2007 through 2011, and $453,000 related to employee stock purchases under the 2008 Employee Stock Purchase Plan.
Under the Company's 2004 Stock Incentive Plan (the "2004 Plan"), the Board of Directors was authorized to grant restricted common stock and options to purchase shares of common stock to employees, directors and consultants. No further awards will be made under the 2004 Plan. The Company's 2008 Omnibus
Incentive Plan (the "2008 Plan," and together with the 2004 Plan, the "Plans") became effective upon the closing of the IPO and will expire January 9, 2018 unless earlier terminated by the Board of Directors. Awards under the 2008 Plan may be made in the form of: stock options, which may be either incentive stock options or non-qualified stock options; stock appreciation rights; restricted stock; restricted stock units; dividend equivalent rights; performance shares; performance units; cash-based awards; other stock-based awards, including unrestricted shares; and any combination of the foregoing.
Generally, the Company's outstanding stock options vest over four years. Stock options granted to certain non-employee directors generally vest over one year. Continued vesting typically terminates when the employment or consulting relationship ends. Vesting generally begins on the date of grant.
The 2008 Plan contains an evergreen provision whereby the authorized shares increase on January 1st of each year in an amount equal to the least of (1) 4% of the total number of shares of the Company's common stock outstanding on December 31st of the preceding year, (2) 2.5 million shares and (3) a number of shares determined by the Company's Board of Directors that is lesser than (1) and (2). The number of additional shares authorized under the 2008 Plan on January 1, 2011 and 2012 was approximately 1,618,000 and 1,676,000, respectively.
Under the terms of the Plans, the maximum term of options intended to be incentive stock options granted to persons who own at least 10% of the voting power of all outstanding stock on the date of grant is 5 years. The maximum term of all other options is 10 years. Options issued under the 2008 Plan that are forfeited or expire will again be made available for issuing grants under the 2008 Plan. Options issued under the 2004 Plan that are forfeited or expire will not be made available for issuing grants under the 2008 Plan. All future equity awards will be made under the Company's 2008 Plan.
As of December 31, 2011, the Company had reserved shares of common stock for the issuance of common stock under the 2008 Employee Stock Purchase Plan, the exercise of warrants and the issuance of options granted under the 2008 Plan as follows:
|
|
|
|
|
|
|
(in thousands) |
|
|
|
|
|
2008 Employee Stock Purchase Plan |
|
|
625 |
|
|
Warrants to purchase common stock |
|
|
2,076 |
|
|
2008 Plan |
|
|
5,031 |
|
|
|
|
|
7,732 |
|
Only employees are eligible to receive incentive stock options. Non-employees may be granted non-qualified options. The Board of Directors has the authority to set the exercise price of all options granted, subject to the exercise price of incentive stock options being no less than 100% of the estimated fair value, as determined by the Board of Directors, of a share of common stock on the date of grant; and no less than 85% of the estimated fair value for non-qualified stock options, except for an employee or non-employee with options who owns more than 10% of the voting power of all classes of stock of the Company, in which case the exercise price shall be no less than 110% of the fair market value per share on the grant date. Options become exercisable as determined by the Board of Directors.
Activity under the Plans is summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands, except per share data) |
|
|
|
|
Outstanding Options |
| ||||
|
|
|
Shares/Options |
|
Number of |
|
Weighted |
| |||
|
Balance at December 31, 2010 |
|
|
204 |
|
|
4,405 |
|
|
8.35 |
|
|
Shares reserved |
|
|
1,618 |
|
|
― |
|
|
― |
|
|
Restricted stock issued |
|
|
(300 |
) |
|
― |
|
|
― |
|
|
Net shares settled under the 2008 Plan |
|
|
9 |
|
|
― |
|
|
― |
|
|
Options granted |
|
|
(1,184 |
) |
|
1,184 |
|
|
17.37 |
|
|
Options exercised |
|
|
― |
|
|
(707 |
) |
|
4.58 |
|
|
Options forfeited under the 2004 Plan |
|
|
― |
|
|
(7 |
) |
|
11.10 |
|
|
Options forfeited under the 2008 Plan |
|
|
122 |
|
|
(122 |
) |
|
11.79 |
|
|
Balance at December 31, 2011 |
|
|
469 |
|
|
4,753 |
|
$ |
11.06 |
|
The options outstanding and exercisable under the Plans, by exercise price, at December 31, 2011 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding |
|
Options Exercisable |
| ||||||||||||||||||||
|
(in thousands, |
|
Number |
|
Weighted |
|
Weighted |
|
Aggregate |
|
Number |
|
Weighted |
|
Weighted |
|
Aggregate |
| ||||||||
|
Range of Exercise Prices: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$0.67 – $2.48 |
|
|
484 |
|
|
|
|
$ |
1.53 |
|
|
|
|
|
484 |
|
|
|
|
$ |
1.53 |
|
|
|
|
|
$6.90 – $8.91 |
|
|
1,230 |
|
|
|
|
$ |
7.96 |
|
|
|
|
|
803 |
|
|
|
|
$ |
7.98 |
|
|
|
|
|
$9.00 – $12.70 |
|
|
1,510 |
|
|
|
|
$ |
11.22 |
|
|
|
|
|
1,006 |
|
|
|
|
$ |
10.98 |
|
|
|
|
|
$12.87 – 16.32 |
|
|
1,437 |
|
|
|
|
$ |
15.58 |
|
|
|
|
|
366 |
|
|
|
|
$ |
14.98 |
|
|
|
|
|
$20.05 – 39.55 |
|
|
92 |
|
|
|
|
$ |
29.73 |
|
|
|
|
|
20 |
|
|
|
|
$ |
27.39 |
|
|
|
|
|
|
|
|
4,753 |
|
|
7.36 |
|
$ |
11.06 |
|
$ |
67,679 |
|
|
2,679 |
|
|
6.61 |
|
$ |
9.04 |
|
$ |
43,364 |
|
|
|
|
|
|
|
(1) |
The aggregate intrinsic value represents the total pre-tax intrinsic value, based on the Company's closing stock price of $25.21 on December 31, 2011, which would have been received by the option holders had all option holders exercised their options as of that date. |
In addition to the options issued under the Plans, on July 6, 2010 the Company issued options to purchase 15,000 shares of its common stock under an agreement for consulting services ("Service Options"). The Service Options have an exercise price of $12.10, and vested ratably quarterly over one year starting on the grant date. As of December 31, 2011, all Service Options were vested and outstanding.
As of December 31, 2011, approximately 4,503,000 options were vested and expected to vest at a weighted average exercise price of $10.93 per share, a weighted average contractual life of 7.3 years and aggregate intrinsic value of $64.7 million.
The weighted average fair values of options granted were $8.90, $6.48 and $4.43 for the years ended December 31, 2011, 2010 and 2009, respectively. The total fair value of shares vested was approximately $6.6 million, $4.6 million and $2.8 million during the years ended December 31, 2011, 2010 and 2009, respectively. The total intrinsic value of options exercised was $16.8 million, $1.6 million and $1.0 million for the years ended December 31, 2011, 2010 and 2009.
The Company records stock-based compensation expense on a straight-line basis over the vesting period. As of December 31, 2011, there was total unrecognized compensation cost of approximately $12.6 million, net of estimated forfeitures, related to non-vested stock option grants to the Company's employees and non-employee directors. The unrecognized compensation cost will be adjusted for future changes in estimated forfeitures, and is expected to be recognized over a remaining weighted average period of 2.4 years as of December 31, 2011.
On February 3, 2011, the Company issued 300,000 shares of restricted stock to its chief executive officer ("CEO") at a fair value of $2.3 million on the date of issuance. The February 3, 2011 grant is subject to performance conditions based on the achievement of certain performance metrics. Upon satisfaction of the performance conditions, 50% of the shares will vest on March 31, 2013 and 50% of the shares will vest on March 31, 2014. For the year ended December 31, 2011, 43,058 shares of common stock were surrendered by the CEO to the Company to cover payroll taxes associated with the taxable income from the vesting of restricted stock previously granted to the CEO. As of December 31, 2011, 1,066,665 shares of restricted stock granted to the CEO were issued and outstanding.
Restricted stock activity for the year ended December 31, 2011 is as follows:
|
|
|
|
|
|
|
|
|
|
(in thousands, except per share data) |
|
Shares |
|
Weighted Average |
| ||
|
Unvested shares at December 31, 2010 |
|
300 |
|
|
$ |
7.64 |
|
|
Unvested shares at December 31, 2011 |
|
469 |
|
|
$ |
5.61 |
|
|
Shares granted in 2011 |
|
300 |
|
|
$ |
7.61 |
|
|
Shares vested in 2011 |
|
131 |
|
|
$ |
10.36 |
|
As of December 31, 2011, the remaining stock-based compensation expense for the restricted stock awards was approximately $2.6 million, which will be recognized on a straight line basis over a remaining weighted average period of 1.79 years.
The Company uses the Black-Scholes pricing model to determine the fair value of stock options. The determination of the fair value of stock-based payment awards on the date of grant using a pricing model is affected by our stock price as well as assumptions regarding a number of complex and subjective variables. These variables include our expected stock price volatility over the term of the awards, actual and projected employee stock option exercise behaviors, risk-free interest rates and expected dividends.
The estimated grant date fair values of the employee stock options were calculated using the Black-Scholes valuation model, based on the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock Option Plans |
|
Years Ended December 31, |
| |||||||
|
|
|
2011 |
|
2010 |
|
2009 |
| |||
|
Risk-free interest rate |
|
|
1.34% - 2.92% |
|
|
2.04% - 3.36% |
|
|
1.99% - 3.53% |
|
|
Expected life |
|
|
6.25 years |
|
|
6.25 years |
|
|
6.25 years |
|
|
Expected dividends |
|
|
― |
|
|
― |
|
|
― |
|
|
Expected volatility |
|
|
48.55% - 50.12% |
|
|
50.15% - 50.74% |
|
|
54.43% - 57.71% |
|
The Company estimates the fair value of each share of stock which will be issued under the 2008 Employee Stock Purchase Plan based upon its stock prices at the beginning of each offering period using the Black-Scholes pricing model and amortizes that value to expense over the plan purchase period. The fair values determined for the years ended December 31, 2011, 2010 and 2009, as well as the assumptions used in calculating those values are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
2008 Employee Stock Purchase Plan |
|
Year Ended |
|
Year Ended |
|
Year Ended |
| |||
|
|
|
2011 |
|
2010 |
|
2009 |
| |||
|
Fair Value |
|
$ |
3.68 - $11.70 |
|
$ |
2.21 - $3.68 |
|
$ |
1.82 - $2.54 |
|
|
Assumptions |
|
|
|
|
|
|
|
|
|
|
|
Risk-free interest rate |
|
|
0.02% - 0.12% |
|
|
0.12% - 0.60% |
|
|
0.60% - 3.20% |
|
|
Expected life |
|
|
0.25 years |
|
|
0.25 years |
|
|
0.25 years |
|
|
Expected dividends |
|
|
― |
|
|
― |
|
|
― |
|
|
Expected volatility |
|
|
45.92% - 97.14% |
|
|
34.50% - 52.08% |
|
|
34.50% - 60.68% |
|
Risk-Free Interest Rate. The risk-free rate is based on U.S. Treasury zero-coupon issues with remaining terms similar to the expected term on the options.
Weighted-Average Expected Term. The expected term of options granted is determined using the average period the stock options are expected to remain outstanding and is based on the options vesting term, contractual terms and historical exercise and vesting information used to develop reasonable expectations about future exercise patterns and post-vesting employment termination behavior. The expected term of the 2008 Employee Stock Purchase Plan is equal to the duration of the purchase period.
Dividend Yield. The Company has never declared or paid any cash dividends and does not plan to pay cash dividends in the foreseeable future, and, therefore, used an expected dividend yield of zero in the valuation model.
Volatility. Since the Company was a private entity until February 2008 with no historical data regarding the volatility of its common stock, the expected volatility used for employee stock options for the years ended December 31, 2011, 2010 and 2009, is based on volatility of similar entities, referred to as "guideline" companies. In evaluating similarity, the Company considered factors such as industry, stage of life cycle and size. The expected volatility for shares of stock issued under the 2008 Employee Stock Purchase Plan is based on average historical volatilities of the Company's stock price.
Forfeitures. ASC 718 requires the Company to estimate forfeitures at the time of grant, and revise those estimates in subsequent periods if actual forfeitures differ from those estimates. The Company uses historical data to estimate pre-vesting option forfeitures and records stock-based compensation expense only for those awards that are expected to vest. All stock-based payment awards are amortized on a straight-line basis over the requisite service periods of the awards, which are generally the vesting periods. If the Company's actual forfeiture rate is materially different from its estimate, the stock-based compensation expense could be significantly different from what the Company has recorded in the accompanying periods.
Warrants
In December 2004, the Company issued warrants to purchase 462,716 shares of common stock at a purchase price of $0.03 per share. The warrants were immediately exercisable at an exercise price of $3.00 per share, with the exercise period expiring in December 2014. As of December 31, 2011 and 2010, 310,872 and 425,915 warrants were outstanding and exercisable, respectively.
In October 2008, the Company issued warrants to purchase 1,290,323 shares of common stock at a purchase price of $0.125 per share and an exercise price of $7.44 per share. The warrants became exercisable on April 29, 2009 and have a seven-year term. As of December 31, 2011 and 2010, 946,455 and 1,290,323 warrants were outstanding and exercisable, respectively.
In October 2008, the Company issued warrants to purchase 322,581 shares of common stock at a purchase price of $0.125 per share and an exercise price of $6.20 per share. These warrants became exercisable on December 31, 2009 and have a seven-year term. As of December 31, 2011 and 2010, 245,276 and 322,581 warrants were outstanding and exercisable, respectively.
|
|||
9. Income Taxes
The provision for income taxes is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
Years Ended |
| |||||||
|
|
|
December 31, |
|
December 31, |
|
December 31, |
| |||
|
Current income taxes: |
|
|
|
|
|
|
|
|
|
|
|
Federal |
|
$ |
― |
|
$ |
― |
|
$ |
― |
|
|
State |
|
|
105 |
|
|
68 |
|
|
56 |
|
|
Total current income taxes |
|
|
105 |
|
|
68 |
|
|
56 |
|
|
Deferred income taxes |
|
|
(15,037 |
) |
|
(14,184 |
) |
|
(12,593 |
) |
|
Change in valuation allowance |
|
|
15,037 |
|
|
14,184 |
|
|
12,593 |
|
|
Provision for income taxes |
|
$ |
105 |
|
$ |
68 |
|
$ |
56 |
|
The Company accounts for income taxes under ASC 740, Income Taxes. Deferred income taxes are determined based upon differences between financial reporting and income tax bases of assets and liabilities and are measured using the enacted income tax rates and laws that will be in effect when the differences are expected to reverse. The Company recognizes any interest and penalties related to unrecognized tax benefits as a component of income tax expense.
No federal current or deferred income taxes were recorded for the years ended December 31, 2011, 2010 and 2009, as the Company's income tax benefits were fully offset by a corresponding increase to the valuation allowance against its net deferred income tax assets. Current state income taxes of $105,000, $68,000 and $56,000 were recorded for the years ended December 31, 2011, 2010 and 2009, respectively.
At December 31, 2011, 2010 and 2009, the Company had federal and state net operating loss carryforwards of approximately $163.0 million, $129.6 million and $100.2 million, respectively, available to offset future taxable income. These net operating loss carryforwards will expire in varying amounts from 2024 through 2031. Approximately $7.1 million of the net operating loss carryforwards are related to excess benefits of tax deductions for stock-based payments that will be recorded in additional paid-in-capital upon utilization.
The Tax Reform Act of 1986 limits the annual utilization of net operating loss and tax credit carryforwards, following an ownership change of the Company. Note that as a result of the Company's equity financings in recent years, the Company underwent changes in ownership for purposes of the Tax Reform Act.
Deferred income taxes reflect the net tax effect of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company's net deferred income taxes are as follows:
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
December 31, |
| ||||
|
|
|
2011 |
|
2010 |
| ||
|
Current deferred income tax assets: |
|
|
|
|
|
|
|
|
Deferred revenue |
|
$ |
1,909 |
|
$ |
1,256 |
|
|
Reserves |
|
|
271 |
|
|
619 |
|
|
Accrued expenses |
|
|
940 |
|
|
502 |
|
|
Stock-based compensation |
|
|
1,507 |
|
|
― |
|
|
Total current deferred income tax assets |
|
|
4,627 |
|
|
2,377 |
|
|
|
|
|
|
|
|
|
|
|
Noncurrent deferred income tax assets: |
|
|
|
|
|
|
|
|
Net operating loss carryforwards |
|
|
61,552 |
|
|
51,163 |
|
|
Stock-based compensation |
|
|
1,507 |
|
|
― |
|
|
Amortization |
|
|
867 |
|
|
591 |
|
|
Depreciation |
|
|
311 |
|
|
― |
|
|
Accrued rent |
|
|
119 |
|
|
― |
|
|
Other |
|
|
45 |
|
|
10 |
|
|
Total noncurrent deferred income tax assets |
|
|
64,401 |
|
|
51,764 |
|
|
|
|
|
|
|
|
|
|
|
Total current deferred income tax liabilities |
|
|
― |
|
|
― |
|
|
|
|
|
|
|
|
|
|
|
Noncurrent deferred income tax liabilities: |
|
|
|
|
|
|
|
|
Other deferred income tax liabilities |
|
|
(63 |
) |
|
(213 |
) |
|
Total noncurrent deferred income tax liabilities |
|
|
(63 |
) |
|
(213 |
) |
|
|
|
|
|
|
|
|
|
|
Less valuation allowance |
|
|
(68,965 |
) |
|
(53,928 |
) |
|
Total deferred income tax assets, net |
|
$ |
― |
|
$ |
― |
|
Due to uncertainty surrounding realization of the deferred income tax assets in future periods, the Company has recorded a 100% valuation allowance against its net deferred tax assets. If it is determined in the future that it is more likely than not that the deferred income tax assets are realizable, the valuation allowance will be reduced.
The reconciliation of the income tax provision computed at the U.S. federal statutory rate to income tax provision is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended |
| |||||||
|
|
|
December 31, |
|
December 31, |
|
December 31, |
| |||
|
Tax at U.S. statutory rate |
|
|
(35.00 |
)% |
|
(35.00 |
)% |
|
(35.00 |
)% |
|
State taxes, net of federal impact |
|
|
(4.49 |
)% |
|
(4.49 |
)% |
|
(3.28 |
)% |
|
Non-deductible items |
|
|
2.54 |
% |
|
5.46 |
% |
|
2.92 |
% |
|
Return to provision differences |
|
|
(3.83 |
)% |
|
(2.44 |
)% |
|
― |
|
|
Change in valuation allowance |
|
|
40.77 |
% |
|
36.66 |
% |
|
35.13 |
% |
|
Other, net |
|
|
0.30 |
% |
|
(0.19 |
)% |
|
0.23 |
% |
|
Effective income tax rate |
|
|
0.29 |
% |
|
0.00 |
% |
|
0.00 |
% |
In accordance with ASC 740, the Company has decided to classify any interest and penalties as a component of income tax expense. To date, there have been no interest or penalties charged to the Company in relation to the underpayment of income taxes. The Company's primary tax jurisdictions are in the United States and in multiple state jurisdictions. The tax years from 2008 through 2011 remain open and are subject to examination by the appropriate governmental agencies.
|
|||
10. Selected Quarterly Data (Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands, except per share data) |
|
2011 |
| ||||||||||
|
|
|
Q1 |
|
Q2 |
|
Q3 |
|
Q4 |
| ||||
|
Revenue |
|
$ |
13,026 |
|
$ |
18,579 |
|
$ |
20,014 |
|
$ |
32,888 |
|
|
Gross profit |
|
|
8,931 |
|
|
13,101 |
|
|
13,179 |
|
|
22,413 |
|
|
Loss from operations |
|
|
(11,047 |
) |
|
(10,028 |
) |
|
(9,585 |
) |
|
(5,623 |
) |
|
Net loss |
|
|
(10,995 |
) |
|
(9,909 |
) |
|
(9,655 |
) |
|
(5,584 |
) |
|
Net loss per share – basic and diluted |
|
|
(0.27 |
) |
|
(0.24 |
) |
|
(0.24 |
) |
|
(0.14 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands, except per share data) |
|
2010 |
| ||||||||||
|
|
|
Q1 |
|
Q2 |
|
Q3 |
|
Q4 (1) |
| ||||
|
Revenue |
|
$ |
7,249 |
|
$ |
10,251 |
|
$ |
12,014 |
|
$ |
14,782 |
|
|
Gross profit |
|
|
3,253 |
|
|
6,580 |
|
|
7,455 |
|
|
8,835 |
|
|
Loss from operations |
|
|
(11,470 |
) |
|
(8,587 |
) |
|
(9,006 |
) |
|
(9,873 |
) |
|
Net loss |
|
|
(11,408 |
) |
|
(8,524 |
) |
|
(8,938 |
) |
|
(9,817 |
) |
|
Net loss per share – basic and diluted |
|
|
(0.34 |
) |
|
(0.26 |
) |
|
(0.27 |
) |
|
(0.26 |
) |
|
|
|
|
|
|
(1) |
During the fourth quarter of 2010, the Company determined that it had incorrectly recognized revenue and expenses associated with the initial warranty obligation and maintenance services included in all previous RIO system sales. Accordingly, in the fourth quarter of 2010, the Company recorded an adjustment to decrease revenue by $1.2 million, to reverse the accrual for its warranty and maintenance obligation by $552,000 and to increase net loss by $644,000, or $(0.02) per basic and diluted share. The adjustment arose over the quarters throughout 2009 and 2010 and did not materially affect the Company's trend in earnings. As the adjustment was related to the correction of an error, the Company performed the analysis required by Staff Accounting Bulletin 99, Materiality, and Staff Accounting Bulletin 108, Considering the Effects of Prior Year Misstatements When Quantifying Misstatements in Current Year Financial Statements. Based on this analysis, the Company concluded that the effect of the error was not material to the quarters and years in the two year period ended December 31, 2010 from both a quantitative and qualitative perspective. |