You should read the following discussion and analysis of financial condition and operating results together with our financial statements and the related notes appearing in this Form 10-K. Some of the information contained in this discussion and analysis or set forth elsewhere in this Form 10-K, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. As a result of many important factors, including those set forth in the section of this Form 10-K captioned "Item 1A. Risk Factors" and elsewhere in this Form 10-K, our actual results could differ materially from the results described in, or implied by, the forward-looking statements contained in the following discussion and analysis. For convenience of presentation some of the numbers have been rounded in the text below.
Overview
We are a vertically integrated, clinical stage gene therapy company with six programs in clinical development and a broad pipeline of preclinical and research programs. We have core capabilities in viral vector design and optimization, gene therapy manufacturing as well as a potentially transformative gene regulation technology. Led by an experienced management team, we have taken a portfolio approach by licensing, acquiring and developing technologies that give us depth across both product candidates and indications. Though initially focusing on ophthalmology, salivary
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gland and neurodegenerative disease programs, we intend to expand our focus in the future to develop additional gene therapy treatments for patients suffering from a range of serious diseases.
We are an exempted company incorporated under the laws of the
We are a clinical stage company and have not generated any product revenues to
date. We have six clinical programs and a pipeline of preclinical programs.
Since inception, we have incurred significant operating losses. Our net losses
for the years ended
Our total operating expenses were
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As a result of these anticipated expenditures and the acquisition, development
and startup of our new Shannon,
Based on our cash and cash equivalents at
Adequate additional funds may not be available to us on acceptable terms, or at all. To the extent that we raise additional capital through the sale of equity or convertible securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a shareholder. Any future debt financing or preferred equity or other financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends and may require the issuance of warrants, which could potentially dilute your ownership interests.
If we raise additional funds through collaborations, strategic alliances, or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce, or terminate our product development programs or any future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Because of the numerous risks and uncertainties associated with drug development, we are unable to predict the timing or amount of increased expenses or when or if we will be able to achieve or maintain profitability. Even if we are able to generate revenue from product sales, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.
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Highlights and Recent Developments
Recent Clinical Development Highlights and Anticipated 2021 Milestones
AAV-AQP1 for the Treatment of Grade 2/3 Radiation-Induced Xerostomia:
? We reported preliminary data from the Phase 1 AQUAx clinical trial in December
2020.
Of the three patients treated in Cohort 1, one patient reached the 12-month
o assessment and two passed the six-month assessment. In all patients, the
investigational gene therapy AAV-hAQP1 has been well tolerated with no dose
limiting toxicity and no serious adverse events reported.
o Encouraging responses have been seen in patient-reported measures of xerostomia
symptoms and in salivary output in the patients treated in Cohort 1.
o Complete resolution of symptoms was observed in the patient who has reached the
12-month timepoint.
We continue to activate clinical trial sites in our Phase 1 AQUAx study, with
? two sites re-opened after shutdowns due to COVID-19, and all five sites are
anticipated to be open and enrolling patients in the first half of 2021.
The single center Phase 1 dose-finding study of AAV-AQP1 at the National
?
fourth dose escalation cohort is now ongoing.
AAV-RPGR for the Treatment of X-Linked Retinitis Pigmentosa (XLRP):
? We and our development partner Janssen are preparing to initiate the Phase 3
Lumeos clinical trial.
? In 2020, we and Janssen were granted Priority Medicines (PRIME) and Advanced
Therapy Medicinal Product (ATMP) designations for AAV-RPGR.
In 2020, we and Janssen announced positive 6-, 9- and 12-month data from the
? Phase 1/2 clinical study (MGT009) of AAV-RPGR at the
Specialists (ASRS) Annual Meeting, the
(EURETINA), and the American Academy of Ophthalmology Annual Meeting:
Data from each time point demonstrated that patients treated with low and
intermediate dose AAV-RPGR experienced statistically significant improvement in
o retinal sensitivity. Nine-month data also indicated significant improvement in
vision-guided mobility. At 12-months, six of seven patients continued to show
improved or stable vision in the treated eye.
AAV-GAD for the Treatment of Parkinson's Disease:
We anticipate filing an Investigational New Drug application (IND) by the third
? quarter of 2021, with material that has been manufactured with our in-house
proprietary manufacturing process at our cGMP manufacturing facility in
AAV-RPE65 for the Treatment of RPE65-associated Retinal Dystrophy:
? We anticipate initiating a Phase 3 pivotal trial of AAV-RPE65 in the second
half of 2021.
AAV-CNGB3 and AAV-CNGA3 for the Treatment of Achromatopsia (ACHM):
We and Janssen continue to advance our ongoing clinical development of
? AAV-CNGB3 and AAV-CNGA3 for the treatment of ACHM associated with mutations in
the CNGB3 and CNGA3 genes.
On
o Track designation to our AAV-CNGA3 gene therapy product candidate for the
treatment of ACHM caused by mutations in the CNGA3 gene.
We and Janssen have now completed dosing of both adults and pediatric patients
o in the Phase 1/2 dose escalation study of AAV-CNGA3 and expect to provide an
update on further clinical studies for both AAV-CNGB3 and AAV-CNGA3 later in
2021.
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Riboswitch Gene Regulation Platform:
We expect to present in-vivo data from our proprietary riboswitch gene
? regulation platform in the second half of 2021, demonstrating regulation of
multiple therapeutic genes in multiple tissues.
Recent Corporate Development Highlights
Second Viral Vector Manufacturing Facility and Plasmid and DNA Production Facility
We expanded our industry-leading manufacturing capabilities by acquiring and
? building a second wholly owned cGMP viral vector manufacturing facility as well
as a cGMP plasmid and DNA production facility located in Shannon,
The campus encompasses approximately 150,000 square feet serving numerous
functions: high capacity cGMP manufacturing hub, clinical supply storage, QC
? laboratories for global release, up to ten flexible and scalable viral vector
suites, fully scalable automated fill and finish, an extensive warehouse and a
separate internal cGMP plasmid and DNA manufacturing facility.
Construction of the cGMP plasmid and DNA manufacturing facility has been
? completed, with the cGMP viral vector manufacturing facility expected to be
completed by the end of 2021.
Expanding Clinical, Regulatory, Manufacturing, MSAT and Preclinical Development Teams
We continue to increase the number of personnel across key functional areas to
? support our broad pipeline of optimized investigational gene therapies. Our
team now includes more than 215 full-time employees.
Components of Our Results of Operations
License Revenue
Our license revenue consisted of the amortization of the upfront payment we received in connection with the Collaboration Agreement.
Operating Expenses
Our operating expenses since inception have consisted primarily of general and administrative costs and research and development costs.
General and Administrative Expenses
General and administrative expenses consist primarily of salaries and other related costs, including share-based compensation, for personnel in our executive, finance, legal, business development and administrative functions. General and administrative expenses also include legal fees relating to intellectual property and corporate matters; professional fees for accounting, auditing, tax and consulting services; insurance costs; travel expenses; and office facility-related expenses, which include direct depreciation costs.
We expect that our general and administrative expenses will increase in the
future as we increase our personnel headcount to support increased research and
development activities. We have also incurred and expect to continue to incur
increased expenses associated with being a public company, including costs of
accounting, audit, legal, regulatory and tax-related services associated with
maintaining compliance with Nasdaq and
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Research and Development Expenses
Research and development expenses consist primarily of costs incurred for our research activities, including our discovery efforts, and the development of our product candidates, and include:
? employee-related expenses, including salaries, benefits and travel of our
research and development personnel;
expenses incurred in connection with third-party vendors that conduct clinical
? and preclinical studies and manufacture the drug product for the clinical
trials and preclinical activities;
? acquisition of in process research and development;
costs associated with clinical and preclinical activities including costs
? related to facilities, supplies, rent, insurance, certain legal fees,
share-based compensation, and depreciation; and
? expenses incurred with the development and operation of our manufacturing
facilities.
We expense research and development costs as incurred.
Research and development activities are central to our business model. We expect
that our research and development expenses will continue to increase
substantially for the foreseeable future as we initiate additional preclinical
and clinical trials of our existing product candidates, including the planned
advancement of AAV-RPGR into the Phase 3 Lumeos clinical trial for the treatment
of patients with XLRP and the initiation of a Phase 3 clinical trial of
AAV-RPE65 for the treatment of retinal dystrophy associated with mutations in
the RPE65 gene, and continue to discover and develop additional product
candidates. Certain of these increases in research and development costs will be
partially offset by the research funding provided in connection with the
Collaboration Agreement we entered into in
We cannot determine with certainty the duration and costs of future clinical trials of our product candidates or any other product candidate we may develop or if, when, or to what extent we will generate revenue from the commercialization and sale of any product candidate for which we obtain marketing approval. We may never succeed in obtaining marketing approval for any product candidate. The duration, costs and timing of clinical trials and development of our existing product candidates or any other product candidate we may develop will depend on a variety of factors, including:
the scope, rate of progress, expense and results of clinical trials of our
? existing product candidates, as well as of any future clinical trials of other
product candidates and other research and development activities that we may
conduct;
? uncertainties in clinical trial design and patient enrollment rates;
the actual probability of success for our product candidates, including the
? safety and efficacy, early clinical data, competition, manufacturing capability
and commercial viability;
? significant and changing government regulation and regulatory guidance;
? the timing and receipt of any marketing approvals; and
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? the expense of filing, prosecuting, defending and enforcing any patent claims
and other intellectual property rights.
A change in the outcome of any of these variables with respect to the
development of a product candidate could mean a significant change in the costs
and timing associated with the development of that product candidate. For
example, if the FDA or another
Other non-operating income (expense)
Other non-operating income (expense) includes the following:
Foreign currency (loss) gain
Our consolidated financial statements are presented in
Critical Accounting Policies and Use of Estimates
Management's discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with GAAP. The preparation of these consolidated financial statements requires us to make estimates and judgements that affect the reporting amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities in our consolidated financial statements. On an ongoing basis, we evaluate our estimates and judgements, including those related to license and collaboration revenue, share-based compensation and accrued expenses. We base our estimates on historical experience, known trends and events and various other factors that we believe to be reasonable under the circumstances, the results of which form the basis for making judgements about the carrying value of assets and liabilities that are not readily apparent from our sources. Actual results may differ from these estimates under different assumptions.
While our significant accounting policies are described in more detail in the notes to our financial statements appearing in this Form 10-K, we believe that the following accounting policies are those most critical to the judgments and estimates used in the preparation of our financial statements.
Collaboration Arrangements
We evaluate our collaborative arrangements pursuant to Accounting Standards Codification ("ASC") 808, Collaborative Arrangements ("ASC 808") and ASC 606, Revenue from Contracts with Customers ("ASC 606"). We consider the nature and contractual terms of collaborative arrangements and assess whether the arrangement involves a joint operating activity pursuant to which we are an active participant and are exposed to significant risks and rewards with respect to the arrangement. If we are an active participant and exposed to significant risks and rewards with respect to the arrangement, we account for the arrangement as a collaboration under ASC 808. To date, we have entered into two
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separate collaboration agreements, both of which are with Janssen, which were determined to be within the scope of ASC 808.
ASC 808 does not address recognition or measurement matters related to collaborative arrangements. Payments between participants pursuant to a collaborative arrangement that are within the scope of other authoritative accounting literature on income statement classification are accounted for using the relevant provisions of that literature. If the payments are not within the scope of other authoritative accounting literature, the income statement classification for the payments is based on an analogy to authoritative accounting literature or if there is no appropriate analogy, a reasonable, rational and consistently applied accounting policy election. Payments received from a collaboration partner to which this policy applies may include upfront payments in respect of a license of intellectual property, development and commercialization-based milestones, and royalties.
Revenue Recognition
Arrangements with collaborators may include licenses to intellectual property, research and development services, manufacturing services for clinical and commercial supply, and participation on joint steering committees. We evaluate the promised goods or services to determine which promises, or group of promises, represent performance obligations. In contemplation of whether a promised good or service meets the criteria required of a performance obligation, we consider the stage of development of the underlying intellectual property, the capabilities and expertise of the customer relative to the underlying intellectual property, and whether the promised goods or services are integral to or dependent on other promises in the contract. When accounting for an arrangement that contains multiple performance obligations, we must develop judgmental assumptions, which may include market conditions, reimbursement rates for personnel costs, development timelines and probabilities of regulatory success to determine the stand-alone selling price for each performance obligation identified in the contract.
When we conclude that a contract should be accounted for as a combined performance obligation and recognized over time, we must then determine the period over which revenue should be recognized and the method by which to measure revenue. We generally recognize revenue using a cost-based input method.
The Collaboration Agreement is accounted for under ASC 808, however, as ASC 808 does not address recognition or measurement matters such as determining the appropriate unit of accounting or when the recognition criteria are met, we account for the consideration received from Janssen in accordance with ASC 606. In accordance with ASC 606, we recognize revenue when the customer or collaborator obtains control of promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. To determine revenue recognition for arrangements that we determine are within the scope of ASC 606, we perform the following five steps:
i. identify the contract(s) with a customer;
ii. identify the performance obligations in the contract;
iii. determine the transaction price;
iv. allocate the transaction price to the performance obligations within the
contract; and
v. recognize revenue when (or as) the entity satisfies a performance obligation.
We only apply the five-step model to contracts when we determine that it is probable we will collect the consideration we are entitled to in exchange for the goods or services we transfer to the customer.
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At contract inception, once the contract is determined to be by analogy within the scope of ASC 606, we assess the goods or services promised within the contract to determine whether each promised good or service is a performance obligation. The promised goods or services for our arrangements typically consist of a license to our intellectual property and research, development and manufacturing services. We may provide options to additional items in such arrangements, which are accounted for as separate contracts when the customer elects to exercise such options, unless the option provides a material right to the customer. Performance obligations are promises in a contract to transfer a distinct good or service to the customer that (i) the customer can benefit from on its own or together with other readily available resources, and (ii) is separately identifiable from other promises in the contract. Goods or services that are not individually distinct performance obligations are combined with other promised goods or services until such combined group of promises meet the requirements of a performance obligation.
We determine transaction prices based on the amount of consideration we expect to receive for transferring the promised goods or services in the contract. Consideration may be fixed, variable, or a combination of both. At contract inception for arrangements that include variable consideration, we estimate the probability and extent of consideration we expect to receive under the contract utilizing either the most likely amount method or expected amount method, whichever best estimates the amount expected to be received. We then consider any constraints on the variable consideration and include in the transaction price variable consideration to the extent it is deemed probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved.
We then allocate the transaction price to each performance obligation based on the relative standalone selling price and recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) control is transferred to the customer and the performance obligation is satisfied. For performance obligations which consist of licenses and other promises, we utilize judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress. We evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition.
We record amounts as accounts receivable when the right to consideration is deemed unconditional. When consideration is received, or such consideration is unconditionally due, from a customer prior to transferring goods or services to the customer under the terms of a contract, a contract liability is recorded as deferred revenue.
Amounts received prior to satisfying the revenue recognition criteria are recognized as deferred revenue in our consolidated balance sheet. Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue - related party, current. Amounts not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue - related party.
Income Taxes
Since we have recurring losses and a valuation allowance against deferred tax
assets, there was no tax expense (benefit) for the years ended
As of
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will begin to expire 2036 and research and development credits in the
Leases
We account for leases in accordance with ASC 842. We determine if an arrangement is a lease at contract inception. A lease exists when a contract conveys the right to control the use of identified property, plant, or equipment for a period of time in exchange for consideration. The definition of a lease embodies two conditions: (1) there is an identified asset in the contract that is land or a depreciable asset (i.e., property, plant, and equipment), and (2) we have the right to control the use of the identified asset. We account for the lease and non-lease components as a single lease component.
From time to time we enter into direct financing lease arrangements that include a lessee obligation to purchase the leased asset at the end of the lease term, a bargain purchase option, or provides for minimum lease payments with a present value of 90% or more of the fair value of the leased asset at the date of lease inception.
Operating leases where we are the lessee are included in right-of-use ("ROU") assets and lease obligations are included on our consolidated balance sheets. The lease obligations are initially and subsequently measured at the present value of the unpaid lease payments at the lease commencement date and subsequent reporting periods.
Finance leases where we are the lessee are included in ROU assets and lease obligations on our consolidated balance sheets. The lease obligations are initially measured in the same manner as for operating leases and are subsequently measured at amortized cost using the effective interest method.
Key estimates and judgments include how we determined (1) the discount rate we use to discount the unpaid lease payments to present value, (2) lease term and (3) lease payments.
ASC 842 requires a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot be readily determined, its incremental borrowing rate. As most of our leases where we are the lessee do not provide an implicit rate, we use our incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. Our incremental borrowing rate for a lease is the rate of interest we would have to pay on a collateralized basis to borrow an amount equal to the lease payments under similar terms. We use the implicit rate when readily determinable.
The lease term for all of our leases includes the non-cancellable period of the lease plus any additional periods covered by either a lessee option to extend (or not to terminate) the lease that is reasonably certain to be exercised, or an option to extend (or not to terminate) the lease controlled by the lessor.
The ROU asset is initially measured at cost, which comprises the initial amount of the lease liability adjusted for lease payments made at or before the lease commencement date less any lease incentives received.
For operating leases, the ROU asset is subsequently measured throughout the lease term at the carrying amount of the lease liability, minus any accrued lease payments, less the unamortized balance of lease incentives received. Lease expense for lease payments is recognized on a straight-line basis over the lease term.
For finance leases, the ROU asset is subsequently amortized using the straight-line method from the lease commencement date to the earlier of the end of its useful life or the end of the lease term unless the lease transfers ownership of the underlying asset to us, or we are reasonably certain to exercise an option to purchase the underlying asset. In those cases, the ROU asset is amortized over the useful life of the underlying asset. Amortization of the ROU asset is recognized and presented separately from interest expense on the lease liability.
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We have elected not to recognize ROU assets and lease liabilities for all short-term leases that have a lease term of 12 months or less at lease commencement. We recognize the lease payments associated with our short-term leases as an expense on a straight-line basis over the lease term.
Research and Development
Research and development costs are charged to expense as incurred. These costs include, but are not limited to, employee-related expenses, including salaries, benefits and travel of our research and development personnel; expenses incurred under agreements with contract research organizations and investigative sites that conduct clinical and preclinical studies and manufacture the drug product for the clinical studies and preclinical activities; acquisition of in-process research and development; facilities; supplies; rent, insurance, certain legal fees, stock-based compensation, depreciation and other costs associated with clinical and preclinical activities and regulatory operations. Research funding under collaboration agreements and refundable research and development credits / tax credits received are recorded as an offset to these costs.
Costs for certain development activities, such as outside research programs funded by us, are recognized based on an evaluation of the progress to completion of specific tasks with respect to their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the financial statements as prepaid or accrued research and development expense, as the case may be.
Share-Based Compensation
Options
We grant share options to employees, non-employee members of our board of directors and non-employee consultants as compensation for services performed. Employee and non-employee members of the board of directors' awards of share-based compensation are accounted for in accordance with ASC 718, Compensation-Stock Compensation, or ASC 718. ASC 718 requires all share-based payments to employees and non-employee directors, including grants of share options, to be recognized in the statement of operations and comprehensive loss based on their grant date fair values. The grant date fair value of share options is estimated using the Black-Scholes option valuation model.
Using this model, fair value is calculated based on assumptions with respect to (i) the fair value of our ordinary shares on the grant date; (ii) expected volatility of our ordinary share price, (iii) the periods of time over which employees and members of our board of directors are expected to hold their options prior to exercise (expected term), (iv) expected dividend yield on our ordinary shares, and (v) risk-free interest rates.
Our ordinary shares were not traded on a public exchange prior to our IPO in
Restricted Share Units
The Company grants restricted share units ("RSUs") to employees and non-employee consultants as compensation for services performed. Awards of RSUs are accounted for in accordance with ASC 718, Compensation - Stock Compensation, or ASC 718. ASC 718 requires all share-based payments to employees and non-employee directors, including grants of RSUs, to be recognized in the consolidated statement of operations and comprehensive loss
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based on their grant date fair values. The grant date fair value of RSUs is determined using the closing market price of the Company's ordinary shares on the date of grant.
Restricted Shares
In connection with certain employment, service and research agreements, we have granted restricted ordinary shares as compensation. The shares are recognized in the statement of operations and comprehensive loss based on their grant date fair values. Compensation cost relating to share grants with service-based graded vesting schedules is recognized based on the vesting schedule.
Results of Operations
Comparison of the Years Ended
2020 2019 Change
License revenue - related party $ 15,562,985 $ 13,291,956 $ 2,271,029
Operating expenses:
General and administrative 44,206,921 46,684,297 (2,477,376)
Research and development 33,910,481 24,875,659 9,034,822
Total operating expenses 78,117,402 71,559,956 6,557,446
Loss from operations (62,554,417) (58,268,000) (4,286,417)
Other non-operating income (expense)
Foreign currency gain 3,426,152 3,199,774 226,378
Interest income 1,275,464 370,603 904,861
Interest expense (139,203) (48,612) (90,591)
Net loss (57,992,004) (54,746,235) (3,245,769)
Other comprehensive income:
Foreign currency translation for the
years ended December 31, 2020 and 2019,
respectively (3,102,864) (2,087,708) (1,015,156)
Total comprehensive loss $ (61,094,868) $ (56,833,943) $ (4,260,925)
License Revenue
License revenue was
General and Administrative Expenses
General and administrative expenses were
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Research and Development Expenses
Research and development expenses for the years ended
2020 2019 Change
Gross research and development expenses
(57.4) (28.1) (29.3)
Tax incentive reimbursement (5.3) (12.0) 6.7
Research and development expenses
Gross research and development expenses for the year ended
Reimbursements under the Collaboration Agreement for the year ended
Tax incentive reimbursement for the year ended
Foreign Currency Gain
Foreign currency gain was
Interest Income
Interest income was
Liquidity and Capital Resources
Since our inception, we have incurred significant operating losses. For the year
ended
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second cGMP viral vector manufacturing facility and our first cGMP plasmid and
DNA production facility in Shannon,
We do not currently have any approved products and have never generated any
revenue from product sales. We have historically financed our operations
primarily through cash on hand and proceeds from the sale of our ordinary
shares, series A ordinary shares and convertible preferred C shares. In
Based on our current cash and cash equivalents at
Cash Flows
We had
The following table summarizes our sources and uses of cash for the period
presented:
For the years ended December 31,
2020 2019
Net cash (used in) provided by operating activities
(37,020,433) (9,370,081)
Net cash provided by financing activities 82,727,383 148,234,904
(Decrease) increase in cash $ (18,260,849) $ 158,909,720
Operating Activities
During the year ended
During the year ended
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consisting of accounts receivable, prepaid expenses, tax incentive receivable,
security deposits and other current assets, increased by
Investing Activities
Net cash used in investing activities for the year ended
Net cash used in investing activities for the year ended
Financing Activities
Net cash provided by financing activities was
Net cash provided by financing activities was
Off-Balance Sheet Arrangements
We have not entered into any off-balance sheet arrangements under applicable
Emerging Growth Company Status
The Jumpstart Our Business Startups Act of 2012, (the "JOBS Act"), permits an "emerging growth company," which we are, to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. We have elected to take advantage of this extended transition period.
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