XILIO THERAPEUTICS, INC. You should read the following discussion and analysis of our financial condition
and results of operations together with our condensed consolidated financial
statements and related notes appearing elsewhere in this Quarterly Report on
Form 10-Q and in our Annual Report on Form 10-K for the year ended
Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the section entitled "Risk Factors" in Part II, Item 1A of this Quarterly Report on Form 10-Q, 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.
Overview
We are a clinical-stage biotechnology company discovering and developing
tumor-activated immuno-oncology, or I-O, therapies with the goal of
significantly improving outcomes for people living with cancer without the
systemic side effects of current I-O treatments. We are leveraging our
proprietary platform to build a pipeline of novel, tumor-activated molecules,
including cytokines and other biologics, which are designed to optimize their
therapeutic index and localize anti-tumor activity within the tumor
microenvironment. Our most advanced tumor-activated cytokine product candidates
are XTX202, an interleukin 2, or IL-2, therapy and XTX301, an interleukin 12, or
IL-12, therapy. We are currently evaluating XTX202 in monotherapy
dose-escalation of an ongoing Phase 1 clinical trial for patients with advanced
solid tumors, and we anticipate initiating patient enrollment in a monotherapy
expansion cohort of the Phase 1 clinical trial in the fourth quarter of 2022 and
initiating patient enrollment in a Phase 2 monotherapy clinical trial in the
first half of 2023. We anticipate reporting preliminary anti-tumor activity and
safety data from the Phase 1/2 clinical trial in the third quarter of 2023. In
To date, we have financed our operations primarily from proceeds raised through
private placements of preferred units and convertible preferred stock, a debt
financing and our initial public offering, or IPO, of common stock in
We have not generated any revenue from product sales and do not expect to
generate any revenue from product sales for at least the next several years, if
at all. All of our programs are in early clinical or preclinical development.
Our ability to generate product revenue sufficient to achieve profitability will
depend heavily on the successful development and eventual commercialization of
one or more of our product candidates, if approved. Since inception, we have
incurred significant operating losses. Our net losses were
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future. We anticipate that our expenses will continue to increase significantly in connection with our ongoing activities, particularly as we:
? continue to advance our current research programs and conduct additional
research programs;
? advance our current product candidates and any future product candidates we may
develop into preclinical and clinical development;
? seek marketing approvals for product candidates that successfully complete
clinical trials, if any;
? obtain, expand, maintain, defend and enforce our intellectual property;
? hire additional research, clinical, regulatory, quality, manufacturing and
general and administrative personnel;
? establish a commercial and distribution infrastructure to commercialize
products for which we may obtain marketing approval, if any;
? continue to discover, validate and develop additional product candidates;
continue to manufacture increasing quantities of our current or future product
? candidates for use in preclinical studies, clinical trials and for any
potential commercialization;
? acquire or in-license other product candidates, technologies or intellectual
property; and
? incur additional costs associated with current and future research, development
and commercialization efforts and operations as a public company.
As a result, we will need substantial additional capital to support our continuing operations and pursue our strategy. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of equity offerings, debt financings and other sources of funding, such as collaborations, licensing arrangements or other strategic transactions. We may be unable to raise additional capital or enter into such other agreements or arrangements when needed on acceptable terms, or at all. Our failure to raise capital or enter into such agreements as and when needed could have a material adverse effect on our business, results of operations and financial condition.
Because of the numerous risks and uncertainties associated with product development, we are unable to predict the timing or amount of increased expenses or when or if we will be able to achieve 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.
As of
Note Regarding the COVID-19 Pandemic
The impact of the COVID-19 pandemic continues to be widespread, rapidly-evolving and unpredictable on global societies, economies, financial markets, supply chains and business practices. The extent of the impact of the COVID-19 pandemic, including variants of the COVID-19 virus, on our business, operations, and clinical development timelines and plans remains uncertain. For a discussion regarding risks and uncertainties related to the impact of the COVID-19 pandemic and its potential impact on our business and financial results, please refer to our Risk Factors in Part II, Item 1A of this Quarterly Report on Form 10-Q.
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Financial Operations Overview
Revenue
We have not generated any revenue since inception and do not expect to generate any revenue from the sale of products for at least the next several years, if at all. If our development efforts for our current or future product candidates are successful and result in regulatory approval or if we enter into collaboration or license agreements with third parties, we may generate revenue in the future from product sales or payments from third-party collaborators or licensors.
Operating Expenses
Research and Development Expenses
Research and development expenses consist primarily of costs incurred for our discovery efforts, research activities and development and testing of our programs and product candidates. These expenses include:
personnel-related expenses, including salaries, bonuses, benefits and
? equity-based compensation expense for employees engaged in research and
development functions;
costs incurred with third-party contract development and manufacturing
? organizations, or CDMOs, to acquire, develop and manufacture materials for both
preclinical studies and current or future clinical trials;
? costs of funding research performed by third parties that conduct research and
development and preclinical activities on our behalf;
costs incurred with third-party contract research organizations, or CROs, and
? other third parties in connection with the conduct of our current or future
clinical trials;
? costs of sponsored research agreements and outside consultants, including their
fees, equity-based compensation and related expenses;
? costs incurred to maintain compliance with regulatory requirements;
? fees for maintaining license and other amounts due under our third-party
licensing agreements;
? expenses incurred for the procurement of materials, laboratory supplies and
non-capital equipment used in the research and development process; and
depreciation, amortization and other direct and allocated expenses, including
? rent, insurance, maintenance of facilities and other operating costs, incurred
as a result of our research and development activities.
We expense research and development costs as incurred. We recognize external development costs based on an evaluation of the progress to completion of specific deliverables using information provided to us by our vendors. Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and are reflected in our financial statements as prepaid expenses or accrued research and development expenses. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are capitalized as assets, even when there is no alternative future use for the research and development. The capitalized amounts are expensed as the related goods are delivered or the services are performed.
We use our personnel and infrastructure resources for our discovery efforts, including the advancement of our platform, developing programs and product candidates and managing external research efforts. A significant portion of our research and development costs have been, and will continue to be, external costs. We track these external costs, such as fees paid to CDMOs, CROs, preclinical study vendors and other third parties in connection with our manufacturing and
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manufacturing process development, clinical trials, preclinical studies and other research activities by program. Due to the number of ongoing programs and our ability to use resources across several projects, personnel-related expenses and indirect or shared operating costs incurred for our research and development programs are not recorded or maintained on a program-by-program basis.
Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We expect that our research and development expenses will continue to increase for the foreseeable future as we advance our programs and product candidates into and through clinical development, and as we continue to develop additional product candidates. We also expect our discovery research efforts and our related personnel costs will continue to increase and, as a result, we expect our research and development expenses, including costs associated with equity-based compensation, will continue to increase above historical levels. In addition, we may incur additional expenses related to milestone and royalty payments payable to third parties with whom we have entered into, or may enter into license, acquisition, option or other agreements to acquire the rights to future products and product candidates.
At this time, we cannot reasonably estimate or know the nature, timing and projected costs of the efforts that will be necessary to complete the development of, and obtain regulatory approval for, any of our product candidates or programs. This is due to the numerous risks and uncertainties associated with drug development, including the uncertainty of:
? the scope, timing, costs and progress of preclinical and clinical development
activities;
? the number and scope of preclinical and clinical programs we decide to pursue;
? our ability to maintain our current research and development programs and to
establish new ones;
? our ability to establish an appropriate safety profile for our product
candidates with IND-enabling studies;
? our ability to hire and retain key research and development personnel;
? the costs associated with the development of any additional product candidates
we develop or acquire through collaborations;
? our successful enrollment in and completion of clinical trials;
our ability to successfully complete clinical trials with safety, potency and
? purity profiles that are satisfactory to the FDA or any comparable foreign
regulatory authority;
? our receipt of regulatory approvals from applicable regulatory authorities;
? our ability to successfully develop, obtain regulatory approval for, and then
successfully commercialize, our product candidates;
? our ability to commercialize products, if and when approved, whether alone or
in collaboration with others;
? the continued acceptable safety profiles of the product candidates following
approval, if any;
our ability to establish and maintain agreements with third-party manufacturers
? for clinical supply for our clinical trials and commercial manufacturing, if
any of our product candidates are approved;
? the terms and timing of any collaboration, license or other arrangement,
including the terms and timing of any milestone payments thereunder, if any;
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our ability to obtain and maintain patent, trade secret and other intellectual
? property protection and regulatory exclusivity for our product candidates if
and when approved; and
? the impact of COVID-19 and its variants on our research and development
employees, contractors and those who may participate in our planned studies.
A change in any of these variables with respect to the development of any of our product candidates would significantly change the costs, timing and viability associated with the development of that product candidate. We may never succeed in obtaining regulatory approval for any product candidate we may develop.
General and Administrative Expenses
General and administrative expenses consist primarily of personnel-related costs, including salaries, bonuses, benefits, recruiting and equity-based compensation, for personnel in our executive, finance, legal, business development, human resources and other administrative functions. General and administrative expenses also include legal fees relating to corporate matters; professional and consulting fees for accounting, auditing, tax, human resources and administrative consulting services; insurance costs; and facility-related expenses, which include depreciation costs and other allocated expenses for rent, maintenance of facilities, recruiting and other general administrative costs. These costs relate to the operation of the business and are in support of but separate from the research and development function and our individual development programs. Costs to secure and defend our intellectual property are expensed as incurred and are classified as general and administrative expenses.
We anticipate that our general and administrative expenses will increase in the
future as we increase our headcount and infrastructure to support the expected
growth in our research and development activities. We also expect to continue to
incur increased expenses associated with operating as a public company,
including increased costs of accounting, audit, legal, regulatory and
tax-related services attributable to maintaining compliance with exchange
listing standards and
We also expect to incur additional intellectual property-related expenses as we file patent applications to protect intellectual property arising from our research and development activities.
Other Income (Expense), Net
Other income (expense), net consists primarily of interest income earned from
our cash and cash equivalents. This interest income is partially offset by
interest expense principally on the note payable under our debt arrangement with
PacWest and gains or losses associated with changes in the fair value of
contingent liabilities associated with the consummation of specified
transactions, including our IPO. Upon completion of our IPO in
Income Taxes
Since our inception, we have not recorded any
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Utilization of our NOL carryforwards and research and development credit carryforwards may be subject to a substantial annual limitation due to ownership change limitations that have occurred previously or that could occur in the future in accordance with Section 382 of the Internal Revenue Code of 1986, or Section 382, as well as similar state provisions. These ownership changes may limit the amount of NOL and research and development credit carryforwards that can be utilized annually to offset future taxable income and taxes, respectively. In general, an ownership change as defined by Section 382 results from transactions increasing the ownership of certain stockholders or public groups in the stock of a corporation by more than 50% over a three-year period. Since our formation, we have raised capital through the issuance of units and capital stock on several occasions. These financings may have resulted in a change of control as defined by Section 382. We have not yet completed a detailed study of our inception to date ownership change activity.
In addition, we have not yet conducted a study of our research and development credit carry forwards. Such a study may result in an adjustment to our research and development credit carryforwards; however, until a study is completed and any adjustment is known, no amount is being presented as an uncertain tax position. A full valuation allowance has been provided against our research and development credits, and, if an adjustment is required, this adjustment would be offset by an adjustment to the valuation allowance. Thus, there would be no impact to the balance sheet or statement of operations and comprehensive loss if an adjustment were required.
Income taxes are determined at the applicable tax rates adjusted for non-deductible expenses, research and development tax credits and other permanent differences. Our income tax provision may be significantly affected by changes to our estimates.
Results of Operations
Comparison of the three months ended
The following tables summarize our results of operations for the three months
ended
Three Months Ended
September 30,
2022 2021 Change
Operating expenses
Research and development $ 13,038 $ 10,470 $ 2,568
General and administrative 7,168 5,491 1,677
Total operating expenses 20,206 15,961 4,245
Loss from operations (20,206) (15,961) (4,245)
Other income (expense), net
Other income (expense), net 416 (290) 706
Total other income (expense), net 416 (290) 706
Net loss $ (19,790) $ (16,251) $ (3,539)
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Research and Development Expenses
The following tables summarize our research and development expenses for the
three months ended
Three Months Ended
September 30,
2022 2021 Change
XTX101 $ 1,394 $ 1,427 $ (33)
XTX202 1,452 1,262 190
XTX301 1,974 1,403 571
Other early programs and indirect research
and development 2,861 2,401 460
Personnel-related (including equity-based
compensation) 5,357 3,977 1,380
Total research and development expenses
Research and development expenses increased by
? research and development headcount and the corresponding increase of
approximately
of approximately
? driven by preclinical development activities, manufacturing activities and
clinical development activities related to our planned Phase 1 clinical trial
for XTX301; and
? development expenses, primarily driven by an increase in external expenses
related to preclinical research and development activities.
General and Administrative Expenses
The following table summarizes our general and administrative expenses for the
three months ended
Three Months Ended
September 30,
2022 2021 Change
Personnel-related (including equity-based
compensation) $ 3,808 $ 2,828 $ 980
Professional and consulting fees 2,057 2,074 (17)
Facility-related and other general and
administrative expenses 1,303 589 714
Total general and administrative expenses
General and administrative expenses increased by
? general and administrative headcount and the corresponding increase of
approximately
of approximately
expenses, primarily driven by increases in costs incurred as a result of
? becoming a publicly traded company, including directors' and officers'
liability insurance and other corporate related costs associated with increased
overall corporate headcount.
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Other Income (Expense), Net
Other income (expense), net, changed by
Comparison of the nine months ended
The following tables summarize our results of operations for the nine months
ended
Nine Months Ended
September 30,
2022 2021 Change
Operating expenses
Research and development $ 44,204 $ 39,836 $ 4,368
General and administrative 21,778 15,652 6,126
Total operating expenses 65,982 55,488 10,494
Loss from operations (65,982) (55,488) (10,494)
Other income (expense), net
Other income (expense), net 226 (611) 837
Total other income (expense), net 226 (611) 837
Net loss $ (65,756) $ (56,099) $ (9,657) Research and Development Expenses
The following tables summarize our research and development expenses for the
nine months ended
Nine Months Ended
September 30,
2022 2021 Change
XTX101 $ 5,428 $ 5,340 $ 88
XTX202 4,017 13,524 (9,507)
XTX301 9,253 2,153 7,100
Other early programs and indirect research
and development 10,234 7,813 2,421
Personnel-related (including equity-based
compensation) 15,272 11,006 4,266
Total research and development expenses
Research and development expenses increased by
driven by an increase of approximately
? activities, an increase of approximately
development activities and an increase of approximately
clinical development activities related to our planned Phase 1 clinical trial
for XTX301;
? research and development headcount and the corresponding increase of
approximately
of approximately
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? development expenses, primarily driven by an increase in external expenses
related to preclinical research and development activities; and
?
clinical trial for XTX202.
These increases were partially offset by a decrease of approximately
General and Administrative Expenses
The following table summarizes our general and administrative expenses for the
nine months ended
Nine Months Ended
September 30,
2022 2021 Change
Personnel-related (including equity-based
compensation) $ 12,612 $ 7,630 $ 4,982
Professional and consulting fees 4,997 6,279 (1,282)
Facility-related and other general and
administrative expenses 4,169 1,743 2,426
Total general and administrative expenses
General and administrative expenses increased by
general and administrative headcount and the corresponding increase of
? approximately
of approximately
approximately
the modification of previously issued stock options; and
expenses, primarily driven by increases in costs incurred as a result of
? becoming a publicly traded company, including directors' and officers'
liability insurance and other corporate related costs associated with increased
overall corporate headcount.
These increases were partially offset by a
Other Income (Expense), Net
Other income (expense), net, changed by
Liquidity and Capital Resources
Sources of Liquidity
Since our inception, we have incurred significant operating losses and negative
cash flows from operations. We have not yet commercialized any of our product
candidates, which are in preclinical or early clinical development, and we do
not expect to generate revenue from sales of any products for several years, if
at all. To date, we have financed our operations primarily from proceeds raised
through private placements of preferred units and convertible preferred stock, a
debt financing and our IPO. Through
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in net proceeds from the sale and issuance of preferred units and convertible
preferred stock, and
Cash Flows
The following table provides information regarding our cash flows for each period presented (in thousands):
Nine Months Ended
September 30,
2022 2021
Net cash provided by (used in):
Operating activities $ (57,500) $ (63,589)
Investing activities (1,358) (722)
Financing activities (48) 144,842
Net (decrease) increase in cash, cash equivalents and
restricted cash $ (58,906) $ 80,531
Operating Activities
Our cash flows from operating activities are greatly influenced by our use of cash for operating expenses and working capital requirements to support our business. We have historically experienced negative cash flows from operating activities as we invested in research and development of our product candidates, including preclinical studies, clinical trials and manufacturing process development. The cash used in operating activities resulted primarily from our net losses adjusted for non-cash charges, which are generally due to equity-based compensation, depreciation and amortization, as well as changes in components of operating assets and liabilities, which are generally due to increased expenses and timing of vendor payments.
During the nine months ended
During the nine months ended
Investing Activities
During the nine months ended
Financing Activities
During the nine months ended
During the nine months ended
Loan and Security Agreement
In
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million prior to
The loan agreement contains customary representations, warranties and covenants and also include customary events of default, including payment defaults, breaches of covenants, a change of control and occurrence of a material adverse effect.
We have the following minimum aggregate future loan payments under the loan
agreement at
Minimum Loan
Payments
2022 $ -
2023 6,667
2024 3,333
Total future principal payments 10,000
Less: unamortized discount (219)
Total notes payable $ 9,781
Capital Requirements
We expect our future capital requirements to increase substantially over time in connection with our ongoing research and development activities, particularly as we advance our current and planned clinical development of our product candidates and expand the research efforts and preclinical activities associated with our other existing programs and discovery platform. In addition, we expect to continue to incur additional costs associated with operating as a public company. As a result, we expect to incur substantial operating losses and negative operating cash flows for the foreseeable future.
Inflation generally affects us by increasing our cost of labor and certain
services. We do not believe that inflation had a material effect on our
financial statements included elsewhere in this Quarterly Report on Form 10-Q.
However,
As of
Because of the numerous risks and uncertainties associated with product development, and because the extent to which we may enter into collaborations with third parties for the development of our product candidates is unknown, we may incorrectly estimate the timing and amounts of increased capital outlays and operating expenses associated with completing the research and development of our product candidates. Our funding requirements and timing and amount of our operating expenditures will depend on many factors, including, but not limited to:
the scope, progress, results and costs of research and development for our
current and future product candidates, including our current and planned
? clinical trials for our clinical-stage cytokine product candidates, XTX202 and
XTX301, and ongoing preclinical development for our current and future product
candidates;
? the scope, prioritization and number of our research and development programs;
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? the scope, costs, timing and outcome of regulatory review of our product
candidates;
the costs of securing manufacturing materials for use in preclinical studies,
? clinical trials and, for any product candidates for which we receive regulatory
approval, if any, use as commercial supply;
? the costs and timing of future commercialization activities for any of our
product candidates for which we receive regulatory approval;
? the amount and timing of revenue, if any, received from commercial sales of any
product candidates for which we receive regulatory approval;
the costs and timing of preparing, filing and prosecuting patent applications,
? maintaining and enforcing our intellectual property and proprietary rights and
defending any intellectual property-related claims;
the extent to which we may acquire or in-license other products, product
? candidates, technologies or intellectual property, as well as the terms of any
such arrangements;
our ability to seek, establish and maintain a collaboration to develop XTX101,
? our tumor-activated mAb product candidate, with a collaborator, including the
financial terms and any cost-sharing arrangements of any such collaboration;
and
? the costs of continuing to expand our operations and operating as a public
company.
Identifying potential product candidates and conducting preclinical studies and clinical trials is a time consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain regulatory approval and achieve product sales. In addition, our product candidates, if approved, may not achieve commercial success. Our commercial revenues, if any, will be derived from sales of products that we do not expect to be commercially available for several years, if ever. Accordingly, we will need to obtain substantial additional capital to achieve our business objectives.
Our expectation with respect to our ability to fund our currently planned operations is based on estimates that are subject to various risks and uncertainties. Our operating plan may change as a result of many factors currently unknown to management and there can be no assurance that our current operating plan will be achieved in the time frame anticipated by us, and we may need to seek additional capital sooner than anticipated.
Adequate additional capital may not be available to us on acceptable terms, or at all. Market volatility resulting from the COVID-19 pandemic, adverse changes in domestic and international fiscal, monetary and other policies and political relations, regional or global conflicts, uncertainty around global economic conditions, or other factors could also adversely impact our ability to access capital as and when needed. To the extent that we raise additional capital through the sale of equity or securities convertible into or exchangeable for equity, the ownership interest of our existing stockholders may be diluted, and the terms of such securities may include liquidation or other preferences that adversely affect the rights of our existing stockholders. Additional debt and preferred equity, if available, may also 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 that we issue warrants, which could potentially dilute the ownership interest of our existing stockholders.
If we raise additional capital through collaborations, partnerships, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our intellectual property, future revenue streams, research programs or product candidates or products, and we may be required to grant licenses on terms that may not be favorable to us. If we are unable to raise additional capital through equity or debt offerings when needed, we may have to significantly delay, reduce or eliminate some or all of our product development or future commercialization efforts, or grant rights to develop and market product candidates or products that we would have otherwise preferred to develop and market ourselves.
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Critical Accounting Policies and Use of Estimates
Our critical accounting policies are those policies that require the most
significant judgments and estimates in the preparation of our condensed
consolidated financial statements. We believe that our most critical accounting
policies are those relating to research and development expenses and related
accruals and equity-based compensation. For a description of our critical
accounting policies and the associated judgments and estimates related thereto,
please see Note 2, Summary of Significant Accounting Policies, of the notes to
our consolidated financial statements included in our Annual Report on Form 10-K
for the year ended
There have been no significant changes to our critical accounting policies and
use of estimates from those described in our Annual Report on Form 10-K for the
year ended
Emerging Growth Company and Smaller Reporting Company Status
As an emerging growth company, or EGC, under the Jumpstart Our Business Startups
Act of 2012, or JOBS Act, we may delay the adoption of certain accounting
standards until such time as those standards apply to private companies. Other
exemptions and reduced reporting requirements under the JOBS Act for EGCs
include presentation of only two years of audited financial statements in a
registration statement for an IPO, an exemption from the requirement to provide
an auditor's report on internal controls over financial reporting pursuant to
Section 404(b) of the Sarbanes-Oxley Act of 2002, an exemption from any
requirement that may be adopted by the
In addition, the JOBS Act provides that an EGC can take advantage of an extended transition period for complying with new or revised accounting standards. This provision allows an EGC to delay the adoption of some accounting standards until those standards would otherwise apply to private companies. We have elected not to "opt out" of such extended transition period, which means that when a standard is issued or revised and it has different application dates for public or private companies, we can adopt the new or revised standard at the time private companies adopt the new or revised standard and may do so until such time that we either (1) irrevocably elect to "opt out" of such extended transition period or (2) no longer qualify as an emerging growth company. As a result, our financial statements may not be comparable to companies that comply with new or revised accounting pronouncements as of public company effective dates.
We are also a "smaller reporting company," as defined in the Securities Exchange Act of 1934, as amended, or the Exchange Act. We may continue to be a smaller reporting company even after we are no longer an emerging growth company, in which case we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies.
Recent Accounting Pronouncements
For a description of recent accounting pronouncements, see Note 2, "Summary of
Significant Accounting Policies" in our audited consolidated financial
statements included in our Annual Report on Form 10-K for the year ended
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