The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our condensed consolidated financial statements and related notes, included in Item 1 of this Report. Unless otherwise specified, all dollar amounts are U.S. dollars.





Overview


We are an in-vitro diagnostic company that has commercialized a proprietary tear testing platform, the TearLab® Osmolarity System that enables eye care practitioners to test for a highly sensitive and specific biomarker using nanoliters of tear film at the point-of-care. Our first product measures tear film osmolarity for the diagnosis of Dry Eye Disease or DED.

We develop technologies to enable eye care practitioners to test a wide range of biomarkers (chemistries, metabolites, genes and proteins) at the point-of-care. Commercializing and further development of that tear testing platform is now the focus of our business.

Our current product, the TearLab® Osmolarity System, enables the rapid measurement of tear osmolarity in the doctor's office. Osmolarity is a quantitative and highly specific biomarker that has been shown to assist in the diagnosis and disease management of DED. Based on the Beaver Dam Offspring Study (2005-2008), prevalence of DED was 14.5% across an adult population aged 21-84, impacting 17.9% of women and 10.5% of men in the study. The innovation of the TearLab® Osmolarity System is its ability to precisely and rapidly measure osmolarity in nanoliter volumes of tear samples, using a highly efficient and novel tear collection system at the point of care. Historically, eye care researchers have relied on expensive instruments to perform tear biomarker analysis. In addition to their cost, these conventional systems are slow, highly variable in their measurement readings, and not categorized as waived by the United States Food and Drug Administration, or the FDA, under regulations promulgated under the Clinical Laboratory Improvement Amendments, or CLIA.

The TearLab® Osmolarity System consists of the following three components: (1) the TearLab disposable, which is a single-use microfluidic microchip; (2) the TearLab Pen, which is a hand-held device that interfaces with the TearLab disposable; and (3) the TearLab Reader, which is a small desktop unit that allows for the docking of the TearLab Pen and provides a quantitative reading for the operator.

We enter into contracts where revenue is derived either from agreements whereby the customer is provided the right to use the TearLab® Osmolarity System at no separate cost to the customer in consideration for a minimum purchase commitment or implied minimum purchase commitment of disposable test cards over the related contract term (which we refer to as either "Use Agreements", "Masters Agreements" or "Flex Agreements"), or from agreements with separate sales of the reader equipment and disposable test cards ("Purchase Agreements").

In October 2008, the TearLab® Osmolarity System received CE mark approval, clearing the way for sales in the European Union and all countries recognizing the CE mark. In connection with the CE mark clearance, we have entered into multi-year agreements with numerous distributors for distribution of the TearLab® Osmolarity System. Currently, we have signed distribution agreements in Central and South America, Europe, Asia, Canada, and Australia. We sell directly to the customer in the United States.

On January 4, 2018, we announced that we had submitted a 510(k) application to the FDA for the potential clearance of the TearLab DiscoveryTMPlatform. The submission covered DiscoveryTM and the MMP-9 biomarker. On February 14, 2018, we announced that the application had successfully passed the acceptance review phase with the FDA. On April 11, 2018 we announced that we received written feedback from the FDA, requesting that we provide additional information to establish correlation to the FDA-cleared predicate chosen to establish 510(k) substantial equivalence. On September 4, 2018, we submitted, and the FDA accepted, our response to the FDA's comments regarding the 510(k) application for the DiscoveryTM Platform. On October 10, 2018, we announced that the FDA determined that the TearLab Discovery™ MMP-9 test, had not met the criteria for substantial equivalence based upon data and information we had submitted. On April 22, 2020, the Company announced the FDA had accepted the resubmission of its 510(k) application for the potential clearance of the TearLab DiscoveryTM MMP-9 test. The submission covers the TearLab DiscoveryTM Platform and its single-use, disposable Test Card measuring the inflammatory biomarker, matrix metalloproteinase 9 (MMP-9).





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TearLab Corporation



RESULTS OF OPERATIONS


Revenue, Cost of Sales and Gross Margin





                                                Three months ended
                (in thousands)                       March 31,
                                           2020        2019       Change

                TearLab revenue           $ 5,091     $ 5,683     $  (592 )
                TearLab - cost of sales     1,861       2,083        (222 )
                TearLab gross profit        3,230       3,600        (370 )
                Gross profit percentage        63 %        63 %




Revenue


TearLab revenue consists of sales of the TearLab® Osmolarity System, which is a hand-held tear film test for the measurement of tear osmolarity, a quantitative and highly specific biomarker that has shown to correlate with dry eye disease ("DED").

The TearLab® Osmolarity System consists of the following three components: (1) the TearLab disposable, which is a single-use microfluidic lab test card; (2) the TearLab pen, which is a hand-held device that interfaces with the TearLab disposable; and (3) the TearLab reader, which is a small desktop unit that allows for the docking of the TearLab disposable and the TearLab pen and provides a quantitative reading for the operator.

Having received 510(k) clearance and a CLIA waiver from the FDA in the United States, we sell to customers in the United States who hold CLIA licenses and actively support and assist our customers to obtain their licenses or provide them with support from certified professionals. This CLIA waiver documentation allows us to sell our product to the approximately 50,000 eye care practitioners in the United States that are candidates to operate under a CLIA waiver certification.

We are working with our established distributors in Central and South America, Europe, Asia, Canada, and Australia to increase sales. The ability for reimbursement to be obtained in many of the countries where we have distributors will facilitate our ability to increase sales and stimulate the commercialization process. In countries where we have distributors, we are supporting physicians in local clinical trials and providing them with the required guidance to understand the relationship between DED and osmolarity and how to manage their patients with objective diagnostic data.

TearLab revenue for the three months ended March 31, 2020 was $5.1 million compared to $5.7 million for the three months ended March 31, 2019. This decrease was driven by the decrease in both reader revenue and test card revenue compared to the first quarter of 2019 due to the impact of COVID-19 in March 2020.





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TearLab Corporation



Cost of Sales


TearLab cost of sales includes costs of goods sold, depreciation of reader systems, warranty, and royalty costs. Our cost of goods sold consists primarily of costs for the manufacture of the TearLab® Osmolarity System, including the costs we incur for the purchase of component parts from our suppliers, applicable freight and shipping costs, fees related to warehousing and logistics inventory management.

TearLab cost of sales decreased 11% for the three months ended March 31, 2020 compared to March 31, 2019. The decrease was driven by lower depreciation as our systems become fully amortized, as well as lower royalty on lower revenue volume. Additionally, in 2019 we received a credit from one of our suppliers for inventory damaged in transit.





Gross Profit


TearLab gross profit for the three months ended March 31, 2020 was $3.2 million compared to the $3.6 million for the three months ended March 31, 2019. The gross profit percentage of revenue for the three months ended March 31, 2020 and 2019 was 63%. Excluding the impact of the 2019 credit from one of our suppliers for inventory damaged in transit, gross profit would have been 64% for the three months ended March 31, 2019.





Operating Expenses



(in thousands)                                        Three months ended March 31,
                                                2020               2019            Change

Sales and marketing                         $        817       $        875     $        (58 )
Clinical, regulatory and research and
development                                          916                874               42
General and administrative                         1,637              1,844             (207 )
Operating expenses                          $      3,370       $      3,593     $       (223 )




Sales and Marketing Expense


Sales and marketing expenses decreased by $0.1 million or 6.6% in the three months ended March 31, 2020, as compared with the three months ended March 31, 2019. The reduction in sales and marketing expenses is attributable to a reduction in employee related payments due to lower sales and the impact of COVID-19 in March 2020.

Clinical, Regulatory and Research and Development Expenses

Total clinical, regulatory and research and development expenses increased 4.8% in the three months ended March 31, 2020 as compared with the three months ended March 31, 2019. The increase was due to product development costs for the resubmittal of the 501(k) with the FDA for the TearLab DiscoveryTM Platform.

General and Administrative Expenses

Total general and administrative expenses decreased $0.2 million or 11.2% in the three months ended March 31, 2020 as compared with the three months ended March 31, 2019. The decrease was primarily due to the impact of tax related costs and employee retention related payouts in Q1 of 2019, as well as the impact of COVID-19 in March 2020.





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TearLab Corporation



Other Income (Expense)



                                                  Three Months Ended
              (in thousands)                          March 31,
                                            2020         2019        Change

              Interest income (expense)   $ (1,442 )   $ (1,350 )   $    (92 )
              Other (net)                       16            4           12
              Other income                $ (1,426 )   $ (1,346 )   $    (80 )




Interest Income (Expense)



Interest expense for the three months ended March 31, 2020 and 2019 was from our long-term debt under the Term Loan Agreement. Interest expense increased for the three months ended March 31, 2020 when compared to the same period in the previous fiscal year based on larger average balances of long-term debt outstanding.





Other (net)



Other income (loss) for the three months ended March 31, 2020 and 2019 consists primarily of foreign exchange transaction gains and losses, based on fluctuations of the Company's foreign denominated currencies.





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TearLab Corporation

Liquidity and Capital Resources





    (in thousands)                March 31, 2020       December 31, 2019       Change
    Cash and cash equivalents    $          7,335     $             7,108     $    227
    Percentage of total assets               52.1 %                  49.7 %

    Working capital              $        (29,456 )   $           (27,899 )   $ (1,557 )




Financial Condition



In December 2017 TearLab raised $3 million in gross proceeds through a registered direct offering to support our operations and regulatory expenses. In addition, in April 2018, with an effective date of March 31, 2018, we renegotiated our Term Loan Agreement with CRG. This new agreement lowers the minimum liquidity requirement from an end of the day cash balance of $5 million to $3 million and it defers cash interest payments due in 2018. These changes will allow our current funding to provide us with the time needed to gain our 510(k) approval for the Discovery™ Platform from the FDA as the Discovery™ Platform is critical to our success moving forward. In November 2018, with amendment No.6 CRG further extended our "Interest-only period," which has the effect of pushing out the principal payments to 2020. Based on our current rate of cash consumption in addition to our projections, we estimate we will need additional capital in the third quarter of 2020. Our prospects for obtaining that capital are uncertain. Due to the Company's historical losses and financial condition, there is substantial doubt about the Company's ability to continue as a going concern.

On May 11, 2020, the Company, entered into an Agreement and Plan of Merger (the "Merger Agreement") by and among the Company, Accelmed Partners II LP, a Cayman Islands exempted limited partnership ("Buyer"), and Accelmed Merger Sub, Inc., a Delaware corporation and a wholly owned subsidiary of Buyer ("Merger Sub"). The Merger Agreement provides that, subject to the terms and conditions set forth therein, Merger Sub will merge with and into the Company (the "Merger"), with the Company surviving the Merger and becoming a wholly owned subsidiary of Buyer. The completion of the Merger is subject to satisfaction of all conditions set forth in the Merger Agreement and cannot be guaranteed. See Note 10 to the financial statements included in this Quarterly Report on Form 10-Q for additional information related to the Merger.

Absent the completion of the Merger, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement and involves risks and uncertainties. Actual results could vary as a result of a number of factors. We have based this estimate on assumptions that may prove to be wrong. We could utilize our available capital resources sooner than we currently expect. Our future funding requirements will depend on many factors, including but not limited to:





  ? Our ability to execute our commercial strategy with our current resources,
    under our new business model;
  ? the cost and results of continuing development of our next generation TearLab
    Discovery™ Platform including the cost of suppliers and service providers that
    require advance payment;
  ? whether government and third-party payers agree to continue reimbursement of
    the TearLab® Osmolarity System at current levels;
  ? the costs of filing, prosecuting, defending and enforcing any patent claims
    and other intellectual property rights; and
  ? the effect of competing technological and market developments.



At the present time, our only product is the TearLab® Osmolarity System, and although we have received 510(k) approval from the FDA and a CLIA waiver approval from the FDA, at this time we do not know when we will generate revenue from the TearLab® Osmolarity System in the United States sufficient to fully fund our operations. If events or circumstances occur such that we do not meet our plans to fund the business, we may be required to reduce operating expenses and reduce the planned levels of inventory and fixed assets which could have an adverse impact on our ability to achieve our intended business objectives and/or continue the development of the TearLab Discovery™ Platform.





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TearLab Corporation



Indebtedness


On March 4, 2015, the Company executed a term loan agreement (the "Term Loan Agreement") with CRG LP and certain of its affiliate funds ("CRG") as lenders providing the Company with access of up to $35,000 under the arrangement. The Company received $15,000 in gross proceeds under the arrangement on March 4, 2015, and an additional $10,000 on October 6, 2015. The Term Loan Agreement matures on December 31, 2020 and bears interest at 13% per annum, with quarterly payments of interest only for the first four years. While interest on the loan is accrued at 13% per annum, the Company may elect to make interest-only payments at 8.5% per annum. The unpaid interest of 4.5% is added to the principal of the loan and is subject to additional accrued interest ("PIK interest"). The accrued interest can be deferred and paid together with the principal in the fifth and sixth years.

As part of Amendment No. 2 to the Term Loan Agreement, and funding of the second tranche, CRG received 35,000 warrants dated as of October 6, 2015 to purchase common shares of the Company at a price of $50.00 per share (the "2015 CRG Warrants"). The 2015 CRG Warrants have a five-year life and are classified as equity on the Condensed Consolidated Balance Sheets as of March 31, 2020 and December 31, 2019. The 2015 CRG Warrants were valued at their issuance date using the Black-Scholes Merton model. The related reduction of the long-term debt will be amortized over the life of the debt. On April 7, 2016, the Company entered into Amendment No. 4 to the Term Loan Agreement and the Company issued CRG additional warrants to purchase 35,000 common shares of the Company's stock at 15.00 per share (the "2016 CRG Warrants" and together with the 2015 CRG Warrants, the "CRG Warrants"), which expire 5 years after issuance.

On October 12, 2017, the Company entered into Amendment No. 5 to the Term Loan Agreement. This amendment reduced the exercise price of all of the CRG Warrants from $15.00 per share to $1.50 per share and provided broad anti-dilution protection such that the CRG Warrants maintained the same 1.22% ownership following any capital raises the Company completed through March 31, 2018.

In connection with the December 2017 offering the Company issued CRG additional warrants to purchase 83,240 shares of commons stock at an exercise price of $1.50 ("2017 CRG Warrants").

On April 4, 2018 with an effective date of March 31, 2018, the Company entered into Amendment No. 6 to the Term Loan Agreement. Pursuant to the terms of this amendment, the cash interest payments due in 2018 were deferred and added to the principal balance under the Term Loan Agreement at the end of each quarter. This amendment also provides for an additional facility fee equal to 3% of the sum of the aggregate amount of the principal drawn under the Term Loan Agreement and any PIK loans issued, so that the total facility fee shall be 9.5%, applicable to the entire balance. In addition, this amendment reduces the minimum liquidity covenant to $3 million. Concurrent with the reduction of the liquidity covenant the Company agreed to repay CRG $1.0 million of principal on the Term Loan Agreement in April 2018. Lastly, this amendment reduced the strike price of the existing CRG Warrants and the 2017 CRG Warrants to $0.44 per share. This amendment was accounted for as a modification in accordance with U.S. GAAP.

On November 12, 2018 the Company entered into Amendment No. 7 to the Term Loan Agreement. Pursuant to the terms of the agreement, the Amendment extends the "Interest-Only Period" under the Term Loan Agreement from the sixteenth (16th) payment date to the twentieth (20th) payment date following the first borrowing date, which has the effect of pushing out the principal payments to 2020. In addition, the cash interest payments under the Term Loan Agreement for periods ending on March 31, 2019 and June 30, 2019 were deferred and added to the principal balance under the Term Loan Agreement at the end of each such quarter. Additionally, if the Federal Drug Administration ("FDA") had received and accepted our application for review of our DiscoveryTM Platform on or before June 30, 2019 the Company could have elected to pay the interest on the outstanding principal amount of the loans under the Term Loan Agreement payable during the quarter ended September 30, 2019 entirely in the form of a PIK Loan. Finally, the Amendment reduced the minimum required revenue for 2018 under the Term Loan Agreement from $25 million to $24 million.

On October 4, 2019 with an effective date of September 30, 2019 the Company entered into Amendment No. 8 to the Term Loan Agreement. Pursuant to the terms of the agreement, the Amendment deferred the cash interest payment for the period ending September 30, 2019 and added it to the principal balance under the Term Loan Agreement.





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TearLab Corporation

The Term Loan Agreement is collateralized by all assets of the Company. Additionally, the terms of the Term Loan Agreement contain various affirmative and negative covenants agreed to by the Company. Among them, the Company must attain minimum certain annual revenue and minimum cash threshold levels. The minimum annual revenue threshold level required by the Term Loan Agreement is $45 million for the calendar year 2020. The minimum cash balance required is $3.0 million, subject to certain conditions.

As of December 31, 2019, the Company was in default of the 2019 minimum revenue threshold of $38.0 million and, the Company will have to raise subordinated debt or equity (the "CRG Equity Cure") of $30.7 million which is equal to twice the difference between the annual revenue and the revenue covenant with the total proceeds from this financing to be used to reduce the principal of the Term Loan Agreement which would cure the default in accordance with the terms of the loan. The Company has 90 days to achieve this "Cure" unless a covenant waiver is given or the Term Loan Agreement is amended. In the event the Company cannot complete the CRG Equity Cure and a covenant waiver is not received, the Company would remain in default of the Term Loan Agreement. In the event of a default, the lender has the option or right to require the Company to repay the current outstanding amount of $36.6 million earlier than anticipated, and if the Company cannot, the lender has the option to invoke the foreclosure on their security interest in our assets and all obligations will become due and payable immediately. See the Risk Factor section of this Form 10-Q for further discussion regarding the Term Loan Agreement and risks associated with the Term Loan Agreement and our failure to satisfy the 2019 revenue covenant thereunder.

On March 31, 2020, the Company entered into a Consent agreement that extends the date on which the principal and interest payments are due under the Term Loan Agreement from March 31, 2020 to May 31, 2020. Additionally, as of March 31, 2020 the Company was not in compliance with the minimum revenue covenant under the Loan Agreement and the Consent temporarily waives any related default until May 31, 2020.

On May 10, 2020, effective May 7, 2020, the Company entered into a Consent (the "Consent") to its Term Loan Agreement, dated as of March 4, 2015, as amended by the Omnibus Amendment Agreement, dated as of April 2, 2015, Amendment 2, dated as of August 6, 2015, Amendment 3, dated as of December 31, 2015, Amendment 4, dated as of April 7, 2016, Amendment 5, dated as of October 12, 2017, Amendment 6, dated as of April 4, 2018, Amendment 7, dated as of November 12, 2018, and Amendment 8, dated as of October 4, 2019, by and among the Company, certain of its subsidiaries from time to time party thereto as guarantors and certain affiliate funds of CRG as lenders. The Consent provides for the lenders' consent to the Company's receipt of the PPP Loan.

On May 11, 2020, the Company, entered into an Agreement and Plan of Merger (the "Merger Agreement") by and among the Company, Accelmed Partners II LP, a Cayman Islands exempted limited partnership ("Buyer"), and Accelmed Merger Sub, Inc., a Delaware corporation and a wholly owned subsidiary of Buyer ("Merger Sub"). The Merger Agreement provides that, subject to the terms and conditions set forth therein, Merger Sub will merge with and into the Company (the "Merger"), with the Company surviving the Merger and becoming a wholly owned subsidiary of Buyer. See Note 10 to the financial statements included in this Quarterly Report on Form 10-Q for additional information related to the Merger.

On May 11, 2020, in connection with the Merger Agreement filed with the SEC on May 11, 2020, the Company entered into a Consent and Amendment No. 9 to the Term Loan Agreement ("Amendment 9"). Amendment 9 provides for the consent to the transaction contemplated in the Merger Agreement. Pursuant to the Amendment and related Trigger Exchange agreement, the issuer prepaid on May 11, 2020 $694 thousand in aggregate principal of the loans outstanding under the Term Loan Agreement and by issuing to CRG an aggregate of 11,850,131 shares of Commons Stock in exchange for and satisfaction of such partial principal payment.

On May 28, 2020, the Company entered into another Consent agreement that extends the date on which the principal and interest payments due under the Loan agreement from May 31, 2020 and June 30, 2020 to July 31, 2020. Additionally, as of March 31, 2020 the Company was not in compliance with the minimum revenue covenant under the Loan Agreement and the Consent temporarily extends the waiver of any related default, which had previously been waived until May 31, 2020 until July 31, 2020. Failure by the Company to make the principal and interest payment on or before July 31, 2020 will result in an immediate event of default under the Term Loan Agreement.

Ongoing Sources and Uses of Cash

Absent the completion of the Merger, we anticipate that our cash and cash equivalents and cash generated from revenue will be sufficient to sustain our operations into the third quarter of 2020. We continually evaluate various financing possibilities but we typically expect our primary sources of cash will be related to the collection of accounts receivable. Our accounts receivable collections will be impacted by our ability to maintain current customers and annuity revenue base, while reducing costs as per our new business model.

Absent the completion of the Merger, we expect our primary uses of cash will be to fund our operating expenses and the development and generation of clinical data for our next generation platform.

See Note 10 to the financial statements included in this Quarterly Report on Form 10-Q for additional information related to the Merger.





Changes in Cash Flows


Cash Provided by Operating Activities

Net cash provided by operating activities during the three months ended March 31, 2020 was $0.4 million. Net cash provided by operating activities during the three-month period was more than our net loss of $1.6 million primarily due to the depreciation of fixed assets, and deferred interest and the amortization of the discount on our long-term debt. In aggregate, these non-cash items totaled $1.5 million.





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TearLab Corporation



The net change in working capital and non-current asset balances related to
operations for the three months ended March 31, 2020 and 2019 consists of the
following:



                                                         Three Months Ended
        (in thousands)                                        March 31,
                                                         2020           2019
        Changes in operating assets and liabilities:

        Accounts receivable, net                       $     (19 )     $    88
        Inventory                                            321          (220 )
        Prepaid expenses and other assets                    141            59
        Accounts payable                                     598           638
        Accrued liabilities                                 (636 )        (443 )
        Deferred rent                                         (3 )          (4 )
                                                       $     402       $   118

Explanations of the more significant net changes in working capital and non-current asset balances are as follows:





    ?   Inventory levels of test cards on hand decreased in the three months ended
        March 31, 2020 due to the management of inventory levels during the
        quarter;

    ?   Accounts payable had a net increase during the three months ended March
        31, 2020 mostly due to invoices received for professional services and
        increase in work performed relating to the development of our next
        generation of product in addition to cash management; and

    ?   Accrued liabilities had a net decrease during the three months ended March
        31, 2020 primarily due to the payment of accrued compensation amounts.



Cash Used in Investing Activities

Net cash used in investing activities for the three months ended March 31, 2020 and 2019 was $0.2 million and $0.01 million, respectively, to acquire fixed assets.

Cash Provided by Financing Activities

There was zero in net cash provided by financing activities during the three months ended March 31, 2020 and 2019.

Off-Balance-Sheet Arrangements

As of March 31, 2020, we did not have any material off-balance-sheet arrangements as defined in Item 303(1)(4)(ii) of SEC Regulation S-K.





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TearLab Corporation

Critical Accounting Policies and Estimates

Management's discussion and analysis of our financial condition and results of operations are based upon our condensed consolidated financial statements which are prepared in accordance with accounting principles that are generally accepted in the United States. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets and liabilities, related disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. We continually evaluate our estimates and judgments, the most critical of which are those related to revenue recognition and inventory valuation. We base our estimates and judgments on historical experience and other factors that we believe to be reasonable under the circumstances. Materially different results can occur as circumstances change and additional information becomes known.

There were no significant changes during the three months ended March 31, 2020 to the items that we disclosed as our critical accounting policies and estimates in Management's Discussion and Analysis of Financial Condition and Results of Operations in the Company's Annual Report on Form 10-K for the year ended December 31, 2019. For further clarification with regards to the Company's specific policies for revenue recognition, see Note 2 of the Notes to the Unaudited Condensed Consolidated Financial Statements for the three months ended March 31, 2020 included in Item 1.

Recent Accounting Pronouncements

For information on the recent accounting pronouncements impacting our business, see Note 2 of the Notes to the Condensed Consolidated Financial Statements for the three months ended March 31, 2020 included in Item 1.

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