The following Management's Discussion and Analysis of Financial Condition and Results of Operations, as well as other sections in this Quarterly Report on Form 10-Q for the quarter endedMarch 31, 2020 (the "Quarterly Report"), should be read in conjunction with our unaudited interim consolidated financial statements and related notes thereto included elsewhere herein and the consolidated financial statements and notes thereto for the year endedDecember 31, 2019 and the related Management's Discussion and Analysis of Financial Condition and Results of Operation, both of which are contained in our Annual Report on Form 10-K for the year endedDecember 31, 2019 (the "Annual Report") filed with theSecurities and Exchange Commission ("SEC") onMarch 30, 2020 . In addition to historical financial information, some of the information contained in the following discussion and analysis contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts, including statements regarding our future results of operations and financial position, business strategy, current and prospective products, product approvals, research and development costs, current and prospective collaborations, timing and likelihood of success, plans and objectives of management for future operations and future results of current and anticipated products, are forward-looking statements. These statements involve known and unknown risks, uncertainties, assumptions and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.
Overview
We are a commercial stage medical technology company focused on designing, developing and marketing a new category of tissue reinforcement materials to address unmet needs in soft tissue reconstruction. We offer a portfolio of advanced reinforced tissue matrices that improve clinical outcomes and reduce overall costs of care in hernia repair, abdominal wall reconstruction and plastic and reconstructive surgery. Our products are an innovative solution that integrate multiple layers of minimally-processed biologic material with interwoven polymers in a unique embroidered pattern, which we refer to as a reinforced tissue matrix. Our first portfolio of products ("OviTex") addresses unmet needs in hernia repair and abdominal wall reconstruction by combining the benefits of biologic matrices and polymer materials while minimizing their shortcomings, at a cost-effective price. Our OviTex products have received 510(k) clearance from the FDA, which clearance was obtained and is currently held by Aroa and have demonstrated safety and clinical effectiveness in our BRAVO study. Ventral hernia recurrence rates in the BRAVO study were 0% among the first 20 patients who reached two year follow-up and 2% among the first 57 patients who reached one year follow-up. Our second portfolio of products, OviTex PRS, addresses unmet needs in plastic and reconstructive surgery. We began commercialization of our OviTex products in theU.S. inJuly 2016 and they are now sold to more than 265 hospital accounts. In the first half of 2017, we began scaling ourU.S. direct commercial presence and we initiated our BRAVO study inApril 2017 . Our OviTex portfolio consists of multiple products for hernia repair and abdominal wall reconstruction, inguinal hernia repair and hiatal hernia repair. In addition, to address the significant increase in the number of robotic-assisted hernia repairs over the last several years we have designed an OviTex product for use in laparoscopic and robotic-assisted surgery ("OviTex LPR") which we began commercializing inNovember 2018 . We introduced additional sizes of our OviTex products in both 25 × 30 cm and 25 × 40 cm sizes inJanuary 2019 . InApril 2019 , our OviTex PRS Reinforced Tissue Matrix ("OviTex PRS") products received 510(k) clearance from the FDA for plastic and reconstructive surgery, which clearance was obtained by Aroa and is currently held by us. We commenced a limited launch inMay 2019 and expect to continue commercializing in a controlled manner to gradually expand our surgeon network throughout 2020. We market our products through a single direct sales force, predominantly in theU.S. We have invested in our direct sales and marketing infrastructure in order to expand our presence and to promote awareness and adoption of our products. As ofMarch 31, 2020 , we had 39 sales territories in theU.S. As part of our commercial strategy, we plan to continue to invest in our commercial organization by hiring additional account managers, clinical development 17
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specialists, business managers and administrative support staff in order to cover the highest potential of accounts for soft tissue reconstruction procedures.
Prior to obtaining FDA clearance for our first OviTex product, we devoted substantially all of our resources to the design and development of our reinforced tissue matrices. Our development efforts to date have included an extensive non-human primate preclinical research data set for OviTex. In addition to our current portfolio, we are developing new product features and designs for both our OviTex and OviTex PRS portfolios. We are currently devoting research and
development resources on the exploration of new packaging technology to increase the shelf life of our OviTex and
OviTex PRS products along with the development of additional versions of our OviTex PRS product lines. We are also investigating the introduction of additional versions of our OviTex hernia product lines, including self-adhering technology to further enhance product compatibility in robotic procedures. We intend to continue to make investments in research and development efforts to develop improvements and enhancements. Substantially all of our revenue to date has been generated by the sale of our OviTex products. Our revenue for the three months endedMarch 31, 2020 and 2019 was$3.7 million and$3.3 million , respectively, an increase of$0.4 million , or 13%. We incurred a net loss of$7.2 million for the three months endedMarch 31, 2020 as compared to$6.0 million for the three months endedMarch 31, 2019 . We have not been profitable since inception and as ofMarch 31, 2020 , we had an accumulated deficit of$175.1 million . We expect to incur losses for the foreseeable future. Our products are manufactured by Aroa at their FDA registered and ISO 13485 facility inAuckland, New Zealand . We maintain our Aroa License for the exclusive supply of ovine rumen and manufacture of our reinforced tissue matrices under which we purchase product from Aroa at a fixed cost equal to 27% of our net sales of licensed products. This revenue sharing arrangement allows us to competitively price our products and pass along cost-savings to our customers.
Components of Our Results of Operations
Revenue
Substantially all of our revenue consists of direct sales of our products to hospital accounts inthe United States . Depending on the terms of our agreements with our customers, we recognize revenue related to product sales either when control transfers, which generally occurs when the product is shipped to the customer, or when the product is utilized in a surgical procedure in the case of consignment agreements. Fees charged to customers for shipping are recognized as revenue. Recent revenue growth has been driven by increasing revenue from product sales due to our expanding customer base, although it is unclear at this point what the long-term effect, if any, the COVID-19 pandemic will have on our ability to continue to generate revenue and expand our customer base.
Cost of Revenue
Cost of revenue primarily consists of the costs of licensed products purchased from Aroa, charges related to excess and obsolete inventory adjustments and costs related to shipping. We purchase product from Aroa at a fixed cost equal to 27% of our net sales of licensed products. The initial term of our Aroa License terminates on the later of (i)August 3, 2022 , or (ii) the expiration of the last patent covering bovine and ovine products, with an option to extend for an additional ten-year period. We expect our cost of revenue to increase in absolute dollars as, and to the extent, our sales volume grows, although it is unclear at this point what the long-term effect, if any, the COVID-19 pandemic will have on product demand which could lead to additional charges to excess and obsolete inventory.
Amortization of Intangible Assets
Amortization of intangible assets relates to the amortization of capitalized milestone amounts paid or probable to be paid to Aroa related to license fees or commercialization rights after future economic benefit has been established for a product. These capitalized milestone amounts relate to regulatory clearances, the receipt of certain supply quantities of product, and amounts based upon aggregate net sales thresholds within a specified territory and are amortized over the remaining useful life of the intellectual property. 18
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Gross Profit and Gross Margin
Our gross profit is calculated by subtracting our cost of revenue and amortization of intangible assets from our revenue. We calculate our gross margin percentage as our gross profit divided by our revenue. Our gross profit has been, and we expect it will continue to be, affected by a variety of factors, including sales volume and excess and inventory obsolescence costs. Our gross profit may increase to the extent our revenue grows.
Sales and Marketing Expenses
Sales and marketing expenses consist of market research and commercial activities related to the sale of OviTex and OviTex PRS and salaries and related benefits, sales commissions and stockbased compensation for employees focused on these efforts. Other significant sales and marketing expenses include costs incurred with postmarket clinical studies, conferences and trade shows, promotional and marketing activities, as well as travel and training expenses. Over time we expect our sales and marketing expenses to increase in absolute dollars, however, due to the impact of the COVID-19 pandemic, we anticipate that our sales and marketing expense will decrease in the near future due to a decrease in sales. Longer term, we expect our sales and marketing expenses to decrease as a percentage of revenue primarily as, and to the extent, our revenue grows.
General and Administrative Expenses
General and administrative expenses consist primarily of salaries and related benefits, including stockbased compensation for personnel in executive, finance, information technology and administrative functions. General and administrative expenses also include professional service fees for legal, accounting, consulting, investor and public relations, insurance costs and direct and allocated facilityrelated costs.
We expect that our general and administrative expenses will decrease in the near future due to decreases in salary and other expenses. However, the reduction in general and administrative expenses may be offset in part by additional expenses we incur related to operating as a public company, including director and officer insurance coverage, legal costs, accounting costs, costs related to exchange listing and costs related to theSEC , compliance and investor relations. We expect our general and administrative expenses to decrease as a percentage of revenue primarily as, and to the extent, our revenue grows.
Research and Development Expenses
Research and development expenses consist primarily of product research, engineering, product development, regulatory compliance and clinical development. These expenses include salaries and related benefits, stockbased compensation, consulting services, costs associated with our preclinical studies, costs incurred with our manufacturing partner under development agreements related to technology transfer, laboratory materials and supplies and an allocation of related facilities costs. We expense research and development costs as they are incurred. We expect that our research and development expenses will decrease in the near future due to the decreases in salary and other expenses. Longer term, we expect research and development expenses in absolute dollars to increase in the future as we develop new products and enhance existing products. We expect research and development expenses as a percentage of revenue to vary over time depending on the level and timing of new product development initiatives.
Interest Expense
Interest expense consists of cash interest under our credit facilities, noncash interest attributable to the accrual of final payment fees and the amortization of deferred financing costs related to our indebtedness. 19
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Change in Fair Value of Preferred Stock Warrant Liability
Prior to our initial public offering ("IPO"), our outstanding warrants to purchase shares of our preferred stock were classified as liabilities, recorded at fair value and were subject to remeasurement at each balance sheet date until they were exercised, expired or were otherwise settled. The change in fair value of our preferred stock warrant liability reflected a noncash charge primarily driven by changes in the fair value of our underlying Series B preferred stock. All outstanding warrants to purchase shares of our preferred stock were converted into warrants to purchase shares of our common stock after our IPO.
Other Income
Other income consists primarily of income earned on our cash, cash equivalents and short-term investments.
Business Update Regarding COVID-19
We continue to closely monitor developments related to the COVID-19 pandemic and our decisions will continue to be driven by the health and well-being of our employees, hospital and physician customers, and their patients while maintaining operations to support our customers and their patients in the near-term. These developments include:
· Surgery Deferrals: To date, among other impacts on our business related to the
pandemic, physicians and their patients are required, or are choosing, to defer
elective surgery procedures in which our products otherwise would be used. The
duration of elective surgery deferrals and the timing and extent of the
economic impact of the pandemic, and the pace at which the economy recovers
therefrom, cannot be determined at this time. We continue to work closely with
our hospital and physician customers and suppliers to navigate through this
unforeseen event while maintaining flexible operations.
· Operations: Our sales, marketing and research and development efforts have
continued since the outbreak of the pandemic, but steps we have taken in
response to the pandemic have adversely affected our business. To protect the
safety, health and well-being of our employees, hospital and physician
customers, and communities, we have implemented preventative measures including
travel restrictions and a requirement that all office-based employees work from
home, except as necessary, as permitted under governmental orders. Similarly,
most of our sales professionals currently are using a virtual selling program,
which includes virtual sales calls with physicians, peer-to-peer discussions
with key opinion leaders, physician webinars and sales professional training,
instead of in-person sales and marketing programs. We expect to continue to
adapt our sales and marketing plans as we better understand the effects of the
COVID-19 pandemic on our business. The change in the manner in which our
workforce is functioning could adversely affect sales and could delay the
product launches we have planned for 2020 and beyond, and could adversely
affect our future growth or cause our future revenue growth to not be
consistent with our previously anticipated timelines.
Our manufacturing, distribution and supply chain has largely been uninterrupted, but could be disrupted as a result of the pandemic because of staffing shortages, production slowdowns, stoppages, or disruptions in delivery systems.
· Cost Containment: We continue to carefully manage expenses and cash spend to
preserve liquidity and we initiated actions in April to generate savings in
areas such as travel, events, and consulting. The base salaries of each of our
senior executives have been reduced by 30% and the base salaries of each of our
vice presidents have been reduced by 25%. In addition, certain senior
executives volunteered to reduce their salaries by an additional 5%, for a
total reduction of 35% for those individuals. Reductions in salary for other
employees varied from 5% to 20%. These salary reductions will continue through
suspended our matching contributions to all participants under our 401(k)
Retirement Plan. These comprehensive spending cuts were necessary to protect
our financial strength in the face of near-term challenges. Yet, despite those
challenges, the Company remains focused on managing the business for the
long-term, including preserving full time jobs to support the expected rebound
in surgical procedure volumes. 20 Table of Contents
· Product Development: We continue to evaluate the timing and scope of planned
next generation product development and commercialization initiatives and we
plan to continue to prioritize and invest in our critical R&D and clinical
programs.
· First Quarter 2020 Results. Due to the impacts from the COVID-19 pandemic, our
total revenue for the first quarter of 2020 increased moderately compared to
the same period in 2019. Based on the ongoing impact from
restrictions on surgical procedures and shelter-in-place policies, we expect revenue to decline in the
second quarter of 2020. We cannot predict with certainty the extent to which the COVID-19 pandemic will impact procedures in the second quarter and beyond.
· Outlook. There is considerable uncertainty and lack of visibility regarding our
near-term revenue growth prospects and product development plans due to the
rapidly evolving environment and continued uncertainties resulting from the
COVID-19 pandemic. At this time, the full extent of the impact of the COVID-19
pandemic on our business, financial condition and results of operations is
uncertain and cannot be predicted with reasonable accuracy and will depend on
future developments that are also uncertain and cannot be predicted with
reasonable accuracy. Results of Operations
Comparison of the Three Months Ended
Three months ended March 31, Change 2020 2019 Dollar Percentage (in thousands, except percentages) Revenue $ 3,726 $ 3,306$ 420 13 % Cost of revenue (excluding amortization of intangible assets) 1,450 1,432 18 1 % Amortization of intangible assets 76
76 - - % Gross profit 2,200 1,798 402 22 % Gross margin 59 % 54 % Operating expenses: Sales and marketing 5,269 3,995 1,274 32 % General and administrative 2,518 1,324 1,194 90 % Research and development 912 1,659 (747) (45) % Total operating expenses 8,699 6,978 1,721 25 % Loss from operations (6,499) (5,180) (1,319) 25 % Other (expense) income: Interest expense (879) (912) 33 (4) % Change in fair value of preferred stock warrant liability - 36 (36) (100) % Other income 158 90 68 76 % Total other (expense) income (721) (786) 65 (8) % Net loss$ (7,220) $ (5,966) $ (1,254) 21 % Revenue Revenue increased by$0.4 million , or 13%, to$3.7 million for the three months endedMarch 31, 2020 from$3.3 million for the three months endedMarch 31, 2019 . The increase in revenue was primarily driven by an increase in unit sales of our products due to the expansion of our commercial organization and increased penetration within existing customer accounts. Though our revenue increased over the prior year period, it was impacted by lower than expected procedure volumes in the second half ofMarch 2020 due to hospitals and patients deferring elective procedures and other factors related to the COVID-19 pandemic. During the three months endedMarch 31, 2020 , we sold 1,081 units of OviTex compared to 820 units of OviTex during the three months endedMarch 31, 2019 , a 32% increase in unit sales volume. We commenced a limited launch of OviTex PRS inMay 2019 , selling 101 units during the three months endedMarch 31, 2020 . 21 Table of Contents Given that onset of COVID-19 impacts inthe United States occurred toward the end of the first quarter of 2020, we expect the negative financial impacts of COVID-19 to be significantly greater in the second quarter of 2020 compared to the first quarter of 2020.
Cost of Revenue
Cost of revenue (excluding amortization of intangible assets) increased slightly to$1.5 million for the three months endedMarch 31, 2020 from$1.4 million for the three months endedMarch 31, 2019 . The increase in cost of revenue for the three months endedMarch 31, 2020 was primarily the result of higher revenue which was partially offset by a$0.3 million decrease in our excess and obsolete inventory adjustment.
Amortization of Intangible Assets
Amortization of intangible assets was
Gross Margin Gross margin increased to 59% for the three months endedMarch 31, 2020 from 54% for the three months endedMarch 31, 2019 . The increase was primarily due to the decrease in the charge recognized for excess and obsolete inventory adjustments as a percentage of revenue for the three months endedMarch 31, 2020 as compared to the prior year period.
Sales and Marketing
Sales and marketing expenses increased by$1.3 million , or 32%, to$5.3 million for the three months endedMarch 31, 2020 from$4.0 million for the three months endedMarch 31, 2019 . The increase was primarily due to higher salary, benefits and commission costs as a result of our sales expansion activities, including hiring of additional sales personnel.
General and Administrative
General and administrative expenses increased by$1.2 million , or 90%, to$2.5 million for the three months endedMarch 31, 2020 from$1.3 million for the three months endedMarch 31, 2019 . The increase was primarily due to a$0.6 million increase in insurance costs, higher professional fees of$0.2 million , higher salaries and benefits of$0.2 million and additional bad debt expense of$0.2 million . Research and Development Research and development expenses decreased by$0.7 million , or 45%, to$0.9 million for the three months endedMarch 31, 2020 from$1.7 million for the three months endedMarch 31, 2019 due to a decrease in licensing payments of$0.5 million , reduced outside development expenses and a lower level of laboratory spend.
Interest Expense
Interest expense decreased by$33,000 , or 4%, to$0.9 million for both the three months endedMarch 31, 2020 and 2019. The decrease was primarily due a lower interest rate during the three months endedMarch 31, 2020 compared to the prior period.
Change in Fair Value of Preferred Stock Warrant Liability
For the three months ended
22 Table of Contents Other Income Other income increased by$68,000 to$0.2 million for the three months endedMarch 31, 2020 from$90,000 in the three months endedMarch 31, 2019 primarily due to a larger cash balance which earned more interest compared to the prior year period.
Liquidity and Capital Resources
Overview
As ofMarch 31, 2020 , we had cash, cash equivalents and short-term investments of$46.7 million , working capital of$51.1 million and an accumulated deficit of$175.1 million . As ofDecember 31, 2019 , we had cash, cash equivalents and short-term investments of$54.6 million , working capital of$57.6 million and an accumulated deficit of$167.9 million . OnNovember 13, 2019 , we closed our IPO in which we issued and sold 4,398,700 shares of our common stock at a public offering price of$13.00 per share, which included 398,700 shares of our common stock sold pursuant to the underwriters' option to purchase additional shares. We received net proceeds of$50.6 million after deducting underwriting discounts and commissions and other expenses. We have incurred operating losses since our inception, and we anticipate that our operating losses will continue in the near term as we seek to invest in our sales and marketing initiatives to support our growth in existing and new markets and in additional research and development activities. We will also continue to incur additional costs operating as a public company. As ofMarch 31, 2020 , we had$30.0 million of borrowings outstanding under our credit facility or the OrbiMed Credit Facility, withOrbiMed Royalty Opportunities IP, LP or OrbiMed. This credit facility matures inNovember 2023 . This facility requires that we maintain a minimum cash balance of$2.0 million . Based on our current business plan, we believe that our existing cash resources and short-term investments will be sufficient to meet our capital requirements and fund our operations for at least the next 12 months from the issuance of this Quarterly Report. If these sources are insufficient to satisfy our liquidity requirements, we may seek to sell additional common or preferred equity or debt securities or enter into a new credit facility. If we raise additional funds by issuing equity or equitylinked securities, our stockholders would experience dilution and any new equity securities could have rights, preferences and privileges superior to those of holders of our common stock. Debt financing, if available, may involve covenants restricting our operations or our ability to incur additional debt. We cannot be assured that additional equity, equitylinked or debt financing will be available on terms favorable to us or our stockholders, or at all, including as a result of market volatility following the COVID-19 pandemic. If we are unable to obtain adequate financing, we may be required to delay the development, commercialization and marketing of our products. Cash Flows The following table summarizes our sources and uses of cash for each of the periods presented: Three months ended March 31, (in thousands) 2020 2019 Cash used in operating activities$ (7,307) $ (7,777) Cash provided by (used in) investing activities 3,932 (548) Cash (used in) provided by financing activities (514) 484 Effect of exchange rate on cash (2) (5) Net decrease in cash and cash equivalents$ (3,891) $ (7,846) Operating Activities During the three months endedMarch 31, 2020 , we used$7.3 million of cash in operating activities, resulting from our net loss of$7.2 million and the change in operating assets and liabilities of$1.2 million , offset by noncash charges of 23 Table of Contents$1.1 million . Our noncash charges were comprised of our excess and obsolete inventory charge of$0.4 million , stockbased compensation expense of$0.4 million , interest expense of$0.1 million and depreciation and amortization expense of$0.1 million . The change in our operating assets and liabilities was primarily related to a decrease in our accounts payable. During the three months endedMarch 31, 2019 , we used$7.8 million of cash in operating activities, resulting from our net loss of$6.0 million and the change in operating assets and liabilities of$2.8 million , offset by noncash charges of$1.0 million . Our noncash charges were comprised of our excess and obsolete inventory charge of$0.7 million , interest expense of$0.1 million and depreciation and amortization expense of$0.1 million . The change in our operating assets was primarily related to a$0.6 million increase in our accounts receivable, a$0.8 million increase in inventory and a$1.5 million decrease in our accounts payable and accrued expenses and other liabilities.
Investing Activities
During the three months ended
During the three months ended
Financing Activities
During the three months endedMarch 31, 2020 , cash used in financing activities was$0.5 million , consisting primarily of payments made for offering costs from our IPO.
During the three months ended
Indebtedness
InNovember 2018 , we entered into the OrbiMed Credit Facility, which consists of up to$35.0 million in term loans (the "OrbiMed Term Loans"). The OrbiMed Term Loans consist of two tranches, a$30.0 million Tranche 1 ("Tranche 1") and a$5.0 million Tranche 2 ("Tranche 2"). Upon closing, we borrowed$30.0 million of Tranche 1 and used a portion of the proceeds to repay borrowings under our credit facility with MidCap and intend to use the remaining proceeds to fund operations and capital expenditures. We elected not to borrow Tranche 2 prior to its expiration onDecember 31, 2019 . Pursuant to the OrbiMed Credit Facility, we provided a first priority security interest in all existing and future acquired assets, excluding intellectual property and certain other assets, owned by us. The OrbiMed Credit Facility contains a negative pledge on intellectual property owned by us. The OrbiMed Credit Facility also contains customary indemnification obligations and customary events of default, including, among other things, (i) nonpayment, (ii) breach of warranty, (iii) nonperformance of covenants and obligations, (iv) default on other indebtedness, (v) judgments, (iv) change of control, (vii) bankruptcy and insolvency, (viii) impairment of security, (ix) key permit events, (x) key person event, (xi) regulatory matters, and (xii) key contracts. In addition, we must maintain a minimum cash balance of$2.0 million . In the event of default under the OrbiMed Credit Facility, we would be required to pay interest on principal and all other due and unpaid obligations at the current rate in effect plus 3%. The OrbiMed Term Loans mature onNovember 16, 2023 and bear interest at a rate equal to 7.75% plus the greater of onemonth LIBOR or 2.0%. We are required to make 60 monthly interest payments beginning onNovember 30, 2018 with the entire principal payment due at maturity. The OrbiMed Term Loans have a prepayment penalty equal to 10.0% of the prepaid principal amount prior to the second anniversary of the OrbiMed Term Loans, 5.0% of the prepaid principal amount after the second anniversary but prior to the third anniversary and 2.5% of the prepaid principal amount after the third anniversary. We are also required to pay an exit fee at the time of maturity or prepayment event equal to 24
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10% of all principal borrowings and an administration fee equal to
Contractual Obligations and Commitments
As of
Critical Accounting Policies and Significant Judgments and Estimates
The Critical Accounting Policies and Significant Judgements and Estimates included in our Annual Report have not materially changed.
OffBalance Sheet Arrangements
We did not have during the periods presented, and we do not currently have, any offbalance sheet arrangements, as defined in the rules and regulations of theSEC .
Internal Controls over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of consolidated financial statements in accordance with GAAP. As a result of becoming a public company, we will be required, under Section 404 of the SarbanesOxley Act of 2002, as amended (the "SarbanesOxley Act"), to furnish a report by management on, among other things, the effectiveness of our internal control over financial reporting beginning with our Annual Report on Form 10K for the year endingDecember 31, 2020 . This assessment will need to include disclosure of any material weaknesses identified by our management in our internal control over financial reporting. TheSEC defines a material weakness as a deficiency, or combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of a company's annual or interim consolidated financial statements will not be detected or prevented on a timely basis. In accordance with the provisions of the SarbanesOxley Act, neither we nor our independent registered public accounting firm has performed an evaluation of our internal control over financial reporting during any period included in this Quarterly Report.
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