MOTUS GI HOLDINGS, INC.

(MOTS)
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Delayed Nasdaq  -  05/18 04:00:01 pm EDT
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05/12MOTUS GI HOLDINGS, INC. Management's Discussion and Analysis of Financial Condition and Results of Operations. (form 10-Q)
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MOTUS GI HOLDINGS, INC. Management's Discussion and Analysis of Financial Condition and Results of Operations. (form 10-Q)

05/12/2022 | 04:24pm EDT

The following discussion and analysis of our financial condition and results of operations should be read together with our financial statements and the related notes and the other financial information included elsewhere in this Quarterly Report. This discussion contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those discussed below and elsewhere in this Quarterly Report, particularly those under "Risk Factors."

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This report on Form 10-Q contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 under Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). Forward-looking statements include statements with respect to our beliefs, plans, objectives, goals, expectations, anticipations, assumptions, estimates, intentions and future performance, and involve known and unknown risks, uncertainties and other factors, which may be beyond our control, and which may cause our actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. All statements other than statements of historical fact are statements that could be forward-looking statements. You can identify these forward-looking statements through our use of words such as "may," "can," "anticipate," "assume," "should," "indicate," "would," "believe," "contemplate," "expect," "seek," "estimate," "continue," "plan," "point to," "project," "predict," "could," "intend," "target," "potential" and other similar words and expressions of the future.

There are a number of important factors that could cause the actual results to differ materially from those expressed in any forward-looking statement made by us. These factors include, but are not limited to:



  ? our limited operating history;

  ? our history of operating losses in each year since inception and expectation
    that we will continue to incur operating losses for the foreseeable future;

  ? our current and future capital requirements to support our development and
    commercialization efforts for the Pure-Vu System and our ability to satisfy
    our capital needs;

  ? our ability to remain compliant with the requirements of The Nasdaq Capital
    Market for continued listing;

  ? our dependence on the Pure-Vu System, our sole product;

  ? our ability to commercialize the Pure-Vu System;

  ? our ability to obtain approval from regulatory agents in different
    jurisdictions for the Pure-Vu System;

  ? our Pure-Vu System and the procedure to cleanse the colon in preparation for
    colonoscopy are not currently separately reimbursable through private or
    governmental third-party payors;

  ? our ability to obtain approval or certification from regulatory or other
    competent entities in different jurisdictions for the Pure-Vu System;

  ? our dependence on third-parties to manufacture the Pure-Vu System;

  ? our ability to maintain or protect the validity of our patents and other
    intellectual property;




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  ? our ability to retain key executives and medical and science personnel;

  ? our ability to internally develop new inventions and intellectual property;

  ? interpretations of current laws and the passages of future laws;

  ? acceptance of our business model by investors;

  ? the accuracy of our estimates regarding expenses and capital requirements

  ? our ability to adequately support growth; and

  ? our ability to project in the short term the hospital medical device
    environment considering the global pandemic and strains on hospital systems



The foregoing does not represent an exhaustive list of matters that may be covered by the forward-looking statements contained herein or risk factors that we are faced with that may cause our actual results to differ from those anticipated in our forward-looking statements. Please see "Part II-Item 1A-Risk Factors" for additional risks which could adversely impact our business and financial performance.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this report or the date of the document incorporated by reference into this report. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise. We have expressed our expectations, beliefs and projections in good faith and we believe they have a reasonable basis. However, we cannot assure you that our expectations, beliefs or projections will result or be achieved or accomplished.



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Overview


We have developed the Pure-Vu System, a medical device that has been cleared by the U.S. Food and Drug Administration (the "FDA") to help facilitate the cleansing of a poorly prepared gastrointestinal tract during colonoscopy and to help facilitate upper gastrointestinal ("GI") endoscopy procedures. The Pure-Vu System is also CE marked in the European Economic Area (EEA) for use in colonoscopy. The Pure-Vu System integrates with standard and slim colonoscopes, as well as gastroscopes, to improve visualization during colonoscopy and upper GI procedures while preserving established procedural workflow and techniques. Through irrigation and evacuation of debris, the Pure-Vu System is designed to provide better-quality exams. Challenges exist for inpatient colonoscopy and endoscopy, particularly for patients who are elderly, with comorbidities, or active bleeds, where the ability to visualize, diagnose and treat is often compromised due to debris, including fecal matter, blood, or blood clots. We believe this is especially true in high acuity patients, like GI bleeding where the existence of blood and blood clots can impair a physician's view and removing them can be critical in allowing a physician the ability to identify and treat the source of bleeding on a timely basis. We believe use of the Pure-Vu System may lead to positive outcomes and lower costs for hospitals by safely and quickly improving visualization of the colon and upper GI tract, potentially enabling effective diagnosis and treatment without delay. In multiple clinical studies to date, involving the treatment of challenging inpatient and outpatient cases, the Pure-Vu System has consistently helped achieve adequate bowel cleanliness rates greater than 95% following a reduced prep regimen. We also believe that the technology may be useful in the future as a tool to help reduce user dependency on conventional pre-procedural bowel prep regimens. Based on our review and analysis of 2019 market data and 2021 projections for the U.S. and Europe, as obtained from iData Research Inc., we believe that during 2021 approximately 1.5 million inpatient colonoscopy procedures were performed in the U.S. and approximately 4.8 million worldwide. Upper GI bleeds occurred in the U.S. at a rate of approximately 400,000 cases per year in 2019, according to iData Research Inc. The Pure-Vu System has been assigned an ICD-10 code in the US. The system does not currently have unique codes with any private or governmental third-party payors in any other country or for any other use; however, we intend to pursue reimbursement activities in the future, particularly in the outpatient colonoscopy market. We received 510(k) clearance in February 2022 from the FDA for our Pure-Vu EVS System and recently commenced commercialization of this product. We do not expect to generate significant revenue from product sales until the COVID-19 pandemic has fully subsided and we further expand our commercialization efforts, which is subject to significant uncertainty.

Recent Developments

On April 21, 2022, the Company announced that it had completed enrollment in the European Union Feasibility Study of the Pure-Vu System, which is evaluating the clinical outcomes in patients with a history of poor bowel preparation using both a low volume preparation with limited diet restrictions and the Pure-Vu System. A poster featuring topline data from this European Union Feasibility Study has been selected to be presented at Digestive Disease Week® in May 2022, the world's premier meeting for physicians, researchers, and industry in the fields of gastroenterology, hepatology, endoscopy, and gastrointestinal surgery.


Financial Operations Overview


We have generated limited revenues to date from the sale of products. We have never been profitable and have incurred significant net losses each year since our inception, including a loss of $4.8 million for the three months ended March 31, 2022, and we expect to continue to incur net operating losses for the foreseeable future. As of March 31, 2022, we had $20.3 million in cash and cash equivalents and an accumulated deficit of $127.6 million. We expect our expenses to increase in connection with our ongoing activities to commercialize and market the Pure-Vu System, including additional expenditures in sales and marketing personnel, clinical affairs and manufacturing. Accordingly, we will need additional financing to support our continuing operations. We will seek to fund our operations through public or private equity or debt financings or other sources, which may include collaborations with third parties. The sale of equity and convertible debt securities may result in dilution to our shareholders and certain of those securities may have rights senior to those of our common shares. If we raise additional funds through the issuance of preferred stock, convertible debt securities or other debt financing, these securities or other debt could contain covenants that would restrict our operations. Any other third party funding arrangement could require us to relinquish valuable rights. The source, timing and availability of any future financing will depend principally upon market conditions, and, more specifically, on the progress of our product and clinical development programs as well as commercial activities. Adequate additional financing may not be available to us on acceptable terms, or at all. Our failure to raise capital as and when needed would have a negative impact on our financial condition and our ability to pursue our business strategy. We will need to generate significant revenues to achieve profitability, and we may never do so. Furthermore, the extent of the impact and effects of the outbreak of the coronavirus COVID-19 on the operation and financial performance of our business will depend on future developments, including the duration and spread of the outbreak, related travel advisories and restrictions, production delays, or the uncertainty with respect to the accessibility of additional liquidity or capital markets, all of which are highly uncertain and cannot be predicted. If the demand for our Pure-Vu system is impacted by this outbreak for an extended period, our results of operations may be materially adversely affected.

We expect to continue to incur significant expenses and increasing operating losses for at least the next several years as we continue to expand our commercial launch. We expect our expenses will increase in connection with our ongoing activities, as we:



  ? continue to expand commercialization;

  ? scale manufacturing with our contracted partners for both the workstation and
    disposable portions of the Pure-Vu System;

  ? develop future generations of the Pure-Vu System to improve user interface,
    optimize handling and reduce the cost structure;

  ? raise sufficient funds to effectuate our business plan, including
    commercialization activities and reimbursement efforts related to our Pure-Vu
    System and our research and development activities, including clinical and
    regulatory development, and the continued development and enhancement of our
    Pure-Vu System; and

  ? operate as a public company.




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Critical Accounting Policies and Estimates

Our accounting policies are essential to understanding and interpreting the financial results reported on the condensed consolidated financial statements. The significant accounting policies used in the preparation of our condensed consolidated financial statements are summarized in Note 3 to the consolidated financial statements and notes thereto found in our Annual Report on Form 10-K for the year ended December 31, 2021. Certain of those policies are considered to be particularly important to the presentation of our financial results because they require us to make difficult, complex or subjective judgments, often as a result of matters that are inherently uncertain.

During the three months ended March 31, 2022, there were no material changes to matters discussed under the heading "Critical Accounting Policies and Significant Judgement and Estimates" in Part II, Item 7 of the Company's Annual Report on Form 10-K for the year ended December 31, 2021.



Results of Operations


Comparison of Three Months Ended March 31, 2022 and 2021



Revenue

As of March 31, 2022, our initial commercial launch of the recently FDA-cleared Pure-Vu EVS System has generated limited revenue. We expect to generate greater revenue from product sales as we expand our commercialization efforts; however, this is subject to significant uncertainty.

Revenue totaled $20.0 thousand for the three months ended March 31, 2022, compared to $51.0 thousand for the three months ended March 31, 2021. The decrease of $31.0 thousand was primarily attributable to the impact in hospitals of the Omicron Covid-19 variant early in the first quarter, and the controlled phase-out of the Pure-Vu Gen 2 System ahead of the EVS launch later in the quarter, which received FDA clearance during the first quarter.



Cost of Revenue


Cost of revenue for the three months ended March 31, 2022 totaled $174.0 thousand, compared to $28.0 thousand for the three months ended March 31, 2021. The increase of $146.0 thousand was primarily attributable to the cost of our system disposable evaluation and commercial units in the amount of $15.0 thousand, and the additional impairment of the remaining inventory of our second generation systems in the amount of $159.0 thousand.



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Research and Development


Research and development expenses include cash and non-cash expenses relating to the advancement of our development and clinical programs for the Pure-Vu System. We have research and development capabilities in electrical and mechanical engineering with laboratories in our facility in Israel for development and prototyping, and electronics design and testing. We also use consultants and third-party design houses to complement our internal capabilities.

Research and development expenses totaled $1.3 million for the three months ended March 31, 2022 compared to $1.3 million for the three months ended March 31, 2021.




Sales and Marketing



Sales and marketing expenses include cash and non-cash expenses primarily related to our sales and marketing personnel and infrastructure supporting the commercialization of the Pure-Vu System.

Sales and marketing expenses for the three months ended March 31, 2022 totaled $1.0 million, compared to $0.7 million for the three months ended March 31, 2021. The increase of $0.3 million was primarily attributable to increases of $0.3 million in salaries and other personnel related cost to support our commercialization efforts of the Pure-Vu EVS System.



General and Administrative


General and administrative expenses consist primarily of costs associated with our overall operations and being a public company. These costs include personnel, legal and financial professional services, insurance, investor relations, compliance related fees, and expenses associated with obtaining and maintaining patents.

General and administrative expenses for the three months ended March 31, 2022 totaled $2.1 million, compared to $2.4 million for the three months ended March 31, 2021. The decrease of $0.3 million was primarily attributable to decreases of $0.1 million in professional services and $0.3 million share-based compensation, partially offset by increases in salaries and other personnel related costs of $0.1 million.



Other Income and Expenses


Other expense, net for the three months ended March 31, 2022 totaled $0.3 million compared to other expense, net of $0.2 million for the three months ended March 31, 2021. The increase of $0.1 million in other expenses, net was primarily attributable to an increase of $0.2 million in finance expense and a decrease of $0.1 million from the gain on the change in estimated fair value of contingent royalty obligation.



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Liquidity and Capital Resources

To date, we have generated minimal revenues, experienced negative operating cash flows and have incurred substantial operating losses from our activities. We expect operating costs will increase significantly as we incur costs associated with commercialization activities related to the Pure-Vu System. We expect to continue to fund our operations primarily through utilization of our current financial resources, future product sales, and through the issuance of debt or equity. As of March 31, 2022, our accumulated deficit was $127.6 million. Such conditions raise substantial doubts about our ability to continue as a going concern.

In March 2021, we entered into an Equity Distribution Agreement (the "Equity Distribution Agreement") with Oppenheimer & Co. Inc. ("Oppenheimer"), under which we may offer and sell from time to time common shares having an aggregate offering price of up to $25.0 million. During the three months ended March 31, 2022, we sold approximately 6.0 million shares of our common stock under this agreement, resulting in net cash proceeds of $3.0 million, after deducting issuance costs of $0.1 million.

We have been continuously evaluating the actual and potential business impacts related to the COVID-19 pandemic. While the full impact of the pandemic continues to evolve, the financial markets have been subject to significant volatility that adversely impacts our ability to enter into, modify, and negotiate favorable terms and conditions relative to equity and debt financing initiatives. The uncertain financial markets, potential disruptions in supply chains, mobility restraints, and changing priorities could also affect our ability to enter into key agreements. The outbreak and government measures taken in response to the pandemic have also had a significant impact, both direct and indirect, on businesses and commerce, as worker shortages have occurred; supply chains have been disrupted; facilities and production have been suspended; and demand for certain goods and services, such as medical services and supplies, have spiked, while demand for other goods and services have fallen. The future progression of the outbreak and its effects on our business and operations are uncertain. We and our third-party contract manufacturers, contract research organizations, and clinical sites may also face disruptions in procuring items that are essential to our research and development activities, including, for example, medical and laboratory supplies, in each case, that are sourced from abroad or for which there are shortages because of ongoing efforts to address the outbreak.

While expected to be temporary, these disruptions will negatively impact our sales, results of operations, financial condition, and liquidity in 2022.

Our ability to continue as a going concern for the next twelve months from the issuance of our Annual Report on Form 10K, depends on our ability to execute our business plan, increase revenue and reduce expenditures. As of March 31, 2022, we had cash and cash equivalents of $20.3 million and an accumulated deficit of $127.6 million. Based on our current business plan, we believe our cash and cash equivalents as of March 31, 2022 will be sufficient to meet our anticipated cash requirements into the first quarter of 2023. We will need to raise significant additional capital to continue to fund operations. We may seek to sell common or preferred equity, convertible debt securities or seek other debt financing. In addition, we may seek to raise cash through collaborative agreements or from government grants. The sale of equity and convertible debt securities may result in dilution to our shareholders and certain of those securities may have rights senior to those of our common shares. If we raise additional funds through the issuance of preferred stock, convertible debt securities or other debt financing, these securities or other debt could contain covenants that would restrict our operations. Any other third-party funding arrangement could require us to relinquish valuable rights. The source, timing and availability of any future financing will depend principally upon market conditions, and, more specifically, on the progress of our product and clinical development programs as well as commercial activities. Funding may not be available when needed, at all, or on terms acceptable to us. Lack of necessary funds may require us, among other things, to delay, scale back or eliminate expenses including those associated with our planned product development, clinical trial and commercial efforts.

As of March 31, 2022, we had total current assets of $22.4 million and total current liabilities of $3.4 million resulting in working capital of $19.0 million. Net cash used in operating activities for the three months ended March 31, 2022 was $5.2 million, which includes a net loss of $4.8 million, offset by non-cash expenses principally related to share based compensation expense of $0.5 million, depreciation and amortization of $0.1 million, amortization of debt issuance costs of $0.1 million, issuance of common stock for board of directors' compensation of $0.1 million, amortization on operating lease right-of- use asset of $0.1 million and inventory impairment of $0.2 million, offset by changes in net working capital items principally related to the increase in prepaid expenses and other current assets of $0.4 million, the increase in accounts payable and accrued expenses of $0.7 million, and an increase in inventory of $0.4 million.



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Net cash used in investing activities for the three months ended March 31, 2022 totaled $1.0 thousand related to the purchase of fixed assets of $1.0 thousand.

Net cash provided by financing activities for the three months ended March 31, 2022 totaled $3.0 million related to proceeds from issuance of common shares pursuant to at-the-market issuance registered offering of $3.1 million, offset by financing fees related to the at the market offering of $0.1 million.

As of March 31, 2022, we had cash and cash equivalents of $20.3 million. We will need additional financing to support our continuing operations. We will seek to fund our operations through public or private equity or debt financings or other sources, which may include collaborations with third parties. The sale of equity and convertible debt securities may result in dilution to our shareholders and certain of those securities may have rights senior to those of our common shares. If we raise additional funds through the issuance of preferred stock, convertible debt securities or other debt financing, these securities or other debt could contain covenants that would restrict our operations. Any other third party funding arrangement could require us to relinquish valuable rights. The source, timing and availability of any future financing will depend principally upon market conditions, and, more specifically, on the progress of our product and clinical development programs as well as commercial activities. Adequate additional financing may not be available to us on acceptable terms, or at all. Our failure to raise capital as and when needed would have a negative impact on our financial condition and our ability to pursue our business strategy. We will need to generate significant revenues to achieve profitability, and we may never do so. Furthermore, the extent of the impact and effects of the outbreak of the coronavirus COVID-19 on the operation and financial performance of our business will depend on future developments, including the duration and spread of the outbreak, related travel advisories and restrictions, production delays, or the uncertainty with respect to the accessibility of additional liquidity or capital markets, all of which are highly uncertain and cannot be predicted. If the demand for our Pure-Vu system is impacted by this outbreak for an extended period, our results of operations may be materially adversely affected.

On July 16, 2021 (the "Effective Date"), we entered into a loan facility (the "Kreos Loan Agreement") with Kreos Capital VI (Expert Fund) LP (the "Lender"). Under the Kreos Loan Agreement, Lender will provide us with access to term loans in an aggregate principal amount of up to $12.0 million. We drew $9.0 million of term loans pursuant to the Kreos Loan Agreement on the Effective Date, and applied $8.2 million of the proceeds, inclusive of a negotiated prepayment premium of approximately $0.2 million, to repay in full all amounts outstanding under, and discharge all obligations in respect of our prior Loan and Security Agreement, entered into in December 2019, as was amended from time to time, (the "SVB Loan Agreement") with Silicon Valley Bank. As a result, the SVB Loan Agreement, together with all documents and agreements executed in connection therewith, including certain liquidity covenants, have terminated and all liens associated therewith have been released as of the Effective Date. We intend to use the remaining proceeds of the Kreos Loan Agreement to enhance our product development and commercial growth plans, and for general corporate purposes. In the fourth quarter of 2021, we drew down the full $3.0 million aggregate principal amount of Tranche C.

Shelf Registration Statement

On March 16, 2021, we filed a shelf registration statement (File No. 333-254343) with the Securities and Exchange Commission (the "2021 Shelf Registration Statement"), which was declared effective on March 26, 2021, that allows us to offer, issue and sell up to a maximum aggregate offering price of $100.0 million of any combination of our common stock, preferred stock, warrants, debt securities, subscription rights and/or units from time to time, together or separately, in one or more offerings. As of March 31, 2022, we have not sold any securities under the 2021 Shelf Registration Statement, except as described below.

The 2021 Shelf Registration Statement includes a prospectus registering an at-the-market offering program pursuant to an Equity Distribution Agreement (the "Equity Distribution Agreement") with Oppenheimer & Co. Inc. ("Oppenheimer"), entered into in March 2021, under which Oppenheimer may offer and sell from time to time shares of our common stock having an aggregate offering price of up to $25.0 million, subject to the provisions of General Instruction I.B.6 of Form S-3, which provides that we may not sell securities in a public primary offering with a value exceeding one-third of our public float in any twelve-month period (approximately $8.8 million beginning effective as of March 29, 2022, the date of filing of our most recent Annual Report on Form 10-K) unless our public float is at least $75 million. If our public float meets or exceeds $75.0 million at any time, we will no longer be subject to the restrictions set forth in General Instruction I.B.6 of Form S-3, at least until the filing of our next Section 10(a)(3) update as required under the Securities Act.

During the quarter ended March 31, 2022, we sold approximately 6.0 million shares of our common stock pursuant to the above-described Equity Distribution Agreement, resulting in net cash proceeds of $3.0 million, after deducting issuance costs of $0.1 million. To date, we have sold an aggregate of approximately 7.2 million shares of our common stock pursuant to the Equity Distribution Agreement, resulting in net cash proceeds of $4.8 million, after deducting issuance costs of $0.2 million.

Our ability to issue securities is subject to market conditions and other factors including, in the case of our debt securities, our credit ratings.

Off-Balance Sheet Arrangements

We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined under SEC rules, such as relationships with unconsolidated entities or financial partnerships, which are often referred to as structured finance or special purpose entities, established for the purpose of facilitating financing transactions that are not required to be reflected on our balance sheets.

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Financials (USD)
Sales 2022 1,32 M - -
Net income 2022 -22,1 M - -
Net Debt 2022 - - -
P/E ratio 2022 -0,60x
Yield 2022 -
Capitalization 14,1 M 14,1 M -
Capi. / Sales 2022 10,7x
EV / Sales 2023 2,42x
Nbr of Employees 30
Free-Float 91,8%
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Timothy P. Moran President, Chief Executive Officer & Director
Mark Pomeranz President, Chief Operating Officer & Director
Andrew L. Taylor Chief Financial Officer
David P. Hochman Chairman
Shervin Joe Korangy Independent Director
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