SS Innovations International, Inc.: Form 10-Q/A for the period ended Sep 30, 2023

Forward-Looking Statements

This Amendment contains certain statements that constitute forward-looking statements. Any and all statements contained in this Amendment that are not statements of historical fact may be deemed forward-looking statements. Terms such as “may,” “might,” “would,” “should,” “could,” “project,” “estimate,” “pro-forma,” “predict,” “potential,” “strategy,” “anticipate,” “attempt,” “develop,” “plan,” “help,” “believe,” “continue,” “intend,” “expect,” “future” and terms of similar import (including the negative of any of the foregoing) may be intended to identify forward-looking statements. However, not all forward-looking statements may contain one or more of these identifying terms. Those statements appear in this Report, and include statements regarding the intent, belief or current expectations of our Company and management that are subject to known and unknown risks, uncertainties and assumptions and other factors that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in “Item 1. Business” and “Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.” in our 2023 Form 10-K, as amended.

Forward-looking statements in this Amendment may include, without limitation, statements regarding:

(i) the plans and objectives of management for future operations, including plans or objectives relating to the marketing of our surgical robotic systems both in and out of India;

(ii) the timing or likelihood of regulatory filing, approvals and required licenses for marketing our surgical robotic systems in the U.S., the European Union (the “EU”) and in other countries outside of India;

(iii) our ability to adequately protect our intellectual property rights and enforce such rights to avoid violation of the intellectual property rights of others;

(iv) the timing, costs and other aspects of our surgical robotic systems;

(v) our estimates regarding the market opportunity, clinical utility, potential advantages and market acceptance of our surgical robotic systems;

(vi) the impact of government laws and regulations;

(vii) our ability to recruit and retain qualified research and development personnel;

(viii) difficulties in maintaining commercial scale manufacturing capacity and capability and our ability to generate growth;

(ix) uncertainty in industry demand;

(x) general economic conditions and market conditions in our industry;

(xi) a projection of income (including income/loss), earnings (including earnings/loss) per share, capital expenditures, dividends, capital structure or other financial items;

(xii) our future financial performance, including any such statement contained in a discussion and analysis of financial condition by management or in the results of operations included pursuant to the rules and regulations of the SEC; and

(xiii) Changes resulting from the restatement of our condensed consolidated financial statements included in this Report.

These statements are not guarantees of future performance and are subject to numerous risks, uncertainties, and assumptions that are difficult to predict.

Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely upon forward-looking statements as predictions of future events. The events and circumstances reflected in the forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, including the securities laws of the United States and the rules and regulations of the SEC, we do not assume any obligation to update any forward-looking statement. We disclaim any intention or obligation to update or revise any forward-looking statement contained herein, whether as a result of new information, future events or otherwise.

Introduction

The Company was originally incorporated in the state of Florida on February 4, 2015, under the name “Avra Surgical Microsystems, Inc.,” and changed its name to “Avra Medical Robotics, Inc.” (AVRA) on November 5, 2015.

From inception through April 13, 2023, we were engaged in developing a fully autonomous medical robotic system using proprietary software which integrated Artificial Intelligence and Deep Learning, or Machine Learning. Our research and development efforts were based in Orlando, Florida, where we established a research partnership with the University of Central Florida.

In July and August 2022, AVRA and the management of Cardio Ventures Inc began discussions to explore potential merger synergies, leading to a formal agreement in November 2022 by and among the Company, a wholly owned subsidiary of the Company (“Merger Sub”), CardioVentures and Dr. Sudhir Srivastava, who, through his holding company, owned a controlling interest in CardioVentures (“Merger Agreement”). Cardio Ventures was primarily seeking a platform to raise funds in the U.S. to support operations of its subsidiary, SSI India. AVRA’s ability to attract funds from its high-net-worth investors became a focal point in these discussions, presenting a path for AVRA shareholders to also benefit from the merger. Consequently, as part of the merger strategy, AVRA raised funds through convertible notes (at the rate of 7% interest per annum), which were subsequently provided to Cardio Ventures via convertible notes issued by Cardio Ventures. Investors like Andrew Economos and Dr. Fred Moll, both existing AVRA shareholders, contributed to these notes, foreseeing significant commercial benefits and the potential for AVRA’s turnaround post-merger, despite AVRA’s status as an inactive company at the time. On April 14, 2023, we consummated the acquisition by merger of CardioVentures, Inc., pursuant to the Merger Agreement.

The Company is currently engaged in the business of developing, manufacturing, and selling a surgical robotic system under our proprietary brand “SSi Mantra,” together with allied accessories and a wide range of surgical instruments capable of supporting cardiac and a variety of other surgical procedures. Having commenced commercial sales of our surgical robotic system in the second half of 2022 and its allied instruments and accessories. Accordingly, the operating results detailed below largely reflect the impact of the consummation of the Reverse Merger transaction in April 2023, when compared with operating results for the corresponding period in 2022.

Our financial performance is largely driven by increasing awareness of the benefits of robotically assisted surgery, improved learning curves for robotic surgeons and the affordability and accessibility of surgical robotic technology. Our financial performance is also dependent on our obtaining regulatory approvals in various regulated markets where we have plans to sell our products. Robotically assisted surgeries are increasingly being recognized as an approved treatment modality from an insurance coverage perspective.

Our manufacturing operations being based in India derive significant operating cost advantages in terms of availability of quality and cost-effective fabrication/3D printing solutions, electronic/electrical/mechanical components, outsourced services and skilled manpower. All these factors help us in having lower costs of production which eventually helps us make our surgical robotic system cost effective and relatively affordable.

The condensed consolidated financial statements appearing elsewhere in this report have been prepared assuming the Company will continue as a going concern. In the second half of 2022, the Company commercially launched its “SSI Mantra” robotic surgical system in India. As of September 30, 2023, we have sold 12 systems, which have performed more than 400 procedures of various types involving varying degrees of complexities.

Results of Operations

Introduction

The following discussion should be read in conjunction with our condensed consolidated financial statements and Notes thereto. This section of the Report generally discusses 2023 and 2022 items and quarter-to- quarter comparisons between 2023 and 2022.

The Company has recently commenced its commercial operations by way of the sale of its product and has not yet established consistent operational revenue cash flows to meet all its fixed operating costs and hence may continue to incur losses for some time. These conditions raise doubt about the Company’s ability to continue as a going concern.

The financial statements appearing elsewhere in this report have been prepared assuming that the Company will continue as a going concern.

The following table provides selected balance sheet data for our Company as of September 30, 2023 (audited) and December 31, 2022:

Balance Sheet Data

* Amounts for the year ended December 31, 2022, represent consolidated financials for Cardio Ventures Inc. (ultimate holding company before the merger transaction).

** Represents Fixed Deposits held by bank as security for bank facilities and certain performance guarantees.

To date, the Company has mainly relied on debt and equity raised in private offerings to finance its operations. Subsequent to September 2023, the Company plans to raise additional capital through further private or public offerings. However, if we are unable to do so and if we experience a shortfall in operating capital, we could be faced with having to limit our expansion plans, research and development and marketing activities

Three months ended September 30, 2023, as compared to three months ended September 30, 2022

Total Revenues. We had revenues of $2,187,006 ($2,133,295 from system sales and $ 53,711 from instrument sales) for the three months ended September 30, 2023, compared to $ 529,351 ($500,636 from system sales and $ 28,715 from instrument sales) for the three months ended September 30, 2022. The increase in net total is primarily due to sale of increased number of surgical robotic systems and instruments in the period ended September 30, 2023 as compared to the period ended September 30, 2022.

Research and development expense. Research and development expenses were $291,909 during the three months ended September 30, 2023 and $156,489 for the three months ended September 30, 2022. Research and development expense primarily consists of salaries paid to engineers, amounting to $155,104 and $107,721 for the period ended September 30, 2023 and 2022, respectively. The increase in the Research and development expenses as compared to the previous year is in line with the Company’s continued focus on improving the design and technological capabilities of its existing SSi Mantra system and further expanding its product offerings.

Stock compensation expense. We had compensation expenses of $ 24,450 and $nil during the three months ended September 30, 2023 and September 30, 2022, respectively. The substantial increase in the stock compensation expense in 2023 is primarily the result of the award of stock grants to advisors.

Depreciation and amortization expense. We had depreciation and amortization expense of $38,644 for the period ended September 30, 2023, as compared to $24,712 for the period ended September 30, 2022. The depreciation and amortization expenses primarily consist of depreciation on fixed assets only.

Selling, general and administrative expense. We incurred $1,795,945 in general and administrative expenses during the three months ended September 30, 2023 and $484,780 September 30, 2022, respectively.

Our SG&A expense comprise of expense relating to salaries and benefits, retirement benefits as well as costs related to recruitment, other compensation expenses of sales and marketing and client management personnel, sales commission, travel and brand building, client events and conferences, training and retention of senior management and other support personnel in enabling functions, telecommunications, utilities, travel and other miscellaneous administrative costs. SG&A expense also include acquisition-related costs, legal and professional fees (which represent the costs of third party legal, tax, accounting, immigration and other advisors), investment in product development, digital technology, advanced automation and robotics, related to grant of our equity awards to members of our board of directors. We expect our SG&A expense to increase as we continue to strengthen our support and enabling functions and invest in leadership development, performance management and training programs.

The increase in SG&A expense resulted from the increased scale of commercial operations during the period September 30, 2023 as compared to the period ended September 30, 2022.

Other income/expenses. We incurred other expenses of $46,438 for the three months ended September 30, 2023 as compared to $60,983 of other expenses during the three months ended September 30, 2022. The increase in interest expense from September 30, 2022 to September 30, 2023 resulted from an increase in bank borrowings for working capital from HDFC bank in India.

Net Loss. We incurred a net loss of $ 1,898,538 for the three months ended September 30, 2023, as compared to a net loss of $486,386 for the three months ended September 30, 2022. The increase in net loss from September 30, 2022 to September 30, 2023 is primarily the result of the increase in general and administrative expenses of $ 1,311,165 respectively.

Nine months ended September 30, 2023, as compared to Nine months ended September 30, 2022

Total Revenues. We had revenues of $4,448,939 ($ 3,913,492 from system sales and $ 535,447 from instrument sales) for the nine months ended September 30, 2023, as compared to $ 529,351 ($ 500,636 from system sales and $ 28,715 from instrument sales) for the nine months ended September 30, 2022. The increase in net total is primarily due to sale of increased number of surgical robotic systems and instruments in the period ended September 30, 2023 as compared to the period ended September 30, 2022.

Research and development expense. Research and development expenses were $780,462 during the nine months ended September 30, 2023 and September 30, 2022 were $956,406. Research and development expense primarily consists of salaries paid to engineers, amounting to $452,227 and $403,308 for the period ended September 30, 2023 and 2022, respectively. The increase in the Research and development expenses as compared to the previous year is in line with the Company’s continued focus on improving the design and technological capabilities of its existing SSi Mantra system and further expanding its product offerings.

Stock compensation expense. We had compensation expenses of $ 32,600 and $nil during the nine months ended September 30, 2023 and September 30, 2022, respectively. The substantial increase in the stock compensation expense in 2023 is primarily the result of the award of stock grants to advisors.

Depreciation and amortization expense. We had depreciation and amortization expense of $105,701 for the period ended September 30, 2023 as compared to $71,745 for the period ended September 30, 2022. The depreciation and amortization expenses primarily consist of depreciation on fixed assets only.

Selling, general and administrative expense. We incurred $8,339,593 and $1,293,997 in general and administrative expenses during the nine months ended September 30, 2023 and September 30, 2022, respectively.

The increase in SG&A expense resulted from the increased scale of commercial operations during the period September 30, 2023 as compared to the period ended September 30, 2022.

Other income/expenses. We incurred $622,178 in other expenses for the nine months ended September 2023, as compared to $104,104 of other expenses during the nine months ended September 30, 2022. The increase in interest expense from September 30, 2022 to September 30, 2023 resulted from an increase in bank borrowings for working capital from HDFC bank in India.

Net Loss. We incurred a net loss of $8,736,042 for the nine months ended September 30, 2023, as compared to a net loss of $2,185,674 for the nine months ended September 30, 2022. The increase in net loss from September 30, 2022, to September 30, 2023 is primarily the result of the increase in general and administrative expenses of $ 7,045,596 respectively.

Liquidity and Capital Resources

The Company expects to require substantial funds for scaling up its operations, for incurring capital expenditure to have its own in-house machining and tooling capacity and to continue to finance its research and development work in the field of surgical robotics.

On April 15, 2023, the Company executed a Convertible Promissory Note (the “Line of Credit Note”) with Sushruta Pvt Ltd. (“Sushruta”), the Bahamian holding company owned by Dr. Sudhir Srivastava, our Chairman, Chief Executive Officer and principal shareholder. Pursuant to the line of credit note, SPL, in its discretion may make multiple advances to the Company through December 31, 2023 (the “Maturity Date”), in an aggregate amount of up to $20,000,000 for working capital purposes. The advances under the line of credit note do not bear interest and are due and payable on or before the maturity date. SPL may, at its option, convert the principal amount of any advance into shares of our common stock, at a conversion price of $0.74 per share. As of September 30, 2023, Sushruta made advances aggregating to $16,980,000 that were outstanding under the line of credit note and exercised its option to convert the full amount of advances made into shares of our common stock at a conversion price of $0.74 per share. Accordingly, 22,945,946 shares of our common stock were issued to Sushruta as of September 30, 2023.

The Company had a working capital surplus of $14,215,627 and an accumulated deficit of $12,369,100 as of September 30, 2023. The Company also had a net loss of $8,736,042 for the nine months ended September 30, 2023 and $1,898,538 for the three months ended September 30, 2023.

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Cash Flows from Operating Activities

During the nine months ended September 30, 2023, net cash used in operating activities was $10,967,911 resulting from our net loss of $8,736,042 partially offset by non-cash charges of $5,245,448 primarily driven by depreciation charges and stock compensation expense. In 2023, we had cash used in our operating assets and liabilities of $7,477,317 primarily driven by increases in accounts receivable, inventory, accounts payable and prepaid expenses.

During the nine months ended September 30, 2022, net cash used in operating activities was $3,155,871, resulting from our net loss of $2,185,674, partially offset by non-cash charges of $195,934. In 2022, we had cash used in our operating assets and liabilities of $1,166,131 primarily due to increases in related party and accounts payable, inventory and prepaid expenses.

Cash Flows from Investing Activities

During the nine months ended September 30, 2023, we had net cash used in investing activities of $326,078 in purchase of property and equipment.

During the nine months ended September 30, 2022, We had net cash provided in investing activities of 378,348 in sale of property and equipment.

Cash Flows from Financing Activities

During the nine months ended September 30, 2023, we had net cash provided by financing activities of $22,645,723, which comprised of $2,705,568 in proceeds from our bank overdraft facility (net), $50,000 in proceeds from issuance of common stock against warrant and options, $16,980,000 in proceeds from issuance of convertible notes to principal shareholder and $ 3,000,000 in proceeds from issuance of convertible notes to other investors. There was a decrease of $89,845 on account of repayment of term loans.

During the nine months ended September 30, 2022, we had net cash provided by financing activities of $2,823,966 which comprised increase in bank overdraft facility(net) by $1,283,088, $1,100,000 in proceeds from issuance of convertible notes to other investors and $440,878 on account of proceeds of term loans.

While we have been successful in raising funds to finance our operations since inception and we believe that we will be successful in obtaining the necessary financing to fund our operations going forward, we do not have any committed sources of funding and there are no assurance that we will be able to secure additional funding. The accompanying condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern; however, if we cannot obtain financing, then we may be forced to further curtail our operations or consider other strategic alternatives. Even if we are successful in raising the additional financing, there is no assurance regarding the terms of any additional investment and any such investment or other strategic alternative would likely substantially dilute our current shareholders.

Critical Accounting Policies

Use of Estimates

The preparation of condensed consolidated financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant estimates included discount rate for measuring significant financing component for deferred collections in revenue contracts, fair value of stock options, incremental borrowing rate for leases and useful life of property plant and equipment.

Off-Balance Sheet Arrangements

There are no off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors.

Management’s Report on Disclosure Controls and Procedures

In connection with the restatement of the Company’s financial statements included in this Amendment, our Chief Executive Officer and Chief Financial Officer re-evaluated the effectiveness of the design and operation of our disclosure controls and procedures and internal control over financial reporting, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), as of September 30, 2023.

To ensure that information required to be disclosed by us in the reports filed or submitted by us under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the rules and forms of the SEC, including to ensure that information required to be disclosed by us in the reports filed or submitted by us under the Exchange Act is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure.

Based on that re-evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that as of September 30, 2023, our disclosure controls and procedures and internal control over financial reporting were not effective, due to material weaknesses in SSi’s internal control in that:

• We failed to design controls and procedures to provide reasonable assurance that U.S. GAAP was being properly applied to the matters resulting the restatement of our financial statements, including accounting for merger transaction, recognition of revenue in case of deferred payment sales, recognition of right of use of certain assets and lease liabilities and functional and other classifications, resulting in the accounting errors described in Note 1. Restatement of Previously Issued Condensed Consolidated Financial Statements, of this Amendment.
• We do not have written documentation of our internal control policies and procedures. Written documentation of key internal controls over financial reporting is a requirement of Section 404 of the Sarbanes-Oxley Act. Management evaluated the impact of our failure to have written documentation of our internal controls and procedures on our assessment of our disclosure controls and procedures and has concluded that the control deficiency that resulted represented a material weakness.
• We do not have sufficient segregation of duties within accounting functions, which is a basic internal control. Due to our size and nature, segregation of all conflicting duties may not always be possible and may not be economically feasible. However, to the extent possible, the initiation of transactions, the custody of assets and the recording of transactions should be performed by separate individuals. Management evaluated the impact of our failure to have segregation of duties on our assessment of our disclosure controls and procedures and procedures and has concluded that the control deficiency that resulted represented a material weakness.

Remediation Plan

The Company has been addressing and remediating these material weaknesses with the support and assistance of the accounting and financial staff employed by our Indian operating subsidiary. We are enhancing the review process for significant transactions to ensure proper accounting treatment under applicable guidelines and are engaging external experts where necessary to assist in the application of accounting principles to complex transactions. In addition, we are implementing a new ERP system which is designed to integrate all business functions within the accounting and financial department to further address the abovementioned weaknesses.

Our Chief Executive Officer and Chief Financial Officer do not expect that our disclosure controls or internal controls will prevent all errors and all fraud. Although our disclosure controls and procedures were designed to provide reasonable assurance of achieving their objectives a control system, no matter how well conceived and operated, can provide only reasonable, not absolute assurance that the objectives of the system are met. Further, the design of any control system is subject to resource constraints and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the fact that judgments in decision-making can be faulty, and that breakdowns can occur because of simple errors or mistakes. Additionally, controls can be circumvented if there exists in an individual a desire to do so. There can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.

(b) Changes in Internal Controls Over Financial Reporting

Except for the remediation efforts described above, there were no changes in our internal controls over financial reporting that occurred during the last fiscal quarter covered by this report that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.