Business | Business Surgalign Holdings, Inc. (the “Company”), is a global medical technology company focused on elevating the standard of care by driving the evolution of digital health. We have a broad portfolio of spinal hardware implants, including solutions for fusion procedures in the lumbar, thoracic, and cervical spine, motion preservation solutions for the lumbar spine, and a minimally invasive surgical implant system for fusion of the sacroiliac joint. We also have a portfolio of advanced and traditional orthobiologics, or biomaterials, products. We currently market and sell products to hospitals, ambulatory surgery centers, and healthcare providers in the United States and in approximately 50 countries worldwide. W e are also developing an artificial intelligence (“AI”) and augmented reality ( “ AR ” ) technology platform called HOLO™ AI, a powerful suite of AI software technology which strives to connect the continuum of care from the pre-op and clinical stage through post-op care. HOLO™ AI is being designed with the goals to achieve better surgical outcomes, reduce complications, and improve patient satisfaction. We believe HOLO™ AI is one of the most advanced AI technologies with applications beyond the spine and operating room. Our HOLO Portal™ surgical guidance system, a component of our HOLO™ AI technology platform, is designed to automatically recognize, identify, and segment patient anatomy to autonomously assist the surgeon throughout the surgical procedure. This proprietary AI-based platform is an intelligent anatomical mapping technology designed to assist surgeons by allowing them to remain in safe anatomical zones, and to enhance surgical performance. We plan to leverage our HOLO™ AI platform to improve patient outcomes as well as increase the adoption of our spinal hardware implants and biomaterials products. We have launched several new products and are in the process of developing a pipeline of new innovative technologies that we plan to integrate with our HOLO AI platform in the future. We are headquartered in Deerfield, Illinois, with commercial, innovation and design centers in San Diego, CA; Wurmlingen, Germany; Poznan, Poland; and Warsaw, Poland. The Company operates one reportable segment: Spine. Reverse Stock Split On May 10, 2022, the stockholders of the Company approved the proposal to authorize the Company’s Board of Directors (the “Board”) to amend the Company’s Amended and Restated Certificate of Incorporation to affect a reverse stock split of the Company’s common stock (the “Reverse Stock Split”). Following Board approval on May 11, 2022, the Reverse Stock Split became effective on May 16, 2022 at a 1-for-30 ratio. The Reverse Stock Split did not modify any rights or preferences of the shares of the Company’s common stock. Proportionate adjustments were made to the exercise prices and the number of shares underlying the Company’s outstanding equity awards, as applicable, and warrants, as well as to the number of shares issued and issuable under the Company’s equity incentive plans. The Reverse Stock Split did not affect the number of authorized shares of common stock or the par value of the common stock. All per share amounts, and references to common shares and common share amounts have been retroactively restated for all periods presented herein. Acquisition of equity interest in INN On December 30, 2021, we completed a Stock Purchase Agreement (“Purchase Agreement”) to acquire 42% of Inteneural Networks Inc. (“INN”) for a non-exclusive license to use INN's AI technology for autonomously segmenting and identifying neural structures in medical images and helping identify possible pathological states in order to advance our digital health strategy. INN is a private technology company that is developing new ways to harness machine learning (“ML”) and AI with the goal of autonomously and accurately identify and segment neural structures in medical images and integrate specific reference information regarding possible pathological states to physicians caring for patients. As consideration for the 42% stake in INN, we paid total consideration of $19.9 million which consisted of $5.0 million in cash, 227,359 shares of our common stock with a fair value of $4.9 million and issued two unsecured promissory notes to the Sellers in an aggregate principal amount of $10.6 million with a fair value of $10.0 million on the date of acquisition. As part of the transaction and subject to certain contingencies, the Company will purchase up to 100% of the equity of INN in three 19.3% tranches for $19.3 million each when the Company achieves three additional clinical, regulatory, and revenue milestones. Prompt Prototypes LLC Acquisition On April 30, 2021, The Company, entered into an Asset Purchase Agreement with Prompt Prototypes LLC (“Prompt”), a California limited liability company, and Peter Kopley, an individual residing in the State of California (the “Sellers”). The Company purchased the assets of Prompt to expand its research and development capabilities and create the capacity to produce certain medical prototypes. Pursuant to the terms of the Agreement, the Company purchased specific assets and assumed certain liabilities of Prompt for a purchase price of $1.1 million. At the closing, the Company paid $0.3 million of cash and issued restricted shares with an aggregate fair market value of $0.2 million to the Seller. The remaining $0.6 million of the purchase price will be paid contingent on Mr. Kopley’s continued employment with the Company, in the form of cash and restricted shares in two equal amounts on the 18th and 36th month anniversaries of the closing date. These payments are considered future compensation. OEM Disposition On July 20, 2020, pursuant to the Equity Purchase Agreement dated as of January 13, 2020 (as amended from time to time, the “OEM Purchase Agreement”), by and between the Company and Ardi Bidco Ltd. (the “Buyer”), the Company completed the sale of its former original equipment manufacturing business, and business related to processing donated human musculoskeletal and other tissue and bovine and porcine animal tissue in producing allograft and xenograft implants using BioCleanse ® , Tutoplast ® and Cancelle ® SP sterilization processes (collectively, the “OEM Businesses”) to Buyer and its affiliates for a purchase price of $440.0 million in cash, subject to certain adjustments (the “Transactions”). More specifically, pursuant to the terms of the OEM Purchase Agreement, the Company sold to the Buyer and its affiliates all of the issued and outstanding shares of RTI OEM, LLC (which, prior to the Transactions, was converted to a corporation and changed its name to “RTI Surgical, Inc.”), RTI Surgical, LLC (which, prior to the Transactions, was converted to a corporation and changed its name to “Pioneer Surgical Technology, Inc.”), Tutogen Medical, Inc. and Tutogen Medical GmbH. The Transactions were previously described in the Proxy Statement filed by the Company with the SEC on June 18, 2020. Subsequent to the Transactions, the Company changed its name to Surgalign Holdings, Inc., operating through its primary subsidiary, Surgalign Spine Technologies, Inc. See Note 3 for further information over discontinued operations. Where obvious and appropriate from the context, references herein to Surgalign or the Company refer to the Company excluding the disposed OEM Businesses. COVID-19 The COVID-19 pandemic has impacted our business results of operations and financial condition and it remains uncertain when our business will return to normal operations. The full extent to which the COVID-19 pandemic has impacted the Company’s business depends on future developments that are highly uncertain and cannot be accurately predicted at this time. While market conditions have improved throughout the country and on a global scale, many government agencies in conjunction with hospitals and healthcare systems continue to defer, reduce or suspend elective surgical procedures. Additionally, the COVID-19 pandemic has adversely impacted hospitals’ staffing and administrative functions, resulting in select contractual delays. We may continue to see delays on this front and both delays and reductions in procedural volumes as hospital systems and/or patients elect to defer spine surgery procedures. Notwithstanding COVID-19, we continue to invest in our digital health strategy, invest in our teams, improve operating processes through building strong foundations, and are taking steps to position ourselves for long-term success by improving patient outcomes. Liquidity On September 30, 2022, we had approximately $13.8 million in cash and $24.9 million in trade accounts payable and accrued expense liabilities, all of which are current. We plan to use our existing cash to fund our general corporate needs. We plan to implement a corporate wide review of our organizational structure, processes and costs, along with continued product rationalization initiatives, efforts of which are currently underway. We believe these actions will result in a significant reduction in operating expenses, significantly decrease our current operating cash flow, and lead to a lower cost basis to operate in 2023. However, based on the Company’s current cash flow forecast the current net working capital available will not be sufficient to meet the Company’s anticipated cash needs beyond the early part of the first quarter of 2023. Additionally, there is no assurance that Surgalign will be successful in implementing these initiatives. Surgalign is seeking to raise additional capital from fundraising efforts currently underway to supplement its cash on hand to fund operations through the end of the first quarter of 2023 and potentially long-term, depending on the financing options available to the company. There can be no assurance that Surgalign will be able to successfully obtain debt or equity financing in a timely manner or on acceptable terms, if at all. A bsent receipt of additional third party financing based on our current cash flow forecast, the Company will not have adequate capital resources to meet its current obligations as they become due past the early part of the first quarter of 2023, which would require the Company to pursue other strategic alternatives such as further corporate realignment, the potential liquidation of certain assets, a sale of the Company or potential merger with another entity, the potential for a bankruptcy filing and/or result in the Company ceasing operations. Going Concern The accompanying condensed consolidated financial statements of the Company have been prepared assuming the Company will continue as a going concern and in accordance with generally accepted accounting principles in the United States of America. The going concern basis of presentation assumes that we will continue in operation one year after the date these financial statements are issued, and we will be able to realize our assets and discharge our liabilities and commitments in the normal course of business. As of September 30, 2022, the Company had cash and cash equivalent of $13.8 million and an accumulated deficit of $585.1 million. For the three and nine months ended September 30, 2022, the Company had a loss from continuing operations of $9.8 million and $15.5 million, and a net loss applicable to Surgalign Holdings, Inc. of $9.8 million and $15.5 million, respectively. The Company has incurred losses from operations in the previous two fiscal years and did not generate positive cash flows from operations in fiscal year 2021 or for the nine months ended September 30, 2022. The Company expects net operating losses for the full year 2022 and 2023 as it works to commercialize its HOLO Portal™ surgical guidance system and further develop its HOLO™ AI platform and spinal device product lines. On February 15, 2022, we issued and sold in an underwritten public offering 1,285,507 shares of common stock and 163,768 of pre-funded warrants to purchase common stock with gross proceeds of $20.0 million at an effective offering price of $13.8000 and $13.7970 per share respectively. In addition, the Company issued warrants to purchase up to an aggregate of 1,086,956 shares of common stock at a strike price of $18.0000 that are exercisable through February 15, 2027. Also in connection with the offering, the Company issued placement agent warrants to purchase an aggregate of up to 86,956 shares of common stock at a strike price of $17.2500 per share that are exercisable through February 15, 2027. Finally, the Company granted the underwriters the option for a period of 30 days from February 15, 2022 to purchase up to 217,391 additional shares of the Company’s common stock at the public offering price of $13.7970 per share and/or warrants to purchase up to 163,043 shares of the Company’s common stock at a public offering price of $0.0030 per warrant. The Underwriters did not exercise the option to purchase the common shares from the Company, but they did exercise the option to purchase the warrants which have not been converted to common shares as of September 30, 2022. We received net proceeds of $17.7 million from the offering after deducting investor fees of $2.3 million. On June 14, 2021, we issued and sold in a registered direct offering an aggregate of 966,183 shares of our common stock and investor warrants to purchase up to an aggregate of 966,183 shares of common stock with gross proceeds of $50.0 million at a strike price of $51.7500. The Company, also in connection with the direct offering, issued placement agent warrants to purchase an aggregate of up to 57,971 shares of our common stock at a strike price of $64.6875 per share that are exercisable through June 14, 2024. We received net proceeds of $45.8 million from the offering after deducting investor fees of $4.2 million. On February 1, 2021, we closed a public offering and sold a total 956,666 shares of our common stock at a price of $45.0000 per share, less the underwriter discounts and commissions. We received gross proceeds of $40.5 million from the offering after deducting the underwriting discounts and commission of $4.0 million. The Company is projecting that it will continue to generate negative operating cash flows over the next 12-months and beyond. In management’s evaluation of the going concern conclusion, we considered the following: i) supply chain and labor issues, potential of a COVID-19 resurgence, inflation, and recent market volatility; ii) negative cash flows that are projected over the next 12-month period; iii) probability of payment of potential milestone payments related to the Holo Surgical Inc. (“Holo Surgical”) and INN acquisitions should any of the milestones be achieved; iv) INN seller notes with an aggregate amount of $10.6 million due on December 31, 2024; and v) various supplier minimum requirements. The Company’s operating plan for the next 12-month period also includes continued investments in its product pipeline that require additional financings, including digital health, hardware, and biologics. We are currently seeking additional funding through the issuance of equity, debt or other financial instruments. The Company remains in discussions with various parties but has not yet been able to finalize terms or reach a binding agreement. Depending on the outcome of financing initiatives, the Company may look to sell certain assets, close down certain parts of its business, or pursue other strategic alternatives. Absent receipt of additional third party financing, based on our current cash flow forecast, the Company will not have adequate capital resources to meet its current obligations as they become due past the early part of the first quarter of 2023. The Company’s ability to meet its current obligations as they become due over the next twelve months and to be able to continue with its operations will depend on obtaining additional resources. No assurance can be given that any of these actions will be completed. If the Company is unable to secure additional financing and implement its planned corporate realignment programs designed to significantly reduce expenses, the Company may be required to seek protection under applicable bankruptcy laws and/or liquidate or reorganize its assets, which could cause us to be delisted from the NASDAQ, further limiting our ability to obtain financing. In consideration of the inherent risks and uncertainties and the Company’s forecasted negative cash flows as described above, management has concluded that substantial doubt exists with respect to the Company’s ability to continue as a going concern within one year after the date the condensed consolidated financial statements are issued. Management continually evaluates plans to raise additional debt and/or equity financing and will continue to attempt to curtail discretionary expenditures in the future; however, in consideration of the risks and uncertainties mentioned, such plans cannot be considered probable of occurring at this time. The recoverability of a major portion of the recorded asset amounts shown in the Company’s accompanying condensed consolidated balance sheets is dependent upon continued operations of the Company, which in turn is dependent upon the Company’s ability to meet its funding requirements on a continuous basis to maintain existing financing to succeed in its future operations. The Company’s condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company be unable to continue in existence. |