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Overview and Basis of Presentation
6 Months Ended
Jun. 30, 2022
Organization Consolidation And Presentation Of Financial Statements [Abstract]  
Overview and Basis of Presentation

Note 1. Overview and Basis of Presentation

Overview and Organization

LENSAR, Inc. (“LENSAR” or the “Company”) is a global medical device business focused on the design, development and commercialization of advanced technology for the treatment of cataracts and management of astigmatism to achieve improved visual outcomes for patients. LENSAR is a public company whose stock is listed and trading under the symbol “LNSR” on The Nasdaq Stock Market LLC (“Nasdaq”). The Company’s revenue is derived from the sale and lease of LENSAR’s laser systems, which may include equipment, a consumable referred to as the Patient Interface Device (“PID”), procedure licenses, training, installation, limited warranty and maintenance agreements through extended warranty. LENSAR has developed its next-generation ALLY™ Adaptive Cataract Treatment System (“ALLY System”), the first platform to integrate its proprietary imaging with a dual-pulsed femtosecond laser and phacoemulsification technology in a single, compact system. The ALLY System, now cleared by the U.S. Food and Drug Administration (“FDA”), enables cataract surgeons to complete the femtosecond-laser-assisted cataract surgery (“FLACS”) procedure in a single, sterile environment. This clearance is the first stage of a planned, two step commercial release strategy. The Company expects to place between 8 and 12 systems in a controlled and targeted initial launch, with the first ALLY Systems being placed in the third quarter and continuing throughout the remainder of 2022. The ALLY System is expected to be made widely available to U.S. cataract surgeons in 2023. The Company’s ability to place systems in 2022 has been limited by supply chain constraints that have delayed the delivery of certain ALLY System raw materials and the completion and testing of ALLY Systems for use as launch-stock inventory. As the second stage of the commercial release strategy, the Company plans to seek an additional 510(k) clearance for the phacoemulsification features of the ALLY System in a subsequent 510(k) submission subject to a third party’s phacoemulsification device receiving clearance and serving as the predicate device. LENSAR was recently informed by the third party that it has withdrawn its 510(k) submission for its standalone phacoemulsification device and plans to resubmit the application at a later date. As this device will be considered the predicate device for purposes of evaluating the ALLY System’s phacoemulsification functionality, LENSAR is unable to submit its second 510(k) submission seeking clearance of the phacoemulsification features within the ALLY System until the predicate device receives FDA clearance. Accordingly, the Company will deliver the ALLY System to surgeons in the initial launch and the subsequent 2023 rollout with the phacoemulsification features remaining disabled and/or removed.

The Company has incurred recurring losses and operating cash outflows since its inception and, as of June 30, 2022, had an accumulated deficit of $91,027. The Company expects to continue to incur losses and cash outflows from operating activities for the foreseeable future. In addition, the Company’s results of operations, financial condition and cash flows have been adversely affected by the COVID-19 pandemic, including supply chain shortages and price increases. The extent to which the COVID-19 outbreak, and current or future variants, will further negatively impact the Company’s business or operating results cannot be determined with certainty at this time. In geographies in which the Company or its customers, partners and service providers operate, health concerns as well as political or governmental developments in response to COVID-19 could result in further economic, social or labor instability or prolonged contractions in the industries in which the Company’s customers or partners operate, slow the sales process, result in customers not purchasing or renewing the Company’s products or failing to make payments, and could otherwise have a material adverse effect on the Company’s business and results of operations and financial condition. The Company has also experienced some supply chain disruptions, and increased costs of various component parts needed for the development of the ALLY System as a result of COVID-19, including increasing lead times required for the ordering of component parts to meet targeted production goals and unpredictability with respect to the availability and delivery timing of these parts. To date, the Company has maintained sufficient inventory to mitigate significant adverse impact from such disruptions and unavailability in the near-term and to facilitate the initial launch of the ALLY System assuming regulatory clearance; however, the Company is continuing to monitor developments with respect to such disruptions and their potential impact on the Company’s business, results of operations and financial condition. If these supply chain shortages and disruptions continue or worsen, or the Company is unable to find suitable alternative component parts, there is no guarantee the Company will be able to meet customer demand for the ALLY System following its initial launch. In addition, pricing increases in component parts for the ALLY System may necessitate an increase in overall cost to customers, which in turn may have an adverse impact on customer demand.

Management believes the Company’s cash and cash equivalents on hand provide sufficient liquidity to meet the Company’s projected obligations for a period of at least twelve months from the date of issuance of these condensed financial statements. As the Company gets closer to the planned commercial launch of the ALLY System, anticipated to be in the third quarter of 2022, it expects annual revenue and selling, general and administrative expenses to increase from current levels. In addition, the successful commercialization of the ALLY System depends in part on the Company’s ability to produce the ALLY System in sufficient quantities and within requested timelines to satisfy customer demand.

The Company expects cash and cash equivalents, together with cash generated from the sale and lease of products, to be sufficient to operate into 2024. The Company’s liquidity needs will be largely determined by the success of its operations regarding the successful

commercialization of its existing products and the progression, additional regulatory clearances and launch of the ALLY System in the future. Such success will depend on the availability of the necessary component parts for the ALLY System. The Company expects it will need to raise additional capital through equity or debt financings or from other sources to continue its operations beyond 2024. The Company may issue securities, including common stock, preferred stock, warrants, and/or debt securities through private placement transactions or registered public offerings in the future. The Company’s ability to raise additional funds will depend, among other factors, on financial, economic and market conditions, many of which are outside of the Company’s control and the Company may be unable to raise financing when needed, or on terms favorable to the Company. If the necessary funds are not available from these sources, the Company may have to delay, reduce or suspend the scope of its sales and marketing efforts, research and development activities, or other components of its operations.

Basis of Presentation

These condensed financial statements of the Company are unaudited and have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) and pursuant to the regulations of the U.S. Securities and Exchange Commission (“SEC”) for interim financial information and, therefore, omit or condense certain footnotes and other information normally included. The condensed financial statements include all adjustments (consisting only of normal recurring adjustments), that management of the Company believes are necessary for a fair statement of the periods presented. These interim financial results are not necessarily indicative of results expected for the full fiscal year. The December 31, 2021 condensed balance sheet data was derived from audited financial statements, but does not include all disclosures required by U.S. GAAP.

 

The accompanying unaudited condensed financial statements and related financial information should be read in conjunction with the Company’s annual audited financial statements and the related notes thereto for the fiscal year ended December 31, 2021, included in the Annual Report on Form 10-K (the “Annual Report”) as filed with the SEC.