Workflow
LENSAR(LNSR)
icon
Search documents
LENSAR(LNSR) - 2023 Q1 - Quarterly Report
2023-05-15 20:32
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended March 31, 2023 or ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission File Number: 001-39473 LENSAR, INC. (Exact name of registrant as specified in its charter) Delaware 32-0125724 (State or other jurisdiction of i ...
LENSAR(LNSR) - 2023 Q1 - Earnings Call Transcript
2023-05-15 14:25
Financial Data and Key Metrics - Revenue for Q1 2023 was $8.3 million, down from $9.3 million in Q1 2022, primarily due to a $1.5 million decrease in revenue from South Korea [22] - Gross margin for Q1 2023 was 52%, up from 50% in Q1 2022, driven by higher-margin procedures in the US and Europe [25] - Net loss for Q1 2023 was $4.3 million, or $0.40 per share, compared to a net loss of $6.7 million, or $0.67 per share, in Q1 2022 [29] - Cash and cash equivalents stood at $8 million as of March 31, 2023, down from $14.7 million at the end of 2022 [29] Business Line Performance - The company installed five ALLY systems in Q1 2023 and four more since April 1, bringing the total install base to 19, with an additional 13 systems in backlog [8] - Procedure volumes in the US increased by 13% compared to Q1 2022, driven by the growing adoption of ALLY systems [23] - In South Korea, procedure volumes decreased by approximately 9,900 procedures, contributing to a 19% overall decline in procedure volumes compared to Q1 2022 [18][24] Market Performance - The US market accounted for 15% of all femtosecond laser-assisted cataract surgical procedures in Q1 2023, up 100 basis points from Q2 2022 [11] - Procedure volumes in Europe increased by 5% compared to Q1 2022 [23] - South Korea's market challenges, particularly with third-party payors, led to a significant decline in procedure volumes and revenue, with no clear resolution timeframe [18][19] Strategic Direction and Industry Competition - The company is focused on expanding the reach of its ALLY system, which has been well-received by the ophthalmic community, with early adopters reporting significant productivity improvements [10][12] - LENSAR has secured its first multi-system agreements and is working on additional contracts, indicating strong demand for ALLY [16][17] - The company is leveraging its advanced technology and marketing efforts to maintain a competitive edge, including active participation in major ophthalmic congresses [15] Management Commentary on Operating Environment and Future Outlook - Management highlighted the positive reception of ALLY, with early adopters reporting time savings of 1.5 to 2 hours per surgical day, leading to increased productivity and ROI [37] - Supply chain issues are easing, with greater availability of raw materials expected to improve ALLY manufacturing efficiency in the remainder of 2023 [26] - The company completed a $20 million private placement, extending its cash runway and enabling strategic investments in inventory, sales, and marketing to capitalize on ALLY's early success [20][30] Other Important Information - The company expects R&D expenditures for 2023 to approximate $7 million, consistent with Q1 2023 levels [28] - LENSAR's remote diagnostic capabilities and service infrastructure are key differentiators, ensuring high system uptime and customer satisfaction [55] Q&A Session Summary Question: Productivity improvements from ALLY adoption - Early adopters of ALLY have reported significant time savings, enabling them to perform 3-4 additional cases per day or reduce overhead costs [37] - Transitioning from previous-generation systems to ALLY has resulted in a 20% increase in procedure volumes among early adopters [38] Question: Customer preferences for ALLY acquisition (leases vs. outright sales) - Customers are increasingly opting for operating leases or outright purchases, depending on their accounting practices and access to tax benefits [40] - The company has seen a higher percentage of systems being purchased outright or through operating leases, with per-procedure fees remaining a consistent component [40] Question: Revenue growth expectations for 2023 - The company anticipates at least 20% revenue growth in 2023, despite challenges in the South Korean market, driven by strong demand for ALLY in the US [48] - Gross margins are expected to remain around 50-52% for 2023, with potential for improvement as supply chain issues abate [50] Question: Cash runway and private placement terms - The $20 million private placement significantly extends the company's cash runway, enabling investments in inventory and sales/marketing to support ALLY's launch [30][52] - Management considered alternative financing options but opted for the private placement due to favorable terms and the need to address immediate liquidity concerns [61][62] Question: Margin improvements and future expectations - Gross margin improvements in Q1 2023 were attributed to higher-margin procedures in the US and Europe, offsetting declines in South Korea [25] - Margins are expected to remain stable in the low 50s for 2023, with potential for further improvement as supply chain challenges ease [50]
LENSAR(LNSR) - 2022 Q4 - Annual Report
2023-03-16 20:51
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year ended December 31, 2022 or ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission File Number: 001-39473 LENSAR, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organizat ...
LENSAR(LNSR) - 2022 Q4 - Earnings Call Transcript
2023-03-16 13:33
LENSAR, Inc. (NASDAQ:LNSR) Q4 2022 Earnings Call Transcript March 16, 2023 8:30 AM ET Company Participants Lee Roth - Burns McClellan Nick Curtis - Chief Executive Officer Tom Staab - Chief Financial Officer Conference Call Participants Ryan Zimmerman - BTIG Operator Good morning, and thank you for your participation. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. As a reminder, this conference call will be recorded. I would now like to turn t ...
LENSAR(LNSR) - 2022 Q3 - Earnings Call Transcript
2022-11-12 16:29
LENSAR, Inc. (NASDAQ:LNSR) Q3 2022 Results Conference Call November 9, 2022 8:30 AM ET Company Participants Lee Roth - Burns McClellan Nick Curtis - Chief Executive Officer Tom Staab - Chief Financial Officer Conference Call Participants Samuel Brodovsky - BTIG Operator Good morning, ladies and gentlemen. Thank you for standing by. Welcome to the LENSAR Third Quarter 2022 Earnings Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to turn the con ...
LENSAR(LNSR) - 2022 Q3 - Quarterly Report
2022-11-09 21:32
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended September 30, 2022 or ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission File Number: 001-39473 LENSAR, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or ...
LENSAR(LNSR) - 2022 Q2 - Quarterly Report
2022-08-08 20:55
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended June 30, 2022 or ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission File Number: 001-39473 LENSAR, INC. (Exact name of registrant as specified in its charter) Delaware 32-0125724 (State or other jurisdiction of in ...
LENSAR(LNSR) - 2022 Q2 - Earnings Call Transcript
2022-08-08 14:59
LENSAR, Inc. (NASDAQ:LNSR) Q2 2022 Earnings Conference Call August 8, 2022 8:30 AM ET Company Participants Lee Roth - Burns McClellan Nicholas Curtis - Chief Executive Officer Thomas Staab - Chief Financial Officer Conference Call Participants Ryan Zimmerman - BTIG Operator Good morning and thank you for your participation. At this time, all participants are in a listen-only mode. Later, we will conduct question-and-answer session. As a reminder, this conference call will be recorded. I would now like to tu ...
LENSAR(LNSR) - 2022 Q1 - Earnings Call Presentation
2022-05-16 09:53
Changing the Cataract Surgery Paradigm Always Surgeon Centric May 2022 Disclaimer This presentation includes estimates regarding market and industry data. Unless otherwise indicated, information concerning the industry and the markets in which LENSAR, Inc. (the "Company," "we," "our" or "us") operates, including management's general expectations, market position, market opportunity and market size, are based on management's knowledge and experience in the markets in which the Company operates, together with ...
LENSAR(LNSR) - 2022 Q1 - Quarterly Report
2022-05-09 20:17
[PART I – FINANCIAL INFORMATION](index=6&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) LENSAR, Inc. presents unaudited condensed financial statements for Q1 2022, reporting a net loss of $6.7 million due to increased operating expenses [Condensed Statements of Operations](index=6&type=section&id=Condensed%20Statements%20of%20Operations) LENSAR's Q1 2022 revenue grew 33% to $9.3 million, but operating loss widened to $6.7 million due to increased R&D expenses Condensed Statements of Operations (Unaudited, in thousands, except per share amounts) | Metric | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | **Total revenue** | **$9,340** | **$7,043** | | Total cost of revenue | $4,648 | $3,149 | | Selling, general and administrative expenses | $6,278 | $6,035 | | Research and development expenses | $4,788 | $2,746 | | **Operating loss** | **$(6,683)** | **$(5,200)** | | **Net loss** | **$(6,674)** | **$(5,182)** | | **Net loss per share (Basic and diluted)** | **$(0.67)** | **$(0.56)** | [Condensed Balance Sheets](index=7&type=section&id=Condensed%20Balance%20Sheets) Total assets decreased to $60.3 million by March 31, 2022, primarily due to reduced cash, while liabilities and equity also declined Condensed Balance Sheet Highlights (Unaudited, in thousands) | Metric | March 31, 2022 | December 31, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $28,984 | $31,637 | | Total current assets | $38,550 | $44,813 | | **Total assets** | **$60,299** | **$66,465** | | Total current liabilities | $7,763 | $8,714 | | **Total liabilities** | **$10,487** | **$11,586** | | **Total stockholders' equity** | **$49,812** | **$54,879** | [Condensed Statements of Cash Flows](index=8&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Net cash used in operating activities improved to $2.6 million in Q1 2022, resulting in a $2.7 million decrease in cash Condensed Statements of Cash Flows (Unaudited, in thousands) | Metric | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(2,607) | $(4,619) | | Net cash used in investing activities | $(46) | $(114) | | **Net decrease in cash and cash equivalents** | **$(2,653)** | **$(4,733)** | [Notes to the Condensed Financial Statements](index=11&type=section&id=Notes%20to%20the%20Condensed%20Financial%20Statements) Notes detail business, accounting policies, ALLY System FDA status, revenue by geography, purchase commitments, and stock-based compensation - The company's next-generation **ALLY™ Adaptive Cataract Treatment System's** 510(k) submission has been accepted for substantive review by the FDA. Commercialization is expected to begin in the **second half of 2022**, subject to clearance[29](index=29&type=chunk) - Management believes the company's cash and cash equivalents are sufficient to meet projected obligations for at least **twelve months** from the issuance date of the financial statements[31](index=31&type=chunk) Revenue by Geographic Region (in thousands) | Region | Q1 2022 | Q1 2021 | | :--- | :--- | :--- | | United States | $3,970 | $3,438 | | South Korea | $1,434 | $998 | | Europe | $1,619 | $889 | | Asia (excluding South Korea) | $780 | $542 | | Other | $138 | $65 | | **Total Product & Service Revenue** | **$7,941** | **$5,932** | - The company has a minimum purchase obligation of approximately **$4.3 million** for manufacturing components, due by **December 31, 2022**. Additionally, it faces potential milestone payments of **$2.4 million** contingent on the regulatory clearance and commercialization of the ALLY system[63](index=63&type=chunk)[64](index=64&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q1 2022 financial performance, noting a 33% revenue increase, a 74% rise in R&D for ALLY, and liquidity sufficient into 2023, with 2022 being a transition year [Overview](index=23&type=section&id=Overview) LENSAR, a medical device company, is preparing to launch its ALLY System in H2 2022, marking 2022 as a transition year - The company is preparing to launch its next-generation **ALLY Adaptive Cataract Treatment System**, which combines femtosecond laser technology with a phacoemulsification system into a single unit[94](index=94&type=chunk) - The FDA has accepted the 510(k) submission for the **ALLY System**, and subject to clearance, commercialization is expected to begin in the **second half of 2022**[94](index=94&type=chunk) - The company views **2022 as a transition year**, shifting focus from manufacturing and selling the LENSAR Laser System to the ALLY System[94](index=94&type=chunk)[131](index=131&type=chunk) [Results of Operations](index=26&type=section&id=Results%20of%20Operations) Q1 2022 total revenue increased 33% to $9.3 million, while R&D expenses surged 74% to $4.8 million for the ALLY System Revenue and Cost of Revenue Comparison (in thousands) | Category | Q1 2022 | Q1 2021 | Change (%) | | :--- | :--- | :--- | :--- | | **Total Revenue** | **$9,340** | **$7,043** | **33%** | | Product Revenue | $6,969 | $5,158 | 35% | | Lease Revenue | $1,399 | $1,111 | 26% | | Service Revenue | $972 | $774 | 26% | | **Total Cost of Revenue** | **$4,648** | **$3,149** | **48%** | - Research and development expenses increased by **$2.1 million**, or **74%**, to **$4.8 million** in Q1 2022 compared to Q1 2021. This was primarily due to continued development of the ALLY System and materials purchased for ALLY inventory[121](index=121&type=chunk) Adjusted EBITDA Reconciliation (Non-GAAP, in thousands) | Metric | Q1 2022 | Q1 2021 | | :--- | :--- | :--- | | Net loss | $(6,674) | $(5,182) | | EBITDA | $(5,833) | $(4,559) | | **Adjusted EBITDA** | **$(4,226)** | **$(2,239)** | [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) LENSAR has an $84.3 million accumulated deficit, with cash sufficient into 2023, but requires additional capital beyond that, facing $7.6 million in contractual obligations - The company expects its cash and cash equivalents to be sufficient to operate through the anticipated clearance and launch of ALLY and **into 2023**[128](index=128&type=chunk) - LENSAR anticipates it will need to raise additional capital through equity or debt financings to continue its operations **beyond 2023**[128](index=128&type=chunk)[132](index=132&type=chunk) - Material contractual obligations at March 31, 2022, include **$3.3 million** in operating lease payments and **$4.3 million** in minimum purchase obligations for inventory components within the **next 12 months**[136](index=136&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) LENSAR faces credit risk concentration with four customers comprising 51% of receivables and holds $29.0 million in cash with minimal interest or foreign currency risk - The company had cash and cash equivalents of **$29.0 million** as of March 31, 2022, held in deposit accounts exceeding FDIC insurance limits[149](index=149&type=chunk) - The company faces credit risk concentration, with **four customers** accounting for **17%**, **14%**, **10%**, and **10%** of its net accounts receivable as of March 31, 2022[150](index=150&type=chunk) - While inflation has not had a material impact to date, a **high rate of inflation** in the future could adversely affect operating results if selling prices do not increase in line with costs[151](index=151&type=chunk) [Item 4. Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2022, with no material changes to internal controls - Based on an evaluation as of the end of the period, the CEO and CFO concluded that the company's disclosure controls and procedures were **effective** at the reasonable assurance level as of **March 31, 2022**[154](index=154&type=chunk) - There were **no changes** in internal control over financial reporting during the quarter that have materially affected, or are reasonably likely to materially affect, these controls[155](index=155&type=chunk) [PART II – OTHER INFORMATION](index=32&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings, with no expected material adverse effects from ordinary course claims - As of the filing date, the company is **not a party to any material legal proceedings**[158](index=158&type=chunk) [Item 1A. Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) This section details risks including operating losses, ALLY System launch dependence, COVID-19 impacts, competition, regulation, IP protection, and future capital needs [Risks Related to Our Business](index=32&type=section&id=Risks%20Related%20to%20Our%20Business) Business risks include a history of operating losses ($84.3 million accumulated deficit), ALLY System dependence, COVID-19 disruptions, and intense competition - The company has a history of **operating losses**, with a **net loss of $6.7 million** for Q1 2022 and an **accumulated deficit of $84.3 million** as of March 31, 2022. It expects to incur losses for the foreseeable future[160](index=160&type=chunk) - The **commercial success of the ALLY System is critical** and depends on receiving regulatory clearances and achieving significant market acceptance[161](index=161&type=chunk) - The **COVID-19 pandemic** and related actions have **impeded global supply chains**, **increased costs**, and had an adverse impact on the business, which is expected to continue[166](index=166&type=chunk) - The company's **future capital needs are uncertain**, and while current cash is expected to last **into 2023**, it will likely need to **raise additional funds beyond that point**[174](index=174&type=chunk)[175](index=175&type=chunk) [Risks Related to Government Regulation](index=46&type=section&id=Risks%20Related%20to%20Government%20Regulation) LENSAR faces extensive government regulation, risking delays in ALLY System 510(k) clearance, post-marketing compliance, QSR adherence, and uncertain clinical trial outcomes - The company's products are regulated as medical devices and are subject to **extensive oversight by the FDA** and foreign counterparts, with non-compliance potentially leading to significant enforcement actions[227](index=227&type=chunk) - There is a **risk of not receiving, or being delayed**, in receiving necessary regulatory clearances for future products, including the **ALLY System**. The FDA has significant discretion in the 510(k) clearance process[230](index=230&type=chunk)[233](index=233&type=chunk) - The clinical trial process is **lengthy, expensive, and has uncertain outcomes**. Delays can occur for numerous reasons, including issues with patient enrollment and regulatory disagreements[252](index=252&type=chunk)[254](index=254&type=chunk) [Risks Related to Intellectual Property Matters](index=57&type=section&id=Risks%20Related%20to%20Intellectual%20Property%20Matters) Success depends on protecting intellectual property, facing risks of patent challenges, infringement, costly litigation, and potential competition from jointly-owned ALLY System IP - **Commercial success depends on obtaining and maintaining issued patents, trademarks, and other intellectual property rights**. Failure to do so could allow competitors to use the company's technologies[275](index=275&type=chunk) - As of March 31, 2022, the company owned approximately **42 U.S. patents**, **35 pending U.S. patent applications**, **75 issued foreign patents**, and **65 pending foreign and Patent Cooperation Treaty applications**[280](index=280&type=chunk) - The company may become a party to **costly intellectual property litigation**, which could interfere with its ability to sell products and divert management's attention and resources[289](index=289&type=chunk) [Risks Related to Owning Our Common Stock](index=64&type=section&id=Risks%20Related%20to%20Owning%20Our%20Common%20Stock) Risks for common stock include potential price depression from share sales, reduced disclosure as an emerging growth company, no anticipated dividends, and anti-takeover provisions - The company is an "**emerging growth company**" and a "**smaller reporting company**," which allows it to take advantage of certain exemptions from various reporting requirements, potentially making its stock **less attractive to investors**[312](index=312&type=chunk)[316](index=316&type=chunk) - The company **does not anticipate paying cash dividends** in the foreseeable future, meaning stockholders must rely on stock appreciation for any return on investment[319](index=319&type=chunk) - **Anti-takeover provisions** in the company's charter documents and Delaware law could discourage takeover attempts and may **depress the trading price** of the common stock[320](index=320&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=69&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) In Q1 2022, the company repurchased 8,142 shares at $5.84 each for employee tax withholding, not under a formal program Common Stock Repurchases (Q1 2022) | Period | Total Shares Purchased | Average Price Paid Per Share ($) | | :--- | :--- | :--- | | January 2022 | 8,142 | $5.84 | | February 2022 | — | — | | March 2022 | — | — | | **Total** | **8,142** | **$5.84** | - The repurchased shares were surrendered by employees to satisfy tax withholding obligations on vested restricted stock awards and are **not part of a formal repurchase program**[332](index=332&type=chunk) [Item 3. Defaults Upon Senior Securities](index=69&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities during the period - None[333](index=333&type=chunk) [Item 4. Mine Safety Disclosures](index=69&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[334](index=334&type=chunk) [Item 5. Other Information](index=69&type=section&id=Item%205.%20Other%20Information) The company reports no other information to disclose for this period - None[335](index=335&type=chunk) [Item 6. Exhibits](index=70&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including officer certifications and XBRL data files - The report includes a list of exhibits filed, such as the Separation and Distribution Agreement, corporate governance documents, and required **officer certifications** under Sarbanes-Oxley[337](index=337&type=chunk)