LENSAR, Inc. (NASDAQ:LNSR) is a commercial-stage medical device company focused on designing, developing, and marketing an advanced femtosecond laser system for the treatment of cataracts and the management of pre-existing or surgically induced corneal astigmatism. The company's current product portfolio includes the LENSAR Laser System and the ALLY® Adaptive Cataract Treatment System, or ALLY System, and its associated consumable components.
Business Overview
LENSAR's revenue is derived from the sale and lease of its 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. The company has developed its next-generation ALLY System, which combines all of the features from the LENSAR Laser System with a dual-pulse laser, integrated in a small, compact cataract treatment system. The ALLY System, which has received clearance from 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.The company executed a controlled and targeted initial launch of the ALLY System beginning in August 2022. The ALLY System is available to U.S. cataract surgeons and has also received regulatory clearance in India and the Philippines. In addition, the company submitted the ALLY System for certification in the European Union (EU) in September 2022 and, in 2023, submitted documentation to distributors in South Korea, Taiwan, and China for additional marketing or certification applications.
LENSAR has built and is continuing to grow its commercial organization, which includes a direct sales force in the United States and distributors in Germany, China, India, South Korea, and other targeted international markets. The company believes there is significant opportunity for it to expand its presence in these countries and other markets and regions, subject to applicable regulatory clearance or certification.
Financials
For the fiscal year ended December 31, 2023, LENSAR reported annual revenue of $42,164,000, a decrease from $45,321,000 in the prior year. The company's annual net income was -$14,383,000, compared to -$19,900,000 in the previous year. LENSAR's annual operating cash flow was -$9,659,000, and its annual free cash flow was -$9,895,000.In the first quarter of 2024, LENSAR reported total revenue of $10,588,000, a 28% increase compared to $8,252,000 in the same period of the prior year. Product revenue increased by 31% to $7,433,000, lease revenue increased by 20% to $1,947,000, and service revenue increased by 25% to $1,208,000. The company's net loss for the quarter was $2,157,000, a significant improvement from the $4,272,000 net loss in the first quarter of 2023.
LENSAR's gross margin for the first quarter of 2024 was 53%, compared to 52% in the same period of the prior year. The company expects a higher concentration of ALLY System sales in the product mix to decrease the gross margin percentage in future quarters, with a full-year gross margin percentage of approximately 50%.
Total operating expenses for the first quarter of 2024 were $8,514,000, a decrease from $8,662,000 in the same period of the prior year. The decrease was primarily attributable to lower research and development (R&D) and administrative costs, partially offset by higher expenses associated with the expansion of the company's commercial team.
As of March 31, 2024, LENSAR had cash and cash equivalents of $19,100,000, compared to $24,600,000 at the end of 2023. The company used $5,400,000 in cash during the first quarter, which is typical for the seasonally lower first quarter of the year.
Geographical Breakdown
LENSAR's U.S. sales represented 70% and 64% of product and service revenue for the first quarter of 2024 and 2023, respectively. The company's international operations, primarily in Germany, China, India, and South Korea, accounted for the remaining 30% and 36% of product and service revenue in the first quarter of 2024 and 2023, respectively.Outlook
LENSAR is focused on the continued commercialization and adoption of its ALLY System in the United States and the pursuit of regulatory clearances or certifications in other key international markets, such as the European Union, South Korea, Taiwan, and China. The company believes the ALLY System's ability to improve surgical efficiency, outcomes, and the overall patient experience will drive increased adoption and market share gains.In the first quarter of 2024, LENSAR placed 10 ALLY Systems, increasing the ALLY installed base to approximately 65 with a backlog of 3 systems as of the end of the quarter. The company has already signed contracts for an additional 18 ALLY Systems in the second quarter of 2024, with 13 of those systems replacing competitive devices and the remaining 5 representing new business in in-office surgery suites.
LENSAR expects the ALLY System's value proposition, which includes improved surgical efficiency, better patient outcomes, and enhanced user experience, to continue driving increased adoption and market share gains. The company believes the conditions in the evolving cataract surgery market, such as declining reimbursement and increasing patient demand for premium services, are creating a "perfect storm" that will drive growth in femtosecond laser-assisted cataract surgery as a percentage of total procedures, with LENSAR well-positioned to capitalize on this trend.
Risks and Challenges
LENSAR faces several risks and challenges, including: - Continued regulatory approvals and certifications for the ALLY System in international markets - Ability to maintain and grow its direct sales force in the United States and network of international distributors - Potential pricing pressure and competition from larger, well-capitalized competitors - Reliance on a network of suppliers and the potential for supply chain disruptions - Ability to accurately forecast customer demand and manage inventory levels - Reimbursement challenges, as procedures using the ALLY System are not fully covered by third-party payorsDespite these risks, LENSAR's focus on innovation, its compelling value proposition, and the favorable market conditions in the cataract surgery industry position the company for continued growth and market share expansion.