Increased ALLY® Adaptive Cataract Treatment
System installed base to 19 systems with a backlog of additional 13
systems as of May 12, 2023
U.S. procedure volumes increased 13% over first
quarter 2022; Procedure volumes increased >20% year-over-year at
sites that have upgraded from LENSAR Laser System (LLS) to ALLY
Significantly strengthened balance sheet
through $20 million private placement
LENSAR, Inc. (Nasdaq: LNSR) (“LENSAR” or “the Company”), a
global medical technology company focused on advanced femtosecond
laser surgical solutions for the treatment of cataracts, today
announced financial results for the quarter ended March 31, 2023
and provided an update on key operational initiatives.
“I am thrilled with the growing momentum ALLY is experiencing.
It has exceeded our expectations thus far, both in terms of systems
and procedure volumes,” said Nick Curtis, President and CEO of
LENSAR, Inc. “We recently concluded a highly successful ASCRS
Annual Meeting, where we signed contracts with two new ALLY
customers, received requests for contracts representing more than
35 additional systems, and completed a record number of demos with
non-LENSAR customers. Additionally, we have begun signing
multi-system deals with several facilities, ahead of schedule, and
have a current backlog of 13 systems pending installation. We
expected that this marketplace traction would happen 12 to 18
months post-launch, but have been pleasantly surprised by how
quickly these orders have come to fruition. Based on the systems
placed to year-to-date, pending installs and our projected sales
pipeline, we believe that 2023 installs will exceed 30, well above
the 20 systems per year that LENSAR has averaged from 2020 to
2022.”
He added, "On the procedure side, we are seeing a higher number
of procedures being performed on ALLY Systems as compared to the
LLS. On average, LLS users who transitioned to ALLY performed over
20% more procedures in Q1 2023 as compared to Q1 2022. Importantly,
the total number of procedures performed on ALLY Systems has
exceeded our internal expectations. We are confident that
utilization will continue to increase, and alongside the growing
ALLY installed base, we believe that LENSAR is positioned to
further increase our market share, and drive growth in the broader
FLACS market. To that end, according to the most recent Market
Scope estimates, 15% of all U.S. FLACS procedures were performed on
LENSAR systems in the first quarter of 2023, which represents an
increase of 100 basis points over the second quarter of 2022, when
we received FDA clearance of ALLY. We continue to believe strongly
in ALLY’s potential to markedly change the cataract treatment
landscape and remain committed to fully capturing the growth
opportunities that we have identified as a result of ALLY. The
proceeds from our recent $20 million private placement will provide
us with the resources we believe are necessary to continue
investing to maximize our market penetration with ALLY and to help
optimally position us to benefit from its tremendous
potential.”
First Quarter 2023 Financial Results
Total revenue for the quarter ended March 31, 2023 was $8.3
million, a decrease of $1.1 million, or 12%, compared to total
revenue of $9.3 million for the quarter ended March 31, 2022. The
decrease in the first quarter of 2023 was due to the elimination of
procedures in South Korea as a result of the ongoing reimbursement
issues with private payors. The region accounted for approximately
9,900 procedures and revenue of $1.5 million in the first quarter
of 2022. Excluding the first quarter 2022 procedure revenue
attributable to South Korea, revenue for the first quarter of 2023
would have increased 5% compared to the prior year first quarter.
Procedure volume in the United States and Europe increased
approximately 13% and 5%, respectively, when comparing the first
quarter of 2023 to 2022. As of March 31, 2023, the Company’s had an
installed base of 15 ALLY Systems.
For the quarters ended March 31, 2023 and 2022, approximately
92% and 89% of our revenue was attributable to recurring sources,
respectively.
The following table provides information about procedure
volume:
Three Months Ended March
31,
2023
2022
Worldwide Procedures
31,600
38,901
Selling, general and administrative expenses for the quarter
ended March 31, 2023 were $6.8 million, an increase of $0.5
million, or 8%, compared to $6.3 million for the quarter ended
March 31, 2022. The increase was primarily due to increased sales
and marketing expenses related to the commercial launch of the ALLY
system.
Research and development expenses were $1.7 million and $4.8
million for the quarters ended March 31, 2023 and 2022,
respectively, a decrease of $3.1 million or 66%. This decrease was
primarily due to significantly lower development costs associated
with the ALLY System’s clearance by the U.S. Food and Drug
Administration (FDA) in the second quarter of 2022. This decrease
included approximately $2.4 million of inventory costs charged to
research and development in the first quarter of 2022 that did not
occur in the same period in 2023. Following the U.S. commercial
clearance of the ALLY System in June 2022, all ALLY System
inventory costs are being capitalized to inventory.
Net loss for the quarter ended March 31, 2023, was $4.3 million,
or ($0.40) per share, compared to net loss of $6.7 million, or
($0.67) per share, for the quarter ended March 31, 2022. Included
within operating expenses are stock-based compensation expenses
recorded for the quarters ended March 31, 2023 and 2022 of $1.7
million and $1.6 million, respectively.
Earnings Before Interest, Taxes, Depreciation and Amortization
(“EBITDA”) for the quarter ended March 31, 2023 was ($3.5) million,
compared with ($5.8) million for the quarter ended March 31, 2022.
Adjusted EBITDA, which we calculate by adding back stock-based
compensation expense to EBITDA, was ($1.8) million for the quarter
ended March 31, 2023 and ($4.2) million for the quarter ended March
31, 2022. EBITDA and Adjusted EBITDA are non-GAAP financial
measures, and a reconciliation of these measures to net loss is set
forth below in this press release.
As of March 31, 2023, the Company had cash and cash equivalents
of $8.0 million as compared to $14.7 million at December 31, 2022.
Cash utilized in the quarter ended March 31, 2023 was $6.7 million.
Given the seasonal nature of the business, the Company generally
experiences its largest cash consumption in the first quarter of
each year. The cash used during the first quarter of 2023 was
primarily associated with building inventory to meet the demand for
ALLY Systems. On May 12, 2023, the Company completed a private
placement generating gross proceeds of approximately $20 million,
as described more fully in a Form 8-K filed today. The proceeds
from this financing will be used both for working capital and sales
and marketing expenses associated with the ongoing launch of
ALLY.
Conference Call:
LENSAR management will host a conference call and live webcast
to discuss the first quarter results and provide a business update
today, May 15, 2023, at 8:30 a.m. ET.
To participate by telephone, please dial (888) 396-8049
(Domestic) or (416) 764-8646 (International). The conference ID
number is 32566197. The live webcast can be accessed under “Events
& Presentations” in the Investor Relations section of the
company’s website at https://ir.lensar.com. Please log in
approximately 5 to 10 minutes prior to the call to register and to
download and install any necessary software. The call and webcast
replay will be available until May 29, 2023.
About LENSAR
LENSAR is a commercial-stage medical device company focused on
designing, developing, and marketing advanced systems for the
treatment of cataracts and the management of visually significant
astigmatism as an integral aspect of the cataract procedure. LENSAR
has developed its next-generation ALLY® Adaptive Cataract Treatment
System, the first platform to integrate proprietary imaging and
software, with an extremely fast dual-pulse femtosecond laser in a
compact, highly ergonomic system. ALLY is designed to transform
cataract surgery by utilizing LENSAR’s advanced technologies with
the ability to perform the entire procedure in an operating room or
in-office surgical suite, delivering operational efficiencies and
reduced overhead. ALLY includes LENSAR’s proprietary Streamline®
software technology, designed to guide surgeons to achieve better
outcomes.
Forward-looking Statements
This press release contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of
1995. All statements contained in this press release that do not
relate to matters of historical fact should be considered
forward-looking statements, including, without limitation,
statements regarding the Company’s business strategies,
commercialization and production of the ALLY® Adaptive Cataract
Treatment System, including the level of
interest among potential customers and new ALLY System
installations, the ALLY System’s performance and market impact,
customer satisfaction with the ALLY System, market trends related
to cataract treatments, expected use of proceeds from the private
placement and seasonality. In some cases, you can identify
forward-looking statements by terms such as “aim,” “anticipate,”
“approach,” “believe,” “contemplate,” “could,” “estimate,”
“expect,” “goal,” “intend,” “look,” “may,” “mission,” “plan,”
“possible,” “potential,” “predict,” “project,” “pursue,” “should,”
“target,” “will,” “would,” or the negative thereof and similar
words and expressions.
Forward-looking statements are based on management’s current
expectations, beliefs and assumptions and on information currently
available to us. Such statements are subject to a number of known
and unknown risks, uncertainties and assumptions, and actual
results may differ materially from those expressed or implied in
the forward-looking statements due to various important factors,
including, but not limited to: our history of operating losses and
ability to achieve or sustain profitability; our ability to
develop, receive and maintain regulatory clearance or certification
of and successfully commercialize the ALLY System and to maintain
our LENSAR Laser System; the impact to our business, financial
condition, results of operations and our suppliers and distributors
as a result of the COVID-19 pandemic and global macroeconomic
conditions; the willingness of patients to pay the price difference
for our products compared to a standard cataract procedure covered
by Medicare or other insurance; our ability to grow our U.S. sales
and marketing organization or maintain or grow an effective network
of international distributors; our future capital needs and our
ability to raise additional funds on acceptable terms, or at all;
the impact to our business, financial condition and results of
operations as a result of a material disruption to the supply or
manufacture of our systems or necessary component parts for such
system or material inflationary pressures affecting pricing of
component parts; our ability to compete against competitors that
have longer operating histories, more established products and
greater resources than we do; our ability to address the numerous
risks associated with marketing, selling and leasing our products
in markets outside the United States; the impact to our business,
financial condition and results of operations as a result of
exposure to the credit risk of our customers; our ability to
accurately forecast customer demand and our inventory levels; the
impact to our business, financial condition and results of
operations if we are unable to secure adequate coverage or
reimbursement by government or other third-party payors for
procedures using our ALLY System or our other future products, or
changes in such coverage or reimbursement; the impact to our
business, financial condition and results of operations of product
liability suits brought against us; risks related to government
regulation applicable to our products and operations; risks related
to our intellectual property and other intellectual property
matters; and the other important factors that are disclosed under
the heading “Risk Factors” contained in the Company’s Annual Report
on Form 10-K for the fiscal year ended December 31, 2022 filed with
the Securities and Exchange Commission (“SEC”), as such factors may
be updated from time to time in its other filings with the SEC,
including the Company’s Quarterly Report on Form 10-Q for the
quarterly period ended March 31, 2023, to be filed with the SEC,
each accessible on the SEC’s website at www.sec.gov and the
Investor Relations section of the Company’s website at
https://ir.lensar.com.
All forward-looking statements are expressly qualified in their
entirety by such factors. Except as required by law, the Company
undertakes no obligation to publicly update or review any
forward-looking statement, whether as a result of new information,
future developments or otherwise. These forward-looking statements
should not be relied upon as representing LENSAR’s views as of any
date subsequent to the date of this press release.
Non-GAAP Financial Measures
The Company prepares and analyzes operating and financial data
and non-GAAP measures to assess the performance of its business,
make strategic and offering decisions and build its financial
projections. The key non-GAAP measures it uses are EBITDA and
Adjusted EBITDA.
EBITDA is defined as net loss before interest expense, interest
income, income tax expense, depreciation and amortization expenses.
EBITDA is a non-GAAP financial measure. EBITDA is specifically
disclosed because the Company believes that EBITDA provides
meaningful supplemental information for investors regarding the
performance of its business and facilitates a meaningful evaluation
of actual results on a comparable basis with historical results.
Adjusted EBITDA is also a non-GAAP financial measure. The Company
believes Adjusted EBITDA, which excludes stock-based compensation
expense, provides meaningful supplemental information for investors
when evaluating its results and comparing it to peer companies as
stock-based compensation expense is a significant non-cash charge
due to the recapitalization of the Company. It uses these non-GAAP
financial measures in order to have comparable financial results to
analyze changes in its underlying business from quarter to quarter.
However, there are a number of limitations related to the use of
non-GAAP measures and their nearest GAAP equivalents. For example,
other companies may calculate non-GAAP measures differently, or may
use other measures to calculate their financial performance and,
therefore, any non-GAAP measures it use may not be directly
comparable to similarly titled measures of other companies.
Investors should not consider the Company’s non-GAAP financial
measures in isolation or as a substitute for an analysis of the
Company’s results as reported under GAAP.
A reconciliation of EBITDA and Adjusted EBITDA to their most
comparable GAAP financial measure are set forth below.
Three Months Ended March
31,
(Dollars in thousands)
2023
2022
Net loss
$
(4,272
)
$
(6,674
)
Less: Interest income
(89
)
(9
)
Add: Depreciation expense
578
541
Add: Amortization expense
276
309
EBITDA
(3,507
)
(5,833
)
Add: Stock-based compensation expense
1,726
1,607
Adjusted EBITDA
$
(1,781
)
$
(4,226
)
LENSAR, Inc.
STATEMENTS OF
OPERATIONS
(In thousands, except per
share amounts)
Three Months Ended March
31,
2023
2022
Revenue
Product
$
5,658
$
6,969
Lease
1,629
1,399
Service
965
972
Total revenue
8,252
9,340
Cost of revenue (exclusive of
amortization)
Product
2,299
2,694
Lease
494
474
Service
1,139
1,480
Total cost of revenue
3,932
4,648
Operating expenses
Selling, general and administrative
expenses
6,755
6,278
Research and development expenses
1,650
4,788
Amortization of intangible assets
276
309
Operating loss
(4,361
)
(6,683
)
Other income
Other income, net
89
9
Net loss
$
(4,272
)
$
(6,674
)
Net loss per share:
Basic and diluted
$
(0.40
)
$
(0.67
)
Weighted-average number of shares used
in calculation of net loss per share:
Basic and diluted
10,716
9,967
LENSAR, Inc.
BALANCE SHEETS
(In thousands, except per
share amounts)
March 31, 2023
December 31, 2022
Assets
Current assets:
Cash and cash equivalents
$
7,970
$
14,674
Accounts receivable, net of allowance of
$43 and $56, respectively
4,660
6,040
Notes receivable, net of allowance of $4
and $4, respectively
203
200
Inventories
15,668
11,740
Prepaid and other current assets
1,474
1,062
Total current assets
29,975
33,716
Property and equipment, net
520
563
Equipment under lease, net
6,248
6,316
Notes and other receivables, long-term,
net of allowance of $16 and $9, respectively
768
442
Intangible assets, net
11,845
12,122
Other assets
2,605
2,685
Total assets
$
51,961
$
55,844
Liabilities and stockholders’
equity
Current liabilities:
Accounts payable
$
4,923
$
5,422
Accrued liabilities
3,493
4,700
Deferred revenue
1,032
768
Operating lease liabilities
544
531
Total current liabilities
9,992
11,421
Long-term operating lease liabilities
2,171
2,272
Other long-term liabilities
360
167
Total liabilities
12,523
13,860
Stockholders’ equity:
Preferred stock, par value $.01 per share,
10,000 shares authorized at March 31, 2023 and December 31, 2022;
no shares issued and outstanding at March 31, 2023 and December 31,
2022
—
—
Common stock, par value $0.01 per share,
150,000 shares authorized at March 31, 2023 and December 31, 2022;
11,103 and 11,093 shares issued and outstanding at March 31, 2023
and December 31, 2022, respectively
111
111
Additional paid-in capital
141,107
139,381
Accumulated deficit
(101,780
)
(97,508
)
Total stockholders’ equity
39,438
41,984
Total liabilities and stockholders’
equity
$
51,961
$
55,844
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230514005086/en/
Thomas R. Staab, II, CFO ir.contact@lensar.com
Lee Roth / Cameron Radinovic Burns McClellan for LENSAR
lroth@burnsmc.com / cradinovic@burnsmc.com
LENSAR (NASDAQ:LNSR)
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