EVO ICL™ Continues to Outpace Refractive
Industry Growth
Record Quarterly U.S. Sales and Multiple
Strategic Agreements Secured
Reiterates Fiscal 2024 Net Sales Outlook and
Increases Adjusted EBITDA
STAAR Surgical Company (NASDAQ: K), a leading developer,
manufacturer and marketer of the EVO family of Implantable
Collamer® Lenses (EVO ICL™) for myopia, astigmatism and presbyopia,
today reported financial results for the first quarter ended March
29, 2024.
First Quarter 2024
Overview
- Net sales up 5% to $77.4 million and up 7% in constant
currency
- ICL sales up 9% and units up 2%
- Gross margin at 78.9% vs. 78.3% year ago
- Net loss of $3.3 million or $0.07 loss per share vs. net income
of $2.7 million or $0.05 income per share year ago
- Adjusted EBITDA of $5.3 million or $0.11 per share vs. $10.0
million or $0.20 per share year ago
- Record cash, cash equivalents and investments available for
sale of $252.1 million at March 29, 2024
“Our first quarter results illustrate the impact of our
commercial focus, which is driving continued market adoption and
share gains of our EVO ICL,” said Tom Frinzi, President and CEO of
STAAR Surgical. “Our strategic investments in people and processes
in recent quarters are now bearing fruit. We are very pleased by
the quickening pace of our momentum to start 2024, marked by
several significant business milestones, including today’s
announcement of the largest-ever practice commitment to EVO ICL in
the U.S.”
Mr. Frinzi continued, “In the first quarter, STAAR continued to
capture market share during a challenging macroeconomic environment
for our surgeon customers and their patients. We saw strong
momentum and remain well positioned to capitalize on our growth
opportunities. In the U.S., sales were $5 million in the quarter,
up 15% year over year and 21% sequentially. In APAC, we generated
9% sales growth, which was above our expectations, including 10%
growth in China. Our EMEA region exceeded our expectations during
the quarter, generating 11% sales growth with Belgium and the
Netherlands joining China and Japan with a 20%+ share of refractive
industry procedures1. Spain, one of Europe’s largest markets for
refractive vision correction, is also quickly approaching 20%
market share. The investments in our European markets started just
a few years ago and are now paying off. For fiscal 2024, we are
reiterating our net sales outlook range of $335 million to $340
million and expect, based on current trends, to be at the higher
end of the range.”
First Quarter 2024 Financial
Results
Net sales were $77.4 million for the first quarter of 2024, up
5% compared to $73.5 million reported in the prior year quarter.
The sales increase in the first quarter was driven by ICL sales
growth of $6.5 million, up 9%, and unit growth of 2% as compared to
the prior year period. Cataract IOL and Other Product sales were
down $2.7 million as compared to the prior year period. The Company
exited its cataract IOL business in fiscal 2023.
Gross profit margin for the first quarter of 2024 was 78.9% of
net sales compared to the prior year quarter of 78.3% of net sales.
Product and country mix favorably impacted gross margin in the
first quarter of 2024 as compared to the prior year quarter.
Operating expenses for the first quarter of 2024 were $63.3
million compared to the prior year quarter of $54.8 million.
General and administrative expenses were $23.2 million compared to
the prior year quarter of $18.1 million. The increase in general
and administrative expenses was due to increased outside services
and facilities costs. Selling and marketing expenses were $26.7
million compared to the prior year quarter of $26.4 million. The
increase in selling and marketing expenses was due to increased
compensation-related expenses, trade shows and meetings expenses
offset by decreased advertising and promotional activities.
Research and development expenses were $13.4 million compared to
the prior year quarter of $10.3 million. The increase in research
and development expenses was due primarily to increased
compensation-related expenses.
Operating loss for the first quarter of 2024 was $2.3 million or
2.9% of net sales as compared to operating income of $2.8 million
or 3.8% of net sales for the first quarter of 2023.
Net loss for the first quarter of 2024 was $3.3 million or $0.07
loss per share compared with net income of $2.7 million or $0.05
income per share for the prior year quarter. The decrease in net
income was attributable to increased SG&A expenses and losses
on foreign currency transactions, partially offset by higher gross
profit.
Cash, cash equivalents and investments available for sale at
March 29, 2024, totaled $252.1 million, compared to $232.4 million
at December 29, 2023.
Outlook
The Company reiterated its prior outlook for fiscal year 2024
net sales and increased its outlook for Adjusted EBITDA. The
Company now expects the following for fiscal year 2024:
- Net sales of $335 million to $340 million.
- Adjusted EBITDA of approximately $39 million and Adjusted
EBITDA per diluted share of approximately $0.75, compared to prior
outlook of Adjusted EBITDA of approximately $36 million and
Adjusted EBITDA per diluted share of approximately $0.70.
The outlook above contemplates EVO ICL sales growth of
approximately 7% in APAC, including 10% in China; 10% growth in the
Americas, including 10% in the U.S.; and EMEA sales consistent with
fiscal year 2023.
Conference Call
The Company will host a conference call and webcast today,
Tuesday, May 7 at 4:15 p.m. Eastern / 1:15 p.m. Pacific to discuss
its financial results and operational progress. To access the
conference call please dial 833-816-1164 for domestic participants
and 412-317-1899 for international participants. No access code is
required. Please ask to be joined into the STAAR Surgical Company
call. The live webcast can be accessed from the investor relations
section of the STAAR website at www.staar.com.
A taped replay of the conference call (Access Code 3030937) will
be available for seven days beginning approximately one hour after
the call’s conclusion. This replay can be accessed by dialing
877-344-7529 for domestic callers and 412-317-0088 for
international callers. An archived webcast will also be available
at www.staar.com.
1 Company estimates as of April 6, 2024,
includes Spain refractive procedure market share of approximately
18%.
Use of Non-GAAP Financial
Measures
To supplement the Company’s financial measures prepared in
accordance with U.S. generally accepted accounting principles
(GAAP), this press release and the accompanying tables include
certain non-GAAP financial measures, including Adjusted EBITDA.
Management uses these non-GAAP financial measures in its evaluation
of Company operating performance and believes investors will find
them useful in evaluating the Company’s operating performance,
including cash flow generation, and in analyzing period-to-period
financial performance of core business operations and underlying
business trends. Non-GAAP financial measures are in addition to,
not a substitute for, or superior to, measures of financial
performance prepared in accordance with GAAP.
EBITDA is a non-GAAP financial measure, which is calculated by
adding interest income and expense, net; provision for income
taxes; and depreciation and amortization to net income. In
calculating Adjusted EBITDA and Adjusted EBITDA per diluted share,
the Company further adjusts for stock-based compensation expense.
As stock-based compensation is a non-cash expense that can vary
significantly based on the timing, size and nature of awards
granted, the Company believes that the exclusion of stock-based
compensation expense can assist investors in comparisons of Company
operating results with other peer companies because (i) the amount
of such expense in any specific period may not directly correlate
to the underlying performance of our business operations and (ii)
such expense can vary significantly between periods as a result of
the timing of grants of new stock-based awards, including
inducement grants in connection with hiring. Additionally, the
Company believes that excluding stock-based compensation from
Adjusted EBITDA and Adjusted EBITDA per diluted share assists
management and investors in making meaningful comparisons between
the Company’s operating performance and the operating performance
of other companies that may use different forms of employee
compensation or different valuation methodologies for their
stock-based compensation. Investors should note that stock-based
compensation is a key incentive offered to employees whose efforts
contributed to the operating results in the periods presented and
are expected to contribute to operating results in future periods.
Investors should also note that such expenses will recur in the
future.
The Company also presents certain financial information on a
constant currency basis, which is intended to exclude the effects
of foreign currency fluctuations. The Company conducts a
significant part of its activities outside the U.S. It receives
sales revenue and pays expenses principally in U.S. dollars, Swiss
francs, Japanese yen and euros. The exchange rates between dollars
and non-U.S. currencies can fluctuate greatly and can have a
significant effect on the Company’s results when reported in U.S.
dollars. In order to compare the Company's performance from period
to period without the effect of currency, the Company will apply
the same average exchange rate applicable in the prior period, or
the “constant currency” rate to sales or expenses in the current
period as well.
In the tables provided below, the Company has included a
reconciliation of Adjusted EBITDA and Adjusted EBITDA per diluted
share to net income and net income per diluted share, the most
directly comparable GAAP financial measure, as well as supplemental
financial information with net sales expressed in constant
currency. The Company has also provided a reconciliation of
forward-looking Adjusted EBITDA and Adjusted EBITDA per diluted
share to net income and net income per diluted share. This
represents forward-looking information, and actual results may
vary. Please see the risks and assumptions referred to in the Safe
Harbor section of this press release.
About STAAR Surgical
STAAR, which has been dedicated solely to ophthalmic surgery for
over 40 years, designs, develops, manufactures and markets
implantable lenses for the eye. These lenses are intended to
provide visual freedom for patients, lessening or eliminating the
reliance on glasses or contact lenses. All of these lenses are
foldable, which permits the surgeon to insert them through a small
incision. STAAR’s lens used in refractive surgery is called an
Implantable Collamer® Lens or “ICL,” which includes the EVO ICL™
product line. More than 3,000,000 ICLs have been sold to date and
STAAR markets these lenses in over 75 countries. To learn more
about the ICL go to: EVOICL.com. Headquartered in Lake Forest, CA,
the company operates manufacturing and packaging facilities in
Aliso Viejo, CA, Monrovia, CA and Nidau, Switzerland. For more
information, please visit the Company’s website at
www.staar.com.
Safe Harbor
All statements that are not statements of historical fact are
forward-looking statements, including statements about any of the
following: any financial projections, anticipated financial
results, estimates and outlook (including as to net sales, Adjusted
EBITDA, and Adjusted EBITDA per diluted share), plans, strategies,
and objectives of management for 2024 and beyond or prospects for
achieving such plans, expectations for sales, revenue, margin,
expenses or earnings, and any statements of assumptions underlying
any of the foregoing, including those relating to financial
performance in the upcoming quarter, fiscal year 2024 and beyond.
Important factors that could cause actual results to differ
materially from those indicated by such forward-looking statements
include risks and uncertainties related to global economic
conditions, as well as the factors set forth in the Company’s
Annual Report on Form 10-K for the year ended December 29, 2023
under the caption “Risk Factors,” which is on file with the
Securities and Exchange Commission and available in the “Investor
Information” section of the company’s website under the heading
“SEC Filings.” We disclaim any intention or obligation to update or
revise any financial projections or forward-looking statement due
to new information or events. These statements are based on
expectations and assumptions as of the date of this press release
and are subject to numerous risks and uncertainties, which could
cause actual results to differ materially from those described in
the forward-looking statements. The risks and uncertainties include
the following: global economic conditions; the impact of COVID-19;
the discretion of regulatory agencies to approve or reject
existing, new or improved products, or to require additional
actions before or after approval, or to take enforcement action;
international conflicts, trade disputes and substantial dependence
on demand from Asia; and the willingness of surgeons and patients
to adopt a new or improved product and procedure.
We intend to use our website as a means of disclosing material
non-public information and for complying with our disclosure
obligations under Regulation FD. Such disclosures will be included
on our website in the ‘Investor Relations’ sections. Accordingly,
investors should monitor such portions of our website, in addition
to following our press releases, SEC filings and public conference
calls and webcasts.
Consolidated Balance Sheets (in 000's)
Unaudited ASSETS March 29, 2024
December 29, 2023 Current assets: Cash and cash equivalents
$
224,024
$
183,038
Investments available for sale
21,125
37,688
Accounts receivable trade, net
64,604
94,704
Inventories, net
38,581
35,130
Prepayments, deposits, and other current assets
17,381
14,709
Total current assets
365,715
365,269
Investments available for sale
6,963
11,703
Property, plant, and equipment, net
72,337
66,835
Finance lease right-of-use assets, net
146
183
Operating lease right-of-use assets, net
34,600
34,387
Goodwill
1,786
1,786
Deferred income taxes
5,125
5,190
Other assets
5,863
3,339
Total assets
$
492,535
$
488,692
LIABILITIES AND STOCKHOLDERS' EQUITY Current
liabilities: Accounts payable
$
16,560
$
13,557
Obligations under finance leases
166
165
Obligations under operating leases
4,403
4,202
Allowance for sales returns
6,284
6,174
Other current liabilities
35,261
40,938
Total current liabilities
62,674
65,036
Obligations under finance leases
-
42
Obligations under operating leases
31,126
31,425
Deferred income taxes
1,074
1,077
Asset retirement obligations
96
103
Pension liability
4,777
5,055
Total liabilities
99,747
102,738
Stockholders' equity: Common stock
491
488
Additional paid-in capital
447,716
436,947
Accumulated other comprehensive loss
(4,712
)
(4,113
)
Accumulated deficit
(50,707
)
(47,368
)
Total stockholders' equity
392,788
385,954
Total liabilities and stockholders' equity
$
492,535
$
488,692
Consolidated Statements of Operations (in 000's except
for per share data) Unaudited Year to Date
% of Sales March 29, 2024 % of Sales March
31, 2023 Fav (Unfav) Amount % Net sales
100.0
%
$
77,356
100.0
%
$
73,528
$
3,828
5.2
%
Cost of sales
21.1
%
16,321
21.7
%
15,966
(355
)
(2.2
)%
Gross profit
78.9
%
61,035
78.3
%
57,562
3,473
6.0
%
Selling, general and administrative expenses: General and
administrative
30.0
%
23,228
24.7
%
18,098
(5,130
)
(28.3
)%
Selling and marketing
34.5
%
26,708
35.8
%
26,354
(354
)
(1.3
)%
Research and development
17.3
%
13,380
14.0
%
10,310
(3,070
)
(29.8
)%
Total selling, general, and administrative expenses
81.8
%
63,316
74.5
%
54,762
(8,554
)
(15.6
)%
Operating income (loss)
-2.9
%
(2,281
)
3.8
%
2,800
(5,081
)
(181.5
)%
Other income (expense): Interest income, net
2.0
%
1,529
2.5
%
1,822
(293
)
(16.1
)%
Gain (loss) on foreign currency transactions
-3.0
%
(2,297
)
0.0
%
34
(2,331
)
(6855.9
)%
Royalty income
0.7
%
508
0.0
%
-
508
0.0
%
Other income, net
0.4
%
330
0.1
%
63
267
423.8
%
Total other income, net
0.1
%
70
2.6
%
1,919
(1,849
)
(96.4
)%
Income (loss) before provision for income taxes
-2.8
%
(2,211
)
6.4
%
4,719
(6,930
)
(146.9
)%
Provision for income taxes
1.5
%
1,128
2.7
%
2,009
881
43.9
%
Net income (loss)
-4.3
%
(3,339
)
3.7
%
2,710
(6,049
)
(223.2
)%
Net income (loss) per share - basic
(0.07
)
0.06
Net income (loss) per share - diluted
(0.07
)
0.05
Weighted average shares outstanding - basic
48,907
48,247
Weighted average shares outstanding - diluted
48,907
49,500
Consolidated Statements of Cash Flows (in 000's)
Unaudited Year to Date March 29, 2024
March 31, 2023 Cash flows from operating activities: Net
income (loss)
$
(3,339
)
$
2,710
Adjustments to reconcile net income (loss) to net cash provided by
(used in) operating activities: Depreciation of property and
equipment
1,237
1,113
Amortization of long-lived intangibles
-
7
Accretion/Amortization of investments available for sale
(120
)
(983
)
Deferred income taxes
61
57
Change in net pension liability
(93
)
(13
)
Stock-based compensation expense
6,339
6,065
Provision for sales returns and bad debts
128
(377
)
Inventory provision
646
614
Changes in working capital: Accounts receivable
29,837
(1,110
)
Inventories
(4,002
)
(3,920
)
Prepayments, deposits and other assets
(5,485
)
(4,249
)
Accounts payable
1,519
(3,168
)
Other current liabilities
(5,048
)
(1,840
)
Net cash provided by (used in) operating activities
21,680
(5,094
)
Cash flows from investing activities: Acquisition of
property and equipment
(5,202
)
(2,901
)
Purchase of investments available for sale
-
(27,445
)
Proceeds from sale or maturity of investments available for sale
21,389
40,279
Net provided by investing activities
16,187
9,933
Cash flows from financing activities: Repayment of finance
lease obligations
(40
)
(42
)
Repurchase of employee common stock for taxes withheld
(1,229
)
(1,849
)
Proceeds from vested restricted stock and exercise of stock options
5,325
530
Net cash provided by (used in) financing activities
4,056
(1,361
)
Effect of exchange rate changes on cash and cash equivalents
(937
)
10
Increase in cash and cash equivalents
40,986
3,488
Cash and cash equivalents, at beginning of the period
183,038
86,480
Cash and cash equivalents, at end of the period
$
224,024
$
89,968
Reconciliation of Non-GAAP Financial Measure Net Income
to Adjusted EBITDA (in 000's except for per share data)
Unaudited
2021
Q1-22 Q2-22 Q3-22 Q4-22
2022
Q1-23 Q2-23 Q3-23 Q4-23
2023
Q1-24 2024 Outlook(2) Net income - (as reported)
$
27,511
$
9,602
$
13,038
$
10,262
$
6,763
$
39,665
$
2,710
$
6,064
$
4,817
$
7,756
$
21,347
$
(3,339
)
$
-
Provision (benefit) for income taxes
3,793
1,925
2,431
2,315
(784
)
5,887
2,009
2,428
1,929
5,983
12,349
1,128
4,500
Other (income) expense, net
2,035
586
1,551
1,128
(5,015
)
(1,750
)
(1,919
)
105
(451
)
(3,334
)
(5,599
)
(70
)
-
Depreciation
3,608
994
1,030
1,077
1,380
4,481
1,113
1,285
1,345
1,368
5,111
1,237
4,300
Amortization of intangible assets
34
8
7
7
6
28
7
10
(2
)
(2
)
13
-
-
Stock-based compensation
14,605
3,894
5,754
5,727
4,996
20,371
6,065
8,423
8,846
182
23,516
6,339
30,300
Adjusted EBITDA
$
51,586
$
17,009
$
23,811
$
20,516
$
7,346
$
68,682
$
9,985
$
18,315
$
16,484
$
11,953
$
56,737
$
5,295
$
39,100
Adjusted EBITDA as a % of Revenue
22.4
%
26.9
%
29.4
%
27.0
%
11.5
%
24.2
%
13.6
%
19.8
%
20.5
%
15.7
%
17.6
%
6.8
%
10.5
%
Net income per share, diluted- (as reported)
$
0.56
$
0.19
$
0.26
$
0.21
$
0.14
$
0.80
$
0.05
$
0.12
$
0.10
$
0.16
$
0.43
$
(0.07
)
$
-
Provision (benefit) for income taxes
0.08
0.04
0.05
0.05
(0.02
)
0.12
0.04
0.05
0.04
0.12
0.25
0.02
0.09
Other (income) expense, net
0.04
0.01
0.03
0.02
(0.10
)
(0.04
)
(0.04
)
-
(0.01
)
(0.07
)
(0.11
)
-
-
Depreciation
0.07
0.02
0.02
0.02
0.03
0.09
0.02
0.03
0.03
0.03
0.10
0.03
0.08
Amortization of intangible assets
-
-
-
-
-
-
-
-
-
-
-
-
-
Stock-based compensation
0.30
0.08
0.12
0.12
0.10
0.41
0.12
0.17
0.18
-
0.48
0.13
0.58
Adjusted EBITDA per share, diluted(1)
$
1.04
$
0.35
$
0.48
$
0.41
$
0.15
$
1.39
$
0.20
$
0.37
$
0.33
$
0.24
$
1.15
$
0.11
$
0.75
Weighted average shares outstanding - Diluted
49,456
49,288
49,223
49,549
49,389
49,380
49,500
49,516
49,370
49,242
49,427
49,275
52,000
(1) Adjusted EBITDA per diluted share may not add due to
rounding (2) 2024 Adjusted EBITDA Outlook line items are all
approximations and assumes breakeven Net Income
ICL Sales by
Geography (in 000's) Unaudited Fiscal Year
Three Months Ended ICL Sales by Region(5)
2021
2022
2023
March 31, 2023 June 30, 2023 September 29,
2023 December 29, 2023 March 29, 2024
Americas(1)
$
14,054
$
20,114
$
22,233
$
5,566
$
5,954
$
5,449
$
5,264
$
6,260
EMEA(2)
37,343
36,715
39,318
10,180
9,782
9,253
10,103
11,299
APAC(3)
161,508
212,883
257,876
54,879
77,376
66,367
59,254
59,592
Global ICL Sales
$
212,905
$
269,712
$
319,427
$
70,625
$
93,112
$
81,069
$
74,621
$
77,151
Global ICL Sales Growth
51
%
27
%
18
%
20
%
19
%
13
%
22
%
9
%
Global ICL Unit Growth
48
%
33
%
19
%
20
%
21
%
14
%
19
%
2
%
Fiscal Year Three Months Ended ICL Sales by
Country(4)(5)
2021
2022
2023
March 31, 2023 June 30, 2023 September 29,
2023 December 29, 2023 March 29, 2024
China
$
107,130
$
147,967
$
185,404
$
35,042
$
61,288
$
48,262
$
40,813
$
38,460
Growth
50
%
38
%
25
%
25
%
33
%
14
%
30
%
10
%
Japan
$
28,688
$
32,623
$
36,352
$
9,203
$
8,563
$
9,091
$
9,495
$
10,227
Growth
56
%
14
%
11
%
6
%
13
%
12
%
16
%
11
%
South Korea
$
15,173
$
17,940
$
19,853
$
6,656
$
3,316
$
4,886
$
4,996
$
6,725
Growth
36
%
18
%
11
%
19
%
(15
)%
1
%
39
%
1
%
United States
$
9,478
$
15,070
$
17,168
$
4,396
$
4,446
$
4,162
$
4,164
$
5,039
Growth
58
%
59
%
14
%
71
%
10
%
6
%
(8
)%
15
%
Notes: _________________
(1) Americas includes the United States, Canada and Latin American
countries (2) EMEA includes Spain, Germany, United Kingdom,
European, Middle East and Africa Distributors (3) APAC includes
China, Japan, South Korea, India and the rest of Asia Pacific
distributors (4) ICL Sales by country includes countries
representing more than 5% of total ICL sales in the most recently
completed fiscal year (5) ICL sales do not include IOL, injector or
other sales.
Reconciliation of Non-GAAP Financial Measure
Constant Currency Sales (in 000's) Unaudited
Year to Date As Reported Constant
Currency Sales March 29, 2024 Effect of
Currency Constant Currency March 31, 2023 $
Change % Change $ Change % Change ICL
$
77,151
$
944
$
78,095
$
70,625
$
6,526
9.2
%
$
7,470
10.6
%
Cataract IOL
-
-
-
1,476
(1,476
)
(100.0
)%
(1,476
)
(100.0
)%
Other
205
22
227
1,427
(1,222
)
(85.6
)%
(1,200
)
(84.1
)%
Total Sales
$
77,356
$
966
$
78,322
$
73,528
$
3,828
5.2
%
$
4,794
6.5
%
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240507967668/en/
Investors & Media Brian Moore Vice President,
Investor Relations and Corporate Development (626) 303-7902, Ext.
3023 bmoore@staar.com
STAAR Surgical (NASDAQ:STAA)
Gráfica de Acción Histórica
De Dic 2024 a Ene 2025
STAAR Surgical (NASDAQ:STAA)
Gráfica de Acción Histórica
De Ene 2024 a Ene 2025