Glaukos Corporation (NYSE: GKOS), an ophthalmic pharmaceutical
and medical technology company focused on novel therapies for the
treatment of glaucoma, corneal disorders and retinal diseases,
today announced financial results for the fourth quarter and full
year ended December 31, 2023. Key highlights include:
- Record net sales of $82.4 million in Q4 2023 increased 16%
year-over-year on a reported basis and 15% year-over-year on a
constant currency basis.
- Glaucoma net sales of $60.6 million in Q4 2023 increased 15%
year-over-year.
- Corneal Health net sales of $21.8 million in Q4 2023 increased
19% year-over-year.
- Gross margin of approximately 77% and non-GAAP gross margin of
approximately 84% in Q4 2023.
- Net sales of $314.7 million in FY 2023 increased 11%
year-over-year on a reported basis and 12% year-over-year on a
constant currency basis.
- Reaffirmed 2024 net sales guidance of $350 million to $360
million.
“Our record fourth quarter results cap off a successful year of
global execution and key milestone achievements, leaving us well
positioned to execute our strategic plans as we enter into what we
believe will be a transformative period for our company over the
coming years,” said Thomas Burns, Glaukos chairman and chief
executive officer. “We continue to successfully advance our robust
pipeline of novel, dropless platform technologies designed to
meaningfully advance the standard of care and improve outcomes for
patients suffering from chronic eye diseases.”
Fourth Quarter 2023 Financial Results
Net sales in the fourth quarter of 2023 of $82.4 million
increased 16% on a reported basis, or 15% on a constant currency
basis, compared to $71.2 million in the same period in 2022.
Gross margin for the fourth quarter of 2023 was approximately
77%, compared to approximately 76% in the same period in 2022.
Non-GAAP gross margin for the fourth quarter of 2023 was
approximately 84%, compared to approximately 84% in the same period
in 2022.
Selling, general and administrative (SG&A) expenses for the
fourth quarter of 2023 increased 21% to $63.0 million, compared to
$51.9 million in the same period in 2022. Non-GAAP SG&A
expenses for the fourth quarter of 2023 increased 22% to $62.3
million, compared to $51.1 million in the same period in 2022.
GAAP and non-GAAP research and development (R&D) expenses
for the fourth quarter of 2023 increased 3% to $37.1 million,
compared to $35.8 million in the same period in 2022.
Loss from operations in the fourth quarter of 2023 was $38.6
million, compared to operating loss of $33.7 million in the fourth
quarter of 2022. Non-GAAP loss from operations in the fourth
quarter of 2023 was $32.4 million, compared to non-GAAP operating
loss of $27.4 million in the fourth quarter of 2022.
Net loss in the fourth quarter of 2023 was $36.8 million, or
($0.75) per diluted share, compared to net loss of $31.5 million,
or ($0.66) per diluted share, in the fourth quarter of 2022.
Non-GAAP net loss in the fourth quarter of 2023 was $30.6 million,
or ($0.63) per diluted share, compared to non-GAAP net loss of
$25.1 million, or ($0.53) per diluted share, in the fourth quarter
of 2022.
Included in non-GAAP loss from operations, non-GAAP net loss and
non-GAAP EPS for the fourth quarter of 2023 is an acquired
in-process R&D (IPR&D) charge of $2.0 million, which caused
the non-GAAP loss per diluted share to have an additional loss of
($0.05) in the fourth quarter of 2023.
Full Year 2023 Financial Results
Net sales in 2023 of $314.7 million increased 11% on a reported
basis, or 12% on a constant currency basis, compared to $282.9
million in 2022.
Gross margin for 2023 was approximately 76%, compared to
approximately 76% in 2022. Non-GAAP gross margin for 2023 was
approximately 83%, compared to approximately 83% in 2022.
SG&A expenses in 2023 increased 16% to $224.1 million,
compared to $192.9 million in 2022. Non-GAAP SG&A expenses in
2023 increased 17% to $221.2 million, compared to $189.6 million in
2022.
R&D expenses in 2023 rose 13% to $138.8 million, compared to
$123.3 million in 2022. Non-GAAP R&D expenses in 2023 rose 13%
to $138.8 million, compared to $123.1 million in 2022.
Loss from operations in 2023 was $128.7 million, compared to
operating loss of $82.3 million in 2022. Non-GAAP loss from
operations in 2023 was $103.8 million, compared to non-GAAP
operating loss of $86.7 million in 2022.
Net loss in 2023 was $134.7 million, or ($2.78) per diluted
share, compared to net loss of $99.2 million, or ($2.09) per
diluted share, in 2022. Non-GAAP net loss in 2023 was $109.7
million, or ($2.27) per diluted share, compared to non-GAAP net
loss of $103.6 million, or ($2.18) per diluted share, in 2022.
During 2022, the company received a $30 million payment related
to the company’s settlement of patent litigation with Ivantis, Inc.
This receipt was recorded as an offset to GAAP operating expenses
in 2022.
Included in non-GAAP loss from operations, non-GAAP net loss and
non-GAAP EPS for 2023 and 2022 are acquired IPR&D charges of
$5.0 million and $10.0 million, respectively, which caused the
non-GAAP loss per diluted share to have an additional loss of
($0.11) and ($0.21) in each of these respective periods.
The company ended the fourth quarter of 2023 with approximately
$301 million in cash and cash equivalents, short-term investments
and restricted cash.
2024 Revenue Guidance
The company expects 2024 net sales to be in the range of $350
million to $360 million based on the latest foreign currency
exchange rates.
Webcast & Conference Call
The company will host a conference call and simultaneous webcast
today at 1:30 p.m. PT (4:30 p.m. ET) to discuss the results and
provide additional information about the company’s financial
outlook. A link to the webcast is available on the company’s
website at http://investors.glaukos.com. To participate in the
conference call, please dial 888-210-2212 (U.S.) or 646-960-0390
(international) and enter Conference ID 7935742. A replay of the
webcast will be archived on the company’s website following
completion of the call.
Quarterly Summary Document
The company has posted a document on its Investor Relations
website under the “Financials & Filings – Quarterly Results”
section titled “Quarterly Summary.” This Quarterly Summary document
is designed to provide the investment community with a summarized
and easily accessible reference document that details the key facts
associated with the quarter, the state of the company’s business
objectives and strategies and any forward statements or guidance
the company may make. This document is provided alongside the
company’s earnings press release and is designed to be read by
investors before the regularly scheduled quarterly conference call.
As such, today’s conference call will be in a format primarily
consisting of a questions and answers session, during which Glaukos
will address any queries investors have regarding the company’s
results. It is the company’s goal that this format will make its
quarterly earnings process more efficient and impactful for the
investment community going forward.
About Glaukos
Glaukos (www.glaukos.com) is an ophthalmic pharmaceutical and
medical technology company focused on developing and
commercializing novel therapies for the treatment of glaucoma,
corneal disorders and retinal diseases. Glaukos first developed
Micro-Invasive Glaucoma Surgery (MIGS) as an alternative to the
traditional glaucoma treatment paradigm, launching its first MIGS
device commercially in 2012, and continues to develop a portfolio
of technologically distinct and leverageable platforms to support
ongoing pharmaceutical and medical device innovations. Products or
product candidates for each of these platforms are designed to
advance the standard of care through better treatment options
across the areas of glaucoma, corneal disorders and retinal
diseases.
Forward-Looking Statements
This communication contains “forward-looking statements” within
the meaning of federal securities laws. All statements other than
statements of historical facts included in this press release that
address activities, events or developments that we expect, believe
or anticipate will or may occur in the future are forward-looking
statements. These statements are based on management’s current
expectations, assumptions, estimates and beliefs. Although we
believe that we have a reasonable basis for forward-looking
statements contained herein, we caution you that they are based on
current expectations about future events affecting us and are
subject to risks, uncertainties and factors relating to our
operations and business environment, all of which are difficult to
predict and many of which are beyond our control, that may cause
our actual results to differ materially from those expressed or
implied by forward-looking statements in this press release. These
potential risks and uncertainties that could cause actual results
to differ materially from those described in forward-looking
statements include, without limitation, uncertainties regarding the
impact of the COVID-19 pandemic or other future public health
crises on our business; the impact of general macroeconomic
conditions including foreign currency fluctuations; the reduced
physician fee and ASC facility fee reimbursement rate finalized by
CMS for 2022 and 2023 for procedures utilizing the Company’s iStent
family of products and its impact on our U.S. combo-cataract
glaucoma revenue; our ability to continue to generate sales of our
commercialized products and develop and commercialize additional
products; our dependence on a limited number of third-party
suppliers, some of which are single-source, for components of our
products; the occurrence of a crippling accident, natural disaster,
or other disruption at our primary facility, which may materially
affect our manufacturing capacity and operations; securing or
maintaining adequate coverage or reimbursement by third-party
payors for procedures using the iStent, the iStent inject W,
iAccess, iPRIME, iStent infinite, iDose TR, our corneal
cross-linking products or other products in development; our
ability to properly train, and gain acceptance and trust from
ophthalmic surgeons in the use of our products; our ability to
compete effectively in the medical device industry and against
current and future technologies (including MIGS technologies); our
compliance with federal, state and foreign laws and regulations for
the approval and sale and marketing of our products and of our
manufacturing processes; the lengthy and expensive clinical trial
process and the uncertainty of timing and outcomes from any
particular clinical trial or regulatory approval processes; the
risk of recalls or serious safety issues with our products and the
uncertainty of patient outcomes; our ability to protect, and the
expense and time-consuming nature of protecting our intellectual
property against third parties and competitors and the impact of
any claims against us for infringement or misappropriation of third
party intellectual property rights and any related litigation; and
our ability to service our indebtedness. These and other known
risks, uncertainties and factors are described in detail under the
caption “Risk Factors” and elsewhere in our filings with the
Securities and Exchange Commission (SEC), including in our
Quarterly Report on Form 10-Q for the quarter ended September 30,
2023, which was filed with the SEC on November 1, 2023, and our
Annual Report on Form 10-K for the year ended December 31, 2023,
which is expected to be filed with the SEC by February 29, 2024.
Our filings with the SEC are available in the Investor Section of
our website at www.glaukos.com or at www.sec.gov. In addition,
information about the risks and benefits of our products is
available on our website at www.glaukos.com. All forward-looking
statements included in this press release are expressly qualified
in their entirety by the foregoing cautionary statements. You are
cautioned not to place undue reliance on the forward-looking
statements in this press release, which speak only as of the date
hereof. We do not undertake any obligation to update, amend or
clarify these forward-looking statements whether as a result of new
information, future events or otherwise, except as may be required
under applicable securities law.
Statement Regarding Use of Non-GAAP Financial
Measures
To supplement the consolidated financial results prepared in
accordance with Generally Accepted Accounting Principles ("GAAP"),
the Company uses certain non-GAAP historical financial measures.
Management makes adjustments to the GAAP measures for items (both
charges and gains) that (a) do not reflect the core operational
activities of the Company, (b) are commonly adjusted within the
Company's industry to enhance comparability of the Company's
financial results with those of its peer group, or (c) are
inconsistent in amount or frequency between periods (albeit such
items are monitored and controlled with equal diligence relative to
core operations). The Company uses the term "Non-GAAP" to exclude
external acquisition-related costs incurred to effect a business
combination; amortization of intangible assets acquired in a
business combination, asset purchase transaction or other
contractual relationship; impairment of goodwill and intangible
assets; certain in-process R&D charges; fair value adjustments
to contingent consideration liabilities and pre-acquisition
contingencies arising from a business combination; integration and
transition costs related to business combinations; fair market
value adjustments to inventories acquired in a business combination
or asset purchase transaction; restructuring charges, duplicative
operating expenses, or asset write-offs (or reversals) associated
with exiting or significantly downsizing a business; gain or loss
from the sale of a business; gain or loss on the mark-to-market
adjustment, impairment, or sale of long-term investments;
mark-to-market adjustments on derivative instruments that hedge
income or expense exposures in a future period; significant legal
litigation costs and/or settlement expenses or proceeds legal and
other associated expenses that are both unusual and significant
related to governmental or internal inquiries; and significant
discrete income and other tax adjustments related to transactions
as well as changes in estimated acquisition-date tax effects
associated with business combinations, and the impact from
implementation of tax law changes and settlements. See “GAAP to
Non-GAAP Reconciliations” for a reconciliation of each non-GAAP
measure presented to the comparable GAAP financial measure.
In addition, in order to remove the impact of fluctuations in
foreign currency exchange rates, the Company also presents certain
net sales information on a constant currency basis, which
represents the outcome that would have resulted had exchange rates
in the current period been the same as the average exchange rates
in effect in the comparable prior period. See “Reported Sales vs.
Prior Periods” for a presentation of certain net sales information
on a reported, GAAP and a constant currency basis.
GLAUKOS CORPORATIONCONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS(unaudited)(in thousands, except per share amounts)
Three Months EndedDecember 31, Year EndedDecember
31,
2023
2022
2023
2022
Net sales
$
82,365
$
71,227
$
314,711
$
282,862
Cost of sales
18,891
17,222
75,575
68,979
Gross profit
63,474
54,005
239,136
213,883
Operating expenses: Selling, general and administrative
63,034
51,927
224,068
192,925
Research and development
37,062
35,812
138,768
123,271
Acquired in-process research and development
2,000
-
5,000
10,000
Litigation-related settlement
-
-
-
(30,000
)
Total operating expenses
102,096
87,739
367,836
296,196
Loss from operations
(38,622
)
(33,734
)
(128,700
)
(82,313
)
Non-operating income (expense): Interest income
2,912
960
9,164
2,375
Interest expense
(3,428
)
(3,409
)
(13,633
)
(13,720
)
Other income (expense), net
2,420
5,021
(558
)
(4,771
)
Total non-operating income (expense)
1,904
2,572
(5,027
)
(16,116
)
Loss before taxes
(36,718
)
(31,162
)
(133,727
)
(98,429
)
Income tax provision
61
298
934
766
Net loss
$
(36,779
)
$
(31,460
)
$
(134,661
)
$
(99,195
)
Basic and diluted net loss per share
$
(0.75
)
$
(0.66
)
$
(2.78
)
$
(2.09
)
Weighted average shares used to compute basic and diluted
net loss per share
48,876
47,738
48,433
47,444
GLAUKOS CORPORATIONCONDENSED CONSOLIDATED BALANCE
SHEETS(in thousands, except par values)
December 31,
2023
December 31,
2022
(unaudited) Assets Current assets: Cash and cash
equivalents
$
93,467
$
119,525
Short-term investments
201,964
233,170
Accounts receivable, net
39,850
36,073
Inventory
41,986
37,841
Prepaid expenses and other current assets
18,194
17,250
Total current assets
395,461
443,859
Restricted cash
5,856
7,078
Property and equipment, net
103,212
94,403
Operating lease right-of-use asset
27,146
25,826
Finance lease right-of-use asset
44,180
46,601
Intangible assets, net
282,956
307,869
Goodwill
66,134
66,134
Deposits and other assets
15,469
10,613
Total assets
$
940,414
$
1,002,383
Liabilities and stockholders' equity Current
liabilities: Accounts payable
$
13,440
$
14,403
Accrued liabilities
60,574
57,956
Total current liabilities
74,014
72,359
Convertible senior notes
282,773
281,400
Operating lease liability
30,427
28,905
Finance lease liability
70,538
72,172
Deferred tax liability, net
7,144
7,264
Other liabilities
13,752
10,278
Total liabilities
478,648
472,378
Stockholders' equity: Preferred stock, $0.001 par value;
5,000 shares authorized; no shares issued or outstanding as of
December 31, 2023 and 2022
-
-
Common stock, $0.001 par value; 150,000 shares authorized; 49,148
and 47,782 shares issued and 49,120 and 47,754 shares outstanding
at December 31, 2023 and 2022, respectively
49
48
Additional paid-in capital
1,059,751
997,470
Accumulated other comprehensive income (loss)
1,165
(2,975
)
Accumulated deficit
(599,067
)
(464,406
)
Less treasury stock (28 shares as of December 31, 2023 and 2022)
(132
)
(132
)
Total stockholders' equity
461,766
530,005
Total liabilities and stockholders' equity
$
940,414
$
1,002,383
GLAUKOS CORPORATIONGAAP to Non-GAAP Reconciliations(in
thousands, except per share amounts and percentage
data)(unaudited) Q4 2023 Q4 2022
GAAP Adjustments Non-GAAP
GAAP Adjustments Non-GAAP
Cost of sales
$
18,891
$
(5,523
)
(a)
$
13,368
$
17,222
$
(5,533
)
(a)
$
11,689
Gross Margin
77.1
%
6.7
%
83.8
%
75.8
%
7.8
%
83.6
%
Operating expenses: Selling,
general and administrative
$
63,034
$
(705
)
(b)
$
62,329
$
51,927
$
(782
)
(b)
$
51,145
Loss from operations
$
(38,622
)
$
6,228
$
(32,394
)
$
(33,734
)
$
6,315
$
(27,419
)
Net loss
$
(36,779
)
$
6,228
(c)
$
(30,551
)
$
(31,460
)
$
6,315
(c)
$
(25,145
)
Basic and diluted net loss per share
$
(0.75
)
$
0.12
$
(0.63
)
$
(0.66
)
$
0.13
$
(0.53
)
(a)
Cost of sales adjustments related to the
acquisition of Avedro, Inc. (Avedro), including amortization of
developed technology intangible assets of $5.5 million in Q4 2023
and amortization of developed technology intangible assets and
stock-based compensation expense related to replacement awards,
totaling $5.5 million in Q4 2022.
(b)
Avedro acquisition-related expenses,
including amortization expense of customer relationship intangible
assets of $0.7 million in Q4 2023 and customer relationship
intangible assets and stock-based compensation expense related to
replacement awards of $0.8 million in Q4 2022.
(c)
Includes total tax effect for non-GAAP
pre-tax adjustments. For non-GAAP adjustments associated with the
U.S., the tax effect is $0 given the Company's U.S. taxable loss
positions in both 2023 and 2022.
GLAUKOS CORPORATIONGAAP to Non-GAAP Reconciliations(in
thousands, except per share amounts and percentage
data)(unaudited) Full Year 2023 Full Year
2022 GAAP Adjustments Non-GAAP
GAAP Adjustments
Non-GAAP Cost of sales
$
75,575
$
(22,092
)
(a)
$
53,483
$
68,979
$
(22,166
)
(a)
$
46,813
Gross Margin
76.0
%
7.0
%
83.0
%
75.6
%
7.8
%
83.5
%
Operating expenses: Selling,
general and administrative
$
224,068
$
(2,820
)
(b)
$
221,248
$
192,925
$
(3,315
)
(b)
$
189,610
Research and development
$
138,768
$
-
$
138,768
$
123,271
$
(127
)
(c)
$
123,144
Litigation-related settlement
$
-
$
-
$
-
$
(30,000
)
$
30,000
(d)
$
-
Loss from operations
$
(128,700
)
$
24,912
$
(103,788
)
$
(82,313
)
$
(4,392
)
$
(86,705
)
Net loss
$
(134,661
)
$
24,912
(e)
$
(109,749
)
$
(99,195
)
$
(4,392
)
(e)
$
(103,587
)
Basic and diluted net loss per share
$
(2.78
)
$
0.51
$
(2.27
)
$
(2.09
)
$
(0.09
)
$
(2.18
)
(a)
Cost of sales adjustments related to the
acquisition of Avedro, Inc. (Avedro), including amortization of
developed technology intangible assets of $22.1 million in 2023 and
amortization of developed technology intangible assets and
stock-based compensation expense related to replacement awards,
totaling $22.2 million in 2022.
(b)
Avedro acquisition-related expenses,
including amortization expense of customer relationship intangible
assets of $2.8 million in 2023 and customer relationship intangible
assets and stock-based compensation expense related to replacement
awards of $3.3 million in 2022.
(c)
Stock-based compensation expense related
to replacement awards from the acquisition of Avedro.
(d)
Settlement proceeds received related to
the Company’s patent infringement litigation.
(e)
Includes total tax effect for non-GAAP
pre-tax adjustments. For non-GAAP adjustments associated with the
U.S., the tax effect is $0 given the Company's U.S. taxable loss
positions in both 2023 and 2022.
Reported Sales vs. Prior Periods (in thousands)
Year-over-Year Percent Change Quarter-over-Quarter
Percent Change
4Q 2023
4Q 2022
3Q 2023
Reported Operations (1) Currency (2)
Reported Operations (1) Currency (2)
International Glaucoma
$
21,857
$
17,530
$
20,280
24.7
%
22.5
%
2.2
%
7.8
%
9.3
%
(1.5
%)
Total Net Sales
$
82,365
$
71,227
$
78,048
15.6
%
15.1
%
0.5
%
5.5
%
5.9
%
(0.4
%)
(1)
Operational growth excludes the effect of
translational currency
(2)
Calculated by converting the current
period numbers using the prior period’s average foreign exchange
rates
Reported Sales vs. Prior Periods (in thousands)
Year-over-Year Percent Change
2023
2022
Reported Operations (1) Currency (2)
International Glaucoma
$
85,560
$
69,577
23.0
%
24.4
%
(1.4
%)
Total Net Sales
$
314,711
$
282,862
11.3
%
11.6
%
(0.3
%)
(1)
Operational growth excludes the effect of
translational currency
(2)
Calculated by converting the current
period numbers using the prior period’s average foreign exchange
rates
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240221978087/en/
Chris Lewis Vice President, Investor Relations & Corporate
Affairs (949) 481-0510 clewis@glaukos.com
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