Full Press Release Details
Vice President, Investor Relations & Corporate Affairs
Announces Fourth Quarter and Full Year 2021
CA - February 22, 2022 - Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical
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, 2021. Key highlights include:
"Our fourth quarter performance caps off
a successful year of execution on many key strategic initiatives despite continued COVID-19 dynamics and other reimbursement challenges
we faced," said Thomas Burns, Glaukos president and chief executive officer. "We continue to successfully invest in and advance
our robust pipeline of novel, dropless platform technologies designed to transform vision by disrupting the standard of care and improving
outcomes for the benefit of patients worldwide suffering from chronic eye diseases."
Fourth Quarter 2021 Financial Results
Net sales in the fourth quarter of 2021 were $73.2
million, compared to $73.2 million in the same period in 2020.
Gross margin for the fourth quarter of 2021 was
approximately 77%, compared to approximately 73% in the same period in 2020. Non-GAAP gross margin for the fourth quarter of 2021 was
approximately 85%, compared to approximately 83% in the same period in 2020.
Selling, general and administrative (SG&A)
expenses for the fourth quarter of 2021 increased 9% to $47.6 million, compared to $43.8 million in the same period in 2020. Non-GAAP
SG&A expenses for the fourth quarter of 2021 increased 16% to $46.7 million, compared to $40.2 million in the same period in 2020.
Research and development (R&D) expenses for
the fourth quarter of 2021 increased 26% to $26.7 million, compared to $21.2 million in the same period in 2020. Non-GAAP R&D expenses
for the fourth quarter of 2021 increased 20% to $25.5 million, compared to $21.3 million in the same period in 2020.
Loss from operations in the fourth quarter of
2021 was $17.9 million, compared to operating loss of $11.4 million in the fourth quarter of 2020. Non-GAAP loss from operations in the
fourth quarter of 2021 was $10.3 million, compared to non-GAAP operating loss of $0.4 million in the fourth quarter of 2020.
Net loss in the fourth quarter of 2021 was $21.9
million, or ($0.47) per diluted share, compared to a net loss of $10.6 million, or ($0.24) per diluted share, in the fourth quarter of
2020. Non-GAAP net loss in the fourth quarter of 2021 was $14.3 million, or ($0.31) per diluted share, compared to non-GAAP net loss of
$0.8 million, or ($0.02) per diluted share, in the fourth quarter of 2020.
Full Year 2021 Financial Results
Net sales increased 31% in 2021 to $294.0 million,
compared to $225.0 million in 2020.
Gross margin for 2021 was approximately 77%, compared
to approximately 59% in 2020. Non-GAAP gross margin for 2021 was approximately 85%, compared to approximately 83% in 2020.
SG&A expenses in 2021 increased 5% to $179.3
million, compared to $171.4 million in 2020. Non-GAAP SG&A expenses in 2021 increased 13% to $172.2 million, compared to $152.3 million
R&D expenses in 2021 rose 18% to $101.0 million,
compared to $85.4 million in 2020. Non-GAAP R&D expenses in 2021 rose 20% to $99.4 million, compared to $82.9 million in 2020.
During 2021, the company incurred $10.0 million
of in-process R&D charges associated with an upfront payment related to an amended licensing arrangement with Intratus, Inc.
in the second quarter of 2021 and an upfront payment related to the execution of a licensing arrangement with Attillaps Holdings, Inc.
in the third quarter of 2021. In addition, during 2021, 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 the third quarter of
Loss from operations in 2021 was $32.9 million,
compared to operating loss of $123.6 million in 2020. Non-GAAP loss from operations in 2021 was $21.8 million, compared to non-GAAP operating
loss of $48.2 million in 2020.
Net loss in 2021 was $49.6 million, or ($1.07)
per diluted share, compared to net loss of $120.3 million, or ($2.70) per diluted share, in 2020. Non-GAAP net loss in 2021 was $38.6
million, or ($0.83) per diluted share, compared to non-GAAP net loss of $51.1 million, or ($1.15) per diluted share, in 2020.
The company ended the fourth quarter of 2021 with
approximately $423 million in cash and cash equivalents, short-term investments and restricted cash.
2022 Revenue Guidance
The company expects 2022 net sales to be in the
range of $265 million to $275 million.
Webcast & Conference Call
The company will host a conference call and simultaneous
webcast today at 1:30 p.m. PST (4:30 p.m. EST) 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 new document on its Investor
Relations website under the "Financials & Filings - Quarterly Results" section titled "Quarterly Summary."
This new 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. Going forward, this document will be 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, beginning with
the first quarter of 2022, the 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 change
will make its quarterly earnings process more efficient and impactful for the investment community going forward.
Glaukos (www.glaukos.com) is an ophthalmic medical
technology and pharmaceutical 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 has since developed 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 duration and severity of the COVID-19 pandemic and its impact on
our business or the economy generally; the reduced physician
fee and ASC facility fee reimbursement rate finalized by CMS for 2022 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, the iStent inject W, 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 competitors (including MIGS competitors); 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;