SAN CLEMENTE, Calif.–(BUSINESS WIRE)–Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and
pharmaceutical company focused on the development and commercialization
of novel surgical devices and sustained pharmaceutical therapies
designed to transform the treatment of glaucoma, today announced
financial results for the first quarter ended March 31, 2019. Key
highlights include:
-
Achieved 35% net sales growth to $54.0 million in the first quarter of
2019, compared to $40.1 million in the first quarter of 2018. -
Reported gross margin of approximately 87% in the first quarter of
2019, compared to approximately 86% in the first quarter of 2018. - Updated 2019 net sales guidance to $225 million to $230 million.
“Glaukos began 2019 by delivering another exceptional quarter, driven by
growing U.S. adoption of our next-generation iStent inject®
Trabecular Micro-Bypass System and strong commercial performance in
key international markets,” said Thomas Burns, Glaukos president and
chief executive officer. “We also continued to make significant clinical
and regulatory progress to advance our expansive and novel pipeline,
with the goal of transforming Glaukos into a global ophthalmic
pharmaceutical and device leader and transforming glaucoma therapy for
the much-needed benefit of patients worldwide.”
First Quarter 2019 Financial Results
Net sales rose 35% in the first quarter of 2019 to $54.0 million,
compared to $40.1 million in the same period in 2018. The growth
primarily reflected unit volume increases worldwide.
Gross margin for the first quarter of 2019 was approximately 87%,
compared to approximately 86% in the same period in 2018.
Operating expenses for the first quarter of 2019 rose 28% to $48.9
million, compared to $38.1 million in the same period in 2018. The
year-over-year increase reflected primarily growth in domestic sales,
marketing and administrative personnel and expenses, the company’s
ongoing expansion of its global direct sales infrastructure, and
increased spending associated with pharmaceutical research and clinical
trials.
Loss from operations in the first quarter of 2019 was $1.9 million,
compared to operating loss of $3.7 million in the first quarter of 2018.
Net loss in the first quarter of 2019 was $1.3 million, or $0.04 per
diluted share, compared to net loss of $2.7 million, or $0.08 per
diluted share, in the first quarter of 2018.
2019 Revenue Guidance
The company updated its 2019 net sales guidance to $225 million to $230
million, compared to $220 million to $230 million previously.
Webcast & Conference Call
The company will host a conference call and simultaneous webcast today
at 1:30 p.m. PDT (4:30 p.m. EDT) 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 833-231-8262 (U.S.)
or 647-689-4107 (international) and enter Conference ID 9977628. A
replay of the webcast will be archived on the company’s website
following completion of the call.
About Glaukos
Glaukos (www.glaukos.com)
is an ophthalmic medical technology and pharmaceutical company focused
on the development and commercialization of novel surgical devices and
sustained pharmaceutical therapies designed to transform the treatment
of glaucoma, one of the world’s leading causes of blindness. The company
pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the
traditional glaucoma treatment and management paradigm. Glaukos launched
the iStent® Trabecular Micro-Bypass Stent, its first MIGS device,
in the United States in July 2012 and launched its next-generation iStent
inject® device in the United States in September 2018. Glaukos is
leveraging its platform technology to build a comprehensive and
proprietary portfolio of micro-scale injectable therapies designed to
address the complete range of glaucoma disease states and progression.
The company believes the iStent inject is the smallest medical
device ever approved by the FDA.
Forward-Looking Statements
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. 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 include, without limitation,
uncertainties about our dependence on the success and market acceptance
of the iStent and the iStent inject; our ability to reach
sustained profitability; our ability to leverage our sales and marketing
infrastructure to increase market penetration and acceptance of our
products both in the United States and internationally; our ability to
bring our pipeline products to market; 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; maintaining
adequate coverage or reimbursement by third-party payors for procedures
using the iStent, the iStent inject 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 successfully develop and commercialize additional products; our
ability to compete effectively in the highly competitive and rapidly
changing medical device industry and against current and future
competitors (including MIGS competitors) that are large public companies
or divisions of publicly traded companies that have competitive
advantages; the timing, effect, expense and uncertainty of navigating
different regulatory approval processes as we develop additional
products and penetrate foreign markets; the impact of any product
liability claims against us and any related litigation; the effect of
the extensive and increasing federal and state regulation in the
healthcare industry on us and our suppliers; the lengthy and expensive
clinical trial process and the uncertainty of timing and outcomes from
any particular clinical trial; 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 that could develop and commercialize similar or identical
products; the impact of any claims against us of infringement or
misappropriation of third party intellectual property rights and any
related litigation; and the market’s perception of our limited operating
history as a public company. 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,
including our Annual Report on Form 10-K for 2018, and will also be
included in our Quarterly Report on Form 10-Q for the quarter ended
March 31, 2019, which we expect to file on or before May 10, 2019. Our
filings with the Securities and Exchange Commission 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.
| GLAUKOS CORPORATION | |||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||
| (unaudited) | |||||||||
| (in thousands, except per share amounts) | |||||||||
|
Three Months Ended March 31, |
|||||||||
| 2019 | 2018 | ||||||||
| Net sales | $ | 54,026 | $ | 40,133 | |||||
| Cost of sales | 7,111 | 5,786 | |||||||
| Gross profit | 46,915 | 34,347 | |||||||
| Operating expenses: | |||||||||
| Selling, general and administrative | 34,925 | 27,155 | |||||||
| Research and development | 13,930 | 10,906 | |||||||
| Total operating expenses | 48,855 | 38,061 | |||||||
| Loss from operations | (1,940 | ) | (3,714 | ) | |||||
| Non-operating income: | |||||||||
| Interest income | 788 | 480 | |||||||
| Other (expense) income, net | (68 | ) | 528 | ||||||
| Total non-operating income | 720 | 1,008 | |||||||
| Loss before taxes | (1,220 | ) | (2,706 | ) | |||||
| Provision for income taxes | 122 | 5 | |||||||
| Net loss | $ | (1,342 | ) | $ | (2,711 | ) | |||
| Basic net loss per share | $ | (0.04 | ) | $ | (0.08 | ) | |||
| Diluted net loss per share | $ | (0.04 | ) | $ | (0.08 | ) | |||
|
Weighted average shares used to compute basic net loss per share |
36,205 | 34,677 | |||||||
| Weighted average shares used to compute diluted net loss per share | 36,205 | 34,677 | |||||||
| GLAUKOS CORPORATION | ||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| (in thousands, except par values) | ||||||||
|
March 31, |
December 31, | |||||||
| 2019 | 2018 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 33,680 | $ | 29,821 | ||||
| Short-term investments | 111,575 | 110,667 | ||||||
| Accounts receivable, net | 20,622 | 18,673 | ||||||
| Inventory, net | 13,432 | 13,282 | ||||||
| Prepaid expenses and other current assets | 4,428 | 4,124 | ||||||
| Total current assets | 183,737 | 176,567 | ||||||
| Restricted cash | 8,813 | 8,775 | ||||||
| Property and equipment, net | 19,535 | 19,153 | ||||||
| Operating lease right-of-use asset | 12,772 | – | ||||||
| Deferred tax asset and receivable, net | 213 | 213 | ||||||
| Deposits and other assets | 2,965 | 2,262 | ||||||
| Total assets | $ | 228,035 | $ | 206,970 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 5,675 | $ | 6,286 | ||||
| Accrued liabilities | 21,672 | 23,964 | ||||||
| Deferred rent | – | 115 | ||||||
| Total current liabilities | 27,347 | 30,365 | ||||||
| Operating lease liability | 12,174 | – | ||||||
| Other liabilities | 3,025 | 2,745 | ||||||
| Total liabilities | 42,546 | 33,110 | ||||||
| Stockholders’ equity: | ||||||||
|
Preferred stock, $0.001 par value; 5,000 authorized; no shares issued and outstanding |
– | – | ||||||
|
Common stock, $0.001 par value; 150,000 authorized; 36,361 and 36,135 shares issued and 36,333 and 36,107 shares outstanding at March 31, 2019 and December 31, 2018, respectively |
36 | 36 | ||||||
| Additional paid-in capital | 390,887 | 378,352 | ||||||
| Accumulated other comprehensive income | 1,174 | 738 | ||||||
| Accumulated deficit | (206,476 | ) | (205,134 | ) | ||||
| Less treasury stock (28 shares) | (132 | ) | (132 | ) | ||||
| Total stockholders’ equity | 185,489 | 173,860 | ||||||
| Total liabilities and stockholders’ equity | $ | 228,035 | $ | 206,970 | ||||
Contacts
Chris Lewis
Director, Investor Relations, Corporate Strategy &
Development
(949) 481-0510
clewis@glaukos.com