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8-K - 8-K - GLAUKOS Corpf8-k.htm

Exhibit 99.1

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FOR IMMEDIATE RELEASE

Contact:

Chris Lewis

Director, Investor Relations, Corporate Strategy & Development

(949) 481-0510

clewis@glaukos.com

Glaukos Corporation Announces Second Quarter 2018 Financial Results

San Clemente, CA – August 2, 2018  – 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 second quarter ended June 30, 2018.  Key highlights include:

·

Achieved 5%  net sales growth to $43.2 million in the second quarter of 2018, compared to $41.3 million in the second quarter of 2017.

·

Reported gross margin of approximately 86% in the second quarter of 2018, compared to approximately 87% in the second quarter of 2017.

·

Raised 2018 net sales guidance to $162 million to $166 million, versus previous guidance of $160 million to $165 million.

·

Obtained U.S. FDA approval of the iStent inject®, and accelerated the iDoseTM Travoprost U.S. pivotal study efforts to target FDA approval in 2021-2022, one year earlier than previously targeted.

“We are very pleased with the company’s continued solid execution through the second quarter, both in the U.S. and international markets, which allowed us to raise our 2018 revenue guidance,” said Thomas Burns, Glaukos president and chief executive officer.  “In addition to achieving record quarterly revenue in the second quarter, we also accomplished a pivotal milestone with U.S. FDA approval of the iStent inject Trabecular Micro-Bypass System, our next-generation trabecular micro-bypass device. Trained surgeons have already successfully completed several initial iStent inject procedures and we are excited to commence full commercial launch activities later this month. iStent inject not only represents a compelling new treatment option for U.S. ophthalmic surgeons and their patients, but also further strengthens our leadership position in the growing Micro-Invasive Glaucoma Surgery market.”

Second Quarter 2018 Financial Results

Net sales rose 5% in the second quarter of 2018 to $43.2 million, compared to $41.3 million in the same period in 2017.

Gross margin for the second quarter of 2018 was approximately 86%,  compared to approximately 87% in the same period in 2017.

Operating expenses for the second quarter of 2018 rose 4% to $41.2 million, compared to $39.6 million in the same period in 2017, which included a $5.3 million in-process R&D charge. The year-over-year increase reflected primarily growth in domestic sales, marketing and administrative personnel and expenses, the


 

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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 second quarter of 2018 was $4.2 million compared to a loss of $3.9 million in the second quarter of 2017, which included the $5.3 million in-process R&D charge.  Net loss in the second quarter of 2018 was $5.4 million, or $0.15 per diluted share, compared to net loss of $3.3 million, or $0.10 per diluted share, in the second quarter of 2017.

2018 Revenue Guidance

The company raised its 2018 net sales guidance to $162 million to $166 million, versus previous guidance of $160 million to $165 million.

Pipeline Update

The company announced it has accelerated the iDose Travoprost U.S. pivotal study efforts to target FDA approval in 2021-2022, one year earlier than previously targeted, advancing this study ahead of the iStent® SA where FDA approval will now be targeted by 2023. In addition, the company finalized the iStent infinite TM 510(k) U.S. pivotal trial protocol with the FDA.

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 866-393-4306 (U.S.) or 734-385-2616 (international) and enter Conference ID 7791765.  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 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


 

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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 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 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 and expense 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; 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 2017 and will also be included in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, which we expect to file on or before August 9, 2018. 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.


 

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GLAUKOS CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited)

(in thousands, except per share amounts)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended
June 30,

 

Six Months Ended
June 30,

 

    

2018

    

2017

    

2018

    

2017

Net sales

 

$

43,161 

 

$

41,285 

 

$

83,294 

 

$

77,192 

Cost of sales

 

 

6,160 

 

 

5,522 

 

 

11,946 

 

 

10,702 

Gross profit

 

 

37,001 

 

 

35,763 

 

 

71,348 

 

 

66,490 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative

 

 

28,638 

 

 

24,675 

 

 

55,793 

 

 

46,156 

In-process research and development

 

 

 

 

5,320 

 

 

 

 

5,320 

Research and development

 

 

12,611 

 

 

9,633 

 

 

23,517 

 

 

18,575 

Total operating expenses

 

 

41,249 

 

 

39,628 

 

 

79,310 

 

 

70,051 

Loss from operations

 

 

(4,248)

 

 

(3,865)

 

 

(7,962)

 

 

(3,561)

Non-operating (expense) income:

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

505 

 

 

311 

 

 

978 

 

 

603 

Other (expense) income, net

 

 

(1,644)

 

 

275 

 

 

(1,109)

 

 

612 

Total non-operating (expense) income

 

 

(1,139)

 

 

586 

 

 

(131)

 

 

1,215 

Loss before taxes

 

 

(5,387)

 

 

(3,279)

 

 

(8,093)

 

 

(2,346)

Provision for income taxes

 

 

11 

 

 

22 

 

 

16 

 

 

77 

Net loss

 

$

(5,398)

 

$

(3,301)

 

$

(8,109)

 

$

(2,423)

Basic net loss per share

 

$

(0.15)

 

$

(0.10)

 

$

(0.23)

 

$

(0.07)

Diluted net loss per share

 

$

(0.15)

 

$

(0.10)

 

$

(0.23)

 

$

(0.07)

Weighted average shares used to compute basic net loss per share

 

 

34,942 

 

 

34,322 

 

 

34,778 

 

 

34,234 

Weighted average shares used to compute diluted net loss per share

 

 

34,942 

 

 

34,322 

 

 

34,778 

 

 

34,234 

 


 

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GLAUKOS CORPORATION

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except par values)

 

 

 

 

 

 

 

 

 

June 30,

 

December 31,

 

 

2018

 

2017

 

    

 

(unaudited)

    

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

24,941 

 

$

24,508 

Short-term investments

 

 

95,207 

 

 

94,506 

Accounts receivable, net

 

 

17,089 

 

 

16,656 

Inventory, net

 

 

13,812 

 

 

11,222 

Prepaid expenses and other current assets

 

 

4,336 

 

 

2,568 

Total current assets

 

 

155,385 

 

 

149,460 

Property and equipment, net

 

 

12,057 

 

 

11,794 

Intangible assets, net

 

 

1,311 

 

 

3,147 

Deferred tax asset, net

 

 

235 

 

 

235 

Deposits and other assets

 

 

2,102 

 

 

1,200 

Total assets

 

$

171,090 

 

$

165,836 

 

 

 

 

 

 

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

3,611 

 

$

6,244 

Accrued liabilities

 

 

16,655 

 

 

20,449 

Deferred rent

 

 

105 

 

 

95 

Total current liabilities

 

 

20,371 

 

 

26,788 

Other liabilities

 

 

2,186 

 

 

846 

Total liabilities

 

 

22,557 

 

 

27,634 

 

 

 

 

 

 

 

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; 35,166 and 34,647 shares issued and 35,138 and 34,619 shares outstanding at June 30, 2018 and December 31, 2017, respectively

 

 

35 

 

 

35 

Additional paid-in capital

 

 

348,611 

 

 

331,073 

Accumulated other comprehensive income (loss)

 

 

311 

 

 

(591)

Accumulated deficit

 

 

(200,292)

 

 

(192,183)

Less treasury stock (28 shares)

 

 

(132)

 

 

(132)

Total stockholders’ equity

 

 

148,533 

 

 

138,202 

Total liabilities and stockholders’ equity

 

$

171,090 

 

$

165,836 

 

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