UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of report (Date of earliest event reported): April 28, 2016
AVINGER, INC.
(Exact name of Registrant as specified in its charter)
Delaware |
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001-36817 |
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20-8873453 |
(State or other jurisdiction of |
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(Commission |
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(I.R.S. Employer |
400 Chesapeake Drive
Redwood City, California 94063
(Address of principal executive office) (Zip Code)
(650) 241-7900
(Registrants telephone number, including area code)
N/A
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 2.02. Results of Operations and Financial Condition.
On May 4, 2016, Avinger, Inc. issued a press release regarding its financial results for the quarter ended March 31, 2016. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K.
This information is intended to be furnished under Item 2.02 of Form 8-K and shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 8.01. Other Events.
On April 28, 2016, after consultation with our compensation consultant, our Compensation Committee recommended and our Board of Directors approved, an annual retainer of $15,000 to be paid to our lead independent director effective as of January 1, 2016.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. |
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Description |
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99.1 |
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Press Release of Avinger, Inc. dated May 4, 2016. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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AVINGER, INC. | |
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Date: May 4, 2016 |
By: |
/s/ Jeffrey M. Soinski |
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Jeffrey M. Soinski |
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Chief Executive Officer |
Exhibit 99.1
FOR IMMEDIATE RELEASE
Avinger, Inc. Announces First Quarter 2016 Results
Initial sales of Pantheris image-guided atherectomy system drive strong revenue growth
Redwood City, California, May 4, 2016 Avinger, Inc. (NASDAQ: AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), today reported results for the first quarter ended March 31, 2016.
First Quarter Highlights
· Received FDA clearance and began commercialization of an enhanced version of the Pantheris image-guided atherectomy system on March 1, 2016
· Received initial Pantheris orders from 60% of lumivascular accounts
· Added 12 new lumivascular accounts, expanding the installed base of lumivascular platform customers to 107
· Continued build-out of the sales force, exiting the quarter with 62 sales professionals
· Revenue of $4.5 million, a 117% increase compared to the first quarter of 2015
We are pleased with the early adoption of Pantheris and the early physician interest in the product, said Jeff Soinski, Avingers president and CEO. The launch of Pantheris is a significant milestone which we expect to drive strong top-line growth in 2016, as we focus on driving adoption of Pantheris in the U.S. by leveraging our growing sales force and our expanding installed base of Lumivascular accounts.
Dr. John B. Simpson, Avingers Founder and Executive Chairman, stated, The reception to Pantheris is encouraging, as physicians continue to integrate visualization of the inside of the vessel into their clinical practice. We believe that the ability of Pantheris to facilitate the understanding of arterial narrowings in real time will significantly improve PAD patient outcomes.
First Quarter 2016 Financial Results
Total revenue was $4.5 million for the first quarter ended March 31, 2016, a 117% increase from the first quarter of 2015 and a 59% increase from the fourth quarter of 2015. Revenue related to Lightbox imaging consoles was $1.2 million, a 100% increase compared to the first quarter of 2015 and consistent with the fourth quarter of 2015. Revenues from disposable devices were $3.3 million, a 125% increase compared to the first quarter of 2015 and a 105% increase from the fourth quarter of 2015. Revenue
results reflect the strong initial sales of Pantheris following FDA clearance on March 1, 2016 as well as continued growth of the companys installed base of lumivascular accounts.
Gross margin for the first quarter of 2016 was 26%, down from 38% in the comparable quarter of 2015. This decrease was primarily attributable to the growth of the companys manufacturing infrastructure in anticipation of the commercial launch of Pantheris.
Operating expenses for the first quarter of 2016 were $16.2 million, compared to $10.2 million in the first quarter of 2015. This growth was primarily attributable to expansion of the companys commercial organization and marketing expenses associated with the launch of Pantheris.
Loss from operations for the first quarter of 2016 was $15.0 million, compared to $9.4 million for the first quarter of 2015.
Adjusted EBITDA, a non-GAAP measure, was a loss of $12.7 million for the first quarter of 2016, compared to a $7.9 million loss for the first quarter of 2015.
Cash and cash equivalents totaled $26.9 million as of March 31, 2016, compared to $43.1 million as of December 31, 2015.
2016 Outlook
The company continues to expect 2016 revenue to be in the range of $25 million to $30 million, representing year-over-year growth ranging from 134% to 180%.
Adjusted EBITDA for 2016 is projected to be a loss of $40 million to $43 million, representing an increased loss of approximately 19% to 28% over 2015, as the company continues to expand its commercial infrastructure related to the launch of Pantheris and invests in the further development of its lumivascular platform products.
Net loss per share for 2016 is projected to be $(4.35) to $(4.55), which assumes a weighted-average share count of 12.8 million.
Conference Call
Avinger will hold a conference call today, May 4, 2016 at 1:30pm PT/4:30pm ET to discuss its first quarter 2016 financial results. Individuals may listen to the call by dialing (855) 638-4817 for domestic callers or (262) 912-6051 for international callers, referencing Conference ID: 87029215. To listen to a live webcast, please visit the investor relations section of Avingers website at: www.avinger.com.
A replay of the call will be available beginning May 4, 2016 at 4:30pm PT/7:30pm ET through midnight on May 5, 2016. To access the replay, dial (800) 585-8367 or (404) 537-3406 and reference Conference ID: 87029215. The webcast will also be available on Avingers website for one year following the completion of the call.
About Avinger, Inc.
Avinger, Inc. is a commercial-stage medical device company that designs, manufactures and sells image-guided, catheter-based systems for the treatment of patients with peripheral artery disease (PAD). PAD is characterized by a build-up of plaque in the arteries that supply blood to the arms and legs. The companys mission is to dramatically improve the treatment of vascular disease through the introduction of products based on its lumivascular platform, the only intravascular image-guided system of therapeutic catheters available in this market. Avingers current lumivascular products include the Lightbox imaging console, the Ocelot family of catheters, which are designed to penetrate total arterial blockages, known as chronic total occlusions, or CTOs, and Pantheris, the first-ever image-guided atherectomy device, designed to precisely remove arterial plaque in PAD patients. For more information, please visit www.avinger.com.
Avinger, Pantheris and the Avinger logo are registered trademarks of Avinger, Inc.
Forward-Looking Statements
This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding physician adoption, expectations for growth, financial and operating guidance, and expectations regarding growth in the companys installed base and new account purchasing patterns. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties, many of which are beyond our control, include our dependency on a limited number of products; ability to demonstrate the benefits of our lumivascular platform; the resource requirements related to Pantheris; the outcome of clinical trial results; potential exposure to third-party product liability and intellectual property litigation; lack of long-term data demonstrating the safety and efficacy of our lumivascular platform products; reliance on third-party vendors; dependency on physician adoption; reliance on key personnel; and requirements to obtain regulatory approval to commercialize our products; as well as the other risks described in the section entitled Risk Factors in our Form 10-K filing made with the Securities and Exchange Commission on March 8, 2016. These forward-looking statements speak only as of the date hereof. Avinger disclaims any obligation to update these forward-looking statements.
Use of Non-GAAP Financial Measures
To supplement our condensed financial statements prepared in accordance with U.S. generally accepted accounting principles (GAAP), we use certain non-GAAP financial measures in this release. Management of the company believes that these non-GAAP financial measures, considered together with GAAP financial information, provide useful information for investors by excluding certain non-cash and other income and expense that are not indicative of the companys core operating performance. Reconciliations of the non-GAAP financial measures used in this release to the most directly comparable GAAP measures for the respective periods can be found in the reconciliation of GAAP to non-GAAP financial information immediately following the financial tables. Non-GAAP financial measures have limitations as analytical tools and should not be considered in isolation or as a substitute for our financial results prepared in accordance with GAAP.
Avinger, Inc.
Statements of Operations Data
(in thousands, except per share data)
(unaudited)
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Three Months Ended |
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March 31, |
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2016 |
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2015 |
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Revenues |
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$ |
4,539 |
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$ |
2,088 |
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Cost of revenues |
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3,360 |
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1,288 |
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Gross profit |
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1,179 |
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800 |
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26 |
% |
38 |
% | ||
Operating expenses: |
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Research and development |
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4,047 |
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3,860 |
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Selling, general and administrative |
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12,161 |
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6,365 |
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Total operating expenses |
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16,208 |
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10,225 |
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Loss from operations |
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(15,029 |
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(9,425 |
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Interest income |
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33 |
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3 |
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Interest expense |
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(1,172 |
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(1,323 |
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Other income (expense), net |
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1 |
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329 |
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Loss before provision for income taxes |
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(16,167 |
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(10,416 |
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Provision for income taxes |
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1 |
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Net loss and comprehensive loss |
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(16,167 |
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(10,417 |
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Adjustment to net loss resulting from convertible preferred stock modification |
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(2,384 |
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Net loss and comprehensive loss attributable to common stockholders |
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$ |
(16,167 |
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$ |
(12,801 |
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Net loss attributable to common stockholders per share, basic and diluted |
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$ |
(1.28 |
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$ |
(1.53 |
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Weighted average common shares used to compute net loss per share, basic and diluted |
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12,669 |
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8,373 |
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Avinger, Inc.
Balance Sheets Data
(in thousands)
(unaudited)
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March 31, |
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December 31, |
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2016 |
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2015 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
26,882 |
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$ |
43,059 |
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Accounts receivable, net |
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4,036 |
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2,060 |
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Inventories |
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6,540 |
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5,405 |
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Prepaid expenses and other current assets |
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1,048 |
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533 |
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Total current assets |
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38,506 |
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51,057 |
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Property and equipment, net |
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3,207 |
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2,822 |
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Other assets |
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453 |
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225 |
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Total assets |
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$ |
42,166 |
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$ |
54,104 |
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Liabilities and stockholders equity |
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Current liabilities: |
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Accounts payable |
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$ |
2,312 |
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$ |
1,113 |
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Accrued compensation |
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3,349 |
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3,083 |
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Accrued expenses and other current liabilities |
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3,413 |
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3,285 |
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Total current liabilities |
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9,074 |
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7,481 |
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Borrowings, net of current portion |
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29,976 |
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29,565 |
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Other long-term liablities |
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1,298 |
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1,469 |
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Total liabilities |
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40,348 |
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38,515 |
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Stockholders equity: |
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Preferred stock |
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Common stock |
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13 |
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13 |
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Additional paid-in capital |
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214,233 |
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211,837 |
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Accumulated deficit |
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(212,428 |
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(196,261 |
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Total stockholders equity |
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1,818 |
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15,589 |
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Total liabilities and stockholders equity |
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$ |
42,166 |
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$ |
54,104 |
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