SECURITIES & EXCHANGE COMMISSION EDGAR FILING
Avinger Inc
Form: 10-K
Date Filed: 2020-03-06
Corporate Issuer CIK: 1506928
© Copyright 2020, Issuer Direct Corporation. All Right Reserved. Distribution of this document is strictly prohibited, subject to the terms of use.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-K
(Mark One)
☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the Fiscal Year Ended December 31, 201 9
or
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Commission File Number: 001-36817
AVINGER, INC.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of
incorporation or organization)
20-8873453
(I.R.S. Employer
Identification Number)
400 Chesapeake Drive
Redwood City, California 94063
(Address of principal executive offices and zip code)
(650) 241-7900
(Telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of Each Class:
Common Stock, par value $0.001 per share
Trading Symbol(s):
AVGR
Name of Each Exchange on which Registered
The Nasdaq Capital Market
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934
during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of
Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an
emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in
Rule 12b-2 of the Exchange Act.
Large accelerated filer ☐
Accelerated filer ☐
Non-accelerated filer ☒
Smaller reporting company ☒
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new
or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒
The aggregate market value of the voting and non-voting common equity held by non-affiliates of the registrant, based on the closing price of a share of
the registrant’s common stock on June 28, 2019, the last business day of the registrant’s most recently completed second fiscal quarter, as reported by the
Nasdaq Global Market on such date, was approximately $19.4 million. This calculation does not reflect a determination that certain persons are affiliates of
the registrant for any other purpose.
As of March 2, 2020, the number of outstanding shares of the registrant’s common stock, par value $0.001 per share, was 16,813,398.
None.
DOCUMENTS INCORPORATED BY REFERENCE
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
AVINGER, INC.
ANNUAL REPORT ON FORM 10-K
FOR THE FISCAL YEAR ENDED DECEMBER 31, 201 9
TABLE OF CONTENTS
Business
Part I
Item 1.
Item 1A. Risk Factors
Item 1B. Unresolved Staff Comments
Item 2.
Item 3.
Item 4. Mine Safety Disclosures
Properties
Legal Proceedings
Selected Financial Data
Part II
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
Item 6.
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
Financial Statements and Supplementary Data
Item 8.
Item 9.
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Item 9A. Controls and Procedures
Item 9B. Other Information
Part III
Item 10. Directors, Executive Officers and Corporate Governance
Item 11. Executive Compensation
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Item 13. Certain Relationships and Related Transactions, and Director Independence
Item 14. Principal Accountant Fees and Services
Part IV
Item 15. Exhibits and Financial Statement Schedules
Item 16. Form 10-K Summary
Signatures
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“Avinger,” “Pantheris,” and “Lumivascular” are trademarks of our company. Our logo and our other trade names, trademarks and service marks
appearing in this Annual Report on Form 10-K are our property. Other trade names, trademarks and service marks appearing in this Annual Report on Form 10-
K are the property of their respective owners. Solely for convenience, our trademarks and trade names referred to in this Annual Report on Form 10-K appear
without the ™ symbol, but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights,
or the right of the applicable licensor to these trademarks and trade names.
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K contains forward-looking statements concerning our business, operations and financial performance and condition, as
well as our plans, objectives and expectations for our business, operations and financial performance and condition. Any statements contained herein that are not
statements of historical facts may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such
as “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,”
“positioned,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the
negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about:
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the outcome of and expectations regarding our clinical studies, including our INSIGHT trial, and plans to conduct further clinical studies;
our plans to modify our current products, or develop new products, to address additional indications;
our ability to obtain additional financing through future equity or debt financings;
the expected timing of 510(k) clearances by FDA, for enhanced versions of Pantheris and Ocelot;
the expected timing of 510(k) submission to FDA, and associated marketing clearances by FDA, for additional versions of Pantheris and Ocelot;
the expected growth in our business and our organization;
our expectations regarding government and third-party payor coverage and reimbursement, including the ability of Pantheris and Ocelot to qualify for
reimbursement codes used by other atherectomy products;
our ability to continue as a going concern;
our ability to retain and recruit key personnel, including the continued development of our sales and marketing infrastructure;
our ability to obtain and maintain intellectual property protection for our products;
our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for, or ability to obtain, additional financing;
our expectations regarding revenue, cost of revenue, gross margins, and expenses, including research and development and selling, general and
administrative expenses;
our expectations regarding the time during which we will be an emerging growth company under the Jumpstart Our Business Startups Act;
our ability to identify and develop new and planned products and acquire new products;
our financial performance;
our ability to remain in compliance with laws and regulations that currently apply or become applicable to our business, both in the United States and
internationally; and
developments and projections relating to our competitors or our industry.
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We believe that it is important to communicate our future expectations to our investors. However, there may be events in the future that we are not able
to accurately predict or control and that may cause our actual results to differ materially from the expectations we describe in our forward-looking statements.
These forward-looking statements are based on management’s current expectations, estimates, forecasts and projections about our business and the industry in
which we operate and management’s beliefs and assumptions and are not guarantees of future performance or development and involve known and unknown
risks, uncertainties and other factors that are in some cases beyond our control. As a result, any or all of our forward-looking statements in this Annual Report on
Form 10-K may turn out to be inaccurate. Factors that may cause actual results to differ materially from current expectations include, among other things, those
listed in Part I, Item 1A under “Risk Factors” and elsewhere in this Annual Report on Form 10-K. Potential investors are urged to consider these factors carefully
in evaluating the forward-looking statements. These forward-looking statements speak only as of the date of this Annual Report on Form 10-K. We assume no
obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.
You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-
looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the
forward-looking statements will be achieved or occur. Except as required by law, we undertake no obligation to update publicly any forward-looking statements
for any reason after the date of this Annual Report on Form 10-K to conform these statements to actual results or to changes in our expectations.
You should read this Annual Report on Form 10-K and the documents that we reference in this Annual Report on Form 10-K and have filed with the
SEC as exhibits to the Annual Report on Form 10-K with the understanding that our actual future results, levels of activity, performance and events and
circumstances may be materially different from what we expect.
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ITEM 1. BUSINESS
Overview
PART I
We are a commercial-stage medical device company that designs, manufactures and sells image-guided, catheter-based systems that are used by
physicians to treat patients with peripheral artery disease, or PAD. Patients with PAD have a build-up of plaque in the arteries that supply blood to areas away
from the heart, particularly the pelvis and legs. Our mission is to significantly improve the treatment of vascular disease through the introduction of products
based on our Lumivascular platform, the only intravascular image-guided system available in this market.
We manufacture and sell a suite of products in the United States and select international markets. Our current products include our Lightbox imaging
console, the Ocelot family of catheters, which are designed to allow physicians to penetrate a total blockage in an artery, known as a chronic total occlusion, or
CTO, and Pantheris, our image-guided atherectomy device which is designed to allow physicians to precisely remove arterial plaque in PAD patients. We
received 510(k) clearance from the U.S. Food and Drug Administration, or FDA, for commercialization of Pantheris in October 2015. We received an additional
510(k) clearance for an enhanced version of Pantheris in March 2016 and commenced sales of Pantheris in the United States and select European countries
promptly thereafter. In May 2018, the Company also received 510(k) clearance from the FDA for its current next-generation version of Pantheris. In April 2019,
the Company received 510(k) clearance from the FDA for its Pantheris SV, a version of Pantheris targeting smaller vessels, and commenced sales in July 2019.
The Pantheris SV has a smaller diameter and longer length that we believe will optimize it for its targeted use. We also offer the Wildcat family of catheters,
which are used for crossing CTOs but do not contain on-board imaging technology. We generate sales of these devices in the U.S. and in select international
markets. We are located in Redwood City, California.
Current treatments for PAD, including bypass surgery, can be costly and may result in complications, high levels of post-surgery pain, and lengthy
hospital stays and recovery times. Minimally invasive, or endovascular, treatments for PAD include stenting, angioplasty, and atherectomy, which is the use of a
catheter-based device for the removal of plaque. These treatments all have limitations in their safety or efficacy profiles and frequently result in recurrence of the
disease, also known as restenosis. We believe one of the main contributing factors to high restenosis rates for PAD patients treated with endovascular
technologies is the amount of vascular injury that occurs during an intervention. Specifically, these treatments often disrupt the membrane between the
outermost layers of the artery, which is referred to as the external elastic lamina, or EEL.
We believe our Lumivascular platform is the only technology that offers real-time visualization of the inside of the artery during PAD treatment through
the use of optical coherence tomography, or OCT, a high resolution, light-based, radiation-free imaging technology. Our Lumivascular platform provides
physicians with real-time OCT images from the inside of an artery, and we believe Ocelot and Pantheris are the first products to offer intravascular visualization
during CTO crossing and atherectomy, respectively. We believe this approach will significantly improve patient outcomes by providing physicians with a clearer
picture of the artery using radiation-free image guidance during treatment, enabling them to better differentiate between plaque and healthy arterial structures.
Our Lumivascular platform is designed to improve patient safety by enabling physicians to direct treatment towards the plaque, while avoiding damage to healthy
portions of the artery.
During the first quarter of 2015, we completed enrollment of patients in VISION, a clinical trial designed to support our August 2015 510(k) submission to
the FDA for our Pantheris atherectomy device. VISION was designed to evaluate the safety and efficacy of Pantheris to perform atherectomy using intravascular
imaging and successfully achieved all primary and secondary safety and efficacy endpoints. We believe the data from VISION allows us to demonstrate that
avoiding damage to healthy arterial structures, and in particular disruption of the external elastic lamina, which is the membrane between the outermost layers of
the artery, reduces the likelihood of restenosis, or re-narrowing, of the diseased artery. Although the original VISION study protocol was not designed to follow
patients beyond six months, we worked with 18 of the VISION sites to re-solicit consent from previous clinical trial patients in order for them to evaluate patient
outcomes through 12 and 24 months following initial treatment. Data collection for the remaining patients from participating sites was completed in May 2017,
and we released the final 12- and 24-month results for a total of 89 patients in July 2017. We commenced commercialization of Pantheris as part of our
Lumivascular platform in the United States and in select international markets in March 2016, after obtaining the required marketing authorizations.
During the fourth quarter of 2017, we began enrolling patients in INSIGHT, a clinical trial designed to support a submission to the FDA to expand the
indication for our Pantheris atherectomy device to include in-stent restenosis. Patient enrollment began in October 2017 and is expected to continue through
2020. Patient outcomes will be evaluated at thirty days, six months and one year following treatment. We plan to submit a 510(k) application with the FDA
seeking a specific indication for treating in-stent restenosis with Pantheris once the trial is fully enrolled and follow-up data through six months are available and
analyzed.
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We focus our direct sales force, marketing efforts and promotional activities on interventional cardiologists, vascular surgeons and interventional
radiologists. We also work on developing strong relationships with physicians and hospitals that we have identified as key opinion leaders. Although our sales
and marketing efforts are directed at these physicians because they are the primary users of our technology, we consider the hospitals and medical centers
where the procedure is performed to be our customers, as they typically are responsible for purchasing our products. We are designing future products to be
compatible with our Lumivascular platform, which we expect to enhance the value proposition for hospitals to invest in our technology. Pantheris qualifies for
existing reimbursement codes currently utilized by other atherectomy products, further facilitating adoption of our products.
We have assembled a team with extensive medical device development and commercialization capabilities. In addition to the commercialization of
Pantheris in the United States and select international markets in March 2016, we began commercializing our initial non-Lumivascular platform products in 2009
and introduced our Lumivascular platform products in the United States in late 2012. We generated revenues of $10.7 million in 2015, $19.2 million in 2016,
$9.9 million in 2017, $7.9 million in 2018, and $9.1 million in 2019. The growth experienced in 2019 is largely due to our next generation Pantheris and the
launch of Pantheris SV.
Our Products
Our current products include our Lightbox imaging console and our various catheters used in PAD treatment. All of our revenues are currently derived
from sales of our Lightbox imaging console and our various PAD catheters and related services in the United States and select international markets. Each of our
current products is, and our future products will be, designed to address significant unmet clinical needs in the treatment of vascular disease.
LUMIVASCULAR PRODUCTS
Name
PRODUCTS
Lightbox (1)
Pantheris SV (small vessel) (2)
Pantheris (next-generation) (3)
Ocelot(4)
Ocelot MVRX(4)
Ocelot PIXL(4)
PIPELINE PRODUCTS
Ocelaris(4)
Clinical
Indication
OCT Imaging
Atherectomy
Atherectomy
CTO Crossing
CTO Crossing
CTO Crossing
Size
(Length,
Diameter)
Regulatory
Status
Original
Clearance Date
N/A
110cm, 7F
140cm, 6F
FDA Cleared
CE Marking
FDA Cleared
CE Marking
FDA Cleared
CE Marking
FDA Cleared
CE Marking
110cm, 6F
FDA Cleared
135/150cm, 5F FDA Cleared
110cm, 6F
CE Marking
November 2012
September 2011
April 2019
October 2018
May 2018
December 2017
November 2012
September 2011
December 2012
December 2012
October 2012
CTO Crossing
140cm, 5F
CE Marking
December 2019
(1) Lightbox is cleared for use with compatible Avinger products.
(2) The Pantheris SV system is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature with a reference diameter
of 2.0 mm to 4.0 mm, using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen, wall
structures and vessel morphologies. The Pantheris SV System is contraindicated for use in the iliac, coronary, cerebral, renal or carotid vasculature.
(3) The Pantheris system is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature with a reference diameter of
3.0 mm to 7.0 mm, using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen, wall
structures and vessel morphologies. The Pantheris System is contraindicated for use in the iliac, coronary, cerebral, renal or carotid vasculature.
(4) The Ocelot system is intended to facilitate the intra-luminal placement of conventional guidewires beyond stenotic lesions including subtotal and chronic total
occlusions in the peripheral vasculature prior to further percutaneous interventions using OCT-assisted orientation and imaging. The system is an adjunct to
fluoroscopy and provides images of vessel lumen, plaques and wall structures. The Ocelot system is contraindicated for use in the iliac, coronary, cerebral,
renal and carotid vasculature.
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NON-IMAGING PRODUCTS
Name
Wildcat (1)
Kittycat 2 (2)
Size
(Length,
Diameter)
110cm, 6F
110cm, 6F
150cm, 5F
Indication
Guidewire
Support
CTO Crossing
CTO Crossing
Regulatory
Status
FDA Cleared
FDA Cleared
CE Marking
FDA Cleared
CE Marking
Original
Clearance Date
February 2009(3)
August 2011
May 2011
October 2011
September 2011
(1) The Wildcat catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including subtotal and chronic
total occlusions) in the peripheral vasculature prior to further percutaneous intervention. The Wildcat catheter is contraindicated for use in the iliac, coronary,
cerebral, renal and carotid vasculature. The Wildcat catheter is intended to be used to support steerable guidewires in accessing discrete regions of the
peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. It may also be used to deliver
saline or contrast.
(2) The Kittycat 2 catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including subtotal and chronic
total occlusions) in the peripheral vasculature prior to further percutaneous intervention. The Kittycat 2 catheter is contraindicated for use in the iliac,
coronary, cerebral, renal and carotid vasculature.
(3) This original clearance date is for the 7F version of Wildcat. The commercially available version of Wildcat is listed and was cleared in August 2010.
Lumivascular Platform Overview
Our Lumivascular platform integrates OCT (optical coherence tomography) visualization with interventional catheters and is the industry’s only system
that provides real-time intravascular imaging simultaneously with treatment in PAD procedures. Our Lumivascular platform consists of a capital component,
Lightbox, and a variety of disposable catheter products, including Ocelot, Ocelot PIXL, Ocelot MVRX and Pantheris catheters.
Lightbox
Lightbox is our proprietary imaging console, which enables the use of Lumivascular catheters during PAD procedures. The console contains an optical
transceiver that transmits light into the artery through an optical fiber and displays a cross-sectional image of the vessel to the physician on a high definition
monitor during the procedure. Lightbox is configured with two monitors, one for the physicians, and one for the Lightbox technician.
Lightbox displays a cross-sectional view of the vessel, which provides physicians with detailed information about the orientation of the catheter and the
surrounding artery and plaque. Layered structures represent relatively healthy portions of the artery and non-layered structures represent the plaque that is
blocking blood flow in the artery. Navigational markers allow the physician to orient the catheter toward the treatment area, helping to avoid damage to the
healthy arterial structures during a procedure. Lightbox received FDA 510(k) clearance in November 2012 and CE Marking in Europe in September 2011. We
are in the process of developing a next-generation Lightbox with a reduced footprint and improved technology. We currently anticipate launching our next-
generation Lightbox in the first half of 2021.
Pantheris
We believe Pantheris is the first atherectomy catheter to incorporate real-time OCT intravascular imaging. Pantheris may be used alone or following a
CTO crossing procedure using Ocelot or other products. Pantheris is a single-use product and provides physicians with the ability to see a cross-sectional view
of the peripheral artery to guide the removal of blockages throughout the procedure. The device restores blood flow by shaving strips of plaque using a high-
speed directional cutting mechanism that enables physicians to specifically target the portion of the artery where the plaque resides while minimizing disruption
to healthy arterial structures. The excised plaque is deposited in the nosecone of the device and removed from the artery within the device.
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In October 2015, we received 510(k) clearance from the FDA for commercialization of Pantheris. We made modifications to Pantheris after the
completion of the VISION trial and commenced sales in the United States and select international markets following receipt of FDA approval for this version of
Pantheris in March 2016. We first received CE Marking for Pantheris in June 2015. We received CE Marking in December 2017 and 510(k) clearance in May
2018 for a next-generation version of Pantheris, which includes new features and design improvements to the handle, shaft, balloon and nose-cone of the device.
The next-generation Pantheris atherectomy device is currently available for commercial sale in the United States and select international markets. All previous
versions of Pantheris have been discontinued.
We also developed a line extension of our Pantheris image-guided atherectomy platform, Pantheris SV (small vessel), a lower profile version of
Pantheris. The Pantheris SV has a smaller diameter and longer length and is designed for use in smaller vessels 2.0 to 4.0 millimeters in diameter. We received
CE Marking in October 2018 and 510(k) clearance in April 2019 for this product and commenced sales in the United States in July 2019.
Ocelot, Ocelot PIXL, Ocelot MVRX and Ocelaris
Ocelot is the first CTO crossing catheter to incorporate real-time OCT imaging, which allows physicians to see the inside of a peripheral artery during a
CTO crossing procedure. Physicians have traditionally relied solely on fluoroscopy and tactile feedback to guide catheters through complicated blockages. Ocelot
allows physicians to accurately navigate through CTOs by utilizing the OCT images to precisely guide the device through the arterial blockage, while minimizing
disruption to the healthy arterial structures. A successful CTO crossing and placement of a guidewire allows the physician to subsequently treat the vessel with a
minimally invasive therapeutic device. We received CE Marking for Ocelot in September 2011 and received FDA 510(k) clearance in November 2012.
We also offer Ocelot PIXL, a lower profile CTO crossing device for below-the-knee arteries and Ocelot MVRX, which offers a different tip design for
peripheral arteries above the knee. We received CE Marking for Ocelot PIXL in October 2012 and received FDA 510(k) clearance in December 2012. We
received FDA 510(k) clearance for Ocelot MVRX in December 2012.
We are also developing Ocelaris, a next generation, image-guided CTO catheter. Ocelaris is a new product extension of our Ocelot family of catheters
and is designed to bring significant improvements to the platform, including enhanced imaging, the ability to spin at speeds up to 1000 RPM, and a steerable tip
for precise maneuverability. We received CE Marking for Ocelaris in December 2019. We expect to submit for 510(k) clearance from the FDA in the first half of
2020.
Other Products
Our first-generation CTO crossing catheters, Wildcat and Kittycat, employ a proprietary design that uses a rotational spinning technique, allowing the
physician to switch between passive and active modes when navigating across a CTO. Once across the CTO, Wildcat and Kittycat allow for placement of a
guidewire and removal of the catheter while leaving the wire in place for additional therapies. Both products require the use of fluoroscopy solely rather than our
Lumivascular (OCT-guided) platform for imaging. Wildcat was our first commercial product and has both FDA 510(k) clearance in the United States and CE
Marking in Europe for crossing peripheral artery CTOs. Kittycat has FDA 510(k) clearance in the United States and CE Marking in Europe for the treatment of
peripheral artery CTOs. Sales of Wildcat and Kittycat 2 have declined and are continuing to decline as we focus on the promotion of our Lumivascular platform
products.
Clinical Development
We have conducted several clinical trials to evaluate the safety and efficacy of our products in both pre-market and post-market assessments. We
received FDA clearance for Wildcat and Ocelot for CTO crossing in 2011 and 2012, respectively, and for Pantheris in October 2015, following completion of
clinical trials of the devices.
CONNECT (Wildcat)
Our clinical trial for the Wildcat catheter, known as the CONNECT trial, was a prospective, multi-center, non-randomized trial that evaluated the safety
and efficacy of Wildcat in crossing CTOs in arteries of the upper leg. The CONNECT trial enrolled 88 patients with CTOs at 15 centers in the United States.
Patients were followed for 30 days post-procedure and an independent group of physicians verified the results to determine crossing efficacy and safety
endpoints. The CONNECT trial demonstrated that Wildcat was able to cross 89% of CTOs following unsuccessful attempts to cross with standard guidewire
techniques. The trial demonstrated a 95% freedom from major adverse events, or MAEs. In the CONNECT trial, MAEs were defined as clinically significant
perforations or embolizations and/or Grade C or greater dissections occurring within 30 days of the procedure. These results represent the second-highest
reported CTO crossing rate of any published CTO clinical trial, exceeded only by our subsequent CONNECT II clinical trial results.
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CONNECT II (Ocelot)
Our clinical trial for Ocelot, known as CONNECT II, was a prospective, multi-center, non-randomized trial that evaluated the safety and efficacy of Ocelot
in crossing CTOs in arteries of the upper leg using OCT intravascular imaging. The CONNECT II trial enrolled 100 patients with CTOs at 14 centers in the
United States and two centers in Europe. Patients were followed for 30 days post-procedure and an independent group of physicians verified the results to
confirm the primary efficacy and safety endpoints. Results from the CONNECT II trial demonstrated that Ocelot surpassed its primary efficacy endpoint by
successfully crossing the CTO in 97% of the cases following unsuccessful attempts to cross with standard guidewire techniques. Ocelot achieved these rates
with 98% freedom from MAEs.
VISION (Pantheris)
VISION was our pivotal, non-randomized, prospective, single-arm trial to evaluate the safety and effectiveness of Pantheris across 20 sites within the
United States and Europe. The objective of the clinical trial was to demonstrate that Pantheris can be used to effectively remove plaque from diseased lower
extremity arteries while using on-board visualization as an adjunct to fluoroscopy. Two groups of patients were treated in VISION: (1) optional roll-ins, which are
typically the first two procedures at a site, and (2) the primary cohort, which are the analyzable group of patients. The data for these two groups were reported
separately in our 510(k) submission to the FDA. Based on final enrollment, the primary cohort included 130 patients. In March 2015, we completed enrollment of
patients in the VISION clinical trial and we submitted for 510(k) clearance from the FDA in August 2015. In October 2015, we received 510(k) clearance from
the FDA for commercialization of Pantheris. We made modifications to Pantheris subsequent to the completion of VISION and received 510(k) clearance on the
enhanced version of Pantheris in March 2016 and received 501(k) clearance in May 2018 for a next-generation version of Pantheris, which includes new
features and design improvements to the handle, shaft, balloon and nose cone of the device as well as 510(k) clearance in April 2019 for Pantheris SV, a lower
profile Pantheris.
VISION’s primary efficacy endpoint required that at least 87% of lesions treated by physicians using Pantheris have a residual stenosis of less than 50%,
as verified by an independent core laboratory. The primary safety endpoint required that less than 43% of patients experience an MAE through six-month follow-
up as adjudicated by an independent Clinical Events Committee, or CEC. MAEs as defined in VISION included cardiovascular-related death, unplanned major
index limb amputation, clinically driven target lesion revascularization, or TLR, heart attack, clinically significant perforation, dissection, embolus, and
pseudoaneurysm. Results from the VISION trial demonstrated that Pantheris surpassed its primary efficacy and safety endpoints; residual restenosis of less
than 50% was achieved in 96.3% of lesions treated in the primary cohort, while MAEs were experienced in 16.6% of patients.
Although not mandated by the FDA to support the market clearance of Pantheris, the protocol for the VISION trial allowed for routine histopathological
analysis of the tissue extracted by Pantheris to be conducted. This process allowed us to determine the amount of adventitia present in the tissue, which in turn
indicated the extent to which the external elastic lamina had been disrupted during Pantheris procedures. We completed histopathological analysis on tissue
from 129 patients in the primary cohort, representing 162 lesions and determined that the average percent area of adventitia was only 1.0% of the total excised
tissue. We believe the low level of EEL disruption will correlate to lower restenosis rates and improved long-term outcomes for patients treated with Pantheris.
We published the results of the histopathological analysis in conjunction with the primary safety and efficacy endpoint data from the VISION trial.
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Final VISION trial data is summarized in the table below.
Patients Treated
Lesions treated
Primary Efficacy Endpoint
Lesions analyzed by core lab
Lesions meeting primary efficacy endpoint criterion of residual restenosis of less than 50% by
core lab
Primary Safety Endpoint (MAEs through 6 months)
Total MAEs Reported
Reported MAEs as a percentage of patients enrolled
Histopathology Results (Non-Endpoint Data)
Lesions with histopathology results
Average percent area of adventitia in all lesions with histopathology results
Roll-In
Cohort
Primary
Cohort
Total
28
34
34
100%
(34/34)
3
11.5%
(3/26)
34
0.56%
130
164
164
96.3%
(158/164)
22
17.6%
(22/125)
162
1.02%
158
198
198
97%
(192/198)
25
16.6%
(25/151)
196
0.94%
Although the original VISION study protocol was not designed to follow patients beyond six months, in 2016 we began working with 18 of the VISION
sites to re-consent patients in order for them to be evaluated for patient outcomes through 12 and 24 months following initial treatment. Data collection for
patients from participating sites was completed in May 2017, and we released the final 12- and 24-month results for a total of 73 patients and 89 lesions in
July 2017. The key metrics reported for this group were freedom from target lesion revascularization, or TLR, at 12 months and 24 months, which were 82% and
74% by patient and 83% and 76% by lesion, respectively, based on Kaplan-Meier curve assessments.
INSIGHT (Pantheris)
INSIGHT is a prospective, global, single-arm, multi-center study to evaluate the safety and effectiveness of Pantheris for treating in-stent restenosis in
lower extremity arteries. In-stent restenosis occurs when a blocked artery previously treated with a stent becomes narrowed again, thereby reducing blood flow.
Physicians often face challenges when treating in-stent restenosis both in terms of safety and efficacy. From a safety standpoint, limitations in imaging
techniques, such X-ray fluoroscopy, and the inability to control the directionality of other atherectomy devices create concerns with impacting the integrity of the
stent during the procedure. In terms of efficacy, current therapies for in-stent restenosis, such as balloon angioplasty, have high rates of recurrent narrowing
within stents.
The INSIGHT trial allows for up to 140 patients to be treated at up to 20 sites in the United States and Europe. Patient enrollment began in October 2017
and will continue through 2020. Patient outcomes will be evaluated at thirty days, six months and one year following treatment. We plan to submit a 510(k)
application with the FDA seeking a specific indication for treating in-stent restenosis with Pantheris once the data through six months are available and analyzed.
We are pursuing additional clinical data programs including a post-market study evaluating safety and efficacy for Pantheris SV.
Sales and Marketing
We focus our sales and marketing efforts primarily on the approximately 10,000 interventional cardiologists, vascular surgeons and interventional
radiologists in the United States that are potential users of our Lumivascular platform products. Our marketing efforts are focused on developing strong
relationships with physicians and hospitals that we have identified as key opinion leaders based on their knowledge of our products, clinical expertise and
reputation. We also use continuing medical education programs and other opportunities to train interventional cardiologists, vascular surgeons, and interventional
radiologists in the use of our Lumivascular platform products and educate them as to the benefits of our products as compared to alternative procedures such as
angioplasty, stenting, bypass surgery or other atherectomy procedures. In addition, we work with physicians to help them develop their practices and with
hospitals to market themselves as centers of excellence in PAD treatment by making our products available to physicians for treating patients.
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Our sales team currently consists of a Vice President, Regional Directors and Managers, and Territory Sales Managers, Clinical Specialists, and one
Vice President of International Sales. Territory Sales managers are responsible for all product sales, which include disposable catheters and sale and service of
our Lightbox console, while Clinical Specialists are primarily responsible for case coverage and account support. We have an extensive hands-on sales training
program, focused on our technologies, Lumivascular image interpretation, case management, sales processes, sales tools and implementing our sales and
marketing programs and compliance with applicable federal and state laws and regulations. Our sales team is supported by our marketing team, which focuses
primarily on clinical training and education, marketing communications and product management. We have partnered with a third-party field service firm for the
installation, service and maintenance of our Lightbox consoles.
No single customer accounted for more than 10% of our revenues during 2019 or 2018.
Competition
The medical device industry is highly competitive, subject to rapid change and significantly affected by new product introductions, results of clinical
research, reimbursement dynamics, corporate combinations and other factors relating to our industry. Because of the market opportunity and the high growth
potential of the PAD treatment market, competitors and potential competitors have historically dedicated, and will continue to dedicate, significant resources to
aggressively develop and commercialize their products.
Our products compete with a variety of products or devices for the treatment of PAD, including other CTO crossing devices, stents, balloons and
atherectomy catheters, as well as products used in vascular surgery. Large competitors in the CTO crossing, stent and balloon market segments include Abbott
Laboratories, AngioDynamics, Becton Dickinson, Boston Scientific, Cardinal Health, Cook Medical, Medtronic and Philips. Competitors in the atherectomy
market include AngioDynamics, Boston Scientific, Cardiovascular Systems, Medtronic and Philips. Some competitors have attempted to combine intravascular
imaging with atherectomy and although we are not aware of any active initiatives in this area, these and other companies may attempt to incorporate on-board
visualization into their products in the future or may have ongoing programs of which we are not aware. Other competitors include pharmaceutical companies
that manufacture drugs for the treatment of symptoms associated with mild to moderate PAD and companies that provide products used by surgeons in
peripheral and coronary bypass procedures. These competitors and other companies may introduce new products that compete with our solution.
Many of our competitors have substantially greater financial, manufacturing, marketing and technical resources than we do. Furthermore, many of our
competitors have well-established brands, widespread distribution channels and broader product offerings, and have established stronger and deeper
relationships with target customers.
To compete effectively, we have to demonstrate that our products are attractive alternatives to other devices and treatments on the basis of:
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procedural safety and efficacy;
acute and long-term outcomes;
ease of use and procedure time;
price;
size and effectiveness of sales force;
radiation exposure for physicians, hospital staff and patients; and
third-party reimbursement.
Intellectual property
In order to remain competitive, we must develop and maintain protection of the proprietary aspects of our technologies. We rely on a combination of
patents, copyrights, trademarks, trade secret laws and confidentiality and invention assignment agreements to protect our intellectual property rights.
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It is our policy to require our employees, consultants, contractors, outside scientific collaborators and other advisors to execute non-disclosure and
assignment of invention agreements on commencement of their employment or engagement. Agreements with our employees also forbid them from using the
proprietary rights of third parties in their work for us. We also require confidentiality or material transfer agreements from third parties that receive our confidential
data or materials.
As of December 31, 2019, we held 31 issued and allowed U.S. patents and had 25 U.S. utility patent applications and 1 PCT applications pending. As of
December 31, 2019, we also had 60 issued and allowed patents from outside of the United States. As of December 31, 2019, we had 43 pending patent
applications outside of the United States, including in Australia, Canada, China, Europe, India and Japan. As we continue to research and develop our products
and technology, we intend to file additional U.S. and foreign patent applications related to the design, manufacture and therapeutic uses of our devices. Our
issued patents expire between the years 2028 and 2035.
Our patent applications may not result in issued patents and our patents may not be sufficiently broad to protect our technology. Any patents issued to us
may be challenged by third parties as being invalid, or third parties may independently develop similar or competing technology that avoids our patents. The
laws of certain foreign countries do not protect our intellectual property rights to the same extent as do the laws of the United States.
As of December 31, 2019, we held five registered U.S. trademarks. In Europe, we hold three registered trademarks. In addition, we held one
International Registration under the Madrid Protocol with granted extensions to China, Europe, Japan, and Korea (reflected in the three European registration
noted above).
Research and Development
Our ongoing research and development activities are primarily focused on improving and enhancing our Lumivascular platform, specifically our core
competency of integrating OCT intravascular imaging onto therapeutic catheters. Our research objectives target areas of unmet clinical need, increase the utility
of the Lumivascular platform and adoption of our products by healthcare providers.
•
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Product line improvements and extensions. We are developing improvements to our Lumivascular platform, including additional catheters for use in
different clinical applications. For example, we are developing next-generation CTO crossing devices to target both the peripheral and coronary CTO
markets.
Additional treatment indications. We intend to seek additional regulatory clearances from FDA to expand the indications for which our products can be
marketed within PAD, as well as in other areas of the body. This includes both expanding the marketed indications for our current products, as well as
development of new products.
Next-generation console. We are focusing our console development efforts on miniaturization, equipment integration and increased processing power in
anticipation of future catheter products. We may also develop a version of our Lumivascular platform that integrates OCT imaging into existing
catheterization lab and operating room imaging systems.
Improved software and user interface. We intend to further develop our software to provide more information and control to our end users during a
procedure. We use physician and staff feedback to improve the features and user functionality of our Lumivascular platform.
In addition to our internal team, we retain third-party contractors from time to time to provide us with assistance on specialized projects. We also work
closely with experts in the medical community to supplement our internal research and development resources.
Manufacturing
All of our products are manufactured in-house using components and sub-assemblies manufactured both in-house at our facility in Redwood City,
California and by outside vendors. We assemble all of our products at our manufacturing facility but certain critical processes such as coating and sterilization
are done by outside vendors. We expect our current manufacturing facility will be sufficient through at least 2020.
Order quantities and lead times for components purchased from outside suppliers are based on our forecasts derived from historical demand and
anticipated future demand. Lead times for components may vary significantly depending on the size of the order, time required to fabricate and test the
components, specific supplier requirements and current market demand for the components and subassemblies. To date, we have not experienced significant
delays in obtaining any of our components or subassemblies.
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We rely on single and limited source suppliers for several of our components and sub-assemblies. For example, we rely on single vendors for our optical
fiber, coating and drive cables that are key components of our catheters, and we rely on single vendors for our laser and data acquisition card that are key
components of our Lightbox. These components are critical to our products and there are relatively few alternative sources of supply for them. Identifying and
qualifying additional or replacement suppliers for any of the components used in our products could involve significant time and cost. Any supply interruption
from our vendors or failure to obtain additional vendors for any of the components used to manufacture our products would limit our ability to manufacture our
products and could therefore harm our business, financial condition and results of operations.
Our manufacturing operations are subject to regulatory requirements of 21 CFR part 820 of the Federal Food, Drug and Cosmetic Act, or FFDCA; the
Quality System Regulation, or QSR, for medical devices sold in the United States, which is enforced by FDA; the Medical Devices Directive 93/42/EEC, which is
required for doing business in the European Union; and applicable requirements relating to the environment, waste management and health and safety matters,
including measures relating to the release, use, storage, treatment, transportation, discharge, disposal and remediation of hazardous substances, and the sale,
labeling, collection, recycling, treatment and disposal of products containing hazardous substances. We cannot ensure that we will not incur material costs or
liability in connection with our operations, or that our past or future operations will not result in claims by or injury to employees or the public.
Other than through accepted purchase orders, our suppliers have no contractual obligations to supply us with, and we are not contractually obligated to
purchase from them, any of our supplies. Any supply interruption from our vendors or failure to obtain additional vendors for any of the components would limit
our ability to manufacture our products and could have a material adverse effect on our business, financial condition and results of operations.
We have registered with FDA as a medical device manufacturer and have obtained a manufacturing license from the California Department of Public
Health, or CDPH. We and our component suppliers are required to manufacture our products in compliance with FDA’s QSR in 21 CFR part 820 of the FFDCA.
The QSR regulates extensively the methods and documentation of the design, testing, control, manufacturing, labeling, quality assurance, packaging, storage
and shipping of our products. FDA enforces the QSR through periodic unannounced inspections that may include the manufacturing facilities of our
subcontractors. Our Quality System has undergone 20 external audits by third-parties and regulatory authorities since 2009, the latest of which was a
surveillance audit conducted in January 2017 by BSI, our European Notified Body, under the Medical Device Single Audit Program, or MDSAP. The audit
resulted in zero observations of non-conformances. In 2018 and 2019, BSI conducted multiple routine audits including surveillance audit, Microbiology audit, a
MDSAP re-certification audit and most recently, a one-day unannounced audit in September 2019. All non-conformances identified in the aforementioned audits
have been either successfully resolved or are being actively addressed via Avinger’s CAPA system.
Our failure or the failure of our component suppliers to maintain compliance with the QSR requirements could result in the shutdown of our
manufacturing operations or the recall of our products, which would harm our business. In the event that one of our suppliers fails to maintain compliance with
our or governmental quality requirements, we may have to qualify a new supplier and could experience manufacturing delays as a result. We have opted to
maintain quality assurance and quality management certifications to enable us to market our products in the member states of the European Union, the
European Free Trade Association and countries which have entered into Mutual Recognition Agreements with the European Union. Our Redwood City facilities
meet the requirements set forth by ISO 13485:2003 Medical devices—Quality management systems—Requirements for regulatory purposes and MDD
93/42/EEC European Union Council Medical Device Directive.
Government Regulation
In general, medical device companies must navigate a challenging regulatory environment. In the United States the FDA regulates the medical device
market to ensure the safety and efficacy of these products. The FDA allows for two primary pathways for a medical device to gain approval for commercialization:
(i) a pre-market notification or 510(k) submission based upon being equivalent to a device already in commercial distribution (a predicate device) or (ii) a PMA
(pre-market approval). A completely novel product must go through the more rigorous PMA process if it cannot receive authorization through a 510(k)
submission. The FDA has established three different classes of medical devices that indicate the level of risk associated with using a device and consequent
degree of regulatory controls needed to govern its safety and efficacy. Class I and Class II devices are considered to have minimal risk to the user and typically
can be marketed without a PMA or 510(k) clearance. Some Class I and almost all Class II devices gain clearance for commercial distribution following review of
an application to the FDA, generally known as the 510(k) process. The devices regarded as the highest risk by the FDA are designated Class III and generally
require the submission of a PMA application for approval prior to commercialization of a product. Class III devices generally include life-sustaining, life-
supporting, or implantable devices or devices without a known predicate technology already approved by the FDA.
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The 510(k) clearance path can be significantly less time-consuming and more arduous than PMA approval, making this route generally preferable for a
medical device company. A 510(k) application must include documentation that its device is substantially equivalent to a technology already cleared through a
510(k) or in distribution before May 28, 1976 for which the FDA has not required a PMA submission. The FDA has 90 days from the date of the pre-market
equivalence acceptance to authorize or decline commercial distribution of the device. However, similar to the PMA process, clearance may take longer than this
three-month window, as the FDA can request additional data to support the submission. If the FDA resolves that the product is not substantially equivalent to a
predicate device, then the device acquires a Class III designation, and a PMA must be approved before the device can be commercialized. All of our currently
marketed products have received commercial clearance and associated indications for use through the 510(k) regulatory pathway, some with the support of
clinical data.
After a device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute a change in its
intended use, requires an additional 510(k) submission and clearance before the modified device can be commercialized. The FDA allows each manufacturer to
make this determination initially, but the FDA can review any such decision and can disagree with the manufacturer’s determination. If the FDA disagrees with
the determination not to seek a new 510(k) clearance or PMA the FDA may retroactively require a new 510(k) clearance or pre-market approval for the modified
device. The FDA could also require a manufacturer to cease marketing and distribution of the modified device and/or recall the modified device until
510(k) clearance or PMA approval is obtained. Also, in these circumstances, a manufacturer may be subject to significant regulatory fines, penalties, and
enforcement actions.
A PMA application must include reasonable scientific and clinical data that demonstrates the device is safe and effective for the intended uses and
indications being sought. The application must also include preclinical testing, technical, manufacturing and labeling information. If the FDA determines the
application can undergo substantive review, it has 180 days to review the submission, but it can typically take longer (up to several years) as this regulatory body
can request additional information or clarifications. The FDA may also impose additional regulatory hurdles for a PMA, including the institution of an advisory
panel of experts to assess the application or provide recommendations as to whether to approve the device. Although the FDA in the end approves or
disapproves the device, in nearly all cases the FDA follows the recommendation from the advisory panel. As part of this process, the FDA will usually inspect
the manufacturing facilities and operations prior to approval to verify compliance with quality control regulations. Significant changes in the manufacturing of a
device, or changes in the intended use, indications and labeling or design of a product require new PMA applications or PMA supplements for a product originally
approved under a PMA. This creates substantial regulatory risk for devices undergoing the PMA route.
Pervasive and Continuing Regulation
After a device is placed on the market, numerous regulatory requirements continue to apply. These include:
•
•
the FDA’s QSR (quality system regulation) that requires manufacturers, including third-party manufacturers, to follow stringent design, testing, control,
documentation and other quality assurance procedures during all aspects of the manufacturing process;
labeling regulations and FDA prohibitions against the promotion of products for uncleared, unapproved or off-label uses; clearance or approval of product
modifications that could significantly affect safety or efficacy or that would constitute a major change in intended use;
• medical device reporting, or MDR, regulations, that require manufacturers report to the FDA if their device may have caused or contributed to a death or
serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction were to recur; and
•
post-market surveillance regulations, which apply when necessary to protect the public health or to provide additional safety and effectiveness data for
the device.
The MDR regulations require that we report to the FDA any incident in which our product may have caused or contributed to a death or serious injury or
in which our product malfunctioned and, if the malfunction were to recur, would likely cause or contribute to death or serious injury.
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We are registered with the FDA as a medical device manufacturer and have obtained a manufacturing license from the California Department of Public
Health (CDPH). The FDA has broad post-market and regulatory enforcement powers. We are subject to unannounced inspections by the FDA and the Food and
Drug Branch of CDPH to determine our compliance with the QSR and other regulations, and these inspections may include the manufacturing facilities of our
suppliers. Our current facility has been inspected by the FDA in 2009, 2011 and 2013, and two, three and zero observations, respectively, were noted during
those inspections. In the latest FDA audit in 2013, there were no observations that involved a material violation of regulatory requirements, and no non-
conformances were noted. Our responses to the observations noted in 2009 and 2011 were accepted by the FDA, and we believe that we are in substantial
compliance with the QSR. BSI, our European Notified Body, inspected our facility several times between 2010 and 2015 and found zero non-conformances. BSI
conducted four external audits in 2016 and zero non-conformances were found in all except for one audit, for which four minor non-conformances were found. A
BSI audit performed in January 2017 resulted in zero non-conformances and an unannounced audit in September 2019, noted only two minor non-
conformances, which were addressed promptly and resolved. In 2015, Avinger joined the medical device-single audit program (MD-SAP) that permits audits by
BSI to substitute for routine FDA inspections.
Failure to comply with applicable regulatory requirements can result in enforcement action by FDA, which may include any of the following sanctions:
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•
warning letters, adverse publicity, fines, injunctions, consent decrees and civil penalties;
repair, replacement, refunds, recall or seizure of our products;
operating restrictions, partial suspension or total shutdown of production;
refusing our requests for 510(k) clearance or pre-market approval of new products, new intended uses or modifications to existing products;
withdrawing 510(k) clearance or pre-market approvals that have already been granted; and
criminal prosecution.
Regulatory System for Medical Devices in Europe
In March 2019, we successfully transferred all current product certificates from BSI-UK to BSI-Netherlands in anticipation of the UK leaving the
European Union. Our products currently CE marked and distributed in the EU will be subject to the new EU MDR regulations (replacing the current MDD)
starting in May 2020 with a transitional period extending to May 27, 2024 or the length of the currently issued Notified Body certification, whichever comes first.
While we have multiple ongoing efforts to update our quality management system and product technical documentation to be fully compliant with the new
requirements and intend to be certified to MDR before the deadline, (as required by our Notified Body BSI). During the transition period, and until such time as
we are fully certified to the new MDR, we will be highly limited in our ability to make significant product changes to existing design and intended purposes of
products (for distribution in the EU only) and/or will be unable to launch new products in the EU. If we do not become fully certified before the end of the
transition period, such limitations could harm our business, financial condition and operating results.
The system of regulating medical devices operates by way of a certification for each medical device. Each certificated device is marked with CE marking
that shows the device has a Certificat de Conformité. There are national bodies known as Competent Authorities in each member state in the EU that oversee
the implementation of the MDD within its jurisdiction. The means for achieving the requirements for CE marking varies according to the nature of the device.
Devices are classified in accordance with their perceived risks, similarly to the U.S. system. The class of a product determines the requirements to be fulfilled
before CE marking can be placed on a product, known as a conformity assessment. Currently conformity assessments for our products are carried out as
required by the MDD. Each member state can appoint Notified Bodies within its jurisdiction. If a Notified Body of one member state has issued a Certificat de
Conformité, the device can be distriubuted throughout the European Union without further conformance tests being required in other member states.
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Federal, State and Foreign Fraud and Abuse Laws
Because of the significant federal funding involved in Medicare and Medicaid, Congress and the states have enacted, and actively enforce, a number of
laws to eliminate fraud and abuse in federal healthcare programs. Our business is subject to compliance with these laws. In March 2010, the Patient Protection
and Affordable Care Act, as amended by the Healthcare and Education Affordability Reconciliation Act, which we refer to collectively as the Affordable Care Act,
was enacted in the United States. The provisions of the Affordable Care Act are effective on various dates. The Affordable Care Act expands the government’s
investigative and enforcement authority and increases the penalties for fraud and abuse, including amendments to both the Anti-Kickback Statute and the False
Claims Act, to make it easier to bring suit under these statutes. The Affordable Care Act also allocates additional resources and tools for the government to police
healthcare fraud, with expanded subpoena power for HHS, additional funding to investigate fraud and abuse across the healthcare system and expanded use of
recovery audit contractors for enforcement.
Anti-Kickback Statutes. The federal Anti-Kickback Statute prohibits persons from knowingly and willfully soliciting, offering, receiving or providing
remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual, or the furnishing or arranging for a good or service, for which
payment may be made under a federal healthcare program such as Medicare or Medicaid. Violation of the Anti-Kickback Statue is a criminal felony, and can
result in criminal sanctions, civil penalties, enforcement under the False Claims Act, and exclusion from federal healthcare programs.
The definition of “remuneration” has been broadly interpreted to include anything of value, including, for example, gifts, certain discounts, the furnishing
of free supplies, equipment or services, credit arrangements, payment of cash and waivers of payments. Several courts have interpreted the statute’s intent
requirement to mean that if any one purpose of an arrangement involving remuneration is to induce referrals of federal healthcare covered businesses, the
statute has been violated. Penalties for violations include criminal penalties and civil sanctions such as fines, imprisonment and possible exclusion from
Medicare, Medicaid and other federal healthcare programs. In addition, some kickback allegations have been claimed to violate the Federal False Claims Act,
discussed in more detail below.
The Anti-Kickback Statute is broad and prohibits many arrangements and practices that are otherwise lawful in businesses outside of the healthcare
industry. Recognizing that the Anti-Kickback Statute is broad and may technically prohibit many innocuous or beneficial arrangements, Congress authorized the
Office of Inspector General, or OIG, of HHS to issue a series of regulations known as “safe harbors.” These safe harbors set forth provisions that, if all their
applicable requirements are met, will assure healthcare providers and other parties that they will not be prosecuted under the Anti-Kickback Statute. The failure
of a transaction or arrangement to fit precisely within one or more safe harbors does not necessarily mean that it is illegal or that prosecution will be pursued.
However, conduct and business arrangements that do not fully satisfy an applicable safe harbor may result in increased scrutiny by government enforcement
authorities such as OIG.
Many states have adopted laws similar to the Anti-Kickback Statute. Some of these state prohibitions apply to referral of recipients for healthcare items or
services reimbursed by any source, not only the Medicare and Medicaid programs.
Government officials have focused their enforcement efforts on the marketing of healthcare services and products, among other activities, and recently
have brought cases against companies, and certain individual sales, marketing and executive personnel, for allegedly offering unlawful inducements to potential
or existing customers in an attempt to procure their business.
Federal False Claims Act. Another development affecting the healthcare industry is the increased use of the federal False Claims Act by federal
prosecutors, and in particular, action brought pursuant to the False Claims Act’s “whistleblower” or “qui tam” provisions. The False Claims Act imposes liability on
any person or entity that, among other things, knowingly presents, or causes to be presented, a false or fraudulent claim for payment by a federal healthcare
program. The qui tam provisions of the False Claims Act allow a private individual to bring actions on behalf of the federal government alleging that the defendant
has violated the False Claims Act and to share in any monetary recovery. In recent years, the number of suits brought against healthcare providers by private
individuals has increased substantially. In addition, various states have enacted false claims laws analogous to the False Claims Act, and many of these state
laws apply where a claim is submitted to any third-party payor and not just a federal healthcare program.
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When an entity is determined to have violated the False Claims Act, it may be required to pay up to three times the actual damages sustained by the
government, plus civil penalties of between $11,463-$22,927 for each separate instance of false claim. As part of any settlement, the government may ask the
entity to enter into a corporate integrity agreement, which imposes certain compliance, certification and reporting obligations. There are many potential bases for
liability under the False Claims Act. Liability arises, primarily, when an entity knowingly submits, or causes another to submit, a false claim for reimbursement to
the federal government. The federal government has used the False Claims Act to assert liability on the basis of inadequate care, kickbacks and other improper
referrals, and improper use of Medicare numbers when detailing the provider of services, in addition to the more predictable allegations as to misrepresentations
with respect to the services rendered. In addition, the federal government has prosecuted companies under the False Claims Act in connection with off-label
promotion of products. Our future activities relating to the reporting of wholesale or estimated retail prices of our products, the reporting of discount and rebate
information and other information affecting federal, state and third-party reimbursement of our products and the sale and marketing of our products may be
subject to scrutiny under these laws.
While we are unaware of any current matters, we are unable to predict whether we will be subject to actions under the False Claims Act or a similar state
law, or the impact of such actions. However, the costs of defending such claims, as well as any sanctions imposed, could significantly affect our financial
performance.
The Sunshine Act. The Physician Payment Sunshine Act, or the Sunshine Act, which was enacted as part of the Affordable Care Act, requires all
United States manufacturers of a prescription drug, device, biologic or other medical supply that has been approved or cleared by the FDA, and is available for
coverage by Medicare, Medicaid or the Children’s Health Insurance Program to report annually to the Secretary of HHS: (i) payments or other transfers of value
made by that entity, or by a third-party as directed by that entity, to physicians and teaching hospitals or to third parties on behalf of physicians or teaching
hospitals; and (ii) physician ownership and investment interests in the drug and device manufacturing entity. The payments required to be reported include the
cost of meals provided to a physician, travel reimbursements and other transfers of value, including those provided as part of contracted services such as speaker
programs, advisory boards, consultation services and clinical trial services. Failure to comply with the reporting requirements can result in significant civil
monetary penalties ranging from $1,000 to $10,000 for each payment or other transfer of value that is not reported (up to a maximum per annual report of
$150,000) and from $10,000 to $100,000 for each knowing failure to report (up to a maximum per annual report of $1,150,000). Additionally, there are criminal
penalties if an entity intentionally makes false statements in such reports. We are subject to the Sunshine Act and the information we disclose may lead to
greater scrutiny, which may result in modifications to established practices and additional costs. Additionally, similar reporting requirements have also been
enacted on the state level domestically, and an increasing number of countries worldwide either have adopted or are considering similar laws requiring
transparency of interactions with healthcare professionals.
Foreign Corrupt Practices Act. The Foreign Corrupt Practices Act, or FCPA, prohibits any United States individual or business from paying, offering, or
authorizing payment or offering of anything of value, directly or indirectly, to any foreign official, political party or candidate for the purpose of influencing any act
or decision of the foreign entity in order to assist the individual or business in obtaining or retaining business. The FCPA also obligates companies whose
securities are listed in the United States to comply with accounting provisions requiring us to maintain books and records that accurately and fairly reflect all
transactions of the corporation, including international subsidiaries, if any, and to devise and maintain an adequate system of internal accounting controls for
international operations.
International Laws. In Europe, various countries have adopted anti-bribery laws providing for severe consequences, in the form of criminal penalties
and/or significant fines, for individuals and/or companies committing a bribery offense. Violations of these anti-bribery laws, or allegations of such violations,
could have a negative impact on our business, results of operations and reputation. For instance, in the United Kingdom, under the Bribery Act 2010, which went
into effect in July 2011, a bribery occurs when a person offers, gives or promises to give a financial or other advantage to induce or reward another individual to
improperly perform certain functions or activities, including any function of a public nature. Bribery of foreign public officials also falls within the scope of the
Bribery Act 2010. Under the new regime, an individual found in violation of the Bribery Act of 2010, faces imprisonment of up to 10 years. In addition, the
individual can be subject to an unlimited fine, as can commercial organizations for failure to prevent bribery.
There are also international privacy laws that impose restrictions on the access, use, and disclosure of health information. All of these laws may impact
our business. Our failure to comply with these privacy laws or significant changes in the laws restricting our ability to obtain required patient information could
significantly impact our business and our future business plans.
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U.S. Healthcare Reform
Changes in healthcare policy could increase our costs and subject us to additional regulatory requirements that may interrupt commercialization of our
current and future solutions. Changes in healthcare policy could increase our costs, decrease our revenues and impact sales of and reimbursement for our
current and future solutions. The Affordable Care Act substantially changes the way healthcare is financed by both governmental and private insurers, and
significantly impacts our industry principally by moving healthcare reimbursement towards more value-based and quality-based payment methodologies. The Act
contains a number of provisions that impact our business and operations, some of which in ways we cannot currently predict, including those governing
enrollment in federal healthcare programs and reimbursement changes.
There will continue to be proposals by legislators at both the federal and state levels, regulators and third-party payors to reduce costs while expanding
individual healthcare benefits. Certain of these changes could impose additional limitations on the prices we will be able to charge for our current and future
solutions or the amounts of reimbursement available for our current and future solutions from governmental agencies or third-party payors. Furthermore, the
current presidential administration and Congress may again attempt broad sweeping changes to the current healthcare laws. We face uncertainties that might
result from modification or repeal of any of the provisions of the Affordable Care Act, including as a result of current and future executive orders and legislative
actions. The impact of those changes on us and potential effect on the medical device industry as a whole is currently unknown. But, any changes to the
Affordable Care Act are likely to have an impact on our results of operations, and may have a material adverse effect on our results of operations. We cannot
predict what other healthcare programs and regulations will ultimately be implemented at the federal or state level or the effect any future legislation or regulation
in the United States may have on our business.
Third-Party Reimbursement
Payment for patient care in the United States is generally made by third-party payors, including private insurers and government insurance programs,
such as Medicare and Medicaid. The Medicare program, the largest single payor in the United States, is a federal governmental health insurance program
administered by the Centers for Medicare and Medicaid Services, or CMS, and covers certain medical care expenses for eligible elderly and disabled individuals.
Because a large percentage of the population with PAD includes Medicare beneficiaries, and private insurers may follow the coverage and payment policies of
Medicare, Medicare’s coverage and payment policies are significant to our operations.
Medicare pays PAD treatment facilities, including hospitals and physician office-based labs, pre-determined amounts for each procedure performed.
These payment amounts differ based on a variety of factors, including:
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Type of procedure performed—angioplasty, stent or atherectomy;
Patient-specific complexities and comorbidities;
Type of facility—hospital, teaching hospital or office-based lab;
Inpatient or outpatient status; and
• Geographic region.
We receive payment from the treatment facility for our products, and the Medicare reimbursement to the facility is intended to cover the overall cost of
treatment, including the cost of products used during the procedure as well as the overhead cost associated with the facility where the procedure is performed.
For procedures performed in hospitals, the physician who performs the procedure is reimbursed separately under the Medicare physician fee schedule. Claims
for PAD procedures are typically submitted by the treatment facility and physician to Medicare or other health insurers using established billing codes. These
codes identify the procedures performed and are relied upon to determine third-party payor reimbursement amounts.
Medicare reimbursement for inpatient PAD procedures that include atherectomy for 2019 range between approximately $10,000 and $16,000. These
amounts include the cost of disposable catheters such as Ocelot and Pantheris. While reimbursement varies based on the type of procedure performed
(e.g., angioplasty, stent or atherectomy), additional device-specific reimbursement is not available. The amount of reimbursement can vary substantially by
geographical region and by facility. Payment rates of other third-party payors may follow Medicare rates, or they may be higher or lower, depending on their
particular reimbursement methodology. Because of the wide variability, it is not possible to identify an average rate for third-party payors other than Medicare.
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Employees
As of December 31, 2019, we had 81 employees, including 23 in manufacturing and operations, 31 in sales and marketing, 8 in research and
development and clinical and regulatory affairs, 8 in quality assurance and 11 in finance, general administrative and executive administration. Of these 81
employees, 7 are part time employees. None of our employees are represented by a labor union or are parties to a collective bargaining agreement and we
believe that our employee relations are good.
Corporate and other Information
We were incorporated in Delaware on March 8, 2007. Our principal executive offices are located at 400 Chesapeake Drive, Redwood City, California
94063, and our telephone number is (650) 241-7900. Our website address is www.avinger.com. References to our website address do not constitute
incorporation by reference of the information contained on the website, and the information contained on the website is not part of this document.
We make available, free of charge on our corporate website, copies of our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current
Reports on Form 8-K, Proxy Statements, and all amendments to these reports, as soon as reasonably practicable after such material is electronically filed with or
furnished to the Securities and Exchange Commission, or the SEC, pursuant to Section 13(a) or 15(d) of the Securities Exchange Act. We also show detail
about stock trading by corporate insiders by providing access to SEC Forms 3, 4 and 5. This information may also be obtained from the SEC’s on-line database,
which is located at www.sec.gov. Our common stock is traded on the Nasdaq Capital Market under the symbol “AVGR”.
We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012. As such, we are eligible for exemptions from
various reporting requirements applicable to other public companies that are not emerging growth companies, including, but not limited to, not being required to
comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002 and reduced disclosure obligations regarding executive
compensation. We will remain an emerging growth company until the earlier of (1) December 31, 2020, (2) the last day of the fiscal year (a) in which we have
total annual gross revenue of at least $1.07 billion or (b) in which we are deemed to be a large accelerated filer, which means the market value of our common
stock that is held by non-affiliates exceeds $700 million as of the prior June 30th, and (3) the date on which we have issued more than $1.0 billion in non-
convertible debt securities during the prior three-year period.
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Item 1A. Risk Factors
Investing in our common stock involves a high degree of risk. We have identified the following risks and uncertainties that may have a material adverse
effect on our business, financial condition, results of operations and future growth prospects. Our business could be harmed by any of these risks. The risks and
uncertainties described below are not the only ones we face. If any of the risks actually occur, our business, financial condition, results of operations, cash flows
and prospects could be materially and adversely affected. The trading price of our common stock could decline due to any of these risks, and you may lose all or
part of your investment. In assessing these risks, you should also refer to the other information contained in this Annual Report on Form 10-K, including our
financial statements and related notes. Please also see “Cautionary Notes Regarding Forward-Looking Statements.”
Risks Related to Our Business
Our quarterly and annual results may fluctuate significantly, may not fully reflect the underlying performance of our business and may result in
decreases in the price of our common stock.
Our quarterly and annual results of operations, including our revenues, profitability and cash flow, may vary significantly in the future and period-to-
period comparisons of our operating results may not be meaningful. Accordingly, the results of any one quarter or period should not be relied upon as an
indication of future performance. Our quarterly and annual financial results may fluctuate as a result of a variety of factors, many of which are outside our control
and, as a result, may not fully reflect the underlying performance of our business. Fluctuation in quarterly and annual results may decrease the value of our
common stock. Factors that may cause fluctuations in our quarterly and annual results include, without limitation:
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our ability to obtain and maintain FDA clearance and approval from foreign regulatory authorities for our products, and the timing of such clearances and
approvals, particularly with respect to current and future generations of Pantheris and Ocelot;
• market acceptance of our Lumivascular platform and products, including Pantheris and Ocelot;
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the availability of reimbursement for our Lumivascular platform products;
our ability to attract new customers and increase the amount of business we generate from existing customers;
results of our clinical trials;
the timing and success of new product and feature introductions by us or our competitors or any other change in the competitive dynamics of our
industry, including consolidation among competitors, customers or strategic partners;
the amount and timing of costs and expenses related to the maintenance and expansion of our business and operations;
changes in our pricing policies or those of our competitors;
general economic, political, industry and market conditions;
the regulatory environment;
the hiring, training and retention of key employees, including our sales team;
the cost and potential outcomes of existing and future litigation;
our ability to obtain additional financing; and
advances and trends in new technologies and industry standards.
We have a history of net losses and we may not be able to achieve or sustain profitability.
We have incurred significant losses in each period since our inception in 2007. We incurred net losses of $19.5 million in 2019 and $27.6 million in
2018. As of December 31, 2019, we had an accumulated deficit of approximately $348.3 million. These losses and our accumulated deficit reflect the substantial
investments we have made to develop our Lumivascular platform and acquire customers.
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We expect our losses to continue for the foreseeable future as we continue to make significant future expenditures to develop and expand our business.
In addition, as a public company, we will continue to incur significant legal, accounting and other expenses. Accordingly, we cannot assure you that we will
achieve profitability in the future or that, if we do become profitable, we will sustain profitability. Our failure to achieve and sustain profitability would negatively
impact the market price of our common stock.
We may not be able to secure additional financing on favorable terms, or at all, to meet our future capital needs and our failure to obtain additional
financing when needed could force us to delay, reduce or eliminate our product development programs and commercialization efforts or cause us to
become insolvent.
We believe that our cash and cash equivalents at December 31, 2019, and expected revenues from operations, will be sufficient to satisfy our capital
requirements and fund our operations through at least the second quarter of 2020. Even though we received net proceeds of $3.7 million from the sales of our
common stock in our January 2020 offering, net proceeds of $3.8 million from the sales of our common stock in our August 2019 offering, proceeds from
issuance of common stock upon the exercise of warrants in March and April of 2019 of $8.0 million, net proceeds of $10.2 million from the sale of our Series C
preferred stock and common stock in our November 2018 offering, net proceeds of $3.0 million from the sale of common stock and warrants in our July 2018
offering, and net proceeds of $15.5 million from the sale of our Series B preferred stock and warrants in our February 2018 offering, we will need to raise
additional funds through future equity or debt financings within the next twelve months to meet our operational needs and capital requirements for product
development, clinical trials and commercialization and may subsequently require additional fundraising. We can provide no assurance that we will be successful
in raising funds pursuant to additional equity or debt financings or that such funds will be raised at prices that do not create substantial dilution for our existing
stockholders. Given the recent decline in our stock price, any financing that we undertake could cause substantial dilution to our existing stockholders.
To date, we have financed our operations primarily through sales of our products and net proceeds from the issuance of our preferred stock and debt
financings, our “at-the-market” program, our initial public offering, or IPO, and our follow-on public offerings. The warrants issued in connection with the Series B
and Series C preferred stock offering in February 2018 prohibit us from entering into certain transactions involving the issuance of securities for a variable price
determined by reference to the trading price of our common stock or otherwise subject to modification following the date of issuance, in each case until February
17, 2021. This prohibition may be waived by holders of two-thirds of the outstanding Series 1 and Series 2 warrants at any time. We do not know when or if our
operations will generate sufficient cash to fund our ongoing operations. We cannot be certain that additional capital will be available as needed on acceptable
terms, or at all. In the future, we may require additional capital in order to (i) continue to conduct research and development activities, (ii) conduct post-market
clinical studies, as well as clinical trials to obtain regulatory clearances and approvals necessary to commercialize our Lumivascular platform products,
(iii) expand our sales and marketing infrastructure and (iv) acquire complementary businesses technologies or products; or (v) respond to business opportunities,
challenges, a decline in sales, increased regulatory obligations or unforeseen circumstances. Our future capital requirements will depend on many factors,
including:
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the degree of success we experience in commercializing our Lumivascular platform products, particularly Pantheris, and any future versions of such
products;
the costs, timing and outcomes of clinical trials and regulatory reviews associated with our future products;
the costs and expenses of maintaining or expanding our sales and marketing infrastructure and our manufacturing operations;
the costs and timing of developing variations of our Lumivascular platform products, especially Pantheris and, if necessary, obtaining FDA clearance of
such variations;
the extent to which our Lumivascular platform is adopted by hospitals for use by interventional cardiologists, vascular surgeons and interventional
radiologists in the treatment of PAD;
the number and types of future products we develop and commercialize;
the costs of defending ourselves against future litigation;
the costs of preparing, filing and prosecuting patent applications and maintaining, enforcing and defending intellectual property-related claims; and
the extent and scope of our general and administrative expenses.
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We may raise additional funds in equity or debt financings or enter into credit facilities in order to access funds for our capital needs. Any debt financing
obtained by us in the future would cause us to incur additional debt service expenses and could include restrictive covenants relating to our capital raising
activities and other financial and operational matters, which may make it more difficult for us to obtain additional capital and pursue business opportunities. In
addition, due to our current level of debt, future equity investors may require that we convert all or a portion of our debt to equity, and our debtholders may not
agree to such terms. If we raise additional funds through further issuances of equity or convertible debt securities, and/or if we convert all or a portion of our
existing debt to equity, our existing stockholders could suffer significant dilution in their percentage ownership of our company, and any new equity securities we
issue could have rights, preferences and privileges senior to those of holders of our common stock. If we are unable to obtain adequate financing or financing on
terms satisfactory to us when we require it, we may terminate or delay the development of one or more of our products, delay clinical trials necessary to market
our products, delay establishment of sales and marketing capabilities or other activities necessary to commercialize our products, and significantly scale back our
operations, or we may become insolvent. If this were to occur, our ability to continue to grow and support our business and to respond to business challenges
could be significantly limited.
We have a significant amount of debt, which may adversely affect our ability to operate our business and our financial position and our ability to
secure additional financing in the future.
As of December 31, 2019, we had $9.0 million in principal and interest outstanding under a Term Loan Agreement, or the Loan Agreement, with CRG
Partners III L.P. and certain of its affiliated funds (collectively “CRG”). Our significant amount of debt may:
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increase our vulnerability to adverse changes in general economic, industry and competitive conditions;
require us to dedicate a substantial portion of our cash flow from operations to make payments on our debt, thereby reducing the availability of our cash
flow to fund working capital, capital expenditures and other general corporate purposes;
limit our flexibility in planning for, or reacting to, changes in our business and the industry in which we operate;
restrict us from exploiting business opportunities;
• make it more difficult to satisfy our financial obligations, including payments on the Loan Agreement;
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place us at a competitive disadvantage compared to our competitors that have less debt obligations; and
limit our ability to borrow additional funds for working capital, capital expenditures, acquisitions, debt service requirements, execution of our business
strategy or other general corporate purposes on satisfactory terms or at all.
The existence of a substantial amount of debt may make it difficult for us to run our business effectively or raise the capital we need to continue our
operations.
Covenants under the Loan Agreement will restrict our business in many ways.
The Loan Agreement contains various covenants that limit, subject to certain exceptions, our ability to, among other things:
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incur or assume liens;
incur additional debt or provide guarantees in respect of obligations of other persons;
issue redeemable stock and preferred stock;
pay dividends or make distributions on capital stock, repurchase, redeem or make payments on capital stock or repay, repurchase, redeem, retire,
defease, acquire or cancel debt prior to the stated maturity thereof;
• make loans, investments or acquisitions;
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create or permit restrictions on the ability of our subsidiaries to pay dividends or make other distributions to us or to guarantee our debt, limit our or any
of our subsidiaries ability to create liens, or make or pay intercompany loans or advances;
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•
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enter into certain transactions with affiliates;
sell, transfer, license, lease or dispose of our or our subsidiaries’ assets, including the capital stock of our subsidiaries; and
dissolve, liquidate, consolidate or merge with or into, or sell substantially all of our assets to another person.
In particular, the Loan Agreement, as amended, includes a covenant that we maintain a minimum of $3.5 million of cash and certain cash equivalents,
and we will have to achieve minimum revenue of $10.0 million in 2020, $12.0 million in 2021 and $15.0 million in 2022. If we fail to meet the applicable minimum
revenue target in any calendar year, the Loan Agreement provides a cure right if we prepay a portion of the outstanding principal equal to 2.0 times the revenue
shortfall. There can be no assurance as to our future compliance with the covenants under the Loan Agreement, as amended.
The covenants contained in the Loan Agreement could adversely affect our ability to:
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finance our operations;
• make needed capital expenditures;
• make strategic acquisitions or investments or enter into alliances;
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withstand a future downturn in our business or the economy in general;
refinance our outstanding indebtedness prior to maturity;
engage in business activities, including future opportunities, that may be in our interest; and
plan for or react to market conditions or otherwise execute our business strategies.
We are also subject to standard event of default provisions under the Loan Agreement that, if triggered, would allow the debt to be accelerated, which
could significantly deplete our cash resources, cause us to raise additional capital at unfavorable terms, require us to sell portions of our business or result in us
becoming insolvent. The existing collateral pledged under the Loan Agreement may prevent us from being able to secure additional debt or equity financing on
favorable terms, or at all, or to pursue business opportunities, including potential acquisitions. If we default under any of these debt covenants and are unable to
cure the default within the relevant cure period, we would need relief from default or else our creditors could exercise their remedies. In addition, potential
sources of equity financing may decline to invest in our company given the amount of debt and the rights that debt holders have to get paid before equity holders.
In order to facilitate equity investments, future equity investors may require that we convert all or a portion of our debt to equity, and our debtholders may not
agree to such terms. The amount of debt could therefore affect our ability to finance our company and prevent us from obtaining necessary operating capital as a
result.
We may not be able to generate sufficient cash to service our credit facility with CRG. If we fail to comply with the obligations under our credit
facility, the lender may be able to accelerate amounts owed under the facility and may foreclose upon the assets securing our obligations.
Borrowings under our credit facility are secured by substantially all of our personal property, including our intellectual property. Our ability to make
scheduled payments or to refinance our debt obligations depends on numerous factors, including the amount of our cash reserves and our actual and projected
financial and operating performance. These amounts and our performance are subject to numerous risks, including the risks in this section, some of which may
be beyond our control. We cannot assure you that we will maintain a level of cash reserves or cash flows from operating activities sufficient to permit us to pay
the principal, premium, if any, and interest on our existing or future indebtedness. If our cash flows and capital resources are insufficient to fund our debt service
obligations, we may be forced to reduce or delay capital expenditures, sell assets or operations, seek additional capital or restructure or refinance our
indebtedness. We cannot assure you that we would be able to take any of these actions, or that these actions would permit us to meet our scheduled debt
service obligations. In addition, in the event of our breach of the Loan Agreement, we may be required to repay any outstanding amounts earlier than anticipated.
If we fail to comply with our obligations under the Loan Agreement, the lender would be able to accelerate the required repayment of amounts due and, if they
are not repaid, could foreclose upon our assets securing our obligations under the Loan Agreement.
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Our limited commercialization experience and number of approved products makes it difficult to evaluate our current business, predict our future
prospects, assess the long-term performance of our products, and forecast our financial performance.
We were incorporated in 2007, began commercializing our initial non-Lumivascular platform products in 2009 and introduced our first Lumivascular
platform products in the United States in late 2012. We received 510(k) clearance from the FDA, for commercialization of Pantheris in October 2015, an
additional 510(k) clearance for an enhanced version of Pantheris in March 2016 and commenced sales of Pantheris in the United States and select international
markets promptly thereafter. Our current next-generation version of Pantheris received FDA clearance in May 2018 and our Pantheris SV received FDA
clearance in April 2019. Our limited commercialization experience and number of approved products make it difficult to evaluate our current business and predict
our future prospects. We have encountered and will continue to encounter risks and difficulties frequently experienced by companies in rapidly-changing
industries. These risks and uncertainties include the risks inherent in clinical trials, market acceptance of our products, and increasing and unforeseen expenses
as we continue to attempt to grow our business.
In addition, we have in the past, and may in the future, become aware of performance issues with our products. For example, prior to becoming
commercially available on March 1, 2016, Pantheris had been used in clinical trials mainly in controlled situations. Since its commercialization and as more
physicians have used Pantheris, we have received additional feedback on its performance, both positive and negative. We have attempted to address certain of
these concerns with our current version of Pantheris. However, there can be no assurance that the changes and improvements will fully address the
performance issues that have been raised by earlier versions of Pantheris. Even if these issues are resolved and physician concerns addressed, future product
performance issues may occur and our reputation could suffer, which could lead to decreased sales of our products. Our revenue has been and continues to be
adversely impacted by these product performance issues. We also had to incur additional expenses to make product changes and improvements, and to replace
products in accordance with our warranty policy. This additional expense, and any future expense that we may incur as a result of future product performance
issues, will negatively impact our financial performance and results of operations. If we are unable to improve the performance of our products to meet the
concerns of physicians, our revenue may decline further or fail to increase.
Our short commercialization experience and limited number of approved products also make it difficult for us to forecast our future financial performance
and such forecasts are limited and subject to a number of uncertainties, including our ability to obtain FDA clearance for new versions of our Lumivascular
platform products we intend to commercialize in the United States. If our assumptions regarding the risks and uncertainties we face, which we use to plan our
business, are incorrect or change due to circumstances in our business or our markets, or if we do not address these risks successfully, our operating and
financial results could differ materially from our expectations and our business could suffer.
Our success depends in large part on a limited number of products, particularly Pantheris (including SV) , all of which have a limited commercial
history. If these products fail to gain, or lose, market acceptance, our business will suffer.
Ocelot, Ocelot PIXL, Ocelot MVRX, Lightbox, Wildcat, Kittycat 2, Pantheris (including SV) are our only products currently cleared for sale, and our current
revenues are wholly dependent on them. Sales of Wildcat and Kittycat 2 have declined and are continuing to decline as we focus on the promotion of our
Lumivascular platform products. In addition, the long-term viability of our company is largely dependent on the successful commercialization and continued
development of Pantheris and we expect that sales of our next-generation Pantheris and Pantheris SV and our other current and future Lumivascular platform
products in the United States will account for substantially all of our revenues for the foreseeable future. Accordingly, our success depends on the continued and
growing acceptance and use of Pantheris and our other Lumivascular platform products by the medical community. All of our products have a limited commercial
history. For example, we received 510(k) clearance from the FDA to commercialize Pantheris in October 2015 as well as a separate FDA clearance to market
enhanced versions of Pantheris in March 2016 and May 2018 and those versions of Pantheris became commercially available in the United States and select
international markets promptly thereafter. Pantheris SV just launched in July 2019 after having received FDA clearance in April 2019. As such, acceptance
among physicians of these products may not increase or may decline.
Our ability to successfully market Pantheris will also be limited due to a number of factors including regulatory restrictions in our labeling. We cannot
assure demand for Pantheris and our other Lumivascular platform products will continue to grow or that our products will significantly penetrate current or new
markets. Market demand for Pantheris and physician adoption of this product also may be negatively impacted by product performance issues and the need to
replace certain products in accordance with our warranty policy. Utilization of our products has been less than we anticipated historically. If demand for Pantheris
and our other Lumivascular platform products does not increase and we cannot sell our products as planned, our financial results will be harmed. In addition,
market acceptance may be hindered if physicians are not presented with compelling data from long-term studies of the safety and efficacy of our Lumivascular
platform products compared to alternative procedures, such as angioplasty, stenting, bypass surgery or other atherectomy procedures. For example, if patients
undergoing treatment with our Lumivascular platform products have retreatment rates higher than or comparable with the retreatment rates of alternative
procedures, it will be difficult to demonstrate the value of our Lumivascular platform products. Any studies we may conduct comparing our Lumivascular platform
with alternative procedures will be expensive, time consuming and may not yield positive results. Physicians will also need to appreciate the value of real-time
imaging in improving patient outcomes in order to change current methods for treating PAD patients. In addition, demand for our Lumivascular platform products
may decline or may not increase as quickly as we expect. Failure of our Lumivascular platform products to significantly penetrate current or new markets, or our
failure to successfully commercialize Pantheris, would harm our business, financial condition and results of operations.
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We are also aware of certain characteristics and features of our Lumivascular platform that may prevent widespread market adoption. For example, in
procedures using the current model of Pantheris, some physicians may prefer to have a technician or second physician assisting with the operation of the
catheter as well as a separate technician to operate the Lightbox, potentially making it less financially attractive for physicians and their hospitals and medical
facilities. It may take significant time and expense to modify our products to allow a single physician to operate the entire system and we can provide no
guarantee that we will be able to make such modifications or obtain any additional and necessary regulatory clearances for such modifications. Although the
OCT images created by our Lightbox may make it possible for physicians to reduce the degree to which fluoroscopy and contrast dye are used when using our
Lumivascular platform products compared to competing endovascular products, physicians are still using both fluoroscopy and contrast dye in these procedures.
As a result, risks of complications from radiation and contrast dye are still present and may limit the commercial success of our products. Finally, it requires
training of technicians and physicians to effectively operate our Lumivascular platform products, including interpreting the OCT images created by our Lightbox,
which may affect adoption of our products by physicians. These or other characteristics and features of our Lumivascular platform may cause our products not to
be widely adopted and harm our business, financial condition and results of operation.
We rely heavily on our sales professionals to market and sell our products. If we are unable to hire, effectively train, manage, improve the
productivity of, and retain our sales professionals, our business will be harmed, which would impair our future revenue and profitability.
Our success largely depends on our ability to hire, train, manage and improve the productivity levels of our sales professionals. We have experienced
direct sales employee and sales management turnover in the past. The loss of any member of our sales team’s senior management could weaken our sales
expertise and harm our business, and we may not be able to find adequate replacements on a timely basis, or at all. The changes in senior management that
have occurred over the past several years may continue to create instability in our sales force leading to attrition in sales representatives in the future.
Competition for sales professionals who are familiar with and trained to sell our products continues to be strong. We train our sales professionals to
better understand our existing and new product technologies and how they can be positioned against our competitors’ products. These initiatives are intended to
improve the productivity of our sales professionals and our revenue and profitability. It takes time for the sales professionals to become productive following their
hiring and training and there can be no assurance that sales representatives will reach adequate levels of productivity, or that we will not experience significant
levels of attrition in the future. Measures we implement to improve the productivity may not be successful and may instead contribute to instability in our
operations, additional departures from our sales organization, or further reduce our revenue, profitability, and harm our business and our stock price may be
adversely impacted as a result.
If our revenue does not improve, or if our cost of revenue and/or operating expenses increase by a greater percentage than our revenue, our gross
margins and operating margins may be adversely impacted, our loss from operations will increase, and our cash used in operating activities will
increase, which could reduce our assets and have a material adverse effect on our stock price.
Our gross margin is impacted by the revenue that we generate and the costs incurred to generate the revenue. To the extent that our revenue does not
grow or declines, it is difficult to improve our gross margins as our fixed costs must be spread over a lower revenue base. Our future revenue may be adversely
affected by a number of factors including the competitive market environment in which we operate, which may result in a decrease in the number of products
sold or a decrease in the average selling prices achieved for our product sales. If our revenue does not improve, or if our cost of revenue increases by a greater
percentage than our revenue, or if we are not able to reduce expenses in the event of a decline in revenue, we may continue to generate losses from operations
and use cash, which could reduce our cash faster than budgeted, cause us to need to obtain additional financing and have a material adverse effect on our
operations and stock price.
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Our ability to compete is highly dependent on demonstrating the benefits of our Lumivascular platform to physicians, hospitals and patients.
In order to generate sales, we must be able to clearly demonstrate that our Lumivascular platform is both a more effective treatment system and more
cost-effective than the alternatives offered by our competitors. If we are unable to convince physicians that our Lumivascular platform leads to significantly lower
rates of restenosis, or narrowing of the artery, and leads to fewer adverse events during treatment than those using competing technologies, our business will
suffer. We must convince hospitals and physicians that our Lumivascular platform results in significantly better patient outcomes at a competitive overall cost. For
example, we may need to demonstrate that the investment hospitals must make if purchasing our Lightbox and the incremental costs of having a technician or a
second physician operate Pantheris can be justified based on the benefits to patients, physicians and hospitals. If we are unable to develop robust clinical data
to support these claims, we will be unable to convince hospitals and third-party payors of these benefits and our business will suffer.
Our value proposition to physicians and hospitals is largely dependent upon our contention that the rate of arterial damage when physicians are using
our imaging products is lower than with non-imaging competing products. If minimizing arterial damage does not significantly impact patient outcomes, meaning
either (i) that restenosis is often triggered without disrupting healthy arterial structures, or (ii) arteries can be damaged during treatment without triggering
restenosis, then we may be unable to demonstrate our Lumivascular platform’s benefits are any different than competing technologies. Furthermore, physicians
may find our imaging system difficult to use, and we may not be able to provide physicians with adequate training to be able to realize the benefits of our
Lumivascular platform. If physicians do not value the benefits of on-board imaging and the enhanced visualization enabled by our products during an
endovascular intervention as compared to our competitors’ products, or do not believe that such benefits improve clinical outcomes, our Lumivascular platform
products may not be widely adopted.
The use, misuse or off-label use of the products in our Lumivascular platform may result in injuries that lead to product liability suits, which could be
costly to our business.
We require limited training in the use of our Lumivascular platform products because we market primarily to physicians who are experienced in the
interventional techniques required to use our device. If demand for our Lumivascular platform continues to grow, less experienced physicians will likely use the
devices, potentially leading to more injury and an increased risk of product liability claims. The use or misuse of our Lumivascular platform products has in the
past resulted, and may in the future result, in complications, including damage to the treated artery, infection, internal bleeding, and limb loss, potentially leading
to product liability claims. Our Lumivascular platform products are contraindicated for use in the carotid, cerebral, coronary, iliac, or renal arteries. Our sales force
does not promote the use of our products for off-label indications, and our U.S. instructions for use specify that our Lumivascular platform products are not
intended for use in the carotid, cerebral, coronary, iliac or renal arteries. However, we cannot prevent a physician from using our Lumivascular platform products
for these off-label applications. The application of our Lumivascular platform products to coronary arteries, as opposed to peripheral arteries, is more likely to
result in complications that have serious consequences. For example, if excised plaque were not captured properly in our device, it could be carried by the
bloodstream to a more narrow location, blocking a coronary artery, leading to a heart attack, or blocking an artery to the brain, leading to a stroke. If our
Lumivascular platform products are defectively designed, manufactured or labeled, contain defective components or are misused, we may become subject to
costly litigation initiated by our customers or their patients. Product liability claims are especially prevalent in the medical device industry and could harm our
reputation, divert management’s attention from our core business, be expensive to defend and may result in sizable damage awards against us. Although we
maintain product liability insurance, the amount or breadth of our coverage may not be adequate for the claims that are made against us.
The expense and potential unavailability of insurance coverage for liabilities resulting from our products could harm us and our ability to sell our
Lumivascular platform products.
We may not have sufficient insurance coverage for future product liability claims. We may not be able to obtain insurance in amounts or scope sufficient
to provide us with adequate coverage against all potential liabilities. Any product liability claims brought against us, with or without merit, could increase our
product liability insurance rates or prevent us from securing continuing coverage, harm our reputation in the industry, significantly increase our expenses, and
reduce product sales. Product liability claims in excess of our insurance coverage would be paid out of cash reserves, harming our financial condition and
operating results.
Some of our customers and prospective customers may have difficulty in procuring or maintaining liability insurance to cover their operations and use of
our Lumivascular platform products. Medical malpractice carriers are also withdrawing coverage in certain states or substantially increasing premiums. If this
trend continues or worsens, our customers may discontinue using our Lumivascular platform products and potential customers may opt against purchasing our
Lumivascular platform products due to the cost or inability to procure insurance coverage.
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Our ability to compete depends on our ability to innovate successfully.
The market for medical devices in general, and in the PAD market in particular, is highly competitive, dynamic, and marked by rapid and substantial
technological development and product innovation. There are few barriers that would prevent new entrants or existing competitors from developing products that
compete directly with ours. Demand for our Lumivascular platform products could be diminished by equivalent or superior products and technologies offered by
competitors. If we are unable to innovate successfully, our Lumivascular platform products could become obsolete and our revenues would decline as our
customers purchase our competitors’ products.
In order to remain competitive, we must continue to develop new product offerings and enhancements to our existing Lumivascular platform products. In
particular, we have developed two additional versions of our Pantheris atherectomy device, next-generation Pantheris and Pantheris SV (small vessel), a lower
profile version of Pantheris. We believe these versions represent significant improvements in reliability and usability compared to prior versions of our products.
We anticipate that our next-generation Pantheris and Pantheris SV will translate into revenue growth and achieve increased physician acceptance. Because we
believe they are important to our future revenues, we are devoting a significant portion of our resources to their continued development. However, we do not yet
know whether these or any other new offerings will be well received and broadly accepted by physicians, and if so, whether sales will be sufficient for us to offset
costs of development, implementation, support, operation, sales and marketing. Additionally, new products may subject us to additional risks of product
performance, customer complaints and litigation. If sales of our new product offerings, including our next-generation Pantheris and Pantheris SV, are lower than
we expect, fail to gain anticipated market acceptance or cause us to expend additional resources to fix unforeseen problems and develop modifications, our
revenues and results of operations may not improve and our business will be adversely affected.
Maintaining adequate research and development personnel and resources to meet the demands of the market is essential. If we are unable to develop
products, applications or features due to certain constraints, such as insufficient cash resources, inability to raise sufficient cash in future equity or debt
financings, high employee turnover, inability to hire sufficient research and development personnel or a lack of other research and development resources, we
may miss market opportunities. Furthermore, many of our competitors expend a considerably greater amount of funds on their research and development
programs than we do, and those that do not may be acquired by larger companies that would allocate greater resources to our competitors’ research and
development programs. Our failure or inability to devote adequate research and development resources or compete effectively with the research and
development programs of our competitors could harm our business.
We compete against companies that have longer operating histories, more established products and greater resources, which may prevent us from
achieving significant market penetration, increasing our revenues or becoming profitable.
Our products compete with a variety of products and devices for the treatment of PAD, including other CTO crossing devices, stents, balloons and
atherectomy catheters, as well as products used in vascular surgery. Large competitors in the CTO crossing, stent and balloon markets include Abbott
Laboratories, AngioDyamics, Boston Scientific, Cardinal Health, Cook Medical, CR Bard and Medtronic. Competitors in the atherectomy market include
AngioDyamics, Boston Scientific, Cardiovascular Systems, Medtronic and Philips. Some competitors have previously attempted to combine intravascular
imaging with atherectomy and may have current programs underway to do so. These and other companies may attempt to incorporate on-board visualization
into their products in the future and may remain competitive with us in marketing traditional technologies. Other competitors include pharmaceutical companies
that manufacture drugs for the treatment of symptoms associated with mild to moderate PAD and companies that provide products used by surgeons in
peripheral and coronary bypass procedures. These competitors and other companies may introduce new products that compete with our products. Many of our
competitors have significantly greater financial and other resources than we do and have well-established reputations, as well as broader product offerings and
worldwide distribution channels that are significantly larger and more effective than ours. Competition with these companies could result in price-cutting, reduced
profit margins and loss of market share, any of which would harm our business, financial condition and results of operations.
Our ability to compete effectively depends on our ability to distinguish our company and our Lumivascular platform from our competitors and their
products, and includes such factors as:
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procedural safety and efficacy;
acute and long-term outcomes;
ease of use and procedure time;
price;
size and effectiveness of sales force;
radiation exposure for physicians, hospital staff and patients; and
third-party reimbursement.
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In addition, competitors with greater financial resources than ours could acquire other companies to gain enhanced name recognition and market share,
as well as new technologies or products that could effectively compete with our existing products, which may cause our revenues to decline and would harm our
business.
If our clinical trials are unsuccessful or significantly delayed, or if we do not complete our clinical trials, our business may be harmed.
Clinical development is a long, expensive, and uncertain process and is subject to delays and the risk that products may ultimately prove unsafe or
ineffective in treating the indications for which they are designed. Completion of clinical trials may take several years or more and failure of the trial can occur at
any time. We cannot provide any assurance that our clinical trials will meet their primary endpoints or that such trials or their results will be accepted by the FDA
or foreign regulatory authorities. Even if we achieve positive early or preliminary results in clinical trials, these results do not necessarily predict final results, and
positive results in early trials may not indicate success in later trials. Many companies in the medical device industry have suffered significant setbacks in late-
stage clinical trials, even after receiving promising results in earlier trials or in the preliminary results from these late-stage clinical trials.
We may experience numerous unforeseen events during, or because of, the clinical trial process that could delay or prevent us from receiving
regulatory clearance or approval for new products or modifications of existing products, including new indications for existing products, including:
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negative or inconclusive results that may cause us to decide, or regulators may require us, to conduct additional clinical and/or preclinical testing which
may be expensive and time consuming;
trial results that do not meet the level of statistical significance required by the FDA or other regulatory authorities;
findings by the FDA or similar foreign regulatory authorities that the product is not sufficiently safe for investigational use in humans;
interpretations of data from preclinical testing and clinical testing by the FDA or similar foreign regulatory authorities that may be different from our own;
delays or failure to obtain approval of our clinical trial protocols from the FDA or other regulatory authorities;
delays in obtaining institutional review board approvals or government approvals to conduct clinical trials at prospective sites;
findings by the FDA or similar foreign regulatory authorities that our or our suppliers’ manufacturing processes or facilities are unsatisfactory;
changes in the review policies of the FDA or similar foreign regulatory authorities or the adoption of new regulations that may negatively affect or delay
our ability to bring a product to market or receive approvals or clearances to treat new indications;
trouble in managing multiple clinical sites;
delays in agreeing on acceptable terms with third-party research organizations and trial sites that may help us conduct the clinical trials; and
the suspension or termination by us, or regulators, of our clinical trials because the participating patients are being exposed to unacceptable health risks.
Failures or perceived failures in our clinical trials will delay and may prevent our product development and regulatory approval process, damage our
business prospects and negatively affect our reputation and competitive position.
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From time to time, we engage outside parties to perform services related to certain of our clinical studies and trials, and any failure of those parties to
fulfill their obligations could increase costs and cause delays.
From time to time, we engage consultants to help design, monitor, and analyze the results of certain of our clinical studies and trials. The consultants we
engage interact with clinical investigators to enroll patients in our clinical trials. We depend on these consultants and clinical investigators to help facilitate the
clinical studies and trials and monitor and analyze data from these studies and trials under the investigational plan and protocol for the study or trial and in
compliance with applicable regulations and standards, commonly referred to as good clinical practices. We may face delays in our regulatory approval process if
these parties do not perform their obligations in a timely, compliant or competent manner. If these third parties do not successfully carry out their duties or meet
expected deadlines, or if the quality, completeness or accuracy of the data they obtain is compromised due to the failure to adhere to our clinical trial protocols
or for other reasons, our clinical studies or trials may be extended, delayed or terminated or may otherwise prove to be unsuccessful, and we may have to
conduct additional studies, which would significantly increase our costs, in order to obtain the regulatory clearances that we need to commercialize our products.
We have limited long-term data regarding the safety and efficacy of our Lumivascular platform products, including Pantheris. Any long-term data that
is generated by clinical trials involving our Lumivascular platform may not be positive or consistent with our short-term data, which would harm our
ability to obtain clearance to market and sell our products.
Our Lumivascular platform is a novel system, and our success depends on its acceptance by the medical community as being safe and effective, and
improving clinical outcomes. Important factors upon which the efficacy of our Lumivascular platform products, including Pantheris, will be measured are long-
term data on the rate of restenosis following our procedure, and the corresponding duration of patency, or openness of the artery, and publication of that data in
peer-reviewed journals. Another important factor that physicians will consider is the rate of reintervention, or retreatment, following the use of our Lumivascular
platform products. The long-term clinical benefits of procedures that use our Lumivascular platform products, including Pantheris, are not known.
The results of short-term clinical experience of our Lumivascular platform products, including Pantheris, do not necessarily predict long-term clinical
benefit. Restenosis rates typically increase over time. We believe that physicians will compare the rates of long-term restenosis and reintervention for procedures
using our Lumivascular platform products against alternative procedures, such as angioplasty, stenting, bypass surgery and other atherectomy procedures. If the
long-term rates of restenosis and reintervention do not meet physicians’ expectations, our Lumivascular platform products may not become widely adopted and
physicians may consider alternative treatments for their patients. Another significant factor that physicians will consider is acute safety data on complications that
occur during the use of our Lumivascular platform products. If the results obtained from any post-market studies that we conduct or post-clearance surveillance
indicate that the use of our Lumivascular platform products are not as safe or effective as other treatment options or as current short-term data would suggest,
adoption of our product may suffer and our business would be harmed. Even if we believe the data collected from clinical studies or clinical experience indicate
positive results, each physician’s actual experience with our products will vary. Physicians who are technically proficient participate in our clinical trials and are
high-volume users of our Lumivascular platform products. Consequently, the results of our clinical trials and their experiences using our products may lead to
better patient outcomes than those of physicians that are less proficient, perform fewer procedures or who use our products infrequently.
Our ability to market our current products in the United States is limited to use in peripheral vessels, and if we want to market our products for other
uses, we will need to file for FDA clearances or approvals and may need to conduct trials to support expanded use, which would be expensive, time-
consuming and may not be successful.
Our current products are cleared in the United States only for crossing sub-total and chronic total occlusions and for performing atherectomy in the
peripheral vasculature. These FFDCA clearances prohibits us from marketing or advertise our products for any other indication within the peripheral vasculature,
which restricts our ability to sell these products and could affect our growth. Additionally, our products are contraindicated for use in the cerebral, carotid,
coronary, iliac, and renal arteries. While off-label use of medical devices is common and the FDA does not regulate physicians’ choice of treatments, the FDA
does restrict a manufacturer’s communications regarding such off-label use. We are not allowed to actively promote or advertise our products for off-label use. In
addition, we cannot make comparative claims regarding the use of our products against any alternative treatments without conducting head-to-head comparative
clinical studies, which would be expensive and time consuming. If our promotional activities fail to comply with the FDA’s regulations or guidelines, we may be
subject to warnings or enforcement action by the FDA and other government agencies. In the future, if we want to market a variation of Ocelot or Pantheris in the
United States for use in other applications for which we do not currently have clearance, such as the coronary arteries, we will need to make modifications to
these products, conduct further clinical trials and obtain new clearances or approvals from the FDA. There can be no assurance that we will successfully
develop these modifications, that future clinical studies will be successful or that the expense of these activities will be offset by additional revenues.
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Our ability to develop, market, and sell our products depends in part upon our working relationships with physicians, and any events that damage
those relationships, or make it more difficult to build and maintain those relationships, could harm our business.
The development, marketing, and sale of our products, including Pantheris, depends upon our ability to maintain strong working relationships with
physicians. We rely on these professionals to provide us with considerable knowledge and experience regarding the development, marketing and sale of our
products. Physicians assist us in clinical trials and as researchers, marketing and product consultants and public speakers. If we cannot maintain our strong
working relationships with these professionals and continue to receive their advice and input, the development and marketing of our products could suffer, which
could harm our business, financial condition and results of operations. The medical device industry’s relationship with physicians is under increasing scrutiny by
the Office of Inspector General, or OIG, the Department of Justice, or DOJ, state attorneys general, and other foreign and domestic government agencies.
Changes to or our failure to comply with laws, rules and regulations governing our relationships with physicians, or an investigation into our compliance by the
OIG, DOJ, state attorneys general and other government agencies, could significantly harm our business by damaging our reputation among, or restricting our
ability to work with, physicians.
We have limited experience manufacturing our Lumivascular platform products in commercial quantities, which could harm our business.
Because we have only limited experience in manufacturing our Lumivascular platform products in commercial quantities, we may encounter production
delays or shortfalls. Such production delays or shortfalls may be caused by many factors, including the following:
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any expansion in our manufacturing capacity, could require changes to our production processes;
key components and sub-assemblies of our Lumivascular platform products are currently provided by a single supplier or limited number of suppliers,
and we do not maintain large inventory levels of these components and sub-assemblies; if we experience a shortage in any of these components or sub-
assemblies, we would need to identify and qualify new supply sources, which could increase our expenses and result in manufacturing delays;
we may experience a delay in completing validation and verification testing for new controlled-environment rooms at our manufacturing facilities; and
we have limited experience in complying with the FDA’s QSR, which applies to the manufacture of our Lumivascular platform products.
If we are unable to keep up with demand for our Lumivascular platform products, our revenues could be impaired, market acceptance for our
Lumivascular platform products could be harmed and our customers might instead purchase our competitors’ products. Our inability to successfully manufacture
our Lumivascular platform products would materially harm our business.
Our manufacturing facilities and processes and those of our third-party suppliers are subject to unannounced FDA and state regulatory inspections for
compliance with QSR. Developing and maintaining a compliant quality system is time consuming and expensive. Failure to maintain, or not fully comply with the
requirements of, a quality system could result in regulatory authorities initiating enforcement actions against us and our third-party suppliers, which could include
the issuance of warning letters, seizures, prohibitions on product sales, recalls and civil and criminal penalties, any one of which could significantly impact our
manufacturing supply and impair our financial results.
If our manufacturing facility becomes damaged or inoperable, or we are required to vacate the facility, or our electronic systems are compromised,
our ability to manufacture and sell our Lumivascular platform products and to pursue our research and development efforts may be jeopardized.
We currently manufacture and assemble our Lumivascular platform products in-house. Our products are comprised of components sourced from a
variety of contract manufacturers, with final assembly completed at our facility in Redwood City, California. Our facility and equipment, or those of our suppliers,
could be harmed or rendered inoperable by natural or man-made disasters, including fire, earthquake, terrorism, flooding and power outages. Further, our
electronic systems may experience service interruptions, denial-of-service and other cyber-attacks, computer viruses or other events. Any of these may render it
difficult or impossible for us to manufacture products, pursue our research and development efforts or otherwise run our business for some period of time. If our
facility is inoperable for even a short period of time, the inability to manufacture our current products, and the interruption in research and development of any
future products, may result in harm to our reputation, increased costs, lower revenues and the loss of customers. Furthermore, it could be costly and time-
consuming to repair or replace our facilities and the equipment we use to perform our research and development work and manufacture our products.
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We depend on third-party vendors to manufacture some of our components , coating and sub-assemblies, which could make us vulnerable to supply
shortages and price fluctuations that could harm our business.
We currently manufacture some of our components and sub-assemblies at our Redwood City facility and rely on third-party vendors for other
components and sub-assemblies used in our Lumivascular platform. Our reliance on third-party vendors subjects us to a number of risks that could impact our
ability to manufacture our products and harm our business, including:
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interruption of supply resulting from modifications to, or discontinuation of, a supplier’s operations;
delays in product shipments resulting from uncorrected defects, reliability issues or a supplier’s failure to consistently produce quality components;
price fluctuations due to a lack of long-term supply arrangements with our suppliers for key components;
inability to obtain adequate supply in a timely manner or on commercially reasonable terms;
difficulty identifying and qualifying alternative suppliers for components in a timely manner;
inability of the manufacturer or supplier to comply with QSR as enforced by the FDA and state regulatory authorities;
inability to control the quality of products manufactured by third parties;
production delays related to the evaluation and testing of products from alternative suppliers and corresponding regulatory qualifications; and
delays in delivery by our suppliers due to changes in demand from us or their other customers.
Any significant delay or interruption in the supply of components or sub-assemblies, or our inability to obtain substitute components, sub-assemblies or
materials from alternate sources at acceptable prices in a timely manner, could impair our ability to meet the demand of our customers and harm our business.
We depend on single and limited source suppliers for some of our product components , coating , and sub-assemblies, and if any of those suppliers
are unable or unwilling to produce these components and sub-assemblies or supply them in the quantities that we need, we would experience
manufacturing delays.
We rely on single and limited source suppliers for several of our components and sub-assemblies. For example, we rely on single vendors for our optical
fiber, coatings and drive cables that are key components of our catheters, and we rely on single vendors for our laser and data acquisition card that are key
components of our Lightbox. These components are critical to our products and there are relatively few alternative sources of supply. We do not carry a
significant inventory of these components. Identifying and qualifying additional or replacement suppliers for any of the components or sub-assemblies used in our
products could involve significant time and cost. Any supply interruption from our vendors or failure to obtain additional vendors for any of the components or
sub-assemblies incorporated into our products would limit our ability to manufacture our products and could therefore harm our business, financial condition and
results of operations.
Our future growth depends on physician adoption of our Lumivascular platform products, which may require physicians to change their current
practices.
We educate physicians on the capabilities of our Lumivascular platform products and advances in treatment for PAD patients. We target our sales efforts
to interventional cardiologists, vascular surgeons and interventional radiologists because they are often the physicians diagnosing and treating both coronary
artery disease and PAD. However, the initial point of contact for many patients may be general practitioners, podiatrists, nephrologists and endocrinologists,
each of whom commonly treat patients experiencing complications or symptoms resulting from PAD. If these physicians are not made aware of our Lumivascular
platform products, they may not refer patients to interventional cardiologists, vascular surgeons and interventional radiologists for treatment using our
Lumivascular platform procedure, and those patients may instead be surgically treated or treated with an alternative interventional procedure. In addition, there is
a significant correlation between PAD and coronary artery disease, and many physicians do not routinely screen for PAD while screening for coronary artery
disease. If we are not successful in educating physicians about screening for PAD and about the capabilities of our Lumivascular platform products, our ability to
increase our revenues may be impaired.
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We depend on our senior management team and the loss of one or more key employees or an inability to attract and retain highly skilled employees
could harm our business.
Our success largely depends upon the continued services of our executive management team and key employees and the loss of one or more of our
executive officers or key employees could harm us and directly impact our financial results. Our employees may terminate their employment with us at any time.
Changes in our executive management team resulting from the hiring or departure of executives could disrupt our business.
We must attract and retain highly qualified personnel. Competition for skilled personnel is intense, especially for engineers with high levels of experience
in designing and developing medical devices and for sales professionals. We have, from time to time, experienced, and we expect to continue to experience,
difficulty in hiring and retaining employees with appropriate qualifications. Many of the companies with which we compete for experienced personnel have greater
resources than we have. If we hire employees from competitors or other companies, their former employers may attempt to assert that these employees or we
have breached legal obligations, resulting in a diversion of our time and resources and, potentially, damages. In addition, job candidates and existing employees,
particularly in the San Francisco Bay Area, often consider the value of the stock awards they receive in connection with their employment. If the perceived value
of our stock awards declines, it may harm our ability to recruit and retain highly skilled employees. In addition, we invest significant time and expense in training
our employees, which increases their value to competitors who may seek to recruit them. If we fail to attract new personnel or fail to retain and motivate our
current personnel, our business would be harmed.
We do not currently intend to devote significant additional resources in the near-term to market our Lumivascular platform internationally, which will
limit our potential revenues from our Lumivascular platform products.
Marketing our Lumivascular platform outside of the United States would require substantial additional sales and marketing, regulatory and personnel
expenses. As part of our product development and regulatory strategy, we plan to expand into select international markets, but we do not currently intend to
devote significant additional resources to market our Lumivascular platform internationally in order to focus our resources and efforts on the U.S. market. Our
decision to market our products primarily in the United States in the near-term will limit our ability to reach all of our potential markets and will limit our potential
sources of revenue. In addition, our competitors will have an opportunity to further penetrate and achieve market share outside of the United States until such
time, if ever, that we devote significant additional resources to market our Lumivascular platform products or other products internationally.
Our ability to utilize our net operating loss carryforwards may be limited.
As of December 31, 2019, we had federal and state net operating loss carryforwards, or NOLs, due to prior period losses of $301.0 million and $216.1
million, respectively, which if not utilized will begin to expire in 2027 for federal purposes and 2019 for state purposes. Out of the total Federal net operating loss
carryforwards, $43.5 million were generated post December, 31, 2017 and have no expiration. Generally, subject to certain limitations, NOLs can be used to
offset taxable income for U.S. federal income tax purposes. However, Section 382 of the Internal Revenue Code of 1986, as amended, may limit the NOLs we
may use in any year for U.S. federal income tax purposes in the event of certain changes in ownership of our company. A Section 382 “ownership change”
generally occurs if one or more stockholders or groups of stockholders who own at least 5% of our stock increase their ownership by more than 50 percentage
points over their lowest ownership percentage within a rolling three-year period. Similar rules may apply under state tax laws. It is possible that prior transactions
with respect to our stock may have caused, and that future issuances or sales of our stock (including certain transactions involving our stock that are outside of
our control) could cause, an “ownership change.” A number of our common and preferred stock financings over the past year may affect our ability to use NOLs.
If an “ownership change” occurs, Section 382 would impose an annual limit on the amount of pre-ownership change NOLs and other tax attributes we can use
to reduce our taxable income, potentially increasing and accelerating our liability for income taxes, and also potentially causing those tax attributes to expire
unused. Any limitation on using NOLs could (depending on the extent of such limitation and the NOLs previously used) result in our retaining less cash after
payment of U.S. federal income taxes during any year in which we have taxable income (rather than losses) than we would be entitled to retain if such NOLs
were available as an offset against such income for U.S. federal income tax reporting purposes, which could harm our profitability. On December 22, 2017, the
Tax Cuts and Jobs Act, or Tax Act, was enacted into law with many significant changes to the U.S. tax laws. The Tax Act limits the utilization of NOLs arising in
tax years beginning after December 31, 2017 to 80% of taxable income per year. However, existing NOLs that arose in years prior to December 31, 2017 are not
affected by these provisions. Our ability to utilize NOLs arising in future tax periods may be limited by the Tax Act.
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We may acquire other companies or technologies or be the target of strategic transactions, which could divert our management’s attention, result in
additional dilution to our stockholders and otherwise disrupt our operations and harm our operating results.
We may in the future seek to acquire or invest in businesses, applications or technologies that we believe could complement or expand our
Lumivascular platform, enhance our technical capabilities or otherwise offer growth opportunities. The pursuit of potential acquisitions may divert the attention of
management and cause us to incur various costs and expenses in identifying, investigating and pursuing suitable acquisitions, whether or not they are
consummated. We may not be able to identify desirable acquisition targets or be successful in entering into an agreement with any particular target or obtain the
expected benefits of any acquisition or investment.
To date, our technology and product development efforts have been organic, and we have no experience in acquiring other businesses. In any
acquisition, we may not be able to successfully integrate acquired personnel, operations and technologies, or effectively manage the combined business
following the acquisition. Acquisitions could also result in dilutive issuances of equity securities, the use of our available cash, or the incurrence of debt, which
could harm our operating results. In addition, if an acquired business fails to meet our expectations, our operating results, business and financial condition may
suffer.
In addition, we sometimes receive inquiries relating to potential strategic transactions, including from third parties who may seek to acquire us. We will
continue to consider and discuss such transactions as we deem appropriate. Such potential transactions may divert the attention of management, and cause us
to incur various costs and expenses in investigating and evaluating such transactions, whether or not they are consummated.
If our technology infrastructure is compromised, damaged or interrupted by a cybersecurity incident, data security breach or other security
problems, our operating results and financial condition could be adversely affected.
We use technology in substantially all aspects of our business operations, and our ability to serve customers most effectively depends on the reliability of
our technology systems. Cybersecurity incidents can include computer viruses, computer denial-of-service attacks, worms, and other malicious software
programs or other attacks, covert introduction of malware to computers and networks, impersonation of authorized users, and efforts to discover and exploit any
design flaws, bugs, security vulnerabilities or security weaknesses, as well as intentional or unintentional acts by employees or other insiders with access
privileges, intentional acts of vandalism by third parties and sabotage.
In addition, our technology infrastructure and systems are vulnerable to damage or interruption from natural disasters, power loss and
telecommunications failures. Any such disruption to our systems, or the technology systems of third parties on which we rely, the failure of these systems to
otherwise perform as anticipated, or the theft, destruction, loss, misappropriation, or release of sensitive and/or confidential information or intellectual property,
could require us to notify affected individuals, federal or state agencies or media outlets of the incident and could result in business disruption, negative publicity,
loss of customers, potential liability, including litigation or other legal actions against us or the imposition of penalties, fines, fees or liabilities, which may not be
covered by our insurance policies, and competitive disadvantage, any or all of which would potentially adversely affect our customer service, decrease the
volume of our business and result in increased costs and lower profits. Moreover, a cybersecurity breach could require us to devote significant management
resources to address the problems associated with the breach and to expend significant additional resources to upgrade further the security measures we
employ to protect information against cyber-attacks and other wrongful attempts to access such information, which could result in a disruption of our operations.
While we have invested, and continue to invest, in technology security initiatives and other measures to prevent security breaches and cyber incidents,
as well as disaster recovery plans, these initiatives and measures may not be entirely effective to insulate us from technology disruption that could result in
adverse effects on our results of operations.
Risks Related to Our Intellectual Property
We may in the future be a party to intellectual property litigation or administrative proceedings that could be costly and could interfere with our ability
to sell our Lumivascular platform products.
The medical device industry has been characterized by extensive litigation regarding patents, trademarks, trade secrets, and other intellectual property
rights, and companies in the industry have used intellectual property litigation to gain a competitive advantage. It is possible that U.S. and foreign patents and
pending patent applications or trademarks controlled by third parties may be alleged to cover our products, or that we may be accused of misappropriating third
parties’ trade secrets. Additionally, our products include hardware and software components that we purchase from vendors, and may include design
components that are outside of our direct control. Our competitors, many of which have substantially greater resources and have made substantial investments in
patent portfolios, trade secrets, trademarks, and competing technologies, may have applied for or obtained or may in the future apply for or obtain, patents or
trademarks that will prevent, limit or otherwise interfere with our ability to make, use, sell and/or export our products or to use product names. They may devote
substantial resources towards obtaining claims that cover the design of our atherectomy products to prevent the marketing and selling of competitive products.
We may become a party to patent or trademark infringement or trade secret claims and litigation as a result of these and other third-party intellectual property
rights being asserted against us. The defense and prosecution of these matters are both costly and time consuming. Vendors from whom we purchase hardware
or software may not indemnify us in the event that such hardware or software is accused of infringing a third-party’s patent or trademark or of misappropriating a
third-party’s trade secret.
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Further, if such patents, trademarks, or trade secrets are successfully asserted against us, this may harm our business and result in injunctions
preventing us from selling our products, license fees, damages and the payment of attorney fees and court costs. In addition, if we are found to willfully infringe
third-party patents or trademarks or to have misappropriated trade secrets, we could be required to pay treble damages in addition to other penalties. Although
patent, trademark, trade secret, and other intellectual property disputes in the medical device area have often been settled through licensing or similar
arrangements, costs associated with such arrangements may be substantial and could include ongoing royalties. We may be unable to obtain necessary
licenses on satisfactory terms, if at all. If we do not obtain necessary licenses, we may not be able to redesign our Lumivascular platform products to avoid
infringement.
Similarly, interference or derivation proceedings provoked by third parties or brought by the U.S. Patent and Trademark Office, or USPTO, may be
necessary to determine the priority of inventions or other matters of inventorship with respect to our patents or patent applications. We may also become
involved in other proceedings, such as re-examination, inter partes review, or opposition proceedings, before the USPTO or other jurisdictional body relating to
our intellectual property rights or the intellectual property rights of others. Adverse determinations in a judicial or administrative proceeding or failure to obtain
necessary licenses could prevent us from manufacturing and selling our Lumivascular platform products or using product names, which would have a significant
adverse impact on our business.
Additionally, we may need to commence proceedings against others to enforce our patents or trademarks, to protect our trade secrets or know-how, or
to determine the enforceability, scope and validity of the proprietary rights of others. These proceedings would result in substantial expense to us and significant
diversion of effort by our technical and management personnel. We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded,
if any, may not be commercially meaningful. We may not be able to stop a competitor from marketing and selling products that are the same or similar to our
products or from using product names that are the same or similar to our product names, and our business may be harmed as a result.
We are aware of patents held by third parties that may be asserted against us in litigation that could be costly and could limit our ability to sell our
Lumivascular platform products.
We are aware of patent families related to catheter positioning, optical coherence tomography, occlusion cutting and atherectomy owned by third parties.
With regard to atherectomy patents, one of our founders, Dr. John Simpson, founded FoxHollow Technologies prior to founding our company. FoxHollow
Technologies developed an atherectomy device that is currently sold by Medtronic, and Dr. Simpson and our Chief Technology Officer, Himanshu Patel, are
listed as inventors on patents covering that device that are now held by Medtronic. We are not currently aware of any claims Medtronic has made or intends to
make against us with respect to Pantheris or any other product or product under development. Because of a doctrine known as “assignor estoppel,” if any of
Dr. Simpson’s earlier patents are asserted against us by Medtronic, we may be prevented from asserting an invalidity defense regarding those patents, and our
defense may be compromised. Medtronic has significantly greater financial resources than we do to pursue patent litigation and could assert these patent
families against us at any time. Adverse determinations in any such litigation could prevent us from manufacturing or selling Pantheris or other products or
products under development, which would significantly harm our business.
Intellectual property rights may not provide adequate protection, which may permit third parties to compete against us more effectively.
In order to remain competitive, we must develop and maintain protection of the proprietary aspects of our technologies. We rely on a combination of
patents, copyrights, trademarks, trade secret laws and confidentiality and invention assignment agreements to protect our intellectual property rights. As of
December 31, 2019, we held 31 issued and allowed U.S. patents and had 25 U.S. utility patent applications and 1 PCT applications pending. As of December 31,
2019, we also had 60 issued and allowed patents outside of the United States. As of December 31, 2019, we had 43 pending patent applications outside of the
United States, including in Australia, Canada, China, Europe, India and Japan. Our patents and patent applications include claims covering key aspects of the
design, manufacture and therapeutic use of OCT imaging catheters, occlusion-crossing catheters, atherectomy devices and our imaging console. Our patent
applications may not result in issued patents and our patents may not be sufficiently broad to protect our technology. Any patents issued to us may be
challenged by third parties as being invalid, or third parties may independently develop similar or competing technology that avoids our patents. Should such
challenges be successful, competitors might be able to market products and use manufacturing processes that are substantially similar to ours. We may not be
able to prevent the unauthorized disclosure or use of our technical knowledge or other trade secrets by consultants, vendors or former or current employees,
despite the existence generally of confidentiality agreements and other contractual restrictions. Monitoring unauthorized use and disclosure of our intellectual
property is difficult, and we do not know whether the steps we have taken to protect our intellectual property will be adequate. In addition, the laws of many
foreign countries will not protect our intellectual property rights to the same extent as the laws of the United States. Consequently, we may be unable to prevent
our proprietary technology from being exploited abroad, which could affect our ability to expand to international markets or require costly efforts to protect our
technology. To the extent our intellectual property protection is incomplete, we are exposed to a greater risk of direct competition. In addition, competitors could
purchase our products and attempt to replicate some or all of the competitive advantages we derive from our development efforts or design around our protected
technology. Our failure to secure, protect and enforce our intellectual property rights could substantially harm the value of our Lumivascular platform, brand and
business.
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We use certain open source software in Lightbox. We may face claims from companies that incorporate open source software into their products or from
open source licensors, claiming ownership of, or demanding release of, the source code, the open source software or derivative works that were developed
using such software, or otherwise seeking to enforce the terms of the applicable open source license. These claims could result in litigation and could require us
to cease offering Lightbox unless and until we can re-engineer it to avoid infringement. This re-engineering process could require significant additional research
and development resources, and we may not be able to complete it successfully. These risks could be difficult to eliminate or manage, and, if not addressed,
could harm our business, financial condition and operating results.
Risks Related to Government Regulation
Failure to comply with laws and regulations could harm our business.
Our business is subject to regulation by various federal, state, local and foreign governmental agencies, including agencies responsible for monitoring
and enforcing employment and labor laws, workplace safety, environmental laws, consumer protection laws, anti-bribery laws, import/export controls, federal
securities laws and tax laws and regulations. In certain jurisdictions, these regulatory requirements may be more stringent than those in the United States and in
other circumstances these requirements may be more stringent in the United States. Noncompliance with applicable regulations or requirements could subject
us to investigations, sanctions, mandatory recalls, enforcement actions, adverse publicity, disgorgement of profits, fines, damages, civil and criminal penalties or
injunctions and administrative actions. If any governmental sanctions, fines or penalties are imposed, or if we do not prevail in any possible civil or criminal
litigation, our business, operating results and financial condition could be harmed. In addition, responding to any action will likely result in a significant diversion of
management’s attention and resources and substantial costs. Enforcement actions and sanctions could further harm our business, operating results and financial
condition.
If we fail to obtain and maintain necessary regulatory clearances or approvals for our Lumivascular platform products, or if clearances or approvals
for future products and indications are delayed or not issued, our commercial operations would be harmed.
Our Lumivascular platform products are medical devices that are subject to extensive regulation by FDA in the United States and by regulatory agencies
in other countries where we do business. Government regulations specific to medical devices are wide-ranging and govern, among other things:
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product design, development and manufacture;
laboratory, preclinical and clinical testing, labeling, packaging, storage and distribution;
pre-marketing clearance or approval;
record keeping;
product marketing, promotion and advertising, sales and distribution; and
post-marketing surveillance, including reporting of deaths or serious injuries and recalls and correction and removals.
Before a new medical device, or a new intended use for, an existing product can be marketed in the United States, a company must first submit and
receive either 510(k) clearance or pre-marketing approval from FDA, unless an exemption applies. Either process can be expensive, lengthy and unpredictable.
We may not be able to obtain the necessary clearances or approvals or may be unduly delayed in doing so, which could harm our business. Furthermore, even
if we are granted regulatory clearances or approvals, they may include significant limitations on the indicated uses for the product, which may limit the market for
the product. Although we have obtained 510(k) clearance to market Pantheris, our image-guided atherectomy device, and our Ocelot family of catheters for
crossing sub and total occlusions in the peripheral vasculature, our clearance can be revoked if safety or efficacy problems develop. Delays in obtaining
clearance or approval could increase our costs and harm our revenues and growth.
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In addition, we are required to timely file various reports with the FDA, including medical device reports, or MDRs, if our devices may have caused or
contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction were to
recur. If these MDRs are not filed timely, regulators may impose sanctions and sales of our products may suffer, and we may be subject to product liability or
regulatory enforcement actions, all of which could harm our business.
If we initiate a correction or removal for one of our devices to reduce a risk to health posed by the device, we would be required to submit a publicly
available Correction and Removal report to the FDA and in many cases, similar reports to other regulatory agencies. This report could be classified by the FDA
as a device recall that could lead to increased scrutiny by the FDA, other international regulatory agencies and our customers regarding the quality and safety of
our devices. Furthermore, the submission of these reports has been and could be used by competitors against us in competitive situations and cause customers
to delay purchase decisions or cancel orders and would harm our reputation.
The FDA and the Federal Trade Commission, or FTC, also regulate the advertising and promotion of our products to ensure that the claims we make are
consistent with our regulatory clearances, that there are adequate and reasonable scientific data to substantiate the claims and that our promotional labeling and
advertising is neither false nor misleading in any respect. If the FDA or FTC determines that any of our advertising or promotional claims are misleading, not
substantiated or not permissible, we may be subject to enforcement actions, including Warning Letters, adverse publicity, and we may be required to revise our
promotional claims and make other corrections or restitutions.
The FDA and state authorities have broad enforcement powers. Our failure to comply with applicable regulatory requirements could result in enforcement
action by the FDA or state agencies, which may include any of the following sanctions:
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adverse publicity, warning letters, fines, injunctions, consent decrees and civil penalties;
repair, replacement, refunds, recall or seizure of our products;
operating restrictions, partial suspension or total shutdown of production;
refusing our requests for 510(k) clearance or pre-market approval of new products, new intended uses or modifications to existing products;
withdrawing 510(k) clearance or pre-market approvals that have already been granted; and
criminal prosecution.
If any of these events were to occur, our business and financial condition would be harmed.
Material modifications to our Lumivascular platform products may require new 510(k) clearances or pre-market approvals or may require us to recall
or cease marketing our Lumivascular platform products until clearances or approvals are obtained.
Material modifications to the intended use or technological characteristics of our Lumivascular platform products will require new 510(k) clearances or
pre-market approvals or require us to recall or cease marketing the modified devices until these clearances or approvals are obtained if such changes were
made via the “Letter-to-File” process of internal documentation. Based on published FDA guidelines, the FDA requires device manufacturers to initially make and
document a determination of whether or not a modification requires a new approval, supplement or clearance; however, the FDA can review a manufacturer’s
decision. Any modification to an FDA-cleared device that would significantly affect its safety or efficacy or that would constitute a major change in its intended
use would require a new 510(k) clearance or possibly a pre-market approval. We may not be able to obtain additional 510(k) clearances or pre-market
approvals for new products or for modifications to, or additional indications for, our Lumivascular platform products in a timely fashion, or at all. Delays in
obtaining required future clearances would harm our ability to introduce new or enhanced products in a timely manner, which in turn would harm our future
growth. We have made modifications to our Lumivascular platform products in the past and will make additional modifications in the future that we believe do not
or will not require additional clearances or approvals. If the FDA disagrees and requires new clearances or approvals for the modifications, we may be required
to recall and to stop selling or marketing our Lumivascular platform products as modified, which could harm our operating results and require us to redesign our
Lumivascular platform products. In these circumstances, we may be subject to significant enforcement actions. We plan to make further modifications to the
design of Ocelaris to enhance our ability to cross CTOs. Future versions of are Lumivacular platform incorporating enhancements may require additional
regulatory clearances or approvals.
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If we or our suppliers fail to comply with the FDA’s QSR, our manufacturing operations could be delayed or shut down and Lumivascular platform
sales could suffer.
Our manufacturing processes and those of our third-party suppliers are required to comply with the FDA’s QSR, which covers the procedures and
documentation of the design, testing, production, control, quality assurance, labeling, packaging, storage and shipping of our Lumivascular platform products.
We are also subject to similar state requirements and licenses. In addition, we must engage in extensive recordkeeping and reporting and must make available
our manufacturing facilities and records for periodic unannounced inspections by governmental agencies, including the FDA, state authorities and comparable
agencies in other countries. If we fail a QSR inspection, our operations could be disrupted and our manufacturing interrupted. Failure to take adequate corrective
action in response to an adverse QSR inspection could result in, among other things, a shut-down of our manufacturing operations, significant fines, suspension
of marketing clearances and approvals, seizures or recalls of our device, operating restrictions and criminal prosecutions, any of which would cause our business
to suffer. Furthermore, our key component suppliers may not currently be or may not continue to be in compliance with applicable regulatory requirements, which
may result in manufacturing delays for our products and cause our revenues to decline.
We have registered with the FDA as a medical device manufacturer and have obtained a manufacturing license from the California Department of Public
Health (CDPH). The FDA has broad post-market and regulatory enforcement powers. We are subject to unannounced inspections by the FDA and the Food and
Drug Branch of CDPH to determine our compliance with the QSR and other regulations, and these inspections may include the manufacturing facilities of our
suppliers. Our current facility has been inspected by the FDA in 2009, 2011 and 2013, and two, three and zero observations, respectively, were noted during
those inspections. BSI, our European Notified Body, inspected our facility in 2014 and 2015 and found zero non-conformances. BSI conducted four external
audits in 2016 and zero non-conformances were found in all except for one audit, for which four minor non-conformances were found. BSI conducted a
recertification audit (for EU) in 2016 followed by surveillance audits in 2017 & 2018, and found no major non-conformances. BSI also audited us for QSR
compliance under MDSAP (Medical Device Single Audit Program) for FDA in July 2016, and found no major non-conformances. Additionally, BSI conducted a
Technical File Audit in 2018 that resulted in one major non-conformance and three minor non-conformances. In 2018 and 2019, BSI conducted multiple routine
audits including a surveillance audit, a Microbiology audit, a MDSAP re-certification audit and most recently, a one-day unannounced audit in September 2019. All
non-conformances identified in the aforementioned audits have been either successfully resolved or are being actively addressed via Avinger’s CAPA system.
We can provide no assurance that we will continue to remain in substantial compliance with the QSR. If the FDA, CDPH or BSI inspect our facility and
discover major compliance problems, we may have to shut down our facility and cease manufacturing until we can take the appropriate remedial steps to correct
the audit findings. Taking corrective action may be expensive, time consuming and a distraction for management and if we experience a shutdown or delay at our
manufacturing facility we may be unable to produce our Lumivascular platform products, which would harm our business.
Our Lumivascular platform products may in the future be subject to product recalls that could harm our reputation.
FDA and similar governmental authorities in other countries have the authority to require the recall of commercialized products in the event of material
regulatory deficiencies or defects in design or manufacture. A government mandated or voluntary recall by us could occur as a result of component failures,
manufacturing errors or design or labeling defects. Recalls of our Lumivascular platform products or products we commercialize in the future would divert
managerial attention, be expensive, harm our reputation with customers and harm our financial condition and results of operations. A recall announcement would
negatively affect our stock price.
Changes in coverage and reimbursement for procedures using our Lumivascular platform products could affect the adoption of our Lumivascular
platform and our future revenues.
Currently, our Lumivascular platform procedure is typically reimbursed by third-party payors, including Medicare and private healthcare insurance
companies, under existing reimbursement codes. These payors may change their coverage and reimbursement policies, as well as payment amounts, in a way
that would prevent or limit reimbursement for our products, which would significantly harm our business. Also, healthcare reform legislation or regulation may be
proposed or enacted in the future, which may adversely affect such policies and amounts. We cannot predict whether and to what extent existing coverage and
reimbursement will continue to be available. If physicians, hospitals and other providers are unable to obtain adequate coverage and reimbursement for
procedures performed using our Lumivascular platform products, they are significantly less likely to use our Lumivascular platform products and our business
would be harmed.
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EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
Healthcare reform measures could hinder or prevent our planned products’ commercial success.
In the United States, there have been, and we expect there will continue to be, a number of legislative and regulatory changes to the healthcare system
in ways that could harm our future revenues and profitability and the future revenues and profitability of our potential customers. Federal and state lawmakers
regularly propose and, at times, enact legislation that would result in significant changes to the healthcare system, some of which are intended to contain or
reduce the costs of medical products and services. The current presidential administration and Congress may continue to attempt broad sweeping changes to
the current healthcare laws. We face uncertainties that might result from modifications or repeal of any of the provisions of the Affordable Care Act, including as
a result of current and future executive orders and legislative actions. The impact of those changes on us and potential effect on the medical device industry as a
whole is currently unknown. Any changes to the Affordable Care Act are likely to have an impact on our results of operations and may have a material adverse
effect on our results of operations. We cannot predict what other healthcare programs and regulations will ultimately be implemented at the federal or state level
or the effect of any future legislation or regulation in the United States may have on our business.
The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare services to contain or
reduce costs of healthcare may harm:
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our ability to set a price that we believe is fair for our products;
our ability to generate revenues and achieve or maintain profitability; and
the availability of capital.
If we fail to comply with healthcare regulations, we could face substantial penalties and our business, operations and financial condition could be
adversely affected.
Even though we do not and will not control referrals of healthcare services or bill directly to Medicare, Medicaid or other third-party payors, certain
federal and state healthcare laws and regulations pertaining to fraud and abuse and patients’ rights are and will be applicable to our business. We are subject to
many healthcare fraud and abuse and patient privacy regulations by both the federal government and the states in which we conduct our business. The
regulations that affect how we operate include:
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the federal healthcare program Anti-Kickback Statute, which prohibits, among other things, any person from knowingly and willfully offering, soliciting,
receiving or providing remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or
recommendation of, any good or service for which payment may be made under federal healthcare programs, such as the Medicare and Medicaid
programs;
the federal False Claims Act, which prohibits, among other things, individuals or entities from knowingly presenting, or causing to be presented, false
claims, or knowingly using false statements, to obtain payment from the federal government;
federal criminal laws that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare
matters;
the Sunshine Act, created under the Affordable Care Act, and its implementing regulations, which require manufacturers of drugs, medical devices,
biologicals and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program to report annually
to the HHS information related to payments or other transfers of value made to physicians and teaching hospitals, as well as ownership and investment
interests held by physicians and their immediate family members;
HIPAA, as amended by the HITECH Act, which protects the security and privacy of protected health information; and
state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by
any third-party payor, including commercial insurers.
The Affordable Care Act, among other things, amends the intent requirement of the Federal Anti-Kickback Statute and criminal healthcare fraud statutes.
A person or entity no longer needs to have actual knowledge of this statute or specific intent to violate it. In addition, the Affordable Care Act provides that the
government may assert that a claim including items or services resulting from a violation of the Federal Anti-Kickback Statute constitutes a false or fraudulent
claim for purposes of the False Claims Act.
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EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
Efforts to ensure that our business arrangements will comply with applicable healthcare laws may involve substantial costs. It is possible that
governmental and enforcement authorities will conclude that our business practices do not comply with current or future statutes, regulations or case law
interpreting applicable fraud and abuse or other healthcare laws and regulations. If any such actions are instituted against us, and we are not successful in
defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of civil, criminal and
administrative penalties, damages, disgorgement, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare
programs, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations, any of which could harm our ability
to operate our business and our results of operations. In addition, the clearance or approval and commercialization of any of our products outside the United
States will also likely subject us to foreign equivalents of the healthcare laws mentioned above, among other foreign laws.
Compliance with environmental laws and regulations could be expensive. Failure to comply with environmental laws and regulations could subject
us to significant liability.
Our research and development and manufacturing operations involve the use of hazardous substances and are subject to a variety of federal, state, local
and foreign environmental laws and regulations relating to the storage, use, discharge, disposal, remediation of, and human exposure to, hazardous substances
and the sale, labeling, collection, recycling, treatment and disposal of products containing hazardous substances. In addition, our research and development and
manufacturing operations produce biological waste materials, such as human and animal tissue, and waste solvents, such as isopropyl alcohol. These operations
are permitted by regulatory authorities, and the resultant waste materials are disposed of in material compliance with environmental laws and regulations. Liability
under environmental laws and regulations can be joint and several and without regard to fault or negligence. Compliance with environmental laws and
regulations may be expensive and non-compliance could result in substantial liabilities, fines and penalties, personal injury and third-party property damage
claims and substantial investigation and remediation costs. Environmental laws and regulations could become more stringent over time, imposing greater
compliance costs and increasing risks and penalties associated with violations. We cannot assure you that violations of these laws and regulations will not occur
in the future or have not occurred in the past as a result of human error, accidents, equipment failure or other causes. The expense associated with
environmental regulation and remediation could harm our financial condition and operating results.
Regulations related to “conflict minerals” may force us to incur additional expenses, may result in damage to our business reputation and may
adversely impact our ability to conduct our business.
Pursuant to the Dodd-Frank Wall Street Reform and Consumer Protection Act, the SEC promulgated final rules regarding disclosure of the use of certain
minerals, known as conflict minerals, that are mined from the Democratic Republic of the Congo and adjoining countries, as well as procedures regarding a
manufacturer’s efforts to prevent the sourcing of such minerals and metals produced from those minerals. These disclosure requirements require ongoing due
diligence efforts and disclosure obligations. We have incurred and expect to incur additional costs to comply with these disclosure requirements, including costs
related to determining the source of any of the relevant minerals and metals used in our products. Additional costs could include the cost of remediation and
other changes to products, processes, or sources of supply as a consequence of such verification activities. In addition, our implementation of these rules could
adversely affect the sourcing, supply, and pricing of materials used in our products. We may face reputational harm if we determine that certain of our
components contain minerals not determined to be conflict free or if we are unable to alter our processes or sources of supply to avoid using such materials.
Reputational harm could adversely affect our business, financial condition or results of operations.
Risks Related to Our Common Stock and Preferred Stock
Our stock price may be volatile, and purchasers of our common stock could incur substantial losses.
Our stock price has fluctuated significantly since our IPO and is likely to continue to fluctuate substantially. As a result of this price fluctuation, investors
may experience losses on their investments in our stock. In addition, the development stage of our operations may make it difficult for investors to evaluate the
success of our business to date and to assess our future viability. The market price for our common stock may be influenced by many factors, including:
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sales of stock by our existing stockholders, including our affiliates;
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the results of our clinical trials;
changes in analysts’ estimates, investors’ perceptions, recommendations by securities analysts or our failure to achieve analysts’ and our own estimates;
the financial projections we may provide to the public, any changes in these projections or our failure to meet these projections;
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actual or anticipated fluctuations in our financial condition and operating results;
quarterly variations in our or our competitors’ results of operations;
general market conditions and other factors unrelated to our operating performance or the operating performance of our competitors;
changes in operating performance and stock market valuations of other technology companies generally, or those in the medical device industry in
particular;
the loss of key personnel, including changes in our board of directors and management;
legislation or regulation of our business;
lawsuits threatened or filed against us;
the announcement of new products or product enhancements by us or our competitors;
announcements related to patents issued to us or our competitors and to litigation; and
developments in our industry.
From time to time, our affiliates may sell stock for reasons due to their personal financial circumstances. These sales may be interpreted by other
stockholders as an indication of our performance and result in subsequent sales of our stock that have the effect of creating downward pressure on the market
price of our common stock. In addition, the stock prices of many companies in the medical device industry have experienced wide fluctuations that have often
been unrelated to the operating performance of those companies.
Our stock price has decreased significantly over the course of the past year. As a result of the decrease in our stock price, the options held by our
employees are less valuable which make it more likely that certain of our employees may leave our company. The loss of key employees could have an adverse
effect on our business.
We may fail to meet our publicly announced guidance or other expectations about our business and future operating results, which would cause our
stock price to decline.
We have provided in the past and may provide guidance in the future about our business and future operating results. In developing this guidance, our
management must make certain assumptions and judgments about our future performance, including projected revenues and the timing of regulatory approvals.
Furthermore, analysts and investors may develop and publish their own projections of our business, which may form a consensus about our future performance.
Our business results may vary significantly from such guidance or that consensus due to a number of factors, many of which are outside of our control, and which
could adversely affect our operations and operating results. Furthermore, if we make downward revisions of our previously announced guidance, or if our publicly
announced guidance of future operating results fails to meet expectations of securities analysts, investors or other interested parties, the price of our common
stock would decline.
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If securities or industry analysts do not publish research or reports about our business, or publish negative reports about our business, our share
price and trading volume could decline.
The trading market for our common stock will depend in part on the research and reports that securities or industry analysts publish about us or our
business, our market and our competitors. We do not have any control over these analysts. The analysts who previously published research reports on our stock
following our IPO have discontinued coverage. Although one new analyst initiated coverage of our business in September 2019, if additional analysts do not
begin regularly publishing reports on us, we could lose visibility in the financial markets, which could cause our share price or trading volume to decline.
Sales of a substantial number of shares of our common stock in the public market, including by our existing stockholders, could cause our stock
price to fall.
Sales of a substantial number of shares of our common stock in the public market, or the perception that these sales might occur, could depress the
market price of our common stock and could impair our ability to raise capital through the sale of additional equity securities. We are unable to predict the effect
that these sales and others may have on the prevailing market price of our common stock.
We will need to raise additional funds through future equity or debt financings to meet our operational needs and capital requirements for product
development, clinical trials and commercialization. We can provide no assurance that we will be successful in raising funds pursuant to additional equity or debt
financings or that such funds will be raised at prices that do not create substantial dilution for our existing stockholders. Given the recent decline in our stock
price, any financing that we undertake in the next nine months could cause substantial dilution to our existing stockholders.
On February 3, 2016, we filed a universal shelf registration statement to offer up to $150.0 million of our securities and entered into an “at-the-market”
program pursuant to a Sales Agreement with Cowen and Company, or Cowen, through which we may, from time to time, issue and sell shares of common stock
having an aggregate offering value of up to $50.0 million. The shelf registration statement also covers the resale of the shares sold to CRG. The registration
statement was declared effective by the SEC on March 8, 2016. During the year ended December 31, 2016, we sold 2,737 shares of common stock through the
“at-the-market” program at an average price of $1,947.40 and raised net proceeds of $5.2 million, after payment of $0.2 million in commissions and fees to
Cowen. During the year ended December 31, 2017, we sold 18,968 shares of common stock through the “at-the-market” program at an average price of
$176.80 and raised net proceeds of $3.2 million, after payment of $0.1 million in commissions and fees to Cowen. In addition, in August 2016 we completed a
follow-on public offering of 24,644 shares of our common stock for net proceeds of approximately $31.5 million after deducting underwriting discounts and
commissions of approximately $2.4 million and other expenses of approximately $0.6 million. The 24,644 shares include the exercise in full by the underwriters
of their option to purchase an additional 3,214 shares of our common stock.
In addition, pursuant to our Securities Purchase Agreement with CRG, the Shelf Registration Statement also registered for resale 870 shares of common
stock held by CRG, which may be sold freely in the public market. On November 3, 2017, we also entered into the Lincoln Park Purchase Agreement, pursuant
to which Lincoln Park is obligated to purchase, at our request, up to $15.0 million of our common stock over a 30-month period, subject to certain limitations set
forth in the Purchase Agreement. The warrants issued in connection with the Series B preferred stock prohibit us from entering into certain transactions involving
the issuance of securities for a variable price determined by reference to the trading price of our common stock or otherwise subject to modification following the
date of issuance, in each case until February 17, 2021. This prohibition may be waived by holders of two-thirds of the outstanding Series 1 and Series 2 warrants
at any time. If these additional shares are sold, or if it is perceived that they will be sold, in the public market, the trading price of our common stock could
decline. Sales of newly issued securities under any registration statement will result in dilution of our stockholders and could cause our stock price to fall.
On March 7, 2019, we filed a universal shelf registration statement (the “Shelf Registration Statement”) to offer up to $50.0 million of our securities. We
have established, and may in the future establish, “at-the-market” programs pursuant to which we may offer and sell shares of our common stock pursuant to
the Shelf Registration Statement. Due to the SEC’s “baby shelf rules,” which prohibit companies with a public float of less than $75 million from issuing securities
under a shelf registration statement in excess of one-third of such company’s public float in a twelve-month period, we are only able to issue a limited number of
shares using the Shelf Registration Statement at this time. In addition, pursuant to our Securities Purchase Agreement with CRG, the Shelf Registration
Statement also registered for resale 870 shares of common stock held by CRG, which may be sold freely in the public market. Under the Shelf Registration
Statement, on August 26, 2019, we completed a public offering of 3,813,559 shares of common stock at an offering price of $1.18 per share. As a result, we
received net proceeds of approximately $3.8 million after underwriting discounts, commissions, legal and accounting fees and the conversion price of the
outstanding shares of Series B preferred stock, issued in our February 2018 offering, was reduced to $1.18 per share as a result. Additionally, on January 31,
2020, we completed a public offering of 6,428,572 shares of common stock at an offering price of $0.70 per share. As a result, we received net proceeds of
approximately $3.7 million after underwriting discounts, commissions, legal and accounting fees, and other ancillary expenses. Due to anti-dilution provisions, the
conversion price of the outstanding shares of Series B preferred stock, which was issued in our February 2018 offering, was reduced to $0.70 per share.
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EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
Our directors and employees may sell our stock through 10b5-1 trading plans or in the market during open windows under our insider trading policy
without such plans in place. Sales of our common stock by our directors and employees could be perceived negatively by investors or cause downward pressure
on our common stock and cause a reduction in the price of our common stock as a result. We have also registered shares of our common stock that we may
issue under our employee equity incentive plans. These shares will be able to be sold freely in the public market upon issuance.
Our 2019 financial statements contain disclosure that there is substantial doubt about our ability to continue as a going concern, and we will need
additional financing to execute our business plan, to fund our operations and to continue as a going concern.
Since inception, we have experienced recurring operating losses and negative cash flows and we expect to continue to generate operating losses and
consume significant cash resources for the foreseeable future. There is substantial doubt regarding our ability to continue as a going concern. Our independent
registered public accounting firm has expressed in its auditors’ report on our 2019 financial statements, included in this Annual Report on Form 10-K, a “going
concern” opinion, meaning that we have recurring losses from operations and negative cash flows from operations that raise substantial doubt regarding our
ability to continue as a going concern. We have prepared our financial statements on a going concern basis, which contemplates the realization of assets and the
satisfaction of liabilities and commitments in the normal course of business. Our 2019 financial statements do not include any adjustment to reflect the possible
future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the outcome of this uncertainty,
with the exception that all borrowings are classified as current on the balance sheets.
The requirements of being a public company may strain our resources, divert management’s attention and affect our ability to attract and retain
executive management and qualified board members.
As a public company, we are subject to the reporting requirements of the Securities Exchange Act of 1934, as amended, or the Exchange Act, the
Sarbanes-Oxley Act, the Dodd-Frank Act, the listing requirements of Nasdaq and other applicable securities laws, rules and regulations. Compliance with these
laws, rules and regulations have increased our legal and financial compliance costs and will make some activities more difficult, time-consuming or costly and
increase demand on our systems and resources, particularly after we are no longer an “emerging growth company.” The Exchange Act requires, among other
things, that we file annual, quarterly and current reports with respect to our business and operating results. The Sarbanes-Oxley Act requires, among other
things, that we maintain effective disclosure controls and procedures and internal control over financial reporting. In order to maintain and, if required, improve our
disclosure controls and procedures and internal control over financial reporting to meet this standard, significant resources and management oversight may be
required. Our management and other personnel now need to devote a substantial amount of time to these compliance initiatives. As a result, management’s
attention may be diverted from other business concerns and our costs and expenses will increase, which could harm our business and operating results. We
may need to hire more employees in the future or engage outside consultants to comply with these requirements, which will increase our costs and expenses.
In addition, changing laws, regulations and standards relating to corporate governance and public disclosure are creating uncertainty for public
companies, increasing legal and financial compliance costs and making some activities more time consuming. These laws, regulations and standards are subject
to varying interpretations, in many cases due to their lack of specificity and, as a result, their application in practice may evolve over time as new guidance is
provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing
revisions to disclosure and governance practices. We intend to invest resources to comply with evolving laws, regulations and standards, and this investment
may result in increased general and administrative expenses and a diversion of management’s time and attention from revenue-generating activities to
compliance activities. If our efforts to comply with new laws, regulations and standards differ from the activities intended by regulatory or governing bodies due to
ambiguities related to their application and practice, regulatory authorities may initiate legal proceedings against us and our business may be harmed.
We will incur additional compensation costs in the event that we decide to pay our executive officers cash compensation closer to that of executive
officers of other public medical device companies, which would increase our general and administrative expense and could harm our profitability. Any future
equity awards will also increase our compensation expense. We also expect that being a public company and compliance with applicable rules and regulations
will make it more expensive for us to obtain director and officer liability insurance, and we may be required to accept reduced coverage or incur substantially
higher costs to obtain coverage. These factors could also make it more difficult for us to attract and retain qualified executive officers and members of our board
of directors, particularly to serve on our audit committee and compensation committee.
As a result of disclosure of information in this Annual Report on Form 10-K and in other filings required of a public company, our business and financial
condition will become more visible, which could be advantageous to our competitors and clients and could result in threatened or actual litigation, including by
competitors and other third parties. If such claims are successful, our business and operating results could be harmed, and even if the claims are resolved in our
favor, these claims, and the time and resources necessary to resolve them, could divert the resources of our management and harm our business and operating
results.
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EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
We are an emerging growth company and we cannot be certain if the reduced disclosure requirements applicable to emerging growth companies will
make our common stock less attractive to investors.
We are an emerging growth company. For as long as we continue to be an emerging growth company, we may take advantage of certain exemptions
from reporting requirements that are applicable to other public companies including, but not limited to, not being required to comply with the auditor attestation
requirements of Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy
statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden
parachute payments not previously approved. We cannot predict if investors will find our common stock less attractive because we will rely on these
exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock
price may be more volatile or decline.
We will remain an emerging growth company until the earlier of (1) the last day of the fiscal year (a) following the fifth anniversary of our IPO which
would be after the fiscal year ended December 31, 2020, (b) in which we have total annual gross revenue of at least $1.07 billion, or (c) in which we are deemed
to be a large accelerated filer, which means the market value of our common stock that is held by non-affiliates exceeds $700 million as of the prior June 30th,
and (2) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period. We cannot predict if
investors will find our common stock less attractive because we may rely on these exemptions. If some investors find our common stock less attractive as a
result, there may be a less active trading market for our common stock and our stock price may suffer or be more volatile.
Nasdaq may delist our securities from its exchange, which could harm our business and limit our stockholders’ liquidity.
Our common stock is currently listed on the Nasdaq Capital Market, which has qualitative and quantitative listing criteria. However, we cannot assure
you that our common stock will continue to be listed on Nasdaq in the future. In order to continue listing our common stock on Nasdaq, we must maintain certain
financial, distribution and stock price levels. Generally, we must maintain a minimum amount in stockholders’ equity and a minimum number of holders of our
common stock.
The continued listing requirements in Nasdaq Marketplace Rule 5550(a)(2) requires issuers to maintain a minimum bid price of at least $1.00 per share.
The trading price of our common stock has closed below $1.00 each trading day since January 27, 2020. As of the date hereof, we have not received any notice
from Nasdaq that we are not in compliance with Nasdaq Marketplace Rule 5550(a)(2). If we fail to comply with Rule 5550(a)(2), Nasdaq may delist our common
stock from trading on its exchange.
If Nasdaq delists our common stock from trading on its exchange and we are not able to list our securities on another national securities exchange, we
expect our securities could be quoted on an over-the-counter market. If this were to occur, we could face significant material adverse consequences, including:
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a limited availability of market quotations for our securities;
Reduced liquidity for our securities;
a determination that our common stock is a “penny stock” which will require brokers trading in our common stock to adhere to more stringent rules and
possibly result in a reduced level of trading activity in the secondary trading market for our securities;
a limited amount of news and analyst coverage; and
A decreased ability to issue additional securities or obtain additional financing in the future.
The National Securities Markets Improvement Act of 1996, which is a federal statute, prevents or preempts the states from regulating the sale of certain
securities, which are referred to as “covered securities.” If our common stock continues to be listed on NASDAQ, our common stock will be a covered security.
Although the states are preempted from regulating the sale of our securities, the federal statute does allow the states to investigate companies if there is a
suspicion of fraud, and, if there is a finding of fraudulent activity, then the states can regulate or bar the sale of covered securities in a particular case.
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EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
Anti-takeover provisions in our amended and restated certificate of incorporation and bylaws and Delaware law could discourage a takeover.
Our amended and restated certificate of incorporation and bylaws contain provisions that might enable our management to resist a takeover. These
provisions include:
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a classified board of directors;
advance notice requirements applicable to stockholders for matters to be brought before a meeting of stockholders and requirements as to the form and
content of a stockholder’s notice;
a supermajority stockholder vote requirement for amending certain provisions of our amended and restated certificate of incorporation and bylaws;
the right to issue preferred stock without stockholder approval, which could be used to dilute the stock ownership of a potential hostile acquirer;
allowing stockholders to remove directors only for cause;
a requirement that the authorized number of directors may be changed only by resolution of the board of directors;
allowing all vacancies, including newly created directorships, to be filled by the affirmative vote of a majority of directors then in office, even if less than a
quorum, except as otherwise required by law;
a requirement that our stockholders may only take action at annual or special meetings of our stockholders and not by written consent;
limiting the forum for certain litigation against us to Delaware; and
limiting the persons that can call special meetings of our stockholders to our board of directors, the chairperson of our board of directors, the chief
executive officer or the president (in the absence of a chief executive officer).
These provisions might discourage, delay or prevent a change in control of our company or a change in our management. The existence of these
provisions could adversely affect the voting power of holders of common stock and limit the price that investors might be willing to pay in the future for shares of
our common stock. In addition, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General
Corporation Law, which generally prohibits a Delaware corporation from engaging in any of a broad range of business combinations with any “interested”
stockholder for a period of three years following the date on which the stockholder became an “interested” stockholder.
Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware will be the sole and exclusive
forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum
for disputes with us or our directors, officers or employees.
Our amended and restated certificate of incorporation provides that, unless we consent to the selection of an alternative forum, the Court of Chancery of
the State of Delaware is the sole and exclusive forum for (i) any derivative action or proceeding brought on our behalf, (ii) any action asserting a claim of breach
of fiduciary duty owed by any of our directors, officers or other employees to us or to our stockholders, (iii) any action asserting a claim arising pursuant to the
Delaware General Corporation Law or our certificate of incorporation or bylaws (iv) any action to interpret apply, enforce or determine the validity of our certificate
of incorporation or bylaws or (v) any action asserting a claim governed by the internal affairs doctrine. The choice of forum provision may limit a stockholder’s
ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers or other employees, which may discourage such
lawsuits against us and our directors, officers and other employees. Alternatively, if a court were to find the choice of forum provision contained in our amended
and restated certificate of incorporation to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in
other jurisdictions, which could harm our business, operating results and financial condition.
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EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
We have not paid dividends in the past and do not expect to pay dividends in the future, and any return on investment may be limited to the value of
our stock.
We have never paid cash dividends and do not anticipate paying cash dividends in the foreseeable future, except the cumulative dividend payable on
our Series A preferred stock. The payment of all other dividends will depend on our earnings, capital requirements, financial condition, prospects and other
factors our board of directors may deem relevant. In addition, our Loan Agreement with CRG prohibits us from, among other things, paying any dividends or
making any other distribution or payment on account of our common stock. The terms of our Series A preferred stock and our Series B preferred stock provide
that we may not pay dividends on our common stock without concurrently declaring dividends on each. If we do not pay dividends, our stock may be less
valuable because a return on your investment will only occur if you sell our common stock after our stock price appreciates. For more information on restrictions
governing our ability to pay dividends, see the section titled “Dividend Policy” below.
CRG has the ability to exert significant control over matters pursuant to the protective provisions therein as well as the covenants and other
restrictions in the Loan Agreement.
Even though Series A preferred stock is non-voting stock, our governing documents, as amended, have protective provisions that will require CRG to
consent to certain significant Company events. For example, CRG’s consent would be necessary to create additional shares of Series A preferred stock, amend
our organizational documents, or approve any merger, sale of assets, or other major corporate transaction. This consent requirement could delay or prevent any
acquisition of our company on terms that other stockholders may desire, and may adversely affect the market price of our common stock.
The Series A preferred stock has a liquidation preference senior to our common stoc k and Series B preferred stoc k.
Series A preferred stock has a liquidation preference that gets paid prior to any payment on our common stock (including shares issuable upon the
exercise of our outstanding warrants) and Series B preferred stock. As a result, if we were to dissolve, liquidate, merge with another company or sell our assets,
the holders of our Series A preferred stock would have the right to receive up to approximately $48.3 million, plus any unpaid dividends from any such
transaction before any amount is paid to the holders of our Series B preferred stock or common stock or pursuant to the redemption rights in the warrants for
fundamental transactions. The payment of the liquidation preferences could result in common stockholders, Series B preferred stockholders and warrant holders
not receiving any consideration if we were to liquidate, dissolve or wind up, either voluntarily or involuntarily. In January 2019, we paid Series A preferred stock
dividends of $2.9 million through the issuance of 2,945 shares of Series A preferred stock. In addition, in December 2019 we paid Series A preferred stock
dividends of $3.6 million through the issuance of 3,580 shares of Series A preferred stock.
The existence of the liquidation preferences may reduce the value of our common stock, make it harder for us to sell shares of common stock in
offerings in the future, or prevent or delay a change of control.
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EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
ITEM 1B. UNRESOLVED STAFF COMMENTS
None.
ITEM 2. PROPERTIES
Through November 30, 2019, we maintained our principal executive offices, comprising 44,200 square feet in two buildings in Redwood City, California,
under a lease agreement that was originally to expire in November 2019. On April 1, 2019, we entered into an amendment to the lease which extended the
lease term for an additional period of five years subsequent to the original expiration of November 30, 2019. As amended, the lease will expire on November 30,
2024. Under the terms of the amendment, we are obligated to pay approximately $5.8 million in base rent payments through November 2024, beginning on
December 1, 2019. This amendment does not extend the term of the lease with respect to the building being subleased. Our facility houses our research and
development, sales, marketing, manufacturing, finance and administrative activities. In February 2016, we entered into an additional non-cancelable operating
lease for 6,600 square feet of warehouse and storage space in Redwood City, California, which lease agreement originally was to expire in November 2019. We
exited this warehouse lease in December 2018 and incurred exit costs of approximately $50,000 which was included in rent expense for 2018.
On October 19, 2017, we entered into an agreement to sublease one of our facilities. The sublease commenced on December 1, 2017, and expired on
November 15, 2019 (which was 15 days prior to the expiration of the facility lease). Prior to December 1, 2018, the sublessee paid a base rent of $3.25 per
rentable square foot, or a total of $79,950 per month. On December 1, 2018 the base rent increased to $3.35 per rentable square foot, or a total of $82,410 per
month. In addition to the base rent, the sublessee paid for the Landlord’s operating expenses and property taxes due and payable with respect to the subleased
facility.
We believe that our current facilities are adequate for our current and anticipated future needs through at least 2020.
ITEM 3. LEGAL PROCEEDINGS
We are not involved in any pending legal proceedings that we believe could have a material adverse effect on our financial condition, results of
operations or cash flows. From time to time we may be involved in legal proceedings or investigations, which could harm our reputation, business and financial
condition and divert the attention of our management from the operation of our business.
Between May 22, 2017 and May 25, 2017, three class actions were filed in the Superior Court of the State of California, County of San Mateo, or the
State Court, against us and certain of our officers and directors. The underwriters of our IPO in January 2015 are also named as defendants. The actions were
captioned Grotewiel v. Avinger, Inc., et al., No. 17-CIV-02240, Gonzalez v. Avinger, Inc., et al., No. 17-CIV-02284, and Olberding v. Avinger, Inc., et al., No. 17-
CIV-02307. These lawsuits allege that the registration statement for our IPO made false and misleading statements and omissions in violation of the Securities
Act of 1933. Plaintiffs seek to represent a class of purchasers of our common stock in and/or traceable to our IPO. Plaintiffs seek, among other things,
unspecified compensatory damages, interest, costs, recission, and attorneys’ fees. On June 12, 2017, defendants removed these actions to the United States
District Court for the Northern District of California, or Federal Court.
On June 22, 2017, and June 23, 2017, plaintiffs Olberding and Gonzalez moved to remand their cases to the State Court. Defendants opposed these
motions. On July 21, 2017, the Federal Court granted the motions to remand the Olberding and Gonzalez actions to the State Court. On August 9, 2017, the
State Court consolidated the Olberding and Gonzalez actions under the caption Gonzalez v. Avinger, Inc., et al., No. 17-CIV-02284, or State Action. On
September 22, 2017, an amended complaint was filed in the State Action. On October 31, 2017, the parties in the State Action stipulated to a stay of
proceedings until judgment is entered in the federal Grotewiel action, or Federal Action. On June 20, 2018, the State Court dismissed the State Action pursuant
to the proposed settlement described below.
On October 11, 2017, the Federal Court appointed a lead plaintiff and approved the selection of a lead counsel in the Federal Action. On November 21,
2017, an amended complaint was filed in the Federal Action. Defendants filed a motion to dismiss that complaint on January 26, 2018. On March 19, 2018,
plaintiff in the Federal Action filed a further amended complaint, on behalf of a class of purchasers of our common stock in and/or traceable to our IPO, as well
as purchasers of our common stock during the period January 30, 2015, to April 10, 2017.
The Company and its directors believe that the foregoing lawsuits were without merit; however, in the interest of avoiding the cost and disruption of
continuing to defend against these lawsuits, the Company entered into a settlement of the actions. The settlement was for a total of $5 million. The Company’s
total contribution to the settlement fund was $1.76 million, which the Company paid in March 2018. On October 24, 2018, the court approved the settlement.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
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EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
PART II
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY
SECURITIES
Our common stock began trading on the Nasdaq Global Market on January 30, 2015 and was transferred to the Nasdaq Capital Market on January 19, 2018,
where it trades under the symbol “AVGR”.
HOLDERS OF RECORD
As of March 2, 2020 there were 16,813,398 shares of our common stock held by 126 holders of record of our common stock. The actual number of
stockholders is greater than this number of record holders, and includes stockholders who are beneficial owners, but whose shares are held in street name by
brokers and other nominees. This number of holders of record also does not include stockholders whose shares may be held in trust by other entities.
DIVIDEND POLICY
Our Series A preferred stock carries an 8% cumulative dividend, which accumulates and is compounded annually. This cumulative dividend is payable in
arrears on December 31 of each year, commencing with December 31, 2018, and at our option is payable in additional shares of Series A preferred stock.
Additionally, the terms of our Series A preferred stock and Series B preferred stock provide that we may not declare dividends on the common stock without
concurrently declaring dividends on such series of preferred stock in an amount equal to that payable had they been converted to common stock prior to the
dividend. We have issued a total of 6,525 shares of Series A preferred stock to pay the preferred dividend to the holder of Series A preferred stock through
December 31, 2019. Other than the preferred dividend on Series A preferred stock, we have never declared or paid any cash dividends on any of our capital
stock. Except with respect to the Series A preferred stock’s cumulative dividend, we do not anticipate paying any dividends in the foreseeable future and
currently intend to retain all available funds and any future earnings for use in the operation of our business and to finance the growth and development of our
business.
Future determination as to the declaration and payment of dividends, if any, will be at the discretion of our board of directors and will depend on then
existing conditions, including our operating results, financial condition, contractual restrictions, capital requirements, business prospects and other factors our
board of directors may deem relevant. In addition, our Loan Agreement with CRG prohibits us from paying any dividends or making any other distribution or
payment on account of our common stock.
RECENT SALES OF UNREGISTERED SECURITIES
There were no sales of unregistered securities during fiscal 2019 other than those transactions previously reported to the SEC on a Quarterly Report on
Form 10-Q or Current Report on Form 8-K.
PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS
None.
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EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
ITEM 6. SELECTED FINANCIAL DATA
This item does not apply to smaller reporting companies.
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and
related notes included elsewhere in this Annual Report on Form 10-K. This discussion and other parts of this Annual Report on Form 10-K contain forward-
looking statements that involve risks and uncertainties, such as statements of our plans, objectives, expectations and intentions, that are based on the beliefs of
our management, as well as assumptions made by, and information currently available to, our management. Our actual results could differ materially from those
discussed in these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the
section of this Annual Report on Form 10-K entitled “Risk factors.”
Overview
We are a commercial-stage medical device company that designs, manufactures and sells image-guided, catheter-based systems that are used by
physicians to treat patients with peripheral artery disease, or PAD. Patients with PAD have a build-up of plaque in the arteries that supply blood to areas away
from the heart, particularly the pelvis and legs. Our mission is to significantly improve the treatment of vascular disease through the introduction of products
based on our Lumivascular platform, the only intravascular image-guided system available in this market.
We manufacture and sell a suite of products in the United States and select international markets. Our current products include our Lightbox imaging
console, the Ocelot family of catheters, which are designed to allow physicians to penetrate a total blockage in an artery, known as a chronic total occlusion, or
CTO, and Pantheris, our image-guided atherectomy device which is designed to allow physicians to precisely remove arterial plaque in PAD patients. We
received 510(k) clearance from the U.S. Food and Drug Administration, or FDA, for commercialization of Pantheris in October 2015. We received an additional
510(k) clearance for an enhanced version of Pantheris in March 2016 and commenced sales of Pantheris in the United States and select European countries
promptly thereafter. In May 2018, the Company also received 510(k) clearance from the FDA for its current next-generation version of Pantheris. In April 2019,
the Company received 510(k) clearance from the FDA for its Pantheris SV, a version of Pantheris targeting smaller vessels, and commenced sales in July 2019.
The Pantheris SV has a smaller diameter and longer length that we believe will optimize it for its targeted use. The Company also offers the Wildcat family of
catheters, which are used for crossing CTOs but do not contain on-board imaging technology. The Company has sales of these devices in the U.S. and in select
international markets. The Company is located in Redwood City, California.
During the first quarter of 2015, we completed enrollment of patients in VISION, a clinical trial designed to support our August 2015 510(k) submission to
the FDA for our Pantheris atherectomy device. VISION was designed to evaluate the safety and efficacy of Pantheris to perform atherectomy using intravascular
imaging and successfully achieved all primary and secondary safety and efficacy endpoints. We believe the data from VISION allows us to demonstrate that
avoiding damage to healthy arterial structures, and in particular disruption of the external elastic lamina, which is the membrane between the outermost layers of
the artery, reduces the likelihood of restenosis, or re-narrowing, of the diseased artery. Although the original VISION study protocol was not designed to follow
patients beyond six months, we worked with 18 of the VISION sites to re-solicit consent from previous clinical trial patients in order for them to evaluate patient
outcomes through 12 and 24 months following initial treatment. Data collection for the remaining patients from participating sites was completed in May 2017,
and we released the final 12- and 24-month results for a total of 89 patients in July 2017. We commenced commercialization of Pantheris as part of our
Lumivascular platform in the United States and in select international markets in March 2016, after obtaining the required marketing authorizations.
During the fourth quarter of 2017, we began enrolling patients in INSIGHT, a clinical trial designed to support a filing with the FDA to expand the
indication for our Pantheris atherectomy device to include in-stent restenosis. Patient enrollment began in October 2017 and is expected to continue through
2020. Patient outcomes will be evaluated at thirty days, six months and one year following treatment. We plan to submit a 510(k) application with the FDA
seeking a specific indication for treating in-stent restenosis with Pantheris once the data through six months are available and analyzed.
46
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
We focus our direct sales force, marketing efforts and promotional activities on interventional cardiologists, vascular surgeons and interventional
radiologists. We also work on developing strong relationships with physicians and hospitals that we have identified as key opinion leaders. Although our sales
and marketing efforts are directed at these physicians because they are the primary users of our technology, we consider the hospitals and medical centers
where the procedure is performed to be our customers, as they typically are responsible for purchasing our products. We are designing future products to be
compatible with our Lumivascular platform, which we expect to enhance the value proposition for hospitals to invest in our technology. Pantheris qualifies for
existing reimbursement codes currently utilized by other atherectomy products, further facilitating adoption of our products.
We have assembled a team with extensive medical device development and commercialization capabilities. In addition to the commercialization of
Pantheris in the United States and select international markets in March 2016, we began commercializing our initial non-Lumivascular platform products in 2009
and introduced our Lumivascular platform products in the United States in late 2012. We generated revenues of $10.7 million in 2015, $19.2 million in 2016,
$9.9 million in 2017, $7.9 million in 2018, and $9.1 million in 2019. The growth experienced in 2019 is largely due to our next generation Pantheris and the
launch of Pantheris SV.
Prior to the introduction of our Lumivascular platform, our non-imaging catheter products were manufactured by a third-party. All of our products are now
manufactured in-house using components and sub-assemblies manufactured both in-house at our facility in Redwood City, California and by outside vendors.
We assemble all of our products at our manufacturing facility but certain critical processes such as coating and sterilization are done by outside vendors. We
expect our current manufacturing facility will be sufficient through at least 2020.
On June 19, 2019, the Company’s Board of Directors approved an amendment to the Company’s amended and restated certificate of incorporation to
effect an additional 1-for-10 reverse stock split of the Company’s common stock. The reverse stock split became effective on June 21, 2019. The par value of
the common stock and convertible preferred stock was not adjusted as a result of the reverse stock split. All common stock, stock options, and restricted stock
units, and per share amounts in this document have been retroactively adjusted for all periods presented to give effect to the reverse stock splits.
During the years ended December 31, 2019 and 2018, our net loss and comprehensive loss was $19.5 million and $27.6 million, respectively. We have
not been profitable since inception, and as of December 31, 2019, our accumulated deficit was $348.3 million. Since inception, we have financed our operations
primarily through private and public placements of our preferred and common securities and, to a lesser extent, debt financing arrangements. In January 2015,
we completed an initial public offering, or IPO, of 12,500 shares. As a result of our IPO, which closed in February 2015, we received net proceeds of
approximately $56.9 million, after underwriting discounts and commissions of approximately $4.5 million and other expenses associated with our IPO of
approximately $3.6 million.
In September 2015, we entered into a Term Loan Agreement, or Loan Agreement, with CRG Partners III L.P. and certain of its affiliated funds,
collectively CRG, under which we were able to borrow up to $50.0 million on or before March 29, 2017, subject to certain terms and conditions. We borrowed
$30.0 million on September 22, 2015 and an additional $10.0 million on June 15, 2016 under the Loan Agreement. Contingent on achievement of certain
revenue milestones, among other conditions, we would have been eligible to borrow an additional $10.0 million, on or prior to March 29, 2017; however, we did
not achieve the level of revenues required to borrow the final $10.0 million. Contemporaneously with the execution of the Loan Agreement, we entered into a
Securities Purchase Agreement with CRG, pursuant to which CRG purchased 870 shares of our common stock on September 22, 2015 at a price of $5,596.40
per share, which represents the 10-day average of closing prices of our common stock ending on September 21, 2015. Pursuant to the Securities Purchase
Agreement, we filed a registration statement covering the resale of the shares sold to CRG and must comply with certain affirmative covenants during the time
that such registration statement remains in effect. We used the proceeds from the CRG borrowing and securities purchase to retire our outstanding principal and
accrued interest with PDL Biopharma, or PDL, and to retire the principal and accrued interest underlying our outstanding promissory notes, or the notes.
On February 3, 2016, we filed a universal shelf registration statement to offer up to $150.0 million of our securities and entered into an “at-the-market”
program pursuant to a Sales Agreement with Cowen and Company, or Cowen, through which we may, from time to time, issue and sell shares of common stock
having an aggregate offering value of up to $50.0 million. The shelf registration statement also covers the resale of the shares sold to CRG. The registration
statement was declared effective by the SEC on March 8, 2016. During the year ended December 31, 2016, we sold 2,737 shares of common stock through the
“at-the-market” program at an average price of $1,947.40 and raised net proceeds of $5.2 million, after payment of $0.2 million in commissions and fees to
Cowen. During the year ended December 31, 2017, we sold 18,968 shares of common stock through the “at-the-market” program at an average price of
$176.80 and raised net proceeds of $3.2 million, after payment of $0.1 million in commissions and fees to Cowen. In addition, in August 2016 we completed a
follow-on public offering of 24,644 shares of our common stock for net proceeds of approximately $31.5 million after deducting underwriting discounts and
commissions of approximately $2.4 million and other expenses of approximately $0.6 million. The 24,644 shares include the exercise in full by the underwriters
of their option to purchase an additional 3,214 shares of our common stock.
47
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
In April 2017, we undertook an organizational realignment which included a reduction in force, that lowered our total headcount by approximately 33%
compared to December 31, 2016. The organizational realignment was designed to focus our commercial efforts on driving catheter utilization in our strongest
markets, around our most productive sales professionals. Our field sales personnel headcount was reduced to 32, down from 60 as of December 31, 2016. This
workforce reduction was designed to reduce operating expenses while continuing to support major product development and clinical initiatives. The strategic
reduction in the field sales force was designed to maintain robust engagement with higher volume users of our Lumivascular technology and position us to
increase utilization of our catheters within our installed base of accounts in 2018 following the launch of our next generation products. In September 2017, we
effected a cost reduction plan, which also included a company-wide reduction in force, lowering our total headcount by an additional 24 employees. Our field
sales personnel headcount was further reduced to a total of 20 people. In addition, as part of the cost reduction plan, in October 2017, we subleased a portion of
the Company’s facilities and consolidated our operations primarily into one building.
On February 14, 2018, we entered into Amendment No. 2 to the Term Loan Agreement (the “Amendment No. 2 Loan Agreement”) with CRG. Under its
terms, the Amendment No. 2 Loan Agreement, among other things: (1) extended the interest-only period through June 30, 2021; (2) extended the period during
which the Company may elect to pay a portion of interest in payment-in-kind, or PIK, interest payments through June 30, 2021 so long as no default has
occurred and is continuing; (3) permitted the Company to make its entire interest payments in PIK interest payments for through December 31, 2019 so long as
no default has occurred and is continuing; (4) extended the maturity date to June 30, 2023; (5) reduced the minimum liquidity requirement to $3.5 million at all
times; (6) eliminated the minimum revenue covenant for 2018 and 2019; (7) reduced the minimum revenue covenant to $15 million for 2020, $20 million for 2021
and $25 million for 2022; and (8) provided CRG with board observer rights.
In addition, on February 14, 2018, we entered into a Series A preferred stock Purchase Agreement (the “Series A Purchase Agreement”) with CRG,
pursuant to which it agreed to convert $38.0 million of the outstanding principal amount of its senior secured term loan (plus the back-end fee and prepayment
premium applicable thereto) under the Loan Agreement into a newly authorized Series A preferred stock. As discussed in the section of this report titled
“Dividend Policy,” the holders of Series A preferred stock are entitled to receive annual accruing dividends at a rate of 8%, payable in additional shares of
Series A preferred stock or cash, at our option. The shares of Series A preferred stock have no voting rights and rank senior to all other classes and series of the
Company’s equity in terms of repayment and certain other rights.
On February 16, 2018, we completed a public offering of 17,979 shares of Series B preferred stock and warrants to purchase 1,797,900 shares of
common stock. As a result, we received net proceeds of approximately $15.5 million after underwriting discounts, commissions, legal and accounting fees. The
Series B preferred stock has a liquidation preference of $0.001 per share, full ratchet price based anti-dilution protection, has no voting rights and is subject to
certain ownership limitations. The Series B preferred stock is immediately convertible at the option of the holder, has no stated maturity, and does not pay
regularly stated dividends or interest. Each share of Series B preferred stock is accompanied by one Series 1 warrant that expires on the seventh anniversary of
the date of issuance to purchase up to 50 shares of common stock and one Series 2 warrant that expires on the earlier of (i) the seventh anniversary of the date
of issuance or (ii) the 60th calendar day following the receipt and announcement of FDA clearance of our Pantheris below-the-knee device (or the same or
similar product with a different name) to purchase up to 50 shares of common stock; provided, however, if at any time during such 60-day period the volume
weighted average price for any trading day is less than the then effective exercise price, the termination date shall be extended to the seven year anniversary of
the initial exercise date. FDA clearance of Pantheris SV was received in April 2019, triggering this 60-day period. During the entire 60-day period following
clearance, the volume weighted average price was less than the then effective exercise price. As such, all Series 2 warrants are currently deemed to expire on
the seventh anniversary of the date of issuance. In addition, pursuant to the Series A Purchase Agreement, we issued to CRG 41,800 shares of Series A
preferred stock at the closing of the Series B Offering. The Series A preferred stock was issued in exchange for the conversion of $38.0 million of the outstanding
principal amount of their senior secured term loan (plus the back-end fee and prepayment premium applicable thereto), totaling approximately $41.8 million. The
Series A preferred stock is initially convertible into 2,090,000 shares of common stock subject to certain limitations contained in the Series A Purchase
Agreement.
On July 12, 2018, we entered into a securities purchase agreement with certain investors pursuant to which we agreed to sell and issue, in a registered
direct offering, an aggregate of 216,618 shares of our common stock at an offering price of $16.425 per share. In a concurrent private placement, or the Private
Placement, we agreed to issue to these investors warrants exercisable for one share of our common stock for each two shares purchased in the registered direct
offering, which equals an aggregate of 108,309 shares of common stock. The closing of such registered direct offering and the concurrent Private Placement
occurred on July 16, 2018, in connection with which we received net proceeds of approximately $3.0 million after deducting placement agent fees and other
expenses payable by us. The warrants have an exercise price of $15.80 per share of our common stock and may be exercised from time to time beginning on
January 17, 2019 and expire on July 16, 2021.
On November 1, 2018, we completed a public offering of 728,500 shares of common stock and 8,586 shares of Series C convertible preferred stock (the
“Series C preferred stock”). As a result, we received net proceeds of approximately $10.2 million after underwriting discounts, commissions, legal and
accounting fees. Upon any dissolution, liquidation or winding up, whether voluntary or involuntary, holders of Series C preferred stock will be entitled to receive
distributions out of our assets, whether capital or surplus, of an amount equal to $0.001 per share of Series C preferred stock before any distributions shall be
made on the common stock but after distributions shall be made on any outstanding Series A preferred stock and any of our existing or future indebtedness. The
Series C preferred stock has no voting rights.
On March 7, 2019, we filed a universal shelf registration statement (the “Shelf Registration Statement”) to offer up to $50.0 million of our securities. We
have established, and may in the future establish, “at-the-market” programs pursuant to which we may offer and sell shares of our common stock pursuant to
the Shelf Registration Statement. Due to the SEC’s “baby shelf rules,” which prohibit companies with a public float of less than $75 million from issuing securities
under a shelf registration statement in excess of one-third of such company’s public float in a twelve-month period, we are only able to issue a limited number of
shares using the Shelf Registration Statement at this time. In addition, pursuant to our Securities Purchase Agreement with CRG, the Shelf Registration
Statement also registered for resale 870 shares of common stock held by CRG, which may be sold freely in the public market. Under the Shelf Registration
Statement, on August 26, 2019, we completed a public offering of 3,813,559 shares of common stock at an offering price of $1.18 per share. As a result, we
received net proceeds of approximately $3.8 million after underwriting discounts, commissions, legal and accounting fees and the conversion price of the
outstanding shares of Series B preferred stock, issued in our February 2018 offering, was reduced to $1.18 per share as a result.
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EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
On January 31, 2020, we completed a public offering of 6,428,572 shares of common stock at an offering price of $0.70 per share. As a result, we
received net proceeds of approximately $3.7 million after underwriting discounts, commissions, legal and accounting fees, and other ancillary expenses. Due to
anti-dilution provisions, the conversion price of the outstanding shares of Series B preferred stock, which was issued in our February 2018 offering, was reduced
to $0.70 per share.
Components of our Results of Operations
Revenues
All of our revenues are currently derived from sales of our Lightbox console, as well as related services, and sales of our various PAD catheters in the
United States and select international markets. We expect our revenues to increase in 2020 due to the availability of our Pantheris small vessel device and
expansion of our sales force. No single customer accounted for more than 10% of our revenues during the years ended December 31, 2019 and 2018.
Revenues may fluctuate from quarter to quarter due to a variety of factors including capital equipment purchasing patterns that are typically increased
towards the end of the calendar year and decreased in the first quarter. In addition, during the first quarter, our results can be harmed by adverse weather and by
resetting of annual patient healthcare insurance plan deductibles, both of which may cause patients to delay elective procedures. In the third quarter, the number
of elective procedures nationwide is historically lower than other quarters throughout the year, which we believe is primarily attributable to the summer vacations
of physicians and their patients.
Cost of Revenues and Gross Margin
Cost of revenues consists primarily of costs related to manufacturing overhead, materials and direct labor. We expense all warranty costs and inventory
provisions as cost of revenues. We periodically write-down inventory for estimated excess, obsolete and non-sellable inventories based on assumptions about
future demand, past usage, changes to manufacturing processes and overall market conditions. A significant portion of our cost of revenues currently consists of
manufacturing overhead costs. These overhead costs include the cost of quality assurance, material procurement, inventory control, facilities, equipment and
operations supervision and management. We expect overhead costs as a percentage of revenues to become less significant as our production volume
increases. Cost of revenues also includes depreciation expense for production equipment, depreciation and related maintenance expense for placed Lightboxes
held by customers and certain direct costs such as those incurred for shipping our products.
We calculate gross margin as gross profit divided by revenues. Our gross margin has been and will continue to be affected by a variety of factors,
primarily production volumes, manufacturing costs, product yields, headcount, charges for excess and obsolete inventories and cost-reduction strategies. We
expect our gross margin to increase over the long term as our production volume increases and as we spread the fixed portion of our manufacturing overhead
costs over a larger number of units produced, thereby reducing our per unit manufacturing costs. We intend to use our design, engineering and manufacturing
capabilities to further advance and improve the efficiency of our manufacturing processes, which we believe will reduce costs and increase our gross margin. In
the future, we may seek to manufacture certain of our products outside the United States to further reduce costs. Our gross margin will likely fluctuate from
quarter to quarter as we continue to introduce new products and sales channels, and as we adopt new manufacturing processes and technologies.
Research and Development Expenses
Research and development, or R&D, expenses consist primarily of engineering, product development, clinical and regulatory affairs, consulting
services, materials, depreciation and other costs associated with products and technologies in development. These expenses include employee compensation,
including stock-based compensation, supplies, materials, quality assurance expenses allocated to R&D programs, consulting, related travel expenses and
facilities expenses. Clinical expenses include clinical trial design, clinical site reimbursement, data management, travel expenses and the cost of manufacturing
products for clinical trials. We expect R&D expenses as a percentage of revenues to vary over time depending on the level and timing of our new product
development efforts, as well as our clinical development, clinical trial and other related activities.
Selling, General and Administrative Expenses
Selling, general and administrative, or SG&A, expenses consist primarily of compensation for personnel, including stock-based compensation, related to
selling and marketing functions, physician education programs, business development, finance, information technology and human resource functions. Other
SG&A expenses include commissions, training, travel expenses, educational and promotional activities, marketing initiatives, market research and analysis,
conferences and trade shows, professional services fees, including legal, audit and tax fees, insurance costs, general corporate expenses and allocated
facilities-related expenses. We expect SG&A expenses to increase compared to the prior year as we expand our commercial efforts.
Interest Income (Expense), net
Interest income (expense), net consists primarily of interest incurred on our outstanding indebtedness and non-cash interest related to the amortization of
debt discount and issuance costs associated with our various debt agreements.
Other Income (Expense), net
Other income (expense), net primarily consists of gains and losses resulting from the remeasurement of foreign exchange transactions and sublease
income.
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EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
Results of Operations:
Revenues
Cost of revenues
Gross profit
Gross margin
Operating expenses:
Research and development
Selling, general and administrative
Total operating expenses
Loss from operations
Interest expense, net
Other income, net
Net loss and comprehensive loss
Year Ended December 31,
2018
2019
$
$
$
9,131
6,264
2,867
31%
5,692
16,534
22,226
(19,359)
(1,192)
1,101
(19,450) $
7,915
6,531
1,384
17%
6,009
18,404
24,413
(23,029)
(5,478)
949
(27,558)
Comparison of Years Ended December 31, 201 9 and 201 8
Revenues. Revenues increased $1.2 million, or 15%, to $9.1 million during the year ended December 31, 2019. The increased revenues in 2019 reflect
the impact of the increased size of our field sales force and the release of the Pantheris SV product.
Cost of Revenues and Gross Margin. Cost of revenues decreased $0.3 million, or 4%, to $6.3 million during the year ended December 31, 2019. This
decrease was primarily attributable to lower excess and obsolescence charges predominantly related to our Lightbox inventories in the year ended December
31, 2019. Gross margin for the year ended December 31, 2019 increased to 31% compared to 17% in the prior year. Stock-based compensation expense within
cost of revenues totaled $0.2 million and $0.1 million for the years ended December 31, 2019 and 2018, respectively.
Research and Development Expenses. R&D expenses decreased $0.3 million, or 5%, to $5.7 million during the year ended December 31, 2019. This
decrease was primarily due to a decrease in personnel-related expenses as a result of fewer employees and lower project spending due to completion of
projects previously in process. Stock-based compensation expense within R&D totaled $0.5 million for each year ended December 31, 2019 and 2018.
Selling, General and Administrative Expenses. SG&A expenses decreased $1.9 million, or 10%, to $16.5 million during the year ended December 31,
2019. This decrease was primarily due to lower professional services expenses and a decrease in stock-based compensation. Stock-based compensation
expense within SG&A totaled $1.4 million and $2.4 million for the years ended December 31, 2019 and 2018, respectively.
Interest Expense, ne t . Interest income (expense), net decreased $4.3 million, or 78%, to a net expense of $1.2 million during the year ended
December 31, 2019. The reason for the decrease is primarily due to deemed dividend recognized when the Series B convertible preferred stock was issued in
February 2018 that resulted in a beneficial conversion feature.
Other income, net. Other income (expense), net remained relatively flat in comparison to the prior year. Other income was primarily attributable to
income derived from subleasing a portion of the Company’s facilities starting in October of 2017 and the remeasurement of foreign exchange transactions. As a
result of the adoption of Topic 842 during the year ended December 31, 2019, the Company recorded $1.1 million of sublease payments received in other
income on the statement of operations and comprehensive loss. To maintain comparability between periods, the Company reclassified these payments received
of approximately $962,000 in the year ended December 31, 2018 that were previously netted against rent expense included in selling, general and administrative
expenses to the same line item on the statement of operations.
Liquidity and Capital Resources
As of December 31, 2019, we had cash and cash equivalents of $10.9 million and an accumulated deficit of $348.3 million, compared to cash and cash
equivalents of $16.4 million and an accumulated deficit of $328.9 million as of December 31, 2018. The Company expects to incur losses for the foreseeable
future. The Company believes that its cash and cash equivalents of $10.9 million at December 31, 2019 and expected revenues and funds from operations will
be sufficient to allow the Company to fund its current operations through at least the second quarter of 2020. We do not know when or if our operations will
generate sufficient cash to fund our ongoing operations. Additional debt financing, if available, may involve covenants restricting our operations or our ability to
incur additional debt. Any additional debt financing or additional equity that we raise may contain terms that are not favorable to us or our stockholders and
require significant debt service payments, which divert resources from other activities. Additional financing may not be available at all, or if available, may not be
in amounts or on terms acceptable to us. If we are unable to obtain additional financing, we may be required to delay the development, commercialization and
marketing of our products and we may be required to significantly scale back our business and operations.
50
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
To date, we have financed our operations primarily through sales of our products and net proceeds from the issuance of our preferred stock and debt
financings, our “at-the-market” program, our initial public offering, or IPO, our follow-on public offerings and other post-IPO private offerings, primarily of
warrants. The warrants issued pursuant to the Series B Purchase Agreement entered into in connection with the Series B preferred stock follow-on in February
2018, or the Series B Offering, prohibit us from entering into certain transactions involving the issuance of securities for a price determined by reference to the
trading price of our common stock or otherwise subject to modification following the date of issuance, in each case for a period of three years from the closing
date of the Series B Offering (and excluding purchases pursuant to the Series B Purchase Agreement, which may be made on the 120 day anniversary of the
closing date of the offering). This prohibition may be waived by holders of two-thirds of the outstanding Series 1 and Series 2 warrants at any time.
On September 22, 2015, the Company entered into a Term Loan Agreement (the “Loan Agreement”), with CRG under which, subject to certain
conditions, the Company had the right to borrow up to $50 million in principal amount from CRG on or before March 29, 2017. The Company borrowed $30
million on September 22, 2015. The Company borrowed an additional $10 million on June 15, 2016 under the Loan Agreement.
On February 14, 2018, the Company and CRG amended the Loan Agreement concurrent with the conversion of $38 million of the principal amount of
the senior secured term loan (plus $3.8 million in back-end fees and prepayment premium applicable thereto) into shares of a newly authorized Series A
convertible preferred stock. To date, the Company has elected to make payment-in-kind for the majority of the 12.5% interest rate and plans to continue doing so
until such time as cash payments are required. As of December 31, 2019, the balance due under the loan, including payment-in-kind, is approximately $9.0
million. On March 2, 2020, the Company and CRG further amended the Loan Agreement to change the date upon which cash payments for interest will
commence from the first quarter of 2020 to the third quarter of 2021. No cash payments for principal will be made until the final two years of the loan, which
matures in June 2023. On February 11, 2019 and again on December 20, 2019, our board of directors declared a dividend on our Series A preferred stock, and
we issued 2,945 and 3,580 shares, respectively, of Series A preferred stock to pay the preferred dividend to the holder of Series A preferred stock.
On February 3, 2016, we filed a universal shelf registration statement to offer up to $150.0 million of our securities and entered into an “at-the-market”
program pursuant to a Sales Agreement with Cowen, as sales agent, through which we issued and sold common stock with an aggregate value of
approximately $8.7 million between the registration statement’s effectiveness on March 8, 2016 and September 2017. During the year ended December 31,
2016, we sold 2,737 shares of common stock through the “at-the-market” program at an average price of $1,947.40 and raised net proceeds of $5.2 million, after
payment of $0.2 million in commissions and fees to Cowen. During the year ended December 31, 2017, we sold 18,968 shares of common stock through the
“at-the-market” program at an average price of $176.80 and raised net proceeds of $3.2 million, after payment of $0.1 million in commissions and fees to Cowen.
In addition, in August 2016, we issued and sold 24,644 shares of our common stock in a follow-on public offering at a public offering price of $1,400.00 per
share, for net proceeds of approximately $31.5 million after deducting underwriting discounts and commissions of approximately $2.4 million and other expenses
of approximately $0.6 million. The 24,644 shares include the exercise in full by the underwriters of their option to purchase an additional 3,214 shares of our
common stock.
On February 16, 2018, we completed a public offering of 17,979 shares of Series B preferred stock and warrants to purchase 1,797,900 shares of
common stock. As a result, we received net proceeds of approximately $15.5 million after underwriting discounts, commissions, legal and accounting fees. The
Series B preferred stock has a liquidation preference of $0.001 per share, full ratchet price based anti-dilution protection, has no voting rights and is subject to
certain ownership limitations. The Series B preferred stock is immediately convertible at the option of the holder, has no stated maturity, and does not pay
regularly stated dividends or interest. Each share of Series B preferred stock is accompanied by one Series 1 warrant that expires on the seventh anniversary of
the date of issuance to purchase up to 50 shares of common stock and one Series 2 warrant that expires on the earlier of (i) the seventh anniversary of the date
of issuance or (ii) the 60th calendar day following the receipt and announcement of FDA clearance of our Pantheris below-the-knee device (or the same or
similar product with a different name) to purchase up to 50 shares of common stock; provided, however, if at any time during such 60-day period the volume
weighted average price for any trading day is less than the then effective exercise price, the termination date shall be extended to the seven year anniversary of
the initial exercise date. FDA clearance of Pantheris SV was received in April 2019, triggering this 60-day period. During the entire 60-day period following
clearance, the volume weighted average price was less than the then effective exercise price. As such, all Series 2 warrants are currently deemed to expire on
the seventh anniversary of the date of issuance. In addition, pursuant to the Series A Purchase Agreement, we issued to CRG 41,800 shares of Series A
preferred stock at the closing of the Series B Offering. The Series A preferred stock was issued in exchange for the conversion of $38.0 million of the outstanding
principal amount of their senior secured term loan (plus the back-end fee and prepayment premium applicable thereto), totaling approximately $41.8 million. The
Series A preferred stock is initially convertible into 2,090,000 shares of common stock subject to certain limitations contained in the Series A Purchase
Agreement.
51
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
On July 12, 2018, we entered into a securities purchase agreement with certain investors pursuant to which we agreed to sell and issue, in a registered
direct offering, an aggregate of 216,618 shares of our common stock at an offering price of $16.425 per share. In a concurrent private placement, or the Private
Placement, we agreed to issue to these investors warrants exercisable for one share of our common stock for each two shares purchased in the registered direct
offering, which equals an aggregate of 108,309 shares of common stock. The closing of such registered direct offering and the concurrent Private Placement
occurred on July 16, 2018, in connection with which we received net proceeds of approximately $3.0 million after deducting placement agent fees and other
expenses payable by us and the conversion price of the outstanding shares of Series B preferred stock, issued in our February 2018 offering, was reduced to
$15.80 per share as a result. The warrants have an exercise price of $15.80 per share of our common stock and may be exercised from time to time beginning
on January 17, 2019 and expire on July 16, 2021.
On November 1, 2018, we completed a public offering of 728,500 shares of common stock and 8,586 shares of Series C convertible preferred stock (the
“Series C preferred stock”). Each share of common stock sold in our November 2018 offering was accompanied by a warrant to purchase one share of common
stock, and each share of Series C preferred stock was accompanied by a warrant to purchase 250 shares of common stock. The warrants issued in our
November 2018 financing expire on the fifth anniversary of the date of issuance. As a result, we received net proceeds of approximately $10.2 million after
underwriting discounts, commissions, legal and accounting fees. Upon any dissolution, liquidation or winding up, whether voluntary or involuntary, holders of
Series C preferred stock will be entitled to receive distributions out of our assets, whether capital or surplus, of an amount equal to $0.001 per share of Series C
preferred stock before any distributions shall be made on the common stock but after distributions shall be made on any outstanding Series A preferred stock
and any of our existing or future indebtedness. The Series C preferred stock has no voting rights.
On March 7, 2019, we filed a universal shelf registration statement (the “Shelf Registration Statement”) to offer up to $50.0 million of our securities. We
have established, and may in the future establish, “at-the-market” programs pursuant to which we may offer and sell shares of our common stock pursuant to
the Shelf Registration Statement. Due to the SEC’s “baby shelf rules,” which prohibit companies with a public float of less than $75 million from issuing securities
under a shelf registration statement in excess of one-third of such company’s public float in a twelve-month period, we are only able to issue a limited number of
shares using the Shelf Registration Statement at this time. In addition, pursuant to our Securities Purchase Agreement with CRG, the Shelf Registration
Statement also registered for resale 870 shares of common stock held by CRG, which may be sold freely in the public market. Under the Shelf Registration
Statement, on August 26, 2019, we completed a public offering of 3,813,559 shares of common stock at an offering price of $1.18 per share. As a result, we
received net proceeds of approximately $3.8 million after underwriting discounts, commissions, legal and accounting fees.
During the year ended December 31, 2019, we received proceeds of approximately $8.0 million from the issuance of 1,998,079 shares of common stock
related to warrant exercises associated with the Series C preferred stock.
On January 31, 2020, we completed a public offering of 6,428,572 shares of common stock at an offering price of $0.70 per share. As a result, we
received net proceeds of approximately $3.7 million after underwriting discounts, commissions, legal and accounting fees, and other ancillary expenses. Due to
anti-dilution provisions, the conversion price of the outstanding shares of Series B preferred stock, which was issued in our February 2018 offering, was reduced
to $0.70 per share.
Cash Flows
Net cash (used in) provided by:
Operating activities
Investing activities
Financing activities
Net change in cash and cash equivalents
Net Cash Used in Operating Activities
Year Ended December 31,
2019
2018
$
$
(17,264) $
(70)
11,867
(5,467) $
(18,466)
(4)
29,491
11,021
Net cash used in operating activities for the year ended December 31, 2019 was $17.3 million, consisted primarily of a net loss of $19.5 million and an
increase in net operating assets of $2.8 million, offset by non-cash charges of $5.0 million. Non-cash charges largely related to stock-based compensation of
$2.1 million, non-cash interest expense of $1.6 million, and depreciation and amortization of $0.9 million. The increase in net operating assets was primarily due
to decreases in the leasehold liability, accounts payable and accrued expenses and other current liabilities, and increases in inventory and accounts receivable;
partially offset by a decrease in other long-term assets and increase in accrued compensation. The net increase in our net operating assets was largely due to
the decrease of the leasehold liability resulting from the adoption of ASC Topic 842 and the increase in inventory due to anticipated demand for our products.
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Net cash used in operating activities for the year ended December 31, 2018 was $18.5 million, consisting primarily of a net loss of $27.6 million and an
increase in net operating assets of $2.2 million, offset by non-cash charges of $11.3 million. Non-cash charges were largely related to non-cash interest charges
of $5.6 million, stock-based compensation of $3.1 million, depreciation and amortization of $1.3 million and provision for excess and obsolete inventories of $0.9
million. The increase in net operating assets was due to decreases in accrued expenses and other liabilities, and other long-term liabilities, offset by decreases
in other assets and accrued compensation in inventories and accounts receivable, offset by an increase in other assets. The increase in operating liabilities was
largely due to decreases in accrued compensation due to our workforce reductions, offset by an increase in accrued expenses and other current liabilities related
to the litigation settlement.
Net Cash Used in Investing Activities
Net cash used in investing activities in the year ended December 31, 2019 was $70,000 consisting of purchases of property and equipment of $88,000,
partially offset by proceeds from the sale of property and equipment.
Net cash used in investing activities in the year ended December 31, 2018 was $4,000 consisting of purchases of property and equipment of $32,000,
partially offset by proceeds of $28,000 from the sale of property and equipment.
Net Cash Provided by Financing Activities
Net cash provided by financing activities in the year ended December 31, 2019 of $11.9 million primarily related to proceeds of $8.0 million from warrant
exercises and net proceeds of $3.8 million from the issuance of common stock in a public offering, net of various issuance costs.
Net cash provided by financing activities in the year ended December 31, 2018 of $29.5 million primarily related to net proceeds of $29.2 million from
the issuances of convertible preferred stock and common stock, net of various issuance costs, in addition to $0.6 million related to proceeds from warrant
exercises.
Off-Balance Sheet Arrangements
We currently have no off-balance sheet arrangements, such as structured finance, special purpose entities, or variable interest entities.
Contractual Obligations
Our principal obligations consist of the operating lease for our facilities, our Loan Agreement with CRG and non-cancellable purchase commitments. The
following table sets out, as of December 31, 2019, our contractual obligations due by period (in thousands):
Operating lease obligations
CRG Loan
Noncancellable purchase commitments
Payments Due by Period
Within
1 Year
2 - 3
Years
4-5 Years
$
$
1,085 $
—
970
2,055 $
2,285 $
9,666
130
12,081 $
2,341 $
4,518
6
6,865 $
More
Than 5
Years
Total
5,711
14,184
1,106
21,001
— $
—
—
— $
The total CRG Loan amount, shown as borrowings on the balance sheet as of December 31, 2019, is $9.0 million. The contractual obligation in the table
above of $14.2 million under the CRG Loan includes future interest to be accrued but not paid in cash as well as a $1.5 million back-end fee to be paid in June
2023 on maturity of the CRG Loan.
CRG
For more information, see Part II, Item 7 “Liquidity and Capital Resources.”
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Lease Agreements
Through November 30, 2019, we maintained our principal executive offices, comprising 44,200 square feet in two buildings in Redwood City, California,
under a lease agreement that was originally to expire in November 2019. On April 1, 2019, we entered into an amendment to the lease which extended the
lease term for an additional period of five years subsequent to the original expiration of November 30, 2019. As amended, the lease will expire on November 30,
2024. Under the terms of the amendment, we are obligated to pay approximately $5.8 million in base rent payments through November 2024, beginning on
December 1, 2019. This amendment does not extend the term of the lease with respect to the building being subleased. Our facility houses our research and
development, sales, marketing, manufacturing, finance and administrative activities. In February 2016, we entered into an additional non-cancelable operating
lease for 6,600 square feet of warehouse and storage space in Redwood City, California, which lease agreement originally was to expire in November 2019. We
exited this warehouse lease in December 2018 and incurred exit costs of approximately $50,000 which is included in rent expense for 2018.
On October 19, 2017, we entered into an agreement to sublease one of our facilities. The sublease commenced on December 1, 2017, and expired on
November 15, 2019 (which was 15 days prior to the expiration of the facility lease). Prior to December 1, 2018, the sublessee paid a base rent of $3.25 per
rentable square foot, or a total of $79,950 per month. On December 1, 2018 the base rent increased to $3.35 per rentable square foot, or a total of $82,410 per
month. In addition to the base rent, the sublessee paid for the Landlord’s operating expenses and property taxes due and payable with respect to the subleased
facility.
Critical Accounting Policies and Estimates
Management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been
prepared in accordance with U.S. generally accepted accounting principles. The preparation of these financial statements requires us to make estimates and
assumptions for the reported amounts of assets, liabilities, revenues, expenses and related disclosures. Our estimates are based on our historical experience
and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the
carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different
assumptions or conditions and any such differences may be material.
While our significant accounting policies are more fully described in Note 2 of our financial statements included in this Annual Report on Form 10-K, we
believe the following discussion addresses our most critical accounting policies, which are those that are most important to our financial condition and results of
operations and require our most difficult, subjective and complex judgments.
Revenue Recognition
The Company’s revenues are derived from (1) sale of Lightboxes, (2) sale of disposables, which consist of catheters and accessories, and (3) sale of
customer service contracts. The Company sells its products directly to hospitals and medical centers as well as through distributors. The Company accounts for
a contract with a customer when there is a legally enforceable contract between the Company and the customer, the rights of the parties are identified, the
contract has commercial substance, and collectability of the contract consideration is probable. The Company’s revenues are measured based on consideration
specified in the contract with each customer, net of any sales incentives and taxes collected from customers that are remitted to government authorities. For all
sales, the Company uses either a signed agreement or a binding purchase order as evidence of an arrangement. The Company’s revenue recognition policies
generally result in revenue recognition at the following points:
1.
2.
3.
Lightbox sales: The Company sells its products directly to hospitals and medical centers. Provided all other criteria for revenue recognition have
been met, the Company recognizes revenue for Lightbox sales directly to end customers when delivery and acceptance occurs, which is defined
as receipt by the Company of an executed form by the customer acknowledging that the training and installation process is complete.
Sales of disposables: Disposable revenues consist of sales of the Company’s catheters and accessories and are recognized when the product
has shipped, risk of loss and title has passed to the customer and collectability is reasonably assured.
Service revenue: Service contract revenue is recognized ratably over the term of the service period and maintenance contract revenue is
recognized as work is performed. To date, service revenue has been insignificant.
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The Company offers its customers the ability to purchase or lease its Lightbox. In addition, the Company provides a Lightbox under a limited commercial
evaluation program to allow certain strategic accounts to install and utilize the Lightbox for a limited trial period of three to six months. When a Lightbox is placed
under a lease agreement or under a commercial evaluation program, the Company retains title to the equipment and it remains capitalized on its balance sheet
under property and equipment. Depreciation expense on these placed Lightboxes is recorded to cost of revenues on a straight-line basis. The costs to maintain
these placed Lightboxes are charged to cost of revenues as incurred.
The Company evaluates its lease and commercial evaluation program agreements and accounts for these contracts under the guidance in Accounting
Standards Codification (“ASC”) 842, Leases and ASU No. 2014 09, Revenue from Contracts with Customers (Topic 606) . The guidance requires arrangement
consideration to be allocated between a lease deliverable and a non-lease deliverable based upon the relative selling-price of the deliverables.
The Company assessed whether the embedded lease is an operating lease or sales-type lease. Based on the Company’s assessment of the guidance
and given that any payments under the lease agreements are dependent upon contingent future sales, it was determined that collectability of the minimum lease
payments is not reasonably predictable. Accordingly, the Company concluded the embedded lease did not meet the criteria of a sales-type lease and accounts
for it as an operating lease. The Company recognizes revenue allocated to the lease as the contingent disposable product purchases are delivered and are
included in revenues within the statement of operations and comprehensive loss.
For sales through distributors, the Company recognizes revenue when control of the product transfers. The distributors are responsible for all marketing,
sales, training and warranty in their respective territories. The standard terms and conditions contained in the Company’s distribution agreements do not provide
price protection or stock rotation rights to any of its distributors. In addition, its distributor agreements do not allow the distributor to return or exchange products,
and the distributor is obligated to pay the Company upon invoice regardless of its ability to resell the product.
The Company estimates reductions in revenue for potential returns of products by customers. In making such estimates, management analyzes
historical returns, current economic trends and changes in customer demand and acceptance of its products. The Company expenses shipping and handling
costs as incurred and includes them in the cost of revenues. When the Company bills shipping and handling costs to customers, such amounts billed are
included as a component of revenue.
Inventories
Inventories are valued at the lower of cost or net realizable value. Cost is determined using the first-in, first-out method for all inventories. The
Company’s policy is to write down inventory that has expired or become obsolete, inventory that has a cost basis in excess of its expected net realizable value,
and inventory in excess of expected requirements. The estimate of excess quantities is subjective and primarily dependent on the estimates of future demand for
a particular product. If the estimate of future demand is too high, the Company may have to increase the reserve for excess inventory for that product and record
a charge to the cost of revenues. Inventory used in clinical trials is expensed at the time of production and recorded as research and development expense.
Stock-Based Compensation
We maintain an equity incentive plan to provide long-term incentive for employees, consultants and members of our board of directors. The plan provides
for the grant of incentive stock options (“ISOs”) to employees and for the grant of non-statutory stock options (“NSOs”), restricted stock, RSUs, stock
appreciation rights, performance units and performance shares to employees, directors and consultants.
Effective January 1, 2017, the Company adopted ASU 2016-09, Compensation-Stock Compensation (Topic 718): Improvements to Employee Share-
Based Payment Accounting, and elected to recognize forfeitures when they occur using a modified retrospective approach. The Company measures the fair
value of RSUs using the closing stock price of a share of the Company’s common stock on the grant date and is recognized as expense on a straight-line basis
over the vesting period of the award. We use the straight-line method for expense attribution. The fair value of stock options is estimated on the date of grant
using the Black-Scholes option pricing model and recognized as expense on a straight-line basis over the vesting period of the award.
The Black-Scholes model requires us to make assumptions and judgments about the variables used in the calculation, including the weighted average period of
time that the options granted are expected to be outstanding, the volatility of common stock, an assumed risk-free interest rate and an estimated forfeiture rate.
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Fair Value of Common Stock. The fair value of our common stock is determined based on the closing price of our common stock on The Nasdaq Capital
Market.
Expected Term. We do not believe we are able to rely on our historical exercise and post-vesting termination activity to provide accurate data for
estimating the expected term for use in determining the fair value-based measurement of our options. Therefore, we have opted to use the “simplified method”
for estimating the expected term of options, which is the arithmetic average of the vesting term and the original contractual term of the option.
Expected Volatility. Due to the Company’s limited operating history and a lack of company specific historical and implied volatility data, the Company
bases its estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded. When selecting these public companies
on which it has based its expected stock price volatility, the Company selected companies with comparable characteristics to it, including enterprise value, stage
of development, risk profile, and position within the industry as well as selecting companies with historical share price information sufficient to meet the expected
life of the stock-based awards. The historical volatility data was computed using the daily closing prices for the selected companies’ shares during the equivalent
period of the calculated expected term of the share-based payments. The Company will continue to analyze the historical stock price volatility and expected term
assumptions as more historical data for the Company’s common stock becomes available.
Risk-free Interest Rate. The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of the grant for zero-coupon U.S. Treasury
notes with remaining terms similar to the expected term of the options.
Dividend Rate. We assumed the expected dividend to be zero as we have never paid dividends and have no current plans to do so.
Expected Forfeiture Rate. As allowed under ASU No. 2016‑09, Compensation-Stock Compensation (Topic 718): Improvements to Employee Share-
Based Payment Accounting, we account for forfeitures as they occur.
Service Period. We amortize all stock-based compensation over the requisite service period of the awards, which is generally the same as the vesting
period of the awards. We amortize the stock-based compensation cost on a straight-line basis over the expected service periods.
If factors change and we employ different assumptions, stock-based compensation expense may differ significantly from what we have recorded in the
past. If there are any modifications or cancellations of the underlying unvested securities, we may be required to accelerate, increase or cancel any remaining
unearned stock-based compensation expense. To the extent that our assumptions are incorrect, the amount of stock-based compensation recorded will change.
JOBS Act Accounting Election
As an emerging growth company under the Jumpstart Our Business Startups Act of 2012, we are eligible to take advantage of certain exemptions from
various reporting requirements that are applicable to other public companies that are not emerging growth companies. We have irrevocably elected not to avail
ourselves of the exemption from new or revised accounting standards and, therefore, are subject to the same new or revised accounting standards as other
public companies that are not emerging growth companies.
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Interest Rate Risk
The risk associated with fluctuating interest rates is primarily limited to our cash equivalents, which are carried at quoted market prices. Due to the short-
term maturities and low risk profile of our cash equivalents, an immediate 100 basis point change in interest rates would not have a material effect on the fair
value of our cash equivalents. We do not currently use or plan to use financial derivatives in our investment portfolio.
Credit Risk
As of December 31, 2019, our cash and cash equivalents were maintained with one financial institution in the United States, and our current deposits are
likely in excess of insured limits. We have reviewed the financial statements of this institution and believe it has sufficient assets and liquidity to conduct its
operations in the ordinary course of business with little or no credit risk to us.
Our accounts receivable primarily relate to revenues from the sale of our Lumivascular platform products to hospitals and medical centers in the United
States. None and one of our customers represented more than 10% of our accounts receivable as of December 31, 2019 and 2018, respectively.
Foreign Currency Risk
Our business is primarily conducted in U.S. dollars. Any transactions that may be conducted in foreign currencies are not expected to have a material
effect on our results of operations, financial position or cash flows.
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EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
The information required by this item appears in a separate section of this Annual Report on Form 10-K beginning on page F-1 and is incorporated
herein by reference.
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
There were no disagreements with Moss Adams LLP.
ITEM 9A. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports under the Securities
Exchange Act of 1934, as amended, or the Exchange Act, and the rules and regulations thereunder, is recorded, processed, summarized and reported within the
time periods specified in the SEC’s rules and forms and that such information is accumulated and communicated to our management, including our principal
executive officer and principal financial officer, as appropriate, to allow for timely decisions regarding required disclosure. In designing and evaluating the
disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only
reasonable assurance of achieving the desired control objectives, and management is required to apply its judgment in evaluating the cost-benefit relationship of
possible controls and procedures.
As required by Rule 13a-15(b) under the Exchange Act, our management, under the supervision and with the participation of our principal executive
officer and principal financial officer, has evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as such term is
defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of December 31, 2019. Based on such evaluation, our principal executive officer and
principal financial officer have concluded that, as of December 31, 2019, our disclosure controls and procedures were effective.
Management’s Annual Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as defined in Rule 13a-15(f) of the
Exchange Act. Our management conducted an evaluation of the effectiveness of our internal control over financial reporting based on the framework in Internal
Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on this evaluation,
management concluded that our internal control over financial reporting was effective as of December 31, 2019.
This Annual Report on Form 10-K does not include an attestation report of our registered public accounting firm on our internal control over financial
reporting due to an exemption established by the JOBS Act for “emerging growth companies.” In addition, we are currently a non-accelerated filer and are
therefore not required to provide an attestation report on our internal control over financial reporting until such time as we are an accelerated filer or large
accelerated filer.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal controls over financial reporting identified in management’s evaluation pursuant to Rules 13a-15(d) and 15d-
15(d) of the Exchange Act that occurred during the year ended December 31, 2019 that materially affected, or are reasonably likely to materially affect, our
internal control over financial reporting.
Inherent Limitations on Effectiveness of Controls
Our management, including our chief executive officer and chief financial officer, believes that our disclosure controls and procedures and internal control
over financial reporting are designed to provide reasonable assurance of achieving their objectives and are effective at the reasonable assurance level. However,
our management does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent all errors and all fraud. A
control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are
met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to
their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and
instances of fraud, if any, have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that
breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of
two or more people or by management override of the controls. The design of any system of controls also is based in part upon certain assumptions about the
likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over
time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of
the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
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ITEM 9B. OTHER INFORMATION
Amendment to Loan Agreement
On March 2, 2020, Avinger, Inc. (the “Company”) entered into Amendment No. 3 to Term Loan Agreement (the “Amendment”) with CRG Partners III
L.P. and certain of its affiliated funds, as lenders (the “Lenders”), which amended the Term Loan Agreement, dated as of September 22, 2015, by and among the
Company, certain of its subsidiaries from time to time party thereto as guarantors and the Lenders (as amended, the “Term Loan Agreement”). The Amendment
amended the Term Loan Agreement to, among other things:
•
•
•
•
Extend the period that the Company can make interest payments in payment in kind (PIK) to June 30, 2020;
Lower the Minimum Revenue Covenants to $10 million for 2020, $12 million for 2021, and $15 million for 2022;
Insert certain terms to clarify that all fees, including the prepayment premium, are due if the obligations are accelerated; and
Insert a new provision to make clear that to the extent the Company divides its assets/liabilities into divisions, such assets/liabilities will be treated as
transferred to a third party.
The foregoing description of the Amendment is qualified in its entirety by reference to the full text of the Amendment, a copy of which is attached hereto
as Exhibit 10.41, and which is incorporated herein in its entirety by reference.
Amendment to Change of Control and Severance Agreements
The Company is party to change of control and severance agreements with each of Jeff Soinski, Himanshu Patel and Mark Weinswig, who serve as the
Company’s Chief Executive Officer, Chief Technology Officer and Chief Financial Officer, respectively. On March 4, 2020, the Company and the respective
employees entered into amendments to such agreements to provide that, in the event the Company terminates the employee’s employment other than for
“cause,” death or disability, or the employee resigns for “good reason” (as such terms are defined in the employee’s employment agreement) and, within 60 days
following the employee’s termination, the employee executes an irrevocable separation agreement and release of claims, the employee is entitled to receive
continuing payments of severance pay at a rate equal to the employee’s monthly base salary and pro-rated target bonus, as then in effect, for a period of 12
months plus one month for every year of service completed for the Company (provided that such severance shall not exceed 18 months), In addition, the
agreements were also amended to provide that if the employee is employed by the Company or the Company’s successor on the date that is 12 months
following a change of control, then the employee will be entitled to a lump sum bonus payment in an amount equal to what the employee would have received as
a severance payment if the employee had been terminated other than for cause, death or disability. The other terms in the change of control and severance
agreements did not change.
The foregoing description of the amendments to the change of control and severance agreements does not purport to be complete and is qualified in its entirety
by reference to the full text of the amendments for each of Mr. Soinski, Mr. Patel and Mr. Weinswig, which are attached hereto as Exhibits 10.42, 10.43 and
10.44, respectively.
Amendment to Amended and Restated Officer and Director Share Purchase Plan
On March 2, 2020, the board of directors of the Company adopted an amendment (the “Plan Amendment”) to the Company’s previously adopted Amended and
Restated Share Purchase Plan (the “Purchase Plan”) to increase the number of shares of common stock available under the Purchase Plan from 60,000 shares
to 185,000 shares. The foregoing description of the Plan Amendment is qualified in its entirety by reference to the Plan Amendment, a copy of which is filed as
Exhibit 10.40 to this Annual Report on Form 10-K and is incorporated herein by reference.
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EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
Directors
PART III
Our business affairs are managed under the direction of our board of directors, which is currently composed of four members. Three of our directors are
independent within the meaning of the listing standards of The Nasdaq Stock Market, or Nasdaq. Our board of directors is divided into three staggered classes
of directors. At each annual meeting of stockholders, a class of directors will be elected for a three-year term to succeed the same class whose term is then
expiring.
The following table sets forth the names, ages as of January 13, 2020 and certain other information for each of the directors with terms expiring at the
2021 annual meeting of stockholders (the “Annual Meeting”) (who are also nominees for election as a director at the Annual Meeting) and for each of the
continuing members of our board of directors:
Directors
James G. Cullen(1)(2)(3)
Jeffrey M. Soinski
Donald A. Lucas(1)(2)(3)(4)
James B. McElwee(1)(2)(3)
Tamara N. Elias(1)(2)(3)
Class
Age
Position
Director
Since
Current
Term
Expires
III
I
II
II
II
77
58
57
67
48
Director and Chairman of the Board of Directors
President, Chief Executive Officer and Director
Director
Director
Director
2014
2014
2013
2011
2019
2021
2022
2020
2020
2021
(1) Member of our audit committee
(2) Member of our compensation committee
(3) Member of our nominating and corporate governance committee
(4) On January 28, 2020, Mr. Lucas passed away. Refer to Form 8-K filed on January 20, 2020
Jeffrey M. Soinski has served as our President, Chief Executive Officer and a member of our Board of Directors since December 2014. From its
formation in September 2009 until the acquisition of its Unisyn business by GE Healthcare in May 2013, Mr. Soinski served as Chief Executive Officer of Medical
Imaging Holdings and its primary operating company Unisyn Medical Technologies, a national provider of technology-enabled products and services to the
medical imaging industry. Mr. Soinski was a Director of Medical Imaging Holdings and its remaining operating company Consensys Imaging Service from
September 2009 until its sale in October 2017. Mr. Soinski served periodically as a Special Venture Partner from July 2008 to June 2013 and as a Special
Investment Partner since October 2016 for Galen Partners, a leading healthcare-focused private equity firm, which included Medical Imaging Holdings as one of
its portfolio companies. From 2001 until its acquisition by C.R. Bard in 2008, Mr. Soinski was President and CEO of Specialized Health Products International, a
publicly-traded manufacturer and marketer of proprietary safety medical products. He served on the board of directors of Merriman Holdings, parent of Merriman
Capital, a San Francisco-based investment banking and brokerage firm, from 2008 until March 2016. Mr. Soinski holds a B.A. degree from Dartmouth College.
We believe Mr. Soinski is qualified to serve as a member of our board of directors because of his extensive corporate finance and business strategy
experience as well as his experience with public companies.
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EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
James G. Cullen has served as a member of our board of directors since December 2014, as our Lead Independent Director since January 2015 and as
our Non-Executive Chairman since December 2017. During the last five years, Mr. Cullen has held board and committee positions with various companies. Mr.
Cullen is currently a director of Keysight Technologies, which was spun out of Agilent Technologies, where he was previously a director. Mr. Cullen previously
served as a director and chairman of the audit committee of Johnson & Johnson and as a director and member of the investment and finance committees of
Prudential Financial. From 1993 to 2000, Mr. Cullen was President, Vice Chairman and Chief Operating Officer of Bell Atlantic Corporation (now Verizon). From
1989 to 1993, he was President and Chief Executive Officer of Bell Atlantic-New Jersey. Mr. Cullen holds a B.A. in Economics from Rutgers University and an
M.S. in Management Science from the Massachusetts Institute of Technology.
We believe Mr. Cullen is qualified to serve as a member of our board of directors because of his extensive experience serving on the boards of public
companies as well as his financial and business expertise.
Donald A. Lucas had served as a member of our board of directors since 2013 until January 2020 and had been an investor in our company since 2011.
Mr. Lucas passed away in January 2020. Mr. Lucas had been a venture capitalist since 1985, having invested in companies such as Oracle, Macromedia and
Cadence Design alongside his father Donald L. Lucas. Mr. Lucas had sourced or led investments in companies such as Intuitive Surgical, Coulter
Pharmaceutical, Dexcom, Infinera, Signifyd, Obalon Therapeutics, Katerra, Bossa Nova Robotics, Filld, Berkeley Lights Inc, and Palantir. Mr. Lucas had served
on the boards of Dexcom and the Silicon Valley Chapter of the JDRF and was a member of the UCSF Diabetes Center Leadership Council. Mr. Lucas had
served on the advisory board for U.S. Bank. Mr. Lucas received a B.A. from Santa Clara University.
James B. McElwee has served as a member of our board of directors since March 2011. Mr. McElwee has served as an independent venture capital
investor since 2010. Mr. McElwee served as general partner of Weston Presidio, a private equity and venture capital firm, from 1992 to 2010. During his tenure
as a general partner and member of the investment committee, Weston Presidio led the start up financing of JetBlue Airways and made investments in Fender
Musical Instruments, The Coffee Connection, Guitar Center, Mapquest, Party City, Petzazz, RE/MAX, and others.
We believe Mr. McElwee is qualified to serve as a member of our board of directors because of his substantial corporate development and business
strategy expertise gained in the venture capital industry.
Tamara N. Elias, M.D., was appointed to our board of directors in December 2019. Dr. Elias served as Vice President of Clinical Product Development at
Aetna from February 2018 to December 2019. From 2015 to 2017, Dr. Elias was Vice President of Corporate Strategy and Business Development for the $8
billion medical segment at Becton Dickinson. From 2007-2015, Dr. Elias was a Partner with Essex Woodlands Healthcare Partners, a healthcare only growth
equity firm founded in 1985. Earlier in her career, Dr. Elias was a management consultant at McKinsey, advising pharmaceutical, diagnostic and device
companies in R&D, product commercialization and M&A. She has also served on the boards of several private companies, including Millenium Pharmacy
Systems (sold to Pharmerica), BreatheAmerica, Influence Health (sold to Healthgrades) and ATS Medical (sold to Medtronic). Dr. Elias holds degrees in Biology
and Anthropology from Yale University, and an M.D. from The Johns Hopkins School of Medicine. She trained as a general surgeon at Massachusetts General
Hospital.
We believe Dr. Elias is qualified to serve as a member of our board of directors because of her substantial corporate development and business strategy
expertise and her experience in the healthcare industry.
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Executive Officers
The following table identifies certain information about our executive officers as of January 13, 2020. Our executive officers are appointed by, and serve
at the discretion of, our board of directors. Each of our executive officers serves at the discretion of our board of directors and holds office until his successor is
duly elected and qualified or until his earlier resignation or removal. There are no family relationships among any of our directors or executive officers.
Name
Jeffrey M. Soinski
Mark Weinswig
Himanshu N. Patel
Age
58
47
59
President, Chief Executive Officer and Director
Chief Financial Officer
Chief Technology Officer
Title
For a brief biography of Mr. Soinski, please see the section of this Annual Report on Form 10-K titled “ Directors.”
Mark Weinswig has served as our Chief Financial Officer since June 2018. Prior to joining the Company, Mr. Weinswig served as Chief Financial Officer
at Aqua Metals, Inc., a heavy metal recycling company, from August 2017 to March 2018. Mr. Weinswig has previously served as Chief Financial Officer of One
Workplace, a designer and manufacturer of customized workspaces, from July 2016 to July 2017. From October 2010 to June 2016, Mr. Weinswig served as
Chief Financial Officer of Emcore Corporation, a Nasdaq-listed designer and manufacturer of indium phosphide optical chips, components, subsystems and
systems for the broadband and specialty fiber optics market. Earlier in his career Mr. Weinswig worked at Coherent, Inc., Avanex Corporation, which merged
with Bookham Technology, Morgan Stanley and PricewaterhouseCoopers. He received an M.B.A. from the University of Santa Clara and a B.S. in business
administration with an accounting major from Indiana University. He has earned the CFA and CPA designations.
Himanshu N. Patel co-founded Avinger in 2007 and has served as our Chief Technology Officer from January 2011 to November 2011 and since
October 2013. From September 1999 to February 2007, Mr. Patel held various research and development positions, including Director of Advanced
Technologies, at FoxHollow Technologies. Mr. Patel previously held research and development positions at EndoTex Interventional Systems and General
Surgical Innovations. Mr. Patel holds a B.S. in Mechanical Engineering from M.S. University of Baroda, India, and an M.S. in Mechanical Engineering from the
University of Florida.
Code of Business Conduct and Ethics
We have adopted a code of business conduct and ethics that applies to all of our employees, officers and directors, including those officers responsible
for financial reporting. The code of business conduct and ethics is available on our website at www.avinger.com. Changes to or waivers of the code will be
disclosed on the same website. We intend to satisfy the disclosure requirement under Item 5.05 of Form 8-K regarding any amendment to, or waiver of, any
provision of the code in the future by disclosing such information on our website.
Board Leadership Structure
We believe that the structure of our board of directors and its committees provides strong overall management of our company. Our board of directors
does not have a formal policy on whether the roles of Chief Executive Officer and Chairman of our board of directors should be separate. However, Messrs.
Soinski and Cullen, respectively, hold these positions at present.
Our Chief Executive Officer, Mr. Soinski, is responsible for setting the strategic direction of our company, the general management and operation of the
business and the guidance and oversight of senior management. In his capacity as Chairman of our board of directors, Mr. Cullen is also responsible for the
guidance and oversight of senior management, monitoring the content, quality and timeliness of information sent to our board of directors, consultation with our
board of directors regarding the oversight of our business affairs, presiding over meetings of our board of directors and performing such additional duties as our
Board may otherwise determine and delegate. At the end of each board meeting, the independent directors are expected to meet in executive session, without
Mr. Soinski present. Following each meeting, Mr. Cullen is expected to provide feedback to Mr. Soinski on his performance and the performance of our
employees during the meeting and to recommend new agenda items for the next meeting.
Director Independence
Our common stock is listed on The Nasdaq Capital Market. Under the Nasdaq listing standards, independent directors must comprise a majority of a
listed company’s board of directors. In addition, the Nasdaq listing standards require that, subject to specified exceptions, each member of a listed company’s
audit, compensation, and nominating and corporate governance committees be independent. Under the Nasdaq listing standards, a director will only qualify as
an “independent director” if, in the opinion of that listed company’s board of directors, that director does not have a relationship that would interfere with the
exercise of independent judgment in carrying out the responsibilities of a director.
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Audit committee members must also satisfy the additional independence criteria set forth in Rule 10A-3 under the Securities Exchange Act of 1934, as
amended, or the “Exchange Act, and the Nasdaq listing standards. Compensation committee members must also satisfy the additional independence criteria set
forth in Rule 10C-1 under the Exchange Act and the Nasdaq listing standards.
Our board of directors has undertaken a review of the independence of each of our directors. Based on information provided by each director
concerning his background, employment and affiliations, our board of directors has determined that Messrs. Cullen, McElwee and Dr. Elias do not have a
relationship that would interfere with the exercise of independent judgment in carrying out the responsibilities of a director and that each of these directors is
“independent” as that term is defined under the Nasdaq listing standards. In making these determinations, our board of directors considered the current and prior
relationships that each non-employee director has with our company and all other facts and circumstances our board of directors deemed relevant in determining
their independence, including the beneficial ownership of our capital stock by each non-employee director, and the transactions involving them described below
in Item 13 under the heading “Related Person Transactions.”
Board Meetings and Committees
During our fiscal year ended December 31, 2019, our board of directors held 13 meetings (including regularly scheduled and special meetings), and each
director attended at least 75% of the aggregate of (i) the total number of meetings of our board of directors held during the period for which he has been a
director and (ii) the total number of meetings held by all committees of our board of directors on which he served during the periods that he served. All of our
directors who were directors at the time attended our 2019 annual meeting of stockholders, either in person or telephonically.
Although we do not have a formal policy regarding attendance by members of our board of directors at annual meetings of stockholders, we strongly
encourage our directors to attend.
Our board of directors has established an audit committee, a compensation committee and a nominating and corporate governance committee. The
composition and responsibilities of each of the committees of our board of directors are described below. Members will serve on these committees until their
resignation or until as otherwise determined by our board of directors.
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Audit Committee
Messrs. McElwee, Cullen and Dr. Elias serve on our audit committee. Mr. Cullen serves as the chair of the audit committee. Our board of directors has
assessed whether all members of the audit committee meet the composition requirements of Nasdaq, including the requirements regarding financial literacy and
financial sophistication. Our board of directors found that Messrs. McElwee, Cullen and Dr. Elias have met the financial literacy and financial sophistication
requirements and that Messrs. McElwee, Cullen and Dr. Elias are independent under SEC and Nasdaq rules. In addition, our board of directors has determined
that Mr. Cullen is an audit committee financial expert within the meaning of Item 407(d) of Regulation S-K under the Securities Act of 1933, as amended, or the
Securities Act. The audit committee’s primary responsibilities include:
•
•
•
appointing, approving the compensation of, and assessing the qualifications and independence of our independent registered public accounting firm,
which currently is Moss Adams LLP;
reviewing and discussing with management and our independent registered public accounting firm our annual and quarterly financial statements and
related disclosures;
preparing the audit committee report required by SEC rules to be included in our annual proxy statements;
• monitoring our internal control over financial reporting, disclosure controls and procedures;
•
•
reviewing our risk management status;
establishing policies regarding hiring employees from our independent registered public accounting firm and procedures for the receipt and retention
of accounting related complaints and concerns;
• meeting independently with our independent registered public accounting firm and management; and
• monitoring compliance with the code of business conduct and ethics for financial management.
All audit and non-audit services must be approved in advance by the audit committee. Our audit committee operates under a written charter that satisfies
the applicable rules and regulations of the SEC and Nasdaq listing standards. A copy of the charter of our audit committee is available on our website at
www.avinger.com under “Investors–Governance.” During our fiscal year ended December 31, 2019, our audit committee held five meetings.
Compensation Committee
Messrs. Cullen, McElwee and Dr. Elias serve on our compensation committee. Mr. McElwee serves as the chair of the compensation committee. Each
member of our compensation committee meets the requirements for independence for compensation committee members under the Nasdaq listing standards
and SEC rules and regulations, including Rule 10C-1 under the Exchange Act. Each member of our compensation committee is also a non-employee director,
as defined pursuant to Rule 16b-3 promulgated under the Exchange Act, and an outside director, as defined pursuant to Section 162(m) of the Internal Revenue
Code. Our compensation committee is responsible for, among other things:
•
•
•
•
annually reviewing and approving corporate goals and objectives relevant to compensation of our chief executive officer and our other executive
officers;
determining the compensation of our chief executive officer and our other executive officers;
reviewing and making recommendations to our board of directors with respect to director compensation; and
overseeing and administering our equity incentive plans.
Our Chief Executive Officer and Chief Financial Officer make compensation recommendations for our other executive officers and initially propose the
corporate and departmental performance objectives under our Executive Incentive Compensation Plan to the compensation committee. From time to time, the
compensation committee may use outside compensation consultants to assist it in analyzing our compensation programs and in determining appropriate levels
of compensation and benefits. For example, we have periodically engaged Radford, a business unit of Aon Hewitt, to help develop our compensation
philosophy, select a group of peer companies to use for compensation benchmarking purposes and advise on cash and equity compensation levels for our
directors, executives and other employees based on current market practices. Our compensation committee operates under a written charter that satisfies the
applicable rules and regulations of the SEC and Nasdaq listing standards. A copy of the charter of our compensation committee is available on our website at
www.avinger.com under “Investors–Governance.” During our fiscal year ended December 31, 2019, our compensation committee held four meetings.
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Nominating and Corporate Governance Committee
Messrs. Cullen, McElwee and Dr. Elias serve on our nominating and governance committee. Dr. Elias serves as the chair of the nominating and
governance committee. Each member of our nominating and corporate governance committee meets the requirements for independence under the Nasdaq
listing standards and SEC rules and regulations. Our nominating and corporate governance committee is responsible for, among other things:
•
•
•
•
•
identifying individuals qualified to become members of our board of directors;
recommending to our board of directors the persons to be nominated for election as directors and to each of our board’s committees;
reviewing and making recommendations to our board of directors with respect to management succession planning;
developing, updating and recommending to our board of directors corporate governance principles and policies; and
overseeing the evaluation of our board of directors and committees.
Our nominating and corporate governance committee operates under a written charter that satisfies the applicable Nasdaq listing standards. A copy of
the charter of our nominating and corporate governance committee is available on our website at www.avinger.com under “Investors–Governance.” During our
fiscal year ended December 31, 2019, our nominating and corporate governance committee held one meeting.
ITEM 11. EXECUTIVE COMPENSATION
Processes and Procedures for Compensation Decisions
Our compensation committee is responsible for the executive compensation programs for our executive officers and reports to our board of directors on
its discussions, decisions and other actions. Our compensation committee reviews and approves corporate goals and objectives relating to the compensation of
our Chief Executive Officer, evaluates the performance of our Chief Executive Officer in light of those goals and objectives and determines and approves the
compensation of our Chief Executive Officer based on such evaluation. Our compensation committee has the sole authority to determine our Chief Executive
Officer’s compensation. In addition, our compensation committee, in consultation with our Chief Executive Officer, reviews and approves all compensation for
other officers, including the directors. Our Chief Executive Officer and Chief Financial Officer also make compensation recommendations for our other executive
officers and initially propose the corporate and departmental performance objectives under our Executive Incentive Compensation Plan to the compensation
committee.
The compensation committee is authorized to retain the services of one or more executive compensation and benefits consultants or other outside
experts or advisors as it sees fit, in connection with the establishment of our compensation programs and related policies.
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Summary Compensation Table
The following table presents summary information regarding the total compensation for services rendered in all capacities that was earned by our Chief
Executive Officer and our two other most highly compensated executive officers in our fiscal years ended December 31, 2019 and 2018. The individuals listed in
the table below are our named executive officers for our fiscal year ended December 31, 2019.
Name and Principal Position
Jeffrey M. Soinski(3)
President and Chief Executive
Officer
Himanshu Patel (3)
Chief Technology Officer
Mark B. Weinswig (4)
Chief Financial Officer
Year
2019
2018
2019
2018
2019
2018
Salary
($)
399,168
Bonus
($)
121,988
Stock
Awards
($)(1)
86,250
Option
Awards
($)(1)
390,000
298,333
280,000
300,000
156,250
84,539
71,101
48,556
74,448
-
815,000
57,500
489,000
57,500
407,500
-
-
-
-
-
-
Non-Equity
Incentive Plan
Compensation
($)
All Other
Compensation
($)(2)
-
-
-
-
-
-
Total ($)
-
607,406
3,000 1,292,539
426,935
820,556
431,948
563,750
-
3,000
-
-
(1) The amounts reported represent the aggregate grant-date fair value of the stock awards and stock options awarded to the named executive officer in 2019
and 2018, calculated in accordance with ASC Topic 718. Such grant-date fair value does not take into account any estimated forfeitures related to service-
vesting conditions. The assumptions used in calculating the grant-date fair value of the options reported in this column are set forth in the section of this
Annual Report on Form 10-K titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies
and Estimates—Stock-Based Compensation.”
(2) The amounts reported for Mr. Soinski and Mr. Patel represent funds contributed to his health savings account of $3,000 during 2018.
(3) Mr. Soinski's and Mr. Patel's salary was increased in February 2019 to $400,000 and $300,000, respectively.
(4) Mr. Weinswig was hired effective June 25, 2018, replacing Matt Ferguson, who resigned August 1, 2018.
Executive Employment Letters
Jeffrey M. Soinski
We entered into an employment offer letter in December 2014 with Jeffrey M. Soinski, our President and Chief Executive Officer. The letter has no
specific term and provides for at-will employment. The letter also provides that, in 2015, Mr. Soinski was eligible to receive an annual performance bonus of up
to 40% of his annual salary based on the achievement of certain goals mutually agreed upon by him and our board of directors. Effective January 1, 2016, Mr.
Soinski’s annual base salary was $390,000 and his target bonus percentage was increased from 40% to 50%. Effective February 1, 2019, Mr. Soinski’s annual
base salary was increased to $400,000.
Pursuant to Mr. Soinski’s employment offer letter, if, within the 12-month period following a “change in control,” we terminate Mr. Soinski’s employment
without “cause,” or Mr. Soinski resigns for “good reason” (as such terms are defined in Mr. Soinski’s employment offer letter), Mr. Soinski will receive accelerated
vesting as to 100% of his outstanding unvested stock options. If we experience a change in control, and Mr. Soinski remains our employee through such date,
Mr. Soinski will receive accelerated vesting as to 50% of his outstanding unvested stock options and/or restricted stock.
If we terminate Mr. Soinski without cause at any time, he will be entitled to receive 12 months of base salary and COBRA medical and dental insurance
coverage, in each case payable in substantially equal installments in accordance with our payroll practices, as severance, in exchange for signing and not
revoking a severance agreement and general release against us and our affiliates within 60 days following his termination of employment.
The letter provided that Mr. Soinski receive payments or reimbursements from us for up to $30,000 of reasonable and documented expenses related to
temporary lodging, travel, and commuting costs incurred by Mr. Soinski prior to August 2015 in connection with his transition from Utah to Redwood City,
California, and reimbursements of up to $100,000 related to the sale of Mr. Soinski’s home in Utah and relocation to California. All relocation benefits owed to
Mr. Soinski have been paid, and no further obligations exist under these provisions.
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Mark Weinswig
Pursuant to an Employment Offer Letter between the Company and Mr. Weinswig, dated as of June 11, 2018, Mr. Weinswig is entitled to receive as
compensation (i) a base salary of $300,000; (ii) a discretionary bonus targeted at 40% of his base salary, subject to achievement of mutually agreed performance
goals and payable semi-annually; and (iii) other standard benefits provided to each of the Company’s executive officers.
401(k) Plan
We maintain a tax-qualified retirement plan that provides eligible employees with an opportunity to save for retirement on a tax advantaged basis. We
may make a discretionary matching contribution to the 401(k) plan, and may make a discretionary employer contribution to each eligible employee each year. To
date, we have not made any matching or profits sharing contributions into the 401(k) plan. All participants’ interests in our matching and profit sharing
contributions, if any, vest pursuant to a four-year graded vesting schedule from the time of contribution. Pre-tax contributions are allocated to each participant’s
individual account and are then invested in selected investment alternatives according to the participants’ directions. The 401(k) plan is intended to qualify under
Sections 401(a) and 501(a) of the Code. As a tax-qualified retirement plan, contributions to the 401(k) plan and earnings on those contributions are not taxable
to the employees until distributed from the 401(k) plan, and all contributions are deductible by us when made.
Pension Benefits and Nonqualified Deferred Compensation
We do not provide a pension plan for our employees, and none of our named executive officers participated in a nonqualified deferred compensation
plan in 2019.
Outstanding Equity Awards at Fiscal Year-End
The following table provides information regarding equity awards held by our named executive officers at December 31, 2019.
Option Awards
Number of
Securities
Underlying
Unexercised
Options (#)
Number of
Securities
Underlying
Unexercised
Options (#)
Option
Exercise
Price
($)(4)
Option
Expiration
Date
Stock Awards
Number of
Shares or
Units of
Stock That
Have Not
Vested (#)
Market
Value of
Shares or
Units of
Stock That
Have Not
Vested
($)(5)
Exercisable
(3)
Unexercisable
Name
Jeffrey M. Soinski
Himanshu Patel
Mark Weinswig
Grant Date
12/31/2014(1)(7)
3/7/2016 (2)(7)
3/7/2016(2)(8)
3/13/2017 (2) (7)
3/13/2017 (2)(8)
9/5/2018(2) (9)
9/18/2019(2) (9)
11/5/2013 (1) (6)
12/31/2014(1)(7)
3/3/2016(2) (7)
3/3/2016(2) (8)
3/13/2017 (2) (7)
3/13/2017 (2) (8)
9/5/2018(2) (9)
9/18/2019(2) (9)
9/5/2018(2) (9)
9/18/2019(2) (9)
1,549
141
—
104
—
—
—
57
435
59
—
52
—
—
—
—
—
66
—
10
—
47
—
—
—
—
—
4
—
24
—
—
—
—
—
1,800
5,184
—
820
—
—
—
8,100
1,800
5,196
—
820
—
—
—
—
—
12/31/2024
3/7/2026
—
3/13/2027
—
—
—
11/5/2023
12/31/2024
3/3/2026
—
3/13/2027
—
—
—
—
—
18
—
37
33,333
75,000
—
—
—
8
—
19
20,000
50,000
—
—
16,666
50,000
—
—
21
—
42
38,000
85,500
—
—
—
9
—
22
22,800
57,000
18,999
57,000
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
(1) Each of the outstanding equity awards was granted pursuant to our 2009 Stock Plan. No additional awards may be granted under the 2009 Stock Plan, and
all awards granted under the 2009 Stock Plan that are repurchased, forfeited, expire, are cancelled or otherwise not issued become available for grant under
the 2015 Plan in accordance with its terms.
(2) Each of the outstanding equity awards was granted pursuant to our 2015 Equity Incentive Plan.
(3) All of our options granted pursuant to our 2009 Stock Plan are early exercisable subject to the Company’s right to repurchase any unvested shares.
(4) This column represents the fair value of a share of our common stock on the date of grant, as determined by our board of directors.
(5) This column represents the market value of the unvested shares of our common stock underlying the RSUs as of December 31, 2019, based on the closing
price of our common stock, as reported on the Nasdaq Global Select Market, of $1.14 per share.
(6) 25% of the shares of our common stock subject to this option vested on October 11, 2014, and the balance vested in 36 successive equal monthly
installments, subject to continued service through each such vesting date.
(7) 25% of the shares of our common stock subject to this option vested on the one year anniversary of the grant date, and the balance vests in 36 successive
equal monthly installments, subject to continued service through each such vesting date.
(8) 25% of the shares of our common stock subject to this stock award vests on the one year anniversary of the grant date, and the balance vests in 3
successive equal annual installments, subject to continued service through each such vesting date.
(9) 33.3% of the shares of our common stock subject to this stock award vests on the one year anniversary of the grant date, and the balance vests in 2
successive equal annual installments, subject to continued service through each such vesting date.
Potential Payments upon Termination or Change of Control
Jeffrey M. Soinski
In March 2018, we entered into a change of control and severance agreement with Jeffrey M. Soinski, which was subsequently amended in March
2020. Under this agreement, as amended, if, within the 18 month period following a “change of control,” we terminate Mr. Soinski’s employment other than for
“cause,” death or disability, or the employee resigns for “good reason” (as such terms are defined in the employee’s employment agreement) and, within 60 days
following the employee’s termination, the employee executes an irrevocable separation agreement and release of claims, the employee is entitled to receive (i)
continuing payments of severance pay at a rate equal to the employee’s monthly base salary and pro rated target bonus, as then in effect, for a period of 12
months plus one month for every year of service completed for the Company (provided that such severance shall not exceed 18 months), (ii) reimbursement of
premiums to maintain group health insurance continuation benefits pursuant to “COBRA” for employee and employee’s dependents for up to 12 months, (iii)
accelerated vesting as to 100% of the employee’s outstanding unvested stock options and/or restricted stock, and (iv) the extension of the post-termination
exercise period of any options held by the employee for a period of 1 year. Additionally, if we experience a change in control, 50% of Mr. Soinski’s outstanding
unvested stock options and/or restricted stock will vest. In the event of any conflict between Mr. Soinski’s change of control and severance agreement and his
offer letter, described above under “Executive Employment Letters,” he will be entitled to the greater of the benefits provided by either. The agreement also
provides that if the employee is employed by the Company or the Company’s successor on the date that is 12 months following a change of control, then the
employee will be entitled to a lump sum bonus payment in an amount equal to what the employee would have received as a severance payment if the employee
had been terminated other than for cause, death or disability.
Himanshu Patel
We previously entered into a change of control and severance agreement with Himanshu Patel, which was subsequently amended in March 2020.
Under this agreement, as amended, if, within the 18 month period following a “change of control,” we terminate Mr. Patel’s employment other than for “cause,”
death or disability, or the employee resigns for “good reason” (as such terms are defined in the employee’s employment agreement) and, within 60 days
following the employee’s termination, the employee executes an irrevocable separation agreement and release of claims, the employee is entitled to receive (i)
continuing payments of severance pay at a rate equal to the employee’s monthly base salary and pro rated target bonus, as then in effect, for a period of 12
months plus one month for every year of service completed for the Company (provided that such severance shall not exceed 18 months), (ii) reimbursement of
premiums to maintain group health insurance continuation benefits pursuant to “COBRA” for employee and employee’s dependents for up to 12 months, (iii)
accelerated vesting as to 100% of the employee’s outstanding unvested stock options and/or restricted stock, and (iv) the extension of the post-termination
exercise period of any options held by the employee for a period of 1 year. The agreement also provides that if the employee is employed by the Company or
the Company’s successor on the date that is 12 months following a change of control, then the employee will be entitled to a lump sum bonus payment in an
amount equal to what the employee would have received as a severance payment if the employee had been terminated other than for cause, death or disability.
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Mark Weinswig
In June 2018, we entered into a change of control and severance agreement with Mark Weinswig, which was subsequently amended in March 2020.
Under this agreement, as amended, if, within the 18 month period following a “change of control,” we terminate Mr. Weinswig’s employment other than for
“cause,” death or disability, or the employee resigns for “good reason” (as such terms are defined in the employee’s employment agreement) and, within 60 days
following the employee’s termination, the employee executes an irrevocable separation agreement and release of claims, the employee is entitled to receive (i)
continuing payments of severance pay at a rate equal to the employee’s monthly base salary and pro rated target bonus, as then in effect, for 12 months plus
one month for every year of service completed for the Company (provided that such severance shall not exceed 18 months), (ii) reimbursement of premiums to
maintain group health insurance continuation benefits pursuant to “COBRA” for employee and employee’s dependents for up to 12 months, (iii) accelerated
vesting as to 100% of the employee’s outstanding unvested stock options and/or restricted stock, and (iv) the extension of the post-termination exercise period of
any options held by the employee for a period of 1 year. Additionally, if we experience a change in control, 50% of Mr. Weinswig’s outstanding unvested stock
options and/or restricted stock will vest. In the event of any conflict between Mr. Weinswig’s change of control and severance agreement and his offer letter,
described above under “Executive Employment Letters,” he will be entitled to the greater of the benefits provided by either. The agreement also provides that if
the employee is employed by the Company or the Company’s successor on the date that is 12 months following a change of control, then the employee will be
entitled to a lump sum bonus payment in an amount equal to what the employee would have received as a severance payment if the employee had been
terminated other than for cause, death or disability.
Executive Incentive Compensation Plan
Our board of directors has adopted an Executive Incentive Compensation Plan, or the Bonus Plan, that is administered by our compensation
committee. The Bonus Plan allows our compensation committee to provide cash incentive awards to selected employees, including our named executive
officers, based upon performance goals established by our compensation committee.
Under the Bonus Plan, our compensation committee determines the performance goals applicable to any award, which goals may include, without
limitation: attainment of research and development milestones, sales bookings, business divestitures and acquisitions, cash flow, cash position, earnings (which
may include any calculation of earnings, including but not limited to earnings before interest and taxes, earnings before taxes, earnings before interest, taxes,
depreciation and amortization and net earnings), earnings per share, net income, net profit, net sales, operating cash flow, operating expenses, operating
income, operating margin, overhead or other expense reduction, product defect measures, product release timelines, productivity, profit, return on assets, return
on capital, return on equity, return on investment, return on sales, revenue, revenue growth, sales results, sales growth, stock price, time to market, total
stockholder return, working capital, and individual objectives such as peer reviews or other subjective or objective criteria. Performance goals that include our
financial results may be determined in accordance with GAAP or such financial results may consist of non-GAAP financial measures and any actual results may
be adjusted by the compensation committee for one-time items or unbudgeted or unexpected items when performance goals that include our financial results
may be determined in accordance with GAAP, or such financial results may consist of non-GAAP financial measures, and any actual results may be adjusted by
the compensation committee for one-time items or unbudgeted or unexpected items when determining whether the performance goals have been met. The
goals may be on the basis of any factors the compensation committee determines relevant, and may be adjusted on an individual, divisional, business unit or
company-wide basis. The performance goals may differ from participant to participant and from award to award.
Our compensation committee may, in its sole discretion and at any time, increase, reduce or eliminate a participant’s actual award, and/or increase,
reduce or eliminate the amount allocated to the bonus pool for a particular performance period. The actual award may be below, at or above a participant’s
target award, in the compensation committee’s discretion. Our compensation committee may determine the amount of any reduction on the basis of such
factors as it deems relevant, and it is not required to establish any allocation or weighting with respect to the factors it considers.
Actual awards are paid in cash only after they are earned, which usually requires continued employment through the date a bonus is paid. Our
compensation committee has the authority to amend, alter, suspend or terminate the Bonus Plan provided such action does not impair the existing rights of any
participant with respect to any earned bonus.
Director Compensation
Our board of directors approved our Outside Director Compensation Policy in January 2015 to compensate each non-employee director for his or her
service, and amended certain aspects of this policy in August 2018. Our board of directors will have the discretion to revise non-employee director compensation
as it deems necessary or appropriate. Under our Outside Director Compensation Policy, non-employee directors will receive compensation in the form of equity
and cash, as described below:
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EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
Cash Compensation. All non-employee directors will be entitled to receive the following cash compensation for their services:
•
•
•
•
•
•
•
•
$35,000 per year for service as a board member;
$25,000 per year additionally for service as chairman of the board;
$20,000 per year additionally for service as chairman of the audit committee;
$10,000 per year additionally for service as an audit committee member;
$15,000 per year additionally for service as chairman of the compensation committee;
$7,500 per year additionally for service as a compensation committee member;
$10,000 per year additionally for service as chairman of the nominating and corporate governance committee; and
$5,000 per year additionally for service as a nominating and corporate governance committee member.
All cash payments to non-employee directors, or the Retainer Cash Payments, will be paid semiannually with the first semiannual installment payable on
the date of our annual meeting of stockholders or, if no annual meeting occurs in a given year, May 1, and the second semiannual installment payable on
November 1 of each year.
Election to Receive RSUs in Lieu of Cash Payments. All non-employee directors may elect to convert a Retainer Cash Payment into RSUs, or Retainer
RSUs, with a grant date fair value equal to the applicable Retainer Cash Payment. Each Retainer RSU will be granted on the date that the applicable Retainer
Cash Payment was scheduled to be paid, and all of the shares underlying the Retainer RSUs will vest and become exercisable six months from the date of
grant, subject to continued service as a director through the applicable vesting date. The Retainer RSUs will be subject to certain terms and conditions as
described below under the section titled “Director Compensation—Equity Compensation.”
Elections to convert a Retainer Cash Payment into a Retainer Option must generally be made on or prior to December 31 of the year prior to the year in
which the Retainer Cash Payment is scheduled to be paid, or such earlier deadline as is established by our board of directors or compensation committee. A
newly appointed non-employee director will be permitted to elect to convert Retainer Cash Payments payable in the same calendar year into Retainer Options,
provided that such election is made prior to the date the individual becomes a non-employee director.
Equity Compensation. Nondiscretionary, automatic grants of RSUs will be made to our non-employee directors.
•
•
Initial Grant. Generally, each person who first becomes a non-employee director will be granted RSUs having a grant date fair value equal to
$115,000, or the Initial Grant. The Initial Grant will be granted on the date of the first meeting of our board of directors or compensation committee
occurring on or after the date on which the individual first became a non-employee director. The Initial Grant will vest and become exercisable as to
one thirty-sixth (1/36th) of the shares subject to such Initial Grant on each monthly anniversary of the commencement of the non-employee director’s
service as a director, subject to the continued service as a director through the applicable vesting date. Notwithstanding the foregoing, Dr. Tamara
Elias was appointed as a non-employee director on December 12, 2019, and she did not receive an Initial Grant.
Annual Grant. Once each calendar year, on the same date that our board of directors grants annual equity awards to our senior executives, each
non-employee director will be granted RSUs having a grant date fair value equal to $75,000, or the Annual Grant. All of the shares underlying the
Annual Grant will vest and become exercisable one year from the date of grant, subject to continued service as a director through the applicable
vesting date.
The grant date fair value is the closing sales price for the Company’s common stock (or the closing bid, if no sales were reported) as quoted on such
exchange or system on the date such award is granted.
Any RSUs granted under our outside director compensation policy will fully vest and become exercisable in the event of a change in control, as defined
in our 2015 Plan, provided that the holder remains a director through such change in control. Further, our 2015 Plan provides that in the event of a merger or
change in control, as defined in our 2015 Plan, each outstanding equity award granted under our 2015 Plan that is held by a non-employee director will fully vest,
all restrictions on the shares subject to such award will lapse and, with respect to awards with performance-based vesting, all performance goals or other
vesting criteria will be deemed achieved at 100% of target levels, and all of the shares subject to such award will become fully exercisable, if applicable, provided
such optionee remains a director through such merger or change in control.
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EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
Compensation for Fiscal Year 201 9
The following table sets forth a summary of the compensation received by our non-employee directors who received compensation during our fiscal year
ended December 31, 2019:
Name
James G. Cullen
Donald A. Lucas (3)
James B. McElwee
Tamara Elias (4)
Fees earned
or
Option awards(1)
paid in cash
87,500 $
$
67,500
65,000
-
Total
Stock
awards(2)
- $
-
-
-
75,000 $
75,000
75,000
-
162,500
142,500
140,000
-
(1) As of December 31, 2019, Messrs. Cullen, Lucas, and McElwee had outstanding options to purchase a total of 327, 310 and 284 shares of our common
stock.
(2) During 2019, all non-employee directors that were directors at the time of grant received an Annual RSU grant.
(3) Mr. Lucas passed away in January 2020.
(4) Dr. Elias was appointed to serve on the board of directors on December 12, 2019. Given the timing of the appointment, she did not receive any form of
compensation during the fiscal year.
Directors who are also our employees receive no additional compensation for their service as directors. During 2019, Jeffrey M. Soinski, our President,
Chief Executive Officer and a director, was also our employee. See the section titled “Summary Compensation Table” below for additional information about the
compensation for Mr. Soinski.
Officer and Director Share Purchase Plan
On August 22, 2018, the Board of Directors of the Company approved the adoption of an Officer and Director Share Purchase Plan (“ODPP”), which
allows executive officers and directors to purchase shares of our common stock at fair market value in lieu of salary or, in the case of directors, director fees.
Eligible individuals may voluntarily participate in the ODPP by authorizing payroll deductions or, in the case of directors, deductions from director fees for the
purpose of purchasing common stock. Elections to participate in the ODPP may only be made during open trading windows under our insider trading policy
when the participant does not otherwise possess material non-public information concerning the Company. The Board of Directors authorized 20,000 shares to
be made available for purchase by officers and directors under the ODPP. Effective on August 28, 2019, the Board of Directors approved an additional 40,000
shares to be made available under the ODPP. Effective on March 2, 2020, the Board of Directors approved an additional 125,000 shares to be made available
under the ODPP.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
Equity Compensation Plan Information
All of our equity compensation plans have been approved by our stockholders. The following table provides information as of December 31, 2019, with
respect to the shares of our common stock that may be issued under our existing equity compensation plans.
(a) Number of
Securities to be
Issued Upon
Exercise of
Outstanding
Options,
Warrants and
Rights
(b) Weighted
Average Exercise
Price of
Outstanding
Options,
Warrants and
Rights (2)
(c) Number of
Securities
Remaining
Available for
Future Issuance
Under Equity
Compensation
Plans (Excluding
Securities
Reflected in
Column (a))
915,905 $
1,309.47
96,896
Plan Category
Equity compensation plans approved by stockholders (1)
(1) Includes the following plans: our 2009 Stock Plan and our 2015 Plan. Our 2015 Plan provides that on the first day of each fiscal year commencing in fiscal
year 2016, the number of shares authorized for issuance under the 2015 Plan is automatically increased by a number equal to the lesser of (i) 42,250 shares
of common stock, (ii) 5.0% of the aggregate number of shares of common stock outstanding on the last day of the preceding fiscal year, or (iii) such number
of shares that may be determined by our board of directors.
(2) The weighted average exercise price does not take into account outstanding restricted stock, or RSUs, which have no exercise price.
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EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
Security Ownership of Certain Beneficial Owners and Management
The following table sets forth certain information with respect to the beneficial ownership of our capital stock as of December 31, 2019 for:
•
•
•
•
each person or group of affiliated persons known by us to be the beneficial owner of more than 5% of our common stock;
each of our named executive officers;
each of our directors and nominees for director; and
all of our current executive officers and directors as a group.
We have determined beneficial ownership in accordance with the rules and regulations of the SEC, and the information is not necessarily indicative of
beneficial ownership for any other purpose. Except as indicated by the footnotes below, we believe, based on information furnished to us, that the persons and
entities named in the table below have sole voting and sole investment power with respect to all shares of our capital stock that they beneficially own, subject to
applicable community property laws.
Applicable percentage ownership is based on 10,364,663 shares of our common stock outstanding as of December 31, 2019. In computing the number
of shares of capital stock beneficially owned by a person and the percentage ownership of such person, we deemed to be outstanding all shares of our capital
stock subject to options held by the person that are currently exercisable or exercisable within 60 days of December 31, 2019. However, we did not deem such
shares of our capital stock outstanding for the purpose of computing the percentage ownership of any other person.
Unless otherwise indicated, the address of each beneficial owner listed in the table below is c/o Avinger, Inc., 400 Chesapeake Drive, Redwood City,
California 94063. The information provided in the table is based on our records, information filed with the SEC and information provided to us, except where
otherwise noted.
Name of Beneficial Owner
Named Executive Officers and Directors:
Jeffrey M. Soinski(1)
Himanshu Patel(2)
Mark Weinswig(3)
James G. Cullen(4)
Donald A. Lucas(5)
James B. McElwee(6)
Tamara N. Elias
All executive officers, directors and director nominees as a group (7 individuals)(7)
Shares Beneficially Owned
Number of
Shares
Percentage
33,155
70,586
22,670
8,248
4,974
4,925
-
144,558
*
*
*
*
*
*
*
*
* Represents ownership of less than 1%
(1) Consists of (i) 31,361 shares of common stock held of record by Mr. Soinski and (ii) 1,794 shares of common stock issuable upon exercise of options
exercisable within 60 days of December 31, 2019.
(2) Consists of (i) 22,610 shares of common stock held of record by Mr. Patel, (ii) warrants to purchase 5,000 shares of common stock, (iii) 603 shares of
common stock issuable upon exercise of options exercisable within 60 days of December 31, 2019 and (iv) 42,373 shares of common stock that are issuable
upon the conversion of shares of Series B preferred stock that are immediately convertible to common stock.
(3) Consists of 22,670 shares of common stock held of record by Mr. Weinswig.
(4) Consists of (i) 4,635 shares of common stock held of record by 2000 James Cullen Generation Skipping Family Trust, (ii) 184 shares of common stock held
by Gilbert Investments, LLC and (iii) 3,429 shares of common stock issuable upon exercise of options exercisable within 60 days of December 31, 2019. Mr.
Cullen has sole voting and dispositive power with respect to shares held by Gilbert Investments, LLC and James Cullen Generation Skipping Family Trust.
Mr. Cullen does not have a pecuniary interest in the James Cullen Generation Skipping Family Trust and disclaims beneficial ownership in Gilbert
Investments, LLC except to the extent of his pecuniary interest therein.
(5) Consists of (i) 58 shares of common stock held of record by Lucas Venture Group III, LP and (ii) 4,602 shares of common stock held of record by Mr. Lucas,
and (iii) 314 shares of common stock issuable upon exercise of options exercisable within 60 days of December 31, 2019.
(6) Consists of (i) 4,639 shares of common stock held of record by Mr. McElwee, and (iii) 286 shares of common stock issuable upon exercise of options
exercisable within 60 days of December 31, 2019.
(7) Consists of (i) 90,759 shares of common stock, (ii) warrants to purchase 5,000 shares of common stock (iii) 6,426 shares of common stock issuable upon
exercise of options exercisable within 60 days of December 31, 2019 and (iv) 42,373 shares of common stock that are issuable upon the conversion of
shares of Series B preferred stock that are immediately convertible to common stock.
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EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
Related Person Transactions
We describe below transactions and series of similar transactions, since the beginning of our last fiscal year, to which we were a party or will be a party,
in which:
•
•
the amounts involved exceeded or will exceed $120,000; and
any of our directors, nominees for director, executive officers or beneficial holders of more than 5% of our outstanding common stock, or any
immediate family member of, or person sharing the household with, any of these individuals or entities (each, a related person), had or will have a
direct or indirect material interest.
Master Services Agreement
We entered into a Master Services Agreement effective September 1, 2015, which we refer to as the MSA, with Consensys Imaging Service, Inc., or
Consensys. Jeffrey M. Soinski, our President, Chief Executive Officer and member of our Board of Directors was also a member of the Board of Directors of
Consensys at the time we entered into the MSA. Under the MSA, we may enter into any number of Statements of Work, each of which is governed by the
general terms of the MSA. We entered into a Statement of Work effective as of January 15, 2016, pursuant to which Consensys provides field engineers to
assist with the installation, service and maintenance of our Lightbox consoles for a fixed fee depending on the type of service. The Statement of Work has no
expiration date and remains in effect. The total amounts we paid to Consensys in 2018 and 2019 were $84,000 and $81,000, respectively.
Other Transactions
We have entered into employment and separation arrangements with certain current and former executive officers. For more information on these
employment and separation agreements, see the section titled “Executive Employment Letters” in Item 11 above.
We have entered into indemnification agreements with our directors and executive officers. The indemnification agreements, as well as our certificate of
incorporation and bylaws, require us to indemnify our directors and executive officers to the fullest extent permitted by Delaware law.
Policies and Procedures for Related Party Transactions
Our board of directors has adopted a written policy that our executive officers, directors, nominees for election as a director, beneficial owners of more
than 5% of any class of our common stock and any members of the immediate family of any of the foregoing persons are not permitted to enter into a related
person transaction with us without the prior consent of our audit committee. Any request for us to enter into a transaction with an executive officer, director,
nominee for election as a director, beneficial owner of more than 5% of any class of our common stock or any member of the immediate family of any of the
foregoing persons in which the amount involved exceeds $120,000 and such person would have a direct or indirect interest must first be presented to our audit
committee for review, consideration and approval. In approving or rejecting any such proposal, our audit committee is to consider the material facts of the
transaction, including, but not limited to, whether the transaction is on terms no less favorable than terms generally available to an unaffiliated third-party under
the same or similar circumstances and the extent of the related person’s interest in the transaction.
Director Independence
Information regarding the independence of directors is disclosed above under Item 10 under the heading “Director Independence” and incorporated herein by
reference.
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EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
Fees Paid to the Independent Registered Public Accounting Firm
The following table represents aggregate fees billed to us for the years ended December 31, 2019 and 2018 by
Moss Adams or E&Y, as applicable. All fees below were approved by our Audit Committee.
Year ending December 31,
Audit fees(1)(2)(3)
Audit related fees
Tax fees
Total
2019
2018
$
$
469,832 $
13,650
—
483,482 $
808,511
13,650
37,785
859,946
(1) Audit fees consist of fees incurred for professional services rendered for the audit of our annual financial statements and review of the quarterly financial
statements, assistance with registration statements filed with the SEC, and services that are normally provided by our independent registered public
accounting firm in connection with regulatory filings or engagements. For the years ended December 31, 2019 and 2018, audit fees also include fees
related to our public offerings and review of documents filed with the SEC of $95,045 and $99,400, respectively.
(2) For the fiscal year ended December 31, 2019, all Audit fees were paid to Moss Adams.
(3) For the fiscal year ended December 31, 2018, Audit fees of $255,000 and $553,511 were paid to E&Y and Moss Adams, respectively.
Auditor Independence
In our fiscal year ended December 31, 2019, there were no other professional services provided by Moss Adams that would have required our audit
committee to consider their compatibility with maintaining the independence of Moss Adams.
Audit Committee Policy on Pre-Approval of Audit and Permissible Non-Audit Services of Independent Registered Public Accounting Firm
Our audit committee has established a policy governing our use of the services of our independent registered public accounting firm. Under this policy,
our audit committee is required to pre-approve all audit and non-audit services performed by our independent registered public accounting firm in order to ensure
that the provision of such services does not impair the public accountants’ independence. All fees paid to E&Y and Moss Adams for our fiscal years ended
December 31, 2019 and 2018 were pre-approved by our audit committee.
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EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(a)(1) Financial Statements
The following Financial Statements are filed as part of this Annual Report on Form 10-K:
PART IV
Report of Independent Registered Public Accounting Firm
Financial Statements
Balance Sheets
Statements of Operations and Comprehensive Loss
Statements of Stockholders’ Equity (Deficit)
Statements of Cash Flows
Notes to Financial Statements
(a)(2) Financial Statement Schedules
F-2
F-3
F-4
F-5
F-6
F-7
All other schedules have been omitted because the information required to be set forth therein is not applicable or is shown in the financial statements
or notes thereto. Financial statement schedules relating to the allowance for doubtful accounts receivable and for sales returns follows (in thousands):
Description
Allowance for doubtful accounts receivable:
Fiscal year ended 2018
Fiscal year ended 2019
Allowance for sales returns:
Fiscal year ended 2018
Fiscal year ended 2019
(a)(3) Exhibits
Balance at
Beginning
of Year
Charged to
costs and
expenses
Write offs
Balance at
End of
Year
$
$
146 $
260 $
120 $
(56) $
6 $
185 $
260
19
Balance at
Beginning
of Year
Charged to
costs and
expenses
Write offs
Balance at
End of
Year
$
$
55 $
10 $
45 $
17 $
90 $
21 $
10
6
The following exhibits are filed as part of, or incorporated by reference into, this Annual Report on Form 10-K.
Exhibit
Number
3.1 (1)
3.2 (1)
3.3 (2)
3.4 (3)
3.5 (4)
3.6 (5)
3.7 (5)
3.8 (6)
4.1 (7)
4.2 (5)
4.3 (8)
4.4 (9)
4.5
10.1 (10)
10.2 (11)
10.3 (11)
10.4 (12)
10.5 (10)
10.6 (10)
10.7 (10)
10.8 (10)
10.9 (11)
Exhibit Title
Amended and Restated Certificate of Incorporation of the registrant.
Bylaws of the registrant.
Certificate of Amendment to the Amended and Restated Certificate of Incorporation.
Avinger, Inc. Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock
Avinger, Inc. Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock
Avinger, Inc. Certificate of Designation of Preferences, Rights and Limitations of Series C Convertible Preferred Stock
Certificate of Amendment to the Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock
Certificate of Amendment to the Restated Certificate of Incorporation of Avinger, Inc.
Specimen Common Stock certificate of the registrant.
Specimen Series 1/2 warrant of the registrant.
Specimen Common Stock certificate of the registrant.
Specimen Series 1/2 warrant of the registrant.
Description of Registrant’s Securities
Form of Indemnification Agreement for directors and executive officers.
2009 Stock Plan and Form of Option Agreement thereunder.
2014 Preferred Stock Plan.
2015 Equity Incentive Plan, as amended
Form of Restricted Stock Unit Award Agreement.
Form of Stock Option Agreement.
2015 Employee Stock Purchase Plan.
Executive Incentive Compensation Plan.
Amended and Restated Investors’ Rights Agreement dated September 2, 2014 by and among the registrant and certain stockholders.
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EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
Exhibit
Number
10.10 (11)
10.11 (11)
10.12 (14)
10.13 (11)
10.14 (11)
10.15 (11)
10.16 (15)
10.17 (4)
10.18 (11)
10.19 (11)
10.20 (13)
10.21 (13)
10.23 (14)
10.24 (16)
10.26 (17)
10.27 (18)
10.28 (4)
10.29 (4)
10.30 (19)
10.31 (20)
10.32 (20)
10.33 (20)
10.34 (20)
10.35 (21)
10.36 (22)
10.37 (23)
10.38 (24)
10.39 (25)
10.40
10.41
10.42
10.43
10.44
23.1
24.1
31.1
31.2
32.1
101.INS
101.SCH
101.CAL
101.DEF
101.LAB
101.PRE
Exhibit Title
Lease Agreement, dated July 30, 2010, by and between the registrant and HCP LS Redwood City, LLC for office space located at 400 and 600
Chesapeake Drive, Redwood City, California.
First Amendment to Lease Agreement dated September 30, 2011 by and between registrant and HCP LS Redwood City, LLC.
Second Amendment to Lease Agreement dated March 4, 2016 by and between the registrant and HCP LS Redwood City, LLC.
Employment Letter dated December 29, 2010 by and between the registrant and Matthew B. Ferguson.
Employment Letter dated December 17, 2014 by and between the registrant and Jeffrey M. Soinski.
Change of Control and Severance Agreement dated March 1, 2012 by and between the registrant and Matthew B. Ferguson.
Change of Control and Severance Agreement dated March 29, 2018 by and between the registrant and Jeffrey M. Soinski.
Registration Rights Agreement, dated as of February , 2018, by and among the registrant, CRG Partners III L.P. and certain of its affiliated
funds, as purchasers.
Note and Warrant Purchase Agreement dated October 29, 2013 by and between the registrant and holders of convertible promissory notes.
Amendment No. 1 to the Note and Warrant Purchase Agreement dated May 6, 2014 by and between the registrant and holders of convertible
promissory notes.
Term Loan Agreement, dated as of September 22, 2015, by and among the registrant, certain of its subsidiaries from time to time party thereto
as guarantors and CRG Partners III L.P. and certain of its affiliated funds, as lenders.
Securities Purchase Agreement, dated as of September 22, 2015, by and among the registrant, CRG Partners III L.P. and certain of its
affiliated funds, as purchasers.
Purchase Agreement, dated as of November 3, 2017, by and between the registrant and Lincoln Park Capital Fund, LLC.
Registration Rights Agreement, dated as of November 3, 2017, by and between the registrant and Lincoln Park Capital Fund, LLC.
Waiver and Consent, dated as of December 14, 2017, by and among the registrant and the lenders party thereto.
Waiver and Consent, dated as of January 24, 2018, by and among the registrant and the lenders party thereto.
Amendment No. 2 to Term Loan Agreement, dated as of February 14, 2018, by and among the registrant and the lenders party thereto.
Series A Preferred Stock Purchase Agreement, dated as of February 14, 2018, by and among the registrant, CRG Partners III L.P. and certain
of its affiliated funds, as purchasers.
Securities Purchase Agreement, dated as of July 12, 2018, by and among the registrant and the purchasers identified on the signature pages
thereto.
Separation Agreement and Release, dated as of August 1, 2018, between the registrant and Matt Ferguson.
Master Consulting Agreement, dated as of August 1, 2018, between the registrant and Matt Ferguson.
Employment Offer Letter, dated as of June 11, 2018, between the registrant and Mark Weinswig.
Change of Control and Severance Agreement, dated as of June 25, 2018, between the registrant and Mark Weinswig.
Officer and Director Share Purchase Plan.
Change of Control and Severance Agreement, dated as of October 10, 2013, between the registrant and Himanshu Patel.
Third Amendment to Lease Agreement dated April 1, 2019 by and between the registrant and HCP LS Redwood City, LLC.
Amended and Restated 2015 Equity Incentive Plan
Amended and Restated Officer and Director Share Purchase Plan
Amendment No. 1 to Amended and Restated Officer and Director Share Purchase Plan
Amendment No. 3 to Term Loan Agreement dated as of March 2, 2020, by and among the registrant and the lenders party thereto
Amendment No. 1 dated March 4, 2020 to the Change of Control and Severance Agreement, dated March 29, 2018, by and between the
registrant and Jeff Soinski
Amendment No. 1 dated March 4, 2020 to the Change of Control and Severance Agreement, dated October 10, 2013, by and between the
registrant and Himanshu Patel
Amendment No. 1 dated March 4, 2020 to the Change of Control and Severance Agreement, dated June 25, 2018, by and between the
registrant and Mark Weinswig
Consent of Independent Registered Public Accounting Firm.
Power of Attorney (included on signature page).
Certification of the Chief Executive Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a), as adopted pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002.
Certification of the Chief Financial Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a), as adopted pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002.
Certifications of the Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002.
XBRL Instance Document
XBRL Taxonomy Extension Schema Document
XBRL Taxonomy Extension Calculation Linkbase Document
XBRL Taxonomy Extension Definition Linkbase Document
XBRL Taxonomy Extension Label Linkbase Document
XBRL Taxonomy Extension Presentation Linkbase Document
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EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
(1) Previously filed as an Exhibit to the Current Report on Form 8-K filed with the Securities and Exchange Commission on February 6, 2015, and
incorporated by reference herein.
(2) Previously filed as an Exhibit to the registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on February 2,
2018.
(3) Previously filed as an Exhibit to Amendment No. 2 to the registrant’s Registration Statement on Form S-1 (File No. 333-222517) filed with the
Securities and Exchange Commission on February 12, 2018, and incorporated by reference herein.
(4) Previously filed as an Exhibit to Amendment No. 3 to the registrant’s Registration Statement on Form S-1 (File No. 333-222517) filed with the
Securities and Exchange Commission on February 13, 2018, and incorporated by reference herein.
(5) Previously filed as an Exhibit to the registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on November 6,
2018, and incorporated by reference herein.
(6) Previously filed as an Exhibit to the registrant's Current Report on Form 8-K filed with the Securities and Exchange Commission on June 21,
2019, and incorporated by reference herein.
(7) Previously filed as an Exhibit to Amendment No. 2 to the registrant’s Registration Statement on Form S-1 (File No. 333-201322) filed with the
Securities and Exchange Commission on January 28, 2015, and incorporated by reference herein.
(8) Previously filed as an Exhibit to the registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on July 13, 2018,
and incorporated by reference herein.
(9) Previously filed as an Exhibit to Amendment No. 1 to the registrant’s Registration Statement on Form S-1 (File No. 333-227689) filed with the
Securities and Exchange Commission on October 19, 2018, and incorporated by reference herein.
(10) Previously filed as an Exhibit to Amendment No. 1 to the registrant’s Registration Statement on Form S-1 (File No. 333-201322) filed with the
Securities and Exchange Commission on January 20, 2015, and incorporated by reference herein.
(11) Previously filed as an Exhibit to the registrant’s Registration Statement on Form S-1 (File No. 333-201322), filed with the Securities and Exchange
Commission on December 30, 2014, and incorporated by reference herein.
(12) Previously filed as an Exhibit to the registrant’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 13,
2018, and incorporated by reference herein.
(13) Previously filed as an Exhibit to the registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on November 12,
2015, and incorporated by reference herein.
(14) Previously filed as an Exhibit to the registrant’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 8,
2016, and incorporated by reference herein.
(15) Previously filed as an Exhibit to the registrant’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 30,
2018, and incorporated by reference herein.
(16) Previously filed as an Exhibit to the registrant’s Registration Statement on Form S-1 (File No. 333-221368), filed with the Securities and Exchange
Commission on November 6, 2017, and incorporated by reference herein.
(17) Previously filed as an Exhibit to the registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on December 14,
2017, and incorporated by reference herein.
(18) Previously filed as an Exhibit to the registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on January 30,
2018, and incorporated by reference herein.
(19) Previously filed as an Exhibit to the registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on July 13, 2018,
and incorporated by reference herein.
(20) Previously filed as an Exhibit to the registrant’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 13,
2018, and incorporated by reference herein.
(21) Previously filed as an Exhibit to the registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on August 24,
2018, and incorporated by reference herein.
(22) Previously filed as an Exhibit to the registrant’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 6,
2019, and incorporated by reference herein.
(23) Previously filed as an Exhibit to the registrant's Current Report on Form 8-K filed with the Securities and Exchange Commission on April 5, 2019,
and incorporated by reference herein.
(24) Previously filed as an Exhibit to the registrant's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 8,
2019, and incorporated by reference herein.
(25) Previously filed as an Exhibit to the registrant's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November
5, 2019, and incorporated by reference herein.
ITEM 16. FORM 10-K SUMMARY
None.
76
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
AVINGER, INC.
INDEX TO FINANCIAL STATEMENTS
As of December 31, 2019 and 201 8, and the
Years Ended December 31, 201 9 and 201 8
Report of Independent Registered Public Accounting Firm
Financial Statements:
Balance Sheets
Statements of Operations and Comprehensive Loss
Statements of Stockholders’ Equity (Deficit)
Statements of Cash Flows
Notes to Financial Statements
F-1
F-2
F-3
F-4
F-5
F-6
F-7
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Stockholders and the Board of Directors of
Avinger, Inc.
Opinion on the Financial Statements
We have audited the accompanying balance sheets of Avinger, Inc. (the “Company”) as of December 31, 2019 and 2018, the related statements of operations
and comprehensive loss, convertible preferred stock and stockholders’ equity, and cash flows for the years then ended, the related notes and the financial
statement schedules (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the
financial position of the Company as of December 31, 2019 and 2018, and the results of its operations and its cash flows for the years then ended, in conformity
with accounting principles generally accepted in the United States of America.
Going Concern Uncertainty
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the
financial statements, the Company’s recurring losses from operations and its need for additional capital raise substantial doubt about its ability to continue as a
going concern. Management’s plans in regard to these matters are also described in Note 1. The financial statements do not include any adjustments to reflect
the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the outcome of this
uncertainty.
Change in Accounting Principle
As disclosed in Note 2 to the financial statements, in 2019 the Company changed its method of accounting for leases due to the adoption of Accounting
Standards Codification (“ASC”) Topic No. 842, and in 2018 the Company changed its method of accounting for revenue recognition due to the adoption of ASC
Topic No. 606.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial
statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and
are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the
Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable
assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor
were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal
control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting.
Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing
procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial
statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall
presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ Moss Adams LLP
San Francisco, California
March 5, 2020
We have served as the Company’s auditor since 2017.
F-2
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
AVINGER, INC.
BALANCE SHEETS
(In thousands, except share and per share data)
Assets
Current assets:
Cash and cash equivalents
Accounts receivable, net of allowance for doubtful accounts of $19 and $260 at December 31, 2019 and
$
2018, respectively
Inventories
Prepaid expenses and other current assets
Total current assets
Right of use asset
Property and equipment, net
Other assets
Total assets
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable
Accrued compensation
Series A preferred stock dividends payable
Accrued expenses and other current liabilities
Leasehold liability, current portion
Borrowings
Total current liabilities
Leasehold liability, long-term portion
Other long-term liabilities
Total liabilities
Commitments and contingencies (Note 8)
Stockholders’ equity:
$
$
December 31,
2019
December 31,
2018
10,943 $
1,458
3,912
311
16,624
4,856
1,661
684
23,825 $
663 $
1,782
—
654
722
8,967
12,788
4,135
7
16,930
16,410
1,154
3,422
635
21,621
—
2,078
—
23,699
1,148
1,197
2,918
1,449
—
7,486
14,198
—
41
14,239
Convertible preferred stock issuable in series, par value of $0.001
Shares authorized: 5,000,000 at December 31, 2019 and 2018
Shares issued and outstanding: 48,503 and 45,671 at December 31, 2019 and 2018, respectively; aggregate
liquidation preference related to Series A convertible preferred stock of $48,325 and $44,718 at December
31, 2019 and 2018, respectively
Common stock, par value of $0.001
Shares authorized: 100,000,000 at December 31, 2019 and 2018
Shares issued and outstanding: 10,364,663 and 3,492,200 at December 31, 2019 and 2018, respectively
Additional paid-in capital
Accumulated deficit
Total stockholders’ equity
Total liabilities and stockholders’ equity
$
—
—
10
355,220
(348,335)
6,895
23,825 $
3
338,342
(328,885)
9,460
23,699
All share and per share data reflect the impact of the reverse stock split. See accompanying notes.
F-3
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
AVINGER, INC.
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except per share data)
Revenues
Cost of revenues
Gross profit
Operating expenses:
Research and development
Selling, general and administrative
Total operating expenses
Loss from operations
Interest income
Interest expense
Other income, net
Net loss and comprehensive loss
Accretion of preferred stock dividends
Deemed dividend arising from beneficial conversion feature of convertible preferred stock
Net loss applicable to common stockholders
Net loss per share attributable to common stockholders, basic and diluted
Weighted average common shares used to compute net loss per share, basic and diluted
$
$
$
Year Ended December 31,
2018
2019
9,131 $
6,264
2,867
5,692
16,534
22,226
(19,359)
288
(1,480)
1,101
(19,450)
(3,580)
—
(23,030) $
(3.18) $
7,239
7,915
6,531
1,384
6,009
18,404
24,413
(23,029)
214
(5,692)
949
(27,558)
(2,918)
(5,216)
(35,692)
(33.42)
1,068
All share and per share data reflect the impact of the reverse stock split. See accompanying notes.
F-4
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
AVINGER, INC.
STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)
(In thousands, except share data)
Convertible Preferred
Stock
Common Stock
Shares
Amount
Shares
Amount
Additional
Paid-
In Capital
Accumulated
Deficit
Total
Stockholders’
Equity
(Deficit)
Balance at December 31, 2017
— $
—
83,359 $
1 $
265,636 $
(301,327) $
(35,690)
Issuance of common stock under officers’
and directors’ purchase plan
Employee stock-based compensation
Exercises of warrants for common stock
Common stock issued to a vendor
Issuance of common stock in July public
offering, net of commissions and
issuance costs
Issuance of Series B preferred stock, net
of commissions and issuance costs
Conversion of Series B preferred stock
—
—
—
—
—
—
—
—
4,401
—
29,050
8,000
—
—
—
—
21
3,080
581
106
—
—
—
—
—
—
216,618
—
3,026
21
3,080
581
106
3,026
17,979
—
—
—
15,525
—
15,525
into common stock
(16,278)
—
813,914
—
—
—
—
Issuance of common stock and Series C
preferred stock in November public
offering, net of commissions and
issuance costs
Conversion of Series C preferred stock
into common stock
Conversion of CRG into Series A
preferred stock
Issuance of common stock to Lincoln Park
Accretion of Series A preferred stock
dividends
Net and comprehensive loss
Balance at December 31, 2018
Issuance of common stock upon vesting
of restricted stock units
Issuance of common stock under officers
and directors purchase plan
Employee stock-based compensation
Exercise of warrants for common stock
Issuance of common stock in August
public offerings, net of commissions
and issuance costs
Issuance of Series A preferred stock to
8,586
—
728,500
—
10,179
—
10,179
(6,416)
— 1,604,000
2
(2)
41,800
—
—
—
45,671
—
—
—
—
—
—
—
4,358
—
—
—
—
— 3,492,200
—
101,488
36,087
—
—
—
— 1,998,079
—
—
—
—
3
—
—
—
2
42,794
314
—
—
—
(2,918)
—
338,342
—
(27,558)
(328,885)
—
72
2,091
7,991
—
—
—
—
—
42,794
314
(2,918)
(27,558)
9,460
—
72
2,091
7,993
—
— 3,813,559
4
3,807
—
3,811
pay dividends
6,525
—
—
—
6,498
—
6,498
Conversion of Series B preferred stock
into common stock
(1,523)
—
380,750
—
—
Conversion of Series C preferred stock
into common stock
(2,170)
—
542,500
1
(1)
—
—
—
—
Accretion of Series A preferred stock
dividends
Net and comprehensive loss
Balance at December 31, 2019
—
—
48,503 $
—
—
—
—
— 10,364,663 $
—
—
10 $
(3,580)
—
355,220 $
—
(19,450)
(348,335) $
(3,580)
(19,450)
6,895
All share and per share data reflect the impact of the reverse stock split. See accompanying notes.
F-5
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
AVINGER, INC.
STATEMENTS OF CASH FLOWS
(In thousands)
Cash flows from operating activities
Net loss
Adjustments to reconcile net loss to net cash used in operating activities:
Year Ended December 31,
2018
2019
$
(19,450) $
(27,558)
890
171
2,091
1,575
—
272
(51)
(248)
(1,169)
128
658
(485)
585
(1,402)
(795)
(34)
(17,264)
(88)
18
(70)
—
—
63
7,993
—
3,811
11,867
(5,467)
16,410
10,943 $
1,281
117
3,080
5,634
106
914
126
(160)
(92)
5
340
(125)
334
—
(2,208)
(260)
(18,466)
(32)
28
(4)
15,525
10,179
21
3,026
581
(155)
314
29,491
11,021
5,389
16,410
— $
60
— $
6,498 $
54 $
3,580 $
462 $
4,680 $
408 $
42,794
—
2,849
2,918
—
—
51
Depreciation and amortization
Amortization of debt issuance costs and debt discount
Stock-based compensation
Noncash interest expense and other charges
Common stock issued for services
Provision for excess and obsolete inventories
Other non-cash charges
Changes in operating assets and liabilities:
Accounts receivable
Inventories
Prepaid expenses and other current assets
Other assets
Accounts payable
Accrued compensation
Leasehold liability
Accrued expenses and other current liabilities
Other long-term liabilities
Net cash used in operating activities
Cash flows from investing activities
Purchase of property and equipment
Proceeds from sale of property and equipment
Net cash used in investing activities
Cash flows from financing activities
Proceeds from the issuance of convertible preferred stock, net of issuance costs
Proceeds from issuance of common stock and convertible preferred stock, net of issuance costs
Proceeds from issuance of common stock under officers’ and directors’ purchase plan
Proceeds from public offerings, net of issuance costs
Proceeds from exercise of common stock warrants
Debt discount in connection with loan amendment
Proceeds from the issuance of common stock
Net cash provided by financing activities
Net change in cash and cash equivalents
Cash and cash equivalents, beginning of period
Cash and cash equivalents, end of period
Supplemental disclosure of cash flow information
Cash paid for interest
Noncash investing and financing activities:
Conversion of CRG loan principal and accrued interest into Series A Convertible preferred stock
Issuance of Series A preferred stock as dividend payment
Disposal of fully depreciated property and equipment
Accretion of Series A Convertible preferred stock dividends
Reclassification of right of use asset to prepaid rent
Increase to right of use asset and leasehold liability arising from lease amendment
Transfer between inventory and property and equipment
See accompanying notes.
F-6
$
$
$
$
$
$
$
$
$
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
AVINGER, INC.
Notes to Financial Statements
1. Organization
Organization, Nature of Business
Avinger, Inc. (the “Company”), a Delaware corporation, was incorporated in March 2007. The Company designs, manufactures and sells image-guided,
catheter-based systems that are used by physicians to treat patients with peripheral artery disease (“PAD”). Patients with PAD have a build-up of plaque in the
arteries that supply blood to areas away from the heart, particularly the pelvis and legs. The Company manufactures and sells a suite of products in the United
States (“U.S.”) and in select international markets. The Company has developed its Lumivascular platform, which integrates optical coherence tomography
(“OCT”) visualization with interventional catheters and is the industry’s only system that provides real-time intravascular imaging during the treatment portion of
PAD procedures. The Company’s Lumivascular platform consists of a capital component, Lightbox, as well as a variety of disposable catheter products. The
Company’s current products include its non-imaging catheters, Wildcat and Kittycat, as well as its Lumivascular platform products, Ocelot, Ocelot PIXL and
Ocelot MVRX, all of which are designed to allow physicians to penetrate a total blockage in an artery, known as a chronic total occlusion (“CTO”). In March 2016,
the Company received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for commercialization of Pantheris, the Company’s image-guided
atherectomy system, designed to allow physicians to precisely remove arterial plaque in PAD patients. In May 2018, the Company also received 510(k)
clearance from the FDA for its next-generation of Pantheris. In April 2019, the Company further received FDA clearance for Pantheris SV, a lower profile
Pantheris, and commenced sales in August 2019. The Company has sales in the U.S. and select international markets. The Company is located in Redwood
City, California.
Liquidity Matters
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the
realization of assets and the satisfaction of liabilities in the normal course of business. The Financial Accounting Standards Board (“FASB”) Accounting
Standards Update (“ASU”) No. 2014-15, Presentation of Financial Statements - Going Concern (Subtopic 205-40) requires the Company to make certain
disclosures if it concludes that there is substantial doubt about the entity’s ability to continue as a going concern within one year from the date of the issuance of
these financial statements.
In the course of its activities, the Company has incurred losses and negative cash flows from operations since its inception. As of December 31, 2019,
the Company had an accumulated deficit of $348.3 million. The Company expects to incur losses for the foreseeable future. The Company believes that its cash
and cash equivalents of $10.9 million at December 31, 2019 and expected revenues and funds from operations will be sufficient to allow the Company to fund its
current operations through at least the third quarter of 2020. Even though we received net proceeds of $3.7 million from the sale of our common stock in our
January 2020 offering, net proceeds of $3.8 million from the sales of our common stock in our August 2019 offering, proceeds from issuance of common stock
upon the exercise of warrants during April and May of 2019 of $8.0 million, net proceeds of $10.2 million from the sale of our Series C preferred stock and
common stock in our November 2018 offering, net proceeds of $3.0 million from the sale of common stock and warrants in our July 2018 offering, and net
proceeds of $15.5 million from the sale of our Series B preferred stock and warrants in our February 2018 offering, the Company will need to raise additional
funds through future equity or debt financings within the next twelve months to meet its operational needs and capital requirements for product development,
clinical trials and commercialization and may subsequently require additional fundraising.
The Company can provide no assurance that it will be successful in raising funds pursuant to additional equity or debt financings or that such funds will
be raised at prices that do not create substantial dilution for our existing stockholders. Given the recent decline in the Company’s stock price, any financing that
we undertake in the next twelve months could cause substantial dilution to our existing stockholders, there can be no assurance that the Company will be
successful in acquiring additional funding at levels sufficient to fund its operations. These conditions raise substantial doubt about the Company’s ability to
continue as a going concern. If the Company is unable to raise additional capital in sufficient amounts or on terms acceptable to it, the Company may have to
significantly reduce its operations or delay, scale back or discontinue the development of one or more of its products. The financial statements do not include
any adjustments that might result from the outcome of this uncertainty. The Company’s ultimate success will largely depend on its continued development of
innovative medical technologies, its ability to successfully commercialize its products and its ability to raise significant additional funding.
F-7
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
Additionally, due to the substantial doubt about the Company’s ability to continue operating as a going concern and the material adverse change clause
in the Loan Agreement with CRG Partners III L.P. and certain of its affiliated funds (collectively “CRG”), the entire amount of borrowings at December 31, 2019
and 2018 has been classified as current in these financial statements. CRG has not invoked the material adverse change clause.
Public Offerings
On February 16, 2018, we completed a public offering of 17,979 shares of Series B preferred stock and warrants to purchase 1,797,900 shares of
common stock. As a result, we received net proceeds of approximately $15.5 million after underwriting discounts, commissions, legal and accounting fees. The
Series B preferred stock has a liquidation preference of $0.001 per share, full ratchet price based anti-dilution protection, has no voting rights and is subject to
certain ownership limitations. The Series B preferred stock is immediately convertible at the option of the holder, has no stated maturity, and does not pay
regularly stated dividends or interest. Each share of Series B preferred stock is accompanied by one Series 1 warrant that expires on the seventh anniversary of
the date of issuance to purchase up to 50 shares of common stock and one Series 2 warrant that expires on the earlier of (i) the seventh anniversary of the date
of issuance or (ii) the 60th calendar day following the receipt and announcement of FDA clearance of our Pantheris below-the-knee device (or the same or
similar product with a different name) to purchase up to 50 shares of common stock; provided, however, if at any time during such 60-day period the volume
weighted average price for any trading day is less than the then effective exercise price, the termination date shall be extended to the seven year anniversary of
the initial exercise date. FDA clearance of Pantheris SV was received in April 2019, triggering this 60-day period. During the entire 60-day period following
clearance, the volume weighted average price was less than the then effective exercise price. As such, all Series 2 warrants are currently deemed to expire on
the seventh anniversary of the date of issuance. In addition, pursuant to the Series A Purchase Agreement, we issued to CRG 41,800 shares of Series A
preferred stock at the closing of the Series B Offering. The Series A preferred stock was issued in exchange for the conversion of $38.0 million of the outstanding
principal amount of their senior secured term loan (plus the back-end fee and prepayment premium applicable thereto), totaling approximately $41.8 million. The
Series A preferred stock is initially convertible into 2,090,000 shares of common stock subject to certain limitations contained in the Series A Purchase
Agreement.
On July 12, 2018, we entered into a securities purchase agreement with certain investors pursuant to which we agreed to sell and issue, in a registered
direct offering, an aggregate of 216,618 shares of our common stock at an offering price of $16.425 per share. In a concurrent private placement, or the Private
Placement, we agreed to issue to these investors warrants exercisable for one share of our common stock for each two shares purchased in the registered direct
offering, which equals an aggregate of 108,309 shares of common stock. The closing of such registered direct offering and the concurrent Private Placement
occurred on July 16, 2018, in connection with which we received net proceeds of approximately $3.0 million after deducting placement agent fees and other
expenses payable by us. The warrants have an exercise price of $15.80 per share of our common stock and expire on July 16, 2021.
On November 1, 2018, we completed a public offering of 728,500 shares of common stock and 8,586 shares of Series C convertible preferred stock (the
“Series C preferred stock”). As a result, we received net proceeds of approximately $10.2 million after underwriting discounts, commissions, legal and
accounting fees. Upon any dissolution, liquidation or winding up, whether voluntary or involuntary, holders of Series C preferred stock will be entitled to receive
distributions out of our assets, whether capital or surplus, of an amount equal to $0.001 per share of Series C preferred stock before any distributions shall be
made on the common stock but after distributions shall be made on any outstanding Series A preferred stock and any of our existing or future indebtedness. The
Series C preferred stock has no voting rights.
On August 26, 2019, we completed a public offering of 3,813,559 shares of common stock at an offering price of $1.18 per share. As a result, we
received net proceeds of approximately $3.8 million after underwriting discounts, commissions, legal and accounting fees and the conversion price of the
outstanding shares of Series B preferred stock, issued in our February 2018 offering, was reduced to $1.18 per share as a result.
On January 31, 2020, we completed a public offering of 6,428,572 shares of common stock at an offering price of $0.70 per share. As a result, we
received net proceeds of approximately $3.7 million after underwriting discounts, commissions, legal and accounting fees, and other ancillary expenses. Due to
anti-dilution provisions, the conversion price of the outstanding shares of Series B preferred stock, which was issued in our February 2018 offering, was reduced
to $0.70 per share.
F-8
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying financial statements have been prepared in accordance with United States generally accepted accounting principles (“U.S. GAAP”)
and pursuant to the rules and regulations of the SEC (“SEC”).
On January 30, 2018, the Company’s Board of Directors approved an amendment to the Company’s amended and restated certificate of incorporation to
effect a 1-for-40 reverse stock split of the Company’s common stock. Further, on June 19, 2019, the Company’s Board of Directors approved an amendment to
the Company’s amended and restated certificate of incorporation to effect an additional 1-for-10 reverse stock split of the Company’s common stock. The reverse
stock split became effective on June 21, 2019. The par values of the common stock and convertible preferred stock were not adjusted as a result of the reverse
stock splits. All common stock, stock options, and restricted stock units, and per share amounts in the financial statements have been retroactively adjusted for
all periods presented to give effect to the reverse stock splits.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts
and disclosures reported in the financial statements. Management uses significant judgment when making estimates related to its common stock valuation and
related stock-based compensation, the valuation of the common stock warrants, the valuation of compound embedded derivatives, provisions for doubtful
accounts receivable and excess and obsolete inventories, clinical trial accruals, and its reserves for sales returns and warranty costs. Management bases its
estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the
basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Although these estimates are
based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may ultimately materially differ from these
estimates and assumptions.
Fair Value of Financial Instruments
The Company has evaluated the estimated fair value of its financial instruments as of December 31, 2019 and 2018. Financial instruments consist of
cash and cash equivalents, accounts receivable and payable, and other current liabilities and borrowings. The carrying amounts of cash and cash equivalents,
accounts receivable and payable, and other current liabilities approximate their respective fair values because of the short-term nature of those instruments.
Based upon the borrowing terms and conditions currently available to the Company, the carrying values of the borrowings approximate their fair value.
Cash and Cash Equivalents
The Company considers all highly liquid investments with an original maturity of three months or less at the time of purchase to be cash equivalents.
Cash equivalents are considered available-for-sale marketable securities and are recorded at fair value, based on quoted market prices. As of December 31,
2019 and 2018, the Company’s cash equivalents are entirely comprised of investments in money market funds. Any related unrealized gains and losses are
recorded in other comprehensive income (loss) and included as a separate component of stockholders’ equity. There were no unrealized gains and losses as of
December 31, 2019 and 2018. Any realized gains and losses and interest and dividends on available-for-sale securities are included in interest income or
expense and computed using the specific identification cost method.
Concentration of Credit Risk, and Other Risks and Uncertainties
Financial instruments that potentially subject the Company to credit risk consist of cash and cash equivalents and accounts receivable to the extent of
the amounts recorded on the balance sheets.
The Company’s policy is to invest in cash and cash equivalents, consisting of money market funds. These financial instruments are held in Company
accounts at one financial institution. The counterparties to the agreements relating to the Company’s investments consist of financial institutions of high credit
standing.
The Company provides for uncollectible amounts when specific credit problems arise. Management’s estimates for uncollectible amounts have been
adequate, and management believes that all significant credit risks have been identified at December 31, 2019 and 2018.
F-9
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
The Company’s accounts receivable are due from a variety of healthcare organizations in the United States and select international markets. At
December 31, 2019 and 2018, no customer represented 10% or more of the Company’s accounts receivable. For the years ended December 31, 2019 and
2018, there were no customers that represented 10% or more of revenues. Disruption of sales orders or a deterioration of financial condition of its customers
would have a negative impact on the Company’s financial position and results of operations.
The Company manufactures its commercial products in-house, including Pantheris and the Ocelot family of catheters. Certain of the Company’s product
components and sub-assemblies continue to be manufactured by sole suppliers. Disruption in component or sub-assembly supply from these manufacturers or
from in-house production would have a negative impact on the Company’s financial position and results of operations.
The Company is subject to certain risks, including that its devices may not be approved or cleared for marketing by governmental authorities or be
successfully marketed. There can be no assurance that the Company’s products will achieve widespread adoption in the marketplace, nor can there be any
assurance that existing devices or any future devices can be developed or manufactured at an acceptable cost and with appropriate performance
characteristics. The Company is also subject to risks common to companies in the medical device industry, including, but not limited to, new technological
innovations, dependence upon third-party payors to provide adequate coverage and reimbursement, dependence on key personnel and suppliers, protection of
proprietary technology, product liability claims, and compliance with government regulations.
Existing or future devices developed by the Company may require approvals or clearances from the FDA or international regulatory agencies. In
addition, in order to continue the Company’s operations, compliance with various federal and state laws is required. If the Company were denied or delayed in
receiving such approvals or clearances, it may be necessary to adjust operations to align with the Company’s currently approved portfolio. If clearance for the
products in the current portfolio were withdrawn by the FDA, this may have a material adverse impact on the Company.
Accounts Receivable
Trade accounts receivable are recorded at the invoiced amount and do not bear interest. The allowance for doubtful accounts is the Company’s best
estimate of the amount of probable credit losses in the Company’s existing accounts receivable. The Company determines the allowance for doubtful accounts
based upon an aging of accounts receivable, historical experience, and management judgment. Accounts receivable balances are reviewed individually for
collectability. To date, the Company has not experienced significant credit-related losses. Accounts receivable provision and recoveries or write-offs are
summarized as follows (in thousands):
Balance, beginning of year
Provision
Recoveries/write-offs
Balance, end of year
Inventories
2019
2018
$
$
260 $
(56)
(185)
19 $
146
120
(6)
260
Inventories are valued at the lower of cost or net realizable value. Cost is determined using the first-in, first-out method for all inventories. The
Company’s policy is to write down inventory that has expired or become obsolete, inventory that has a cost basis in excess of its expected net realizable value,
and inventory in excess of expected requirements. The estimate of excess quantities is subjective and primarily dependent on the estimates of future demand for
a particular product. If the estimate of future demand is too high, the Company may have to increase the reserve for excess inventory for that product and record
a charge to the cost of revenues. Inventory used in clinical trials is expensed at the time of production and recorded as research and development expense.
Property and Equipment
Property and equipment are recorded at cost. Repairs and maintenance costs are expensed as incurred. Depreciation and amortization are calculated
using the straight-line method over the estimated useful lives of the assets of generally three to five years. Depreciation expense includes the amortization of
assets acquired under capital leases and equipment located at customer sites. Equipment held by customers is comprised of the Lightboxes located at customer
sites under a lease or placement agreement and are recorded at cost. Upon execution of a lease or placement agreement, the related equipment is reclassified
from inventory to the property and equipment account. Depreciation expense for equipment held by customers is recorded as a component of cost of revenues.
Leasehold improvements and assets recorded under capital leases are amortized using the straight-line method over the shorter of the lease term or estimated
useful economic life of the asset.
F-10
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
Impairment of Long-Lived Assets
The Company reviews long-lived assets, including property and equipment, for impairment whenever events or changes in business circumstances
indicate that the carrying amount of the assets may not be fully recoverable. If indicators of impairment exist, an impairment loss would be recognized when
estimated undiscounted future cash flows expected to result from the use of the asset and its eventual disposition are less than its carrying amount. Impairment,
if any, is measured as the amount by which the carrying amount of the long-lived asset exceeds its fair value. The Company has not recorded any impairment of
long-lived assets since inception through December 31, 2019.
Revenue Recognition
The Company’s revenues are derived from (1) sale of Lightboxes, (2) sale of disposables, which consist of catheters and accessories, and (3) sale of
customer service contracts. The Company sells its products directly to hospitals and medical centers as well as through distributors. The Company accounts for
a contract with a customer when there is a legally enforceable contract between the Company and the customer, the rights of the parties are identified, the
contract has commercial substance, and collectability of the contract consideration is probable. The Company’s revenues are measured based on consideration
specified in the contract with each customer, net of any sales incentives and taxes collected from customers that are remitted to government authorities. For all
sales, the Company uses either a signed agreement or a binding purchase order as evidence of an arrangement. The Company’s revenue recognition policies
generally result in revenue recognition at the following points:
1.
2.
3.
Lightbox sales: The Company sells its products directly to hospitals and medical centers. Provided all other criteria for revenue recognition have
been met, the Company recognizes revenue for Lightbox sales directly to end customers when delivery and acceptance occurs, which is defined
as receipt by the Company of an executed form by the customer acknowledging that the training and installation process is complete.
Sales of disposables: Disposable revenues consist of sales of the Company’s catheters and accessories and are recognized when the product
has shipped, risk of loss and title has passed to the customer and collectability is reasonably assured.
Service revenue: Service contract revenue is recognized ratably over the term of the service period and maintenance contract revenue is
recognized as work is performed. To date, service revenue has been insignificant.
The Company offers its customers the ability to purchase or lease its Lightbox. In addition, the Company provides a Lightbox under a limited commercial
evaluation program to allow certain strategic accounts to install and utilize the Lightbox for a limited trial period of three to six months. When a Lightbox is placed
under a lease agreement or under a commercial evaluation program, the Company retains title to the equipment and it remains capitalized on its balance sheet
under property and equipment. Depreciation expense on these placed Lightboxes is recorded to cost of revenues on a straight-line basis. The costs to maintain
these placed Lightboxes are charged to cost of revenues as incurred.
The Company evaluates its lease and commercial evaluation program agreements and accounts for these contracts under the guidance in Accounting
Standards Codification (“ASC”) 842, Leases and ASU No. 2014 09, Revenue from Contracts with Customers (Topic 606) . The guidance requires arrangement
consideration to be allocated between a lease deliverable and a non-lease deliverable based upon the relative selling-price of the deliverables.
The Company assessed whether the embedded lease is an operating lease or sales-type lease. Based on the Company’s assessment of the guidance
and given that any payments under the lease agreements are dependent upon contingent future sales, it was determined that collectability of the minimum lease
payments is not reasonably predictable. Accordingly, the Company concluded the embedded lease did not meet the criteria of a sales-type lease and accounts
for it as an operating lease. The Company recognizes revenue allocated to the lease as the contingent disposable product purchases are delivered and are
included in revenues within the statement of operations and comprehensive loss.
F-11
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
For sales through distributors, the Company recognizes revenue when control of the product transfers from the Company to the distributor. The
distributors are responsible for all marketing, sales, training and warranty in their respective territories. The standard terms and conditions contained in the
Company’s distribution agreements do not provide price protection or stock rotation rights to any of its distributors. In addition, its distributor agreements do not
allow the distributor to return or exchange products, and the distributor is obligated to pay the Company upon invoice regardless of its ability to resell the
product.
The Company estimates reductions in revenue for potential returns of products by customers. In making such estimates, management analyzes
historical returns, current economic trends and changes in customer demand and acceptance of its products. The Company expenses shipping and handling
costs as incurred and includes them in the cost of revenues. When the Company bills shipping and handling costs to customers, such amounts billed are
included as a component of revenue.
Cost of Revenues
Cost of revenues consists primarily of manufacturing overhead costs, material costs and direct labor. A significant portion of the Company’s cost of
revenues currently consists of manufacturing overhead costs. These overhead costs include the cost of quality assurance, material procurement, inventory
control, facilities, equipment and operations supervision and management. Cost of revenues also includes depreciation expense for the Lightboxes under lease
agreements, product warranty costs, product written-off due to excess or obsolescence, and certain direct costs such as shipping costs.
Product Warranty Costs
The Company typically offers a one-year warranty for parts and labor on its products commencing upon the transfer of title and risk of loss to the
customer. The Company accrues for the estimated cost of product warranties upon invoicing its customers, based on historical results. Warranty costs are
reflected in the statement of operations and comprehensive loss as a cost of revenues. The warranty obligation is affected by product failure rates, material
usage and service delivery costs incurred in correcting a product failure. Should actual product failure rates, material usage or service delivery costs differ from
these estimates, revisions to the estimated warranty liability would be required. Periodically the Company assesses the adequacy of its recorded warranty
liabilities and adjusts the amounts as necessary. Warranty provisions and claims are summarized as follows (in thousands):
Balance, beginning of year
Warranty provision
Usage/Release
Balance, end of year
Research and Development
2019
2018
272 $
71
(128)
215 $
390
333
(451)
272
$
$
The Company expenses research and development costs as incurred. Research and development expenses include personnel and personnel-related
costs, costs associated with pre-clinical and clinical development activities, and costs for prototype products that are manufactured prior to market approval for
that prototype product; internal and external costs associated with the Company’s regulatory compliance and quality assurance functions, including the costs of
outside consultants and contractors that assist in the process of submitting and maintaining regulatory filings, and overhead costs, including allocated facility and
related expenses.
Clinical Trials
The Company accrues and expenses costs for its clinical trial activities performed by third parties, including clinical research organizations and other
service providers, based upon estimates of the work completed over the life of the individual study in accordance with associated agreements. The Company
determines these estimates through discussion with internal personnel and outside service providers as to progress or stage of completion of trials or services
pursuant to contracts with clinical research organizations and other service providers and the agreed-upon fee to be paid for such services.
Stock-Based Compensation
Stock-based compensation for the Company includes amortization related to all stock options, restricted stock units (“RSU”), based on the grant-date
estimated fair value. The fair value of stock options is estimated on the date of grant using the Black-Scholes option pricing model and recognized as expense
on a straight-line basis over the vesting period of the award. The Company measures the fair value of RSUs using the closing stock price of a share of the
Company’s common stock on the grant date and is recognized as expense on a straight-line basis over the vesting period of the award. As allowed under ASU
No. 2016‑09, Compensation-Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting, we account for forfeitures as they
occur.
F-12
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
Foreign Currency
The Company records net gains and losses resulting from foreign exchange transactions as a component of foreign currency exchange losses in other
income (expense), net. During the years ended December 31, 2019 and 2018, the Company recorded $11,000 and $(13,000) of foreign currency exchange net
(gains)/losses, respectively.
Income Taxes
The Company utilizes the liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on
differences between financial reporting and tax reporting bases of assets and liabilities and are measured using enacted tax rates and laws that are expected to
be in effect when the differences are expected to reverse. Valuation allowances are established when necessary to reduce deferred tax assets to the amounts
expected to be realized. The Company’s policy is to record interest and penalties on uncertain tax positions as income tax expense when they occur. During the
years ended December 31, 2019 and 2018, the Company did not recognize accrued interest or penalties related to unrecognized tax benefits.
Net Loss per Share Attributable to Common Stockholders
Basic net loss per share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted
average number of shares of common stock outstanding during the period, without consideration for potential dilutive common shares. Diluted net loss per share
attributable to common stockholders is computed by dividing the net loss attributable to common stockholder by the weighted average number of shares of
common stock and dilutive potential shares of common stock outstanding during the period. Any common stock shares subject to repurchase are excluded from
the calculations as the continued vesting of such shares is contingent upon the holders’ continued service to the Company. As of December 31, 2019 and 2018,
there were no shares subject to repurchase. Since the Company was in a loss position for all periods presented, basic net loss per share attributable to common
stockholders is the same as diluted net loss per share attributable to common stockholders as the inclusion of all potentially dilutive common shares would have
been anti-dilutive.
Net loss per share attributable to common stockholders was determined as follows (in thousands, except per share data):
Net loss attributable to common stockholders
Weighted average common stock outstanding
Net loss per share attributable to common stockholders, basic and diluted
Year Ended December 31,
2019
2018
$
$
(23,030) $
7,239
(3.18) $
(35,692)
1,068
(33.42)
The following potentially dilutive securities outstanding have been excluded from the computations of diluted weighted average shares outstanding
because such securities have an antidilutive impact due to losses reported:
Common stock options
Convertible preferred stock
Unvested restricted stock units
Common stock warrant equivalents
Comprehensive Loss
Year Ended December 31,
2018
2019
7,549
45,015
471,252
3,197,208
3,721,024
7,179
41,398
92,245
2,077,871
2,218,693
For the years ended December 31, 2019 and 2018, there was no difference between comprehensive loss and the Company’s net loss.
Segment and Geographical Information
The Company operates and manages its business as one reportable and operating segment. The Company’s chief executive officer, who is the chief
operating decision maker, reviews financial information on an aggregate basis for purposes of allocating resources and evaluating financial performance.
Primarily all of the Company’s long-lived assets, which are comprised of property and equipment, are based in the United States. For the years ended
December 31, 2019 and 2018, 93% and 94%, respectively, of the Company’s revenues were in the United States, based on the shipping location of the external
customer.
F-13
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
Recent Accounting Pronouncements
Adopted:
In May 2014, the FASB issued ASU No. 2014-09 , Revenue from Contracts with Customers (Topic 606) , which supersedes the revenue recognition
requirements in ASC 605, Revenue Recognition. This ASU is based on the principle that revenue is recognized to depict the transfer of goods or services to
customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The ASU also requires
additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant
judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. In August 2015, FASB issued ASU No. 2015-
14, Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date , which effectively delayed the adoption date by one year, to an effective
date for public entities for annual and interim periods beginning after December 15, 2017.
In March 2016, the FASB issued ASU No. 2016-08, Revenue from Contracts with Customers (Topic 606): Principal Versus Agent Considerations
(Reporting Revenue Gross Versus Net), to clarify certain aspects of the principal-versus-agent guidance in its new revenue recognition standard.
In April 2016, the FASB issued ASU No. 2016-10, Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and
Licensing to clarify how to identify the performance obligations and the licensing implementation guidance in its new revenue recognition standard.
In May 2016, the FASB issued ASU No. 2016-12, Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical
Expedients, to address certain issues identified by the Transition Resource Group, (the “TRG”) in the guidance on assessing collectability, presentation of sales
tax, noncash consideration, and completed contracts and contracts modifications at transition.
The Company adopted ASC 606 and related ASUs on January 1, 2018, using the modified retrospective approach. The adoption did not have a material
impact on the Company’s financial statements.
In May 2017, the FASB issued ASU No. 2017-09, Compensation - Stock Compensation (Topic 718): Scope of Modification Accounting, which provides
guidance on determining which changes to the terms and conditions of share-based payment awards require an entity to apply modification accounting under
Topic 718. The amendments in this ASU should be applied prospectively to an award modified on or after the adoption date. The Company adopted this
guidance on January 1, 2018 and such adoption did not have a material impact on the Company’s financial statements.
In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments .
This update clarifies how certain cash receipts and cash payments are presented and classified in the statement of cash flows. This ASU is effective for public
business entities for fiscal years beginning after December 15, 2017, and for interim periods therein with early adoption permitted and must be applied
retrospectively to all periods presented. The Company adopted this guidance on January 1, 2018 and such adoption did not have a material impact on the
Company’s financial statements.
In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842). Topic 842 amends a number of aspects of lease accounting, including
requiring lessees to recognize leases with a term greater than one year as a right-of-use asset and corresponding liability, measured at the present value of the
lease payments. In July, the FASB issued supplemental adoption guidance and clarification to Topic 842 within ASU No. 2018-10, Codification Improvements to
Topic 842, Leases and ASU No. 2018-11, Leases (Topic 842): Targeted Improvements. The Company adopted this guidance on January 1, 2019 using the
modified retrospective approach. This adoption resulted in the recognition of a right of use asset and a corresponding leasehold liability related to the Company’s
building lease on the balance sheet of approximately $1.8 million with no material impact on the statements of operations and comprehensive loss. To maintain
comparability between periods, the Company reclassified sublease payments received of approximately $962,000 that were netted against rent expense
included in selling, general and administrative expenses in the year ended December 31, 2018 to other income on the statement of operations and
comprehensive loss. In addition, the Company elected to take advantage of the available practical expedients.
F-14
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
In June 2018, the FASB issued ASU No. 2018-07, Compensation - Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based
Payment Accounting, which expands the scope of Topic 718 to include share based payment transactions for acquiring goods and services from nonemployees
and applies to all share-based payment transactions in which a grantor acquires goods or services to be used or consumed in a grantor’s own operations by
issuing share-based payment awards. Topic 718 does not apply to share-based payments used to effectively provide (1) financing to the issuer or (2) awards
granted in conjunction with selling goods or services to customers as part of a contract accounted for under Topic 606. This update is effective for public
business entities for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year. Early adoption is permitted, but no earlier
than an entity’s adoption date of Topic 606. The Company adopted this guidance on July 1, 2018 and such adoption did not have a material impact on the
Company’s financial statements.
3. Fair Value Measurements
The Company measures certain financial assets and liabilities at fair value on a recurring basis. Fair value is an exit price, representing the amount that
would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based
measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability. A three-tier fair value
hierarchy is established as a basis for considering such assumptions and for inputs used in the valuation methodologies in measuring fair value:
Level 1—Quoted prices in active markets for identical assets or liabilities.
Level 2—Inputs other than quoted prices included within Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets
or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially
the full term of the assets or liabilities.
Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
As of December 31, 2019 and 2018, cash equivalents were all categorized as Level 1 and consisted of money market funds. As of December 31, 2019
and 2018, there were no financial assets and liabilities categorized as Level 2. During the year ended December 31, 2018, the Company issued warrants to
purchase common stock categorized as Level 3, see Note 9 for further details. There were no transfers between fair value hierarchy levels during the years
ended December 31, 2019 and 2018.
4. Inventories
Inventories consisted of the following (in thousands):
Raw materials
Work-in-process
Finished products
Total inventories
5. Property and Equipment, Net
Property and equipment, net, consisted of the following (in thousands):
Computer software
Computer equipment
Machinery and equipment
Furniture and fixture
Leasehold improvements
Equipment held by customers
Less: Accumulated depreciation and amortization
Add: Construction-in-progress
F-15
December 31,
2019
2018
1,426 $
596
1,890
3,912 $
1,162
158
2,102
3,422
December 31,
2019
2018
122 $
144
1,878
78
311
3,076
5,609
(3,948)
—
1,661 $
124
197
1,784
78
326
2,718
5,227
(3,155)
6
2,078
$
$
$
$
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
Depreciation expense for the years ended December 31, 2019 and 2018, was approximately $890,000 and $934,000, respectively. Property and
equipment include certain equipment that is leased to customers and located at customer premises. The Company retains the ownership of the equipment held
for evaluation and has the right to remove the equipment if it is not being utilized according to expectations. Depreciation expense relating to the leased
equipment held by customers of $586,000 and $499,000 was recorded in cost of revenues during the years ended December 31, 2019 and 2018, respectively.
The net book value of this equipment was $1.2 million and $1.4 million at December 31, 2019 and 2018, respectively.
6. Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following (in thousands):
Accrued sales tax
Accrued professional fees
Accrued travel expenses
Accrued product warranty costs
Accrued clinical trial costs
Accrued restructuring charge
Other accrued liabilities
7. Borrowings
CRG
December 31,
2019
2018
18 $
30
89
214
101
—
202
654 $
435
41
74
272
111
98
418
1,449
$
$
On September 22, 2015, the Company entered into a Term Loan Agreement, as amended (the “Loan Agreement”) with CRG under which, subject to
certain conditions, the Company had the right to borrow up to $50 million in principal amount from CRG on or before March 29, 2017. The Company borrowed
$30 million on September 22, 2015. The Company borrowed an additional $10 million on June 15, 2016 under the Loan Agreement.
On February 14, 2018, the Company and CRG further amended the Loan Agreement concurrent with the conversion of $38 million of the principal
amount of the senior secured term loan (plus $3.8 million in back-end fees and prepayment premium applicable thereto) into a newly authorized Series A
convertible preferred stock (see below). On March 2, 2020, the Loan Agreement was again amended as set forth below.
Under the Loan Agreement, as amended, no cash payments for either principal or interest are due until the third quarter of 2021. The accrued interest
will be accrued and included in the debt balance based (to the extent not paid) on principal amounts outstanding at the beginning of the quarter at an interest
rate of 12.5%. Beginning in the third quarter of 2021, the Company will be required to make quarterly principal payments (in addition to the interest) of $1.4
million with total principal payments of $2.7 million in 2021, $5.5 million in 2022 and $2.7 million in 2023.
The Company may voluntarily prepay the borrowings in full, with a prepayment premium beginning at 5.0% and declining by 1.0% annually thereafter,
with no premium being payable if prepayment occurs after seven and half years of the loan. Each tranche of borrowing required the payment, on the borrowing
date, of a financing fee equal to 1.5% of the borrowed loan principal, which is recorded as a discount to the debt. In addition, a facility fee equal to 15.0% of the
amounts borrowed plus any payment-in-kind (“PIK”) is to be payable at the end of the term or when the borrowings are repaid in full. A long-term liability is being
accreted using the effective interest method for the facility fee over the term of the Loan Agreement with a corresponding discount to the debt. The borrowings
are collateralized by a security interest in substantially all of the Company’s assets.
The Loan Agreement requires that the Company adheres to certain affirmative and negative covenants, including financial reporting requirements,
certain minimum financial covenants for pre-specified liquidity and revenue requirements and a prohibition against the incurrence of indebtedness, or creation of
additional liens, other than as specifically permitted by the terms of the Loan Agreement. In particular, the covenants of the original Loan Agreement included a
covenant that the Company maintain a minimum of $5 million of cash and certain cash equivalents, and the Company had to achieve certain minimum revenues.
If the Company fails to meet the applicable minimum revenue target in any calendar year, the Loan Agreement provides the Company with a cure right if it
prepays a portion of the outstanding principal equal to 2.0 times the revenue shortfall. In addition, the Loan Agreement prohibits the payment of cash dividends
on the Company’s capital stock and also places restrictions on mergers, sales of assets, investments, incurrence of liens, incurrence of indebtedness and
transactions with affiliates. CRG may accelerate the payment terms of the Loan Agreement upon the occurrence of certain events of default set forth therein,
which include the failure of the Company to make timely payments of amounts due under the Loan Agreement, the failure of the Company to adhere to the
covenants set forth in the Loan Agreement, the insolvency of the Company or upon the occurrence of a material adverse change.
F-16
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
On February 14, 2018, the Company entered into Amendment No. 2 to the Loan Agreement to, among other things:
•
•
•
•
extend the interest only payment period and the period during which the Company may elect to pay a portion of the interest in PIK interest
payments through June 30, 2021;
provide for a 15% facility fee to be paid on the maturity date;
permit the Company to make the entire interest payment for payment dates in 2018 and 2019 in PIK interest payments, provided no default has
occurred and is continuing;
extend the maturity date to June 30, 2023;
• modify certain of the covenants, including the indebtedness covenant, lien covenant and restricted payments covenant, to eliminate or modify
permitted exceptions to the restrictions in those covenants;
• modify the financial covenants to reduce the minimum liquidity requirement to $3.5 million at all times, to eliminate the minimum revenue
requirements for 2018 and 2019, and to reduce the minimum revenue requirements to $15 million for 2020, $20 million for 2021 and $25 million
for 2022; and
provide CRG with board observer rights.
•
On March 2, 2020, the Company entered into Amendment No. 3 to the Loan Agreement to, among other things:
• Extend the period that the Company can make interest payments in payment in kind (PIK) to June 30, 2020;
• Lower the Minimum Revenue Covenants to $10 million for 2020, $12 million for 2021, and $15 million for 2022;
•
•
Insert certain terms to clarify that all fees, including the prepayment premium, are due if the obligations are accelerated; and
Insert a new provision to make clear that to the extent the Company divides its assets/liabilities into divisions, such assets/liabilities will be
treated as transferred to a third party.
As of December 31, 2019, the Company was in compliance with all applicable covenants under the Loan Agreement.
As of December 31, 2019, principal, final facility fee and PIK payments under the Loan Agreement, which incorporates all aforementioned amendments
including those occurring after our fiscal year end, were as follows (in thousands):
Year Ending December 31,
2020
2021
2022
2023
Less: Amount of PIK additions and facility fee to be accreted subsequent to December 31, 2019
Less: Amount representing debt financing costs
Borrowings, as of December 31, 2019
$
$
—
3,400
6,266
4,518
14,184
(4,629)
(588)
8,967
In connection with drawdowns under the Loan Agreement, the Company recorded aggregate debt discounts of $1.3 million as contra-debt. The debt
discounts are being amortized as non-cash interest expense using the effective interest method over the term of the Loan Agreement. As of December 31, 2019
and 2018, the balance of the aggregate debt discount was approximately $588,000 and $757,000, respectively. The Company’s interest expense associated
with the amortization of debt discount amounted to $169,000 and $117,000 during the years ended December 31, 2019 and 2018, respectively. The Company
incurred total interest expense of approximately $1.5 million and $5.4 million during the years ended December 31, 2019 and 2018, respectively.
Due to the substantial doubt about the Company’s ability to continue operating as a going concern and the material adverse change clause in the Loan
Agreement with CRG, the entire amount of borrowings at December 31, 2019 and 2018 is classified as current in these financial statements. CRG has not
invoked the material adverse change clause.
F-17
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
8. Commitments and Contingencies
Lease Commitments
The Company’s operating lease obligations primarily consist of leased office, laboratory, and manufacturing space under a non-cancelable operating
lease that originally were to expire in November 2019. In addition to the minimum future lease commitments presented below, the lease requires the Company
to pay property taxes, insurance, maintenance, and repair costs. The lease includes a rent holiday concession and escalation clauses for increased rent over the
lease term. Rent expense is recognized using the straight-line method over the term of the lease. The Company records deferred rent calculated as the
difference between rent expense and the cash rental payments. In connection with the facility lease, the landlord also provided incentives of $369,000 to the
Company in the form of leasehold improvements. These amounts were reflected as deferred rent and are being amortized as a reduction to rent expense over
the original term of the Company’s operating lease.
On October 19, 2017, the Company entered into an agreement to sublease one of its facilities. The sublease agreement commenced on approximately
December 1, 2017 and expired on November 15, 2019 (which was 15 days prior to the expiration of the facility lease). The sublessee paid a base rent of
$82,410 per month. In addition to the base rent, the sublessee paid the Landlord’s operating expenses and property taxes due and payable with respect to the
subleased facility.
Upon the adoption of Topic 842 on January 1, 2019, the Company recognized a right of use asset and a corresponding leasehold liability related to this
lease of approximately $1.8 million, representing the present value of the remaining minimum lease payments as of that date. The asset was being reduced over
the remaining period of the lease on a straight-line basis. The leasehold liability is being reduced as payments are made.
Additionally, as a result of the adoption of Topic 842, the Company recorded $1.1 million of sublease payments received in other income on the
statement of operations and comprehensive loss during the year ended December 31, 2019. To maintain comparability between periods, the Company
reclassified these payments received of approximately $962,000 in the year ended December 31, 2018 that were previously netted against rent expense
included in selling, general and administrative expenses to the same line item on the statement of operations.
On April 1, 2019, we entered into an amendment to the lease which extended the lease term for an additional period of five years subsequent to the
original expiration of November 30, 2019. As amended, the lease will expire on November 30, 2024. Under the terms of the amendment, we are obligated to pay
approximately $5.8 million in base rent payments through November 2024, beginning on December 1, 2019. This amendment does not extend the term of the
lease with respect to the building being subleased.
In connection with the amendment the Company adjusted its right-of-use asset and lease liability to $6.0 million. As of the date of the amendment, the
operating lease was included on the balance sheet at the present value of the future base payments discounted at a 6.5% discount rate using the rate of interest
that the Company would have to pay to borrow on a collateralized basis over a similar term and amount equal to the lease payments in a similar economic
environment as the lease do provide an implicit rate.
For the year ended December 31, 2019, our operating lease expense, excluding variable maintenance fees and other expenses paid by the Company
on a monthly basis, was approximately $1.4 million. Rent expense for the year ended December 31, 2018 was approximately $2.0 million. Operating right-of-use
asset amortization for the year ended December 31, 2019 was approximately $676,000. Due to payments being made in excess of operating lease expense
recognized, the Company recorded approximately $461,000 as prepaid rent included in other assets on the balance sheet as of December 31, 2019.
The following table presents the future operating lease payments and lease liability included on the balance sheet related to the Company’s operating
lease as of December 31, 2019 (in thousands):
Year Ending December 31,
2020
2021
2022
2023
2024
Less: Imputed interest
Leasehold liability as of December 31, 2019
Indemnification
$
$
1,085
1,123
1,162
1,203
1,138
5,711
(854)
4,857
In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and may
provide for indemnification of the counterparty. The Company’s exposure under these agreements is unknown because it involves claims that may be made
against it in the future, but have not yet been made. To date, the Company has not been subject to any claims or been required to defend any action related to
its indemnification obligations.
F-18
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
The Company indemnifies each of its directors and officers for certain events or occurrences, subject to certain limits, while the director is or was serving
at the Company’s request in such capacity, as permitted under Delaware law and in accordance with its certificate of incorporation and bylaws. The term of the
indemnification period lasts as long as a director may be subject to any proceeding arising out of acts or omissions of such director in such capacity. The
maximum amount of potential future indemnification is unlimited; however, the Company currently holds director liability insurance. This insurance allows the
transfer of risk associated with the Company’s exposure and may enable it to recover a portion of any future amounts paid. The Company believes that the fair
value of these indemnification obligations is minimal. Accordingly, it has not recognized any liabilities relating to these obligations for any period presented.
Legal Proceedings
Except as set forth below, we are not involved in any pending legal proceedings that we believe could have a material adverse effect on our financial
condition, results of operations or cash flows. From time to time we may be involved in legal proceedings or investigations, which could harm our reputation,
business and financial condition and divert the attention of our management from the operation of our business.
Between May 22, 2017 and May 25, 2017, three class actions were filed in the Superior Court of the State of California, County of San Mateo, or the
State Court, against us and certain of our officers and directors. The underwriters of our IPO in January 2015 are also named as defendants. The actions were
captioned Grotewiel v. Avinger, Inc., et al., No. 17-CIV-02240, Gonzalez v. Avinger, Inc., et al., No. 17-CIV-02284, and Olberding v. Avinger, Inc., et al., No. 17-
CIV-02307. These lawsuits allege that the registration statement for our IPO made false and misleading statements and omissions in violation of the Securities
Act of 1933. Plaintiffs seek to represent a class of purchasers of our common stock in and/or traceable to our IPO. Plaintiffs seek, among other things,
unspecified compensatory damages, interest, costs, recission, and attorneys’ fees. On June 12, 2017, defendants removed these actions to the United States
District Court for the Northern District of California, or Federal Court.
On June 22, 2017, and June 23, 2017, plaintiffs Olberding and Gonzalez moved to remand their cases to the State Court. Defendants opposed these
motions. On July 21, 2017, the Federal Court granted the motions to remand the Olberding and Gonzalez actions to the State Court. On August 9, 2017, the
State Court consolidated the Olberding and Gonzalez actions under the caption Gonzalez v. Avinger, Inc., et al., No. 17-CIV-02284, or State Action. On
September 22, 2017, an amended complaint was filed in the State Action. On October 31, 2017, the parties in the State Action stipulated to a stay of
proceedings until judgment is entered in the federal Grotewiel action, or Federal Action. On June 20, 2018, the State Court dismissed the State Action pursuant
to the proposed settlement described below.
On October 11, 2017, the Federal Court appointed a lead plaintiff and approved the selection of a lead counsel in the Federal Action. On November 21,
2017, an amended complaint was filed in the Federal Action. Defendants filed a motion to dismiss that complaint on January 26, 2018. On March 19, 2018,
plaintiff in the Federal Action filed a further amended complaint, on behalf of a class of purchasers of our common stock in and/or traceable to our IPO, as well
as purchasers of our common stock during the period January 30, 2015, to April 10, 2017.
The Company and its directors believe that the foregoing lawsuits were without merit; however, in the interest of avoiding the cost and disruption of
continuing to defend against these lawsuits, the Company entered into a settlement of the actions. The settlement is for a total of $5 million. The Company’s total
contribution to the settlement fund is $1.76 million, which the Company paid in March 2018. On October 24, 2018, the court approved the settlement.
9. Stockholders’ Equity
Convertible Preferred Stock
As of December 31, 2019, the Company’s certificate of incorporation, as amended and restated, authorizes the Company to issue up to 5,000,000
shares of convertible preferred stock with $0.001 par value per share, of which 48,503 shares were issued and outstanding.
Series A Convertible Preferred Stock
On February 14, 2018, the Company entered into a Series A Purchase Agreement with CRG, pursuant to which it agreed to convert $38.0 million of the
outstanding principal amount of its senior secured term loan (plus $3.8 million in back-end fees, accrued interest, debt discount and prepayment premium
applicable thereto), totaling $41.8 million, into a newly authorized Series A convertible preferred stock (the “Series A preferred stock”). The Series A preferred
stock was initially convertible into 2,090,000 shares of common stock subject to certain limitations contained in the Series A Purchase Agreement. Under the
terms of the Series A Purchase Agreement, the holders of Series A preferred stock are entitled to receive annual accruing dividends at a rate of 8%, payable in
additional shares of Series A preferred stock or cash, at the Company’s option. The shares of Series A preferred stock have no voting rights and rank senior to
all other classes and series of the Company’s equity in terms of repayment and certain other rights. In January 2019 and December 2019, 2,945 and 3,580
additional shares, respectively, were issued to CRG as payment of dividends accrued through December 31, 2019. As of December 31, 2019, 48,325 shares of
Series A preferred stock were outstanding. The Series A preferred stock accrued additional dividends of approximately $3.6 million and $2.9 million during the
years ended December 31, 2019 and 2018, respectively.
F-19
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
Series B Convertible Preferred Stock
On February 16, 2018, the Company completed a public offering of 17,979 shares of Series B convertible preferred stock (the “Series B preferred
stock”). As a result, the Company received net proceeds of approximately $15.5 million after underwriting discounts, commissions, legal and accounting fees.
The Series B preferred stock has a liquidation preference of $0.001 per share, full ratchet price based anti-dilution protection, has no voting rights and is subject
to certain ownership limitations. The Series B preferred stock is immediately convertible at the option of the holder, has no stated maturity, and does not pay
regularly stated dividends or interest. During the year ended December 31, 2019, 1,523 of these shares converted into 380,750 shares of common stock and
178 shares of Series B preferred stock remained outstanding.
The Company evaluated the Series B convertible preferred stock issuance in accordance with the provisions of ASC 815, Derivatives and Hedging,
including consideration of embedded derivatives requiring bifurcation. The issuance of the convertible preferred stock could generate a beneficial conversion
feature (“BCF”), which arises when a debt or equity security is issued with an embedded conversion option that is beneficial to the investor or in the money at
inception because the conversion option has an effective conversion price that is less than the market price of the underlying stock at the commitment date. The
Company recognized the BCF by allocating the intrinsic value of the conversion option, which is the number of shares of common stock available upon
conversion multiplied by the difference between the effective conversion price per share and the fair value of common stock per share on the commitment date,
to additional paid-in capital, resulting in a discount on the convertible preferred stock. As the Series B convertible preferred stock may be converted immediately,
the Company recognized a BCF of $5.2 million as a deemed dividend in the statements of operations as of February 16, 2018.
Series C Convertible Preferred Stock
On November 1, 2018, the Company completed a public offering of 728,500 shares of common stock and 8,586 shares of Series C convertible preferred
stock (the “Series C preferred stock”). As a result, we received net proceeds of approximately $10.2 million after underwriting discounts, commissions, legal and
accounting fees. Upon any dissolution, liquidation or winding up, whether voluntary or involuntary, holders of Series C preferred stock will be entitled to receive
distributions out of our assets, whether capital or surplus, of an amount equal to $0.001 per share of Series C preferred stock before any distributions shall be
made on the common stock but after distributions shall be made on any outstanding Series A preferred stock and any of our existing or future indebtedness. The
Series C preferred stock has no voting rights. As of December 31, 2018, there were 2,170 shares of Series C preferred stock outstanding. During the year ended
December 31, 2019, all 2,170 of these shares were converted into 542,500 shares of common stock and no shares remained outstanding.
Common Stock
At December 31, 2019, the Company’s certificate of incorporation, as amended and restated, authorizes the Company to issue up to 100,000,000 shares
of common stock with $0.001 par value per share, of which 10,364,663 shares were issued and outstanding.
Common Stock Warrants
In connection with the issuance of the Company’s Series E convertible preferred stock in September 2014 through January 2015, the Company issued
warrants to purchase an aggregate of up to the number of shares of common stock equal to 50% of the number of shares of the Company’s Series E
Convertible preferred stock purchased by such investor, all of which expired on September 2, 2019.
On February 16, 2018, in connection with the Company’s completed public offering of Series B preferred stock, the Company issued two series of
warrants that together provide for the purchase, by the investors in that offering, of an aggregate of 1,797,900 shares of common stock (the “Series B
Warrants”). Each share of Series B preferred stock is accompanied by one warrant to purchase one share of common stock at $4.00 per share that expires on
the seventh anniversary of the date of issuance to purchase up to 50 shares of common stock and one warrant that expires on the earlier of (i) the seventh
anniversary of the date of issuance or (ii) the 60th calendar day following the receipt and announcement of FDA clearance of the Company’s Pantheris below-
the-knee device (or the same or similar product with a different name) to purchase up to 50 shares of common stock; provided, however, if at any time during
such 60-day period the volume weighted average price for any trading day is less than the then effective exercise price, the termination date shall be extended to
the seven year anniversary of the initial exercise date. FDA clearance of Pantheris SV was received in April 2019, triggering this 60-day period. During the entire
60-day period following clearance, the volume weighted average price was less than the then effective exercise price. As such, all Series 2 warrants are
currently deemed to expire on the seventh anniversary of the date of issuance. The Company determined that the Series B Warrants should be classified as
equity. As of December 31, 2019, Series B Warrants to purchase an aggregate of 1,768,850 shares of common stock remain outstanding.
F-20
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
On July 13, 2018, in connection with the Company’s completed public offering of 216,618 shares of common stock, the Company issued warrants that
provide for the purchase of 108,309 shares of common stock at $15.80 per share. Each share of common stock is accompanied by one half of one warrant that
expires on the third anniversary of the date of issuance. The Company determined that these warrants should be classified as equity. As of December 31, 2019,
all of these warrants remain outstanding.
On November 1, 2018, in connection with the Company’s completed public offering of 728,500 shares of common stock and 8,586 shares of Series C
convertible preferred stock, the Company issued warrants to provide for the purchase of 2,875,000 shares of common stock. Each share of common stock is
accompanied by one warrant to purchase one share of common stock at $4.00 per share. These warrants expire on the 5th anniversary of the date of issuance.
Each share of preferred stock is accompanied by one warrant to purchase 250 shares of common stock. The Company determined that the warrants should be
classified as equity. As of December 31, 2018, all 2,875,000 of these warrants were outstanding at a conversion rate of ten warrants for each share of common
stock. During the year ended December 31, 2019, warrants were exercised for an aggregate of 1,998,079 shares of common stock with proceeds to the
Company of approximately $8.0 million. As of December 31, 2019, warrants to purchase an aggregate of 876,840 shares of common stock remain outstanding.
The Company accounted for the common stock warrants issued during the year ended December 31, 2018 as issuance costs relating to the respective
equity financing, and used the Black-Scholes method to estimate their fair value. The fair value of the common stock warrants issued in July 2018 and
November 2018 was not significant. The assumptions used to estimate the fair values of the common stock warrants issued in February 2018 were as follows:
Expected term (years)
Expected volatility
Risk-free interest rate
Dividend rate
7
55%
2%
—
As of December 31, 2019 and 2018, warrants to purchase an aggregate of 2,753,999 and 4,757,539 shares of common stock were outstanding,
respectively.
Stock Plans
In January 2015, the Board of Directors adopted and the Company’s stockholders approved the 2015 Equity Incentive Plan (“2015 Plan”). The 2015
Plan replaced the 2009 Stock Plan (the “2009 Plan”) which was terminated immediately prior to consummation of the Company’s IPO (collectively the “Plans.)”
The 2015 Plan provides for the grant of incentive stock options (“ISOs”) to employees and for the grant of non-statutory stock options (“NSOs”), restricted stock,
RSUs, stock appreciation rights, performance units and performance shares to employees, directors and consultants. Initially a total of 3,300 shares of common
stock were reserved for issuance pursuant to the 2015 Plan. The shares reserved for issuance under the 2015 Plan included shares reserved but not issued
under the 2009 Plan, plus any share awards granted under the 2009 Plan that expire or terminate without having been exercised in full or that are forfeited or
repurchased. In addition, the number of shares available for issuance under the 2015 Plan includes an automatic annual increase on the first day of each fiscal
year beginning in fiscal 2016, equal to the lesser of 4,225 shares, 5.0% of the outstanding shares of common stock as of the last day of the immediately
preceding fiscal year or an amount as determined by the Board of Directors. In addition, during fiscal 2018, the Board of Directors approved an additional
300,000 shares of common stock for issuance under the 2015 Plan. The Company’s stockholders approved this increase on June 8, 2018. On June 19, 2019,
the Company’s stockholders approved an additional 800,000 increase to the 2015 Plan. As of December 31, 2019, 96,896 shares were available for grant under
the 2015 Plan.
Pursuant to the Plans, ISOs and NSOs may be granted with exercise prices at not less than 100% of the fair value of the common stock on the date of
grant and the exercise price of ISOs granted to a stockholder, who, at the time of grant, owns stock representing more than 10% of the voting power of all
classes of the stock of the Company, shall be not less than 110% of the fair market value per share of common stock on the date of grant. The Company’s Board
of Directors determines the vesting schedule of the options. Options granted generally vest over four years and expire ten years from the date of grant.
F-21
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
Stock option activity under the Plans is set forth below:
Balance at December 31, 2017
Options granted
Options expired
Options forfeited
Balance at December 31, 2018
Options expired
Options forfeited
Balance at December 31, 2019
Number of
Shares
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Contractual
Life
(in years)
Intrinsic
Value
7,663 $
3,100 $
(2,550) $
(259) $
7,954 $
(448) $
(105) $
7,401 $
2,917.30
16.70
2,725.80
3,493.70
1,707.30
3,061.09
1,929.52
1,309.47
$
$
6.81 $
Exercisable at December 31, 2019
7,224 $
1,310.25
6.80 $
Vested and expected to vest at December 31, 2019
7,401 $
1,309.47
6.81 $
Additional information related to the status of options as of December 31, 2019 is summarized as follows:
Options Outstanding
Options Vested
Exercise
Price
Options
Outstanding
Weighted
Average
Remaining
Contractual Life
Weighted
Average
Exercise
Price
Number
Exercisable
Weighted
Average
Exercise
Price
—
—
—
—
—
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
16.70
204.00
820.00
1,052.00
1,420.00
1,472.00
1,800.00
1,980.00
4,364.00
4,404.00
4,952.00
5,040.00
5,184.00
5,196.00
5,940.00
6,084.00
7,290.00
7,844.00
8,100.00
3,100
5
1,001
46
70
10
2,440
28
10
25
18
24
151
241
14
11
3
110
94
7,401
8.44 $
7.56 $
7.21 $
7.18 $
6.84 $
6.83 $
5.00 $
0.32 $
5.18 $
6.43 $
6.33 $
1.47 $
6.19 $
6.18 $
2.02 $
5.58 $
4.04 $
5.91 $
3.73 $
6.81 $
16.70
204.00
820.00
1,052.00
1,420.00
1,472.00
1,800.00
1,980.00
1,980.00
4,404.00
4,952.00
5,040.00
5,184.00
5,196.00
5,940.00
6,084.00
7,290.00
7,844.00
8,100.00
1,309.47
3,100 $
3 $
856 $
36 $
70 $
8 $
2,440 $
28 $
10 $
25 $
18 $
24 $
141 $
233 $
14 $
11 $
3 $
110 $
94 $
7,224 $
16.70
204.00
820.00
1,052.00
1,420.00
1,472.00
1,800.00
1,980.00
1,980.00
4,404.00
4,952.00
5,040.00
5,184.00
5,196.00
5,940.00
6,084.00
7,290.00
7,844.00
8,100.00
1,310.25
There were no options exercised during the year ended December 31, 2019. As of December 31, 2019, there was approximately $72,000 of remaining
unamortized stock-based compensation expense associated with unvested stock options, which will be expensed over a weighted average remaining service
period of approximately 1.0 years. Because of the Company’s net operating losses, the Company did not realize any tax benefits from share-based payment
arrangements for the years ended December 31, 2019 and 2018.
F-22
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
The Company’s RSUs generally vest annually over three or four years in equal increments. The Company measures the fair value of RSUs using the
closing stock price of a share of the Company’s common stock on the grant date and is recognized as expense on a straight-line basis over the vesting period of
the award. A summary of all RSU activity is presented below:
Awards outstanding at December 31, 2017
Awarded
Released
Forfeited
Awards outstanding at December 31, 2018
Awarded
Released
Forfeited
Awards outstanding at December 31, 2019
Weighted
Average
Grant Date
Fair Value
Weighted
Average
Remaining
Contractual
Term
2,377.80
15.00
2,739.70
59.70
17.34
1.24
17.95
10.57
4.09
2.87
3.09
1.81
Number of
Shares
509 $
297,753 $
(128) $
(4,068) $
294,066 $
764,151 $
(101,575) $
(48,138) $
908,504 $
As of December 31, 2019, there was approximately $3.0 million of remaining unamortized stock-based compensation expense associated with RSUs,
which will be expensed over a weighted average remaining service period of approximately 1.8 years. The 908,504 outstanding non-vested and expected to vest
RSUs have an aggregate fair value of approximately $1.0 million. The Company used the closing market price of $1.14 per share at December 31, 2019, to
determine the aggregate fair value for the RSUs outstanding at that date. For the years ended December 31, 2019 and 2018, the fair value of RSUs vested was
approximately $116,000 and $1,500, respectively.
2018 Officer and Director Share Purchase Plan
On August 22, 2018, the Board of Directors of the Company approved the adoption of an Officer and Director Share Purchase Plan (“ODPP”), which
allows executive officers and directors to purchase shares of our common stock at fair market value in lieu of salary or, in the case of directors, director fees.
Eligible individuals may voluntarily participate in the ODPP by authorizing payroll deductions or, in the case of directors, deductions from director fees for the
purpose of purchasing common stock. Elections to participate in the ODPP may only be made during open trading windows under our insider trading policy
when the participant does not otherwise possess material non-public information concerning the Company. The Board of Directors authorized 20,000 shares to
be made available for purchase by officers and directors under the ODPP. Effective on August 28, 2019, the Board of Directors approved an additional 40,000
shares to be made available under the ODPP. Common stock issued under the ODPP during the year ended December 31, 2019 totaled 36,087 shares. As of
December 31, 2019, there were 20,204 shares reserved for issuance under the ODPP.
10. Stock-Based Compensation
Total noncash stock-based compensation expense relating to the Company’s stock options and RSUs recognized, before taxes, during the years ended
December 31, 2019 and 2018, is as follows (in thousands):
Cost of revenues
Research and development expenses
Selling, general and administrative expenses
Year Ended December 31,
2018
2019
$
$
169 $
535
1,387
2,091 $
97
547
2,436
3,080
F-23
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
11. Income Taxes
For the years ended December 31, 2019 and 2018, the Company’s provision for income taxes consisted of zero state income tax expense. A
reconciliation of the statutory U.S. federal rate to the Company’s effective tax rate is as follows (in thousands):
Tax at federal statutory rate
State taxes, net of federal benefit
Permanent differences
Change in valuation allowance
Research credits
Other
Provision for taxes
Year Ended December 31,
2018
2019
(4,084) $
(1,022)
97
5,205
(192)
(4)
— $
(5,787)
(1,023)
228
6,582
—
—
—
$
$
Significant components of the Company’s net deferred tax assets as of December 31, 2019 and 2018 consist of the following (in thousands):
Deferred tax assets:
Federal, state and foreign net operating losses
Research and other credits
Operating lease liability
Accruals and other
Total deferred tax assets
Less: Valuation allowance
Total net deferred tax assets
Deferred liabilities:
Fixed assets
Operating lease right of use asset
Total deferred tax liabilities
Net deferred tax assets (liabilities)
As of December 31,
2019
2018
75,863 $
4,361
1,237
2,847
84,308
(82,755)
1,553
(198)
(1,355)
(1,553)
— $
70,286
3,655
—
4,317
78,258
(78,082)
176
(176)
—
(176)
—
$
$
The valuation allowance increased by $4.7 million and increased by $7.6 million during the years ended December 31, 2019 and 2018, respectively.
In connection with the adoption of ASC 842 in the quarter ended March 31, 2019, the Company recognized a deferred tax liability in the amount of $1.4
million related lease liabilities and a deferred tax asset in the amount of $1.2 million for the year ended December 31, 2019. Additionally, the Company
decreased the net deferred tax asset by $6,000, retroactive to December 31, 2018. The net effect of these adjustments to the deferred tax asset and liability is
offset with an adjustment to the valuation allowance.
As of December 31, 2019, the Company had approximately $301.0 million of federal and $216.1 million of state net operating loss carryforwards
available to offset future taxable income. If not utilized, the federal and state net operating loss carryforwards begin to expire in 2027 and 2019, respectively.
Out of the Federal net operating loss carryforwards, $43.5 million were generated post December 31, 2017 and have no expiration.
As of December 31, 2019, the Company also had approximately $3.4 million and $3.6 million of research and development tax credit carryforwards
available to reduce future taxable income, if any, for federal and California purposes, respectively. The federal credit carryforwards expire beginning in 2027, and
the California research credits do not expire and may be carried forward indefinitely.
The Company's ability to utilize the net operating loss and tax credit carryforwards in the future may be subject to substantial restrictions in the event of
past or future ownership changes as defined in Section 382 of the Internal Revenue Code and similar state tax laws. In the event the Company should
experience an ownership change, as defined, utilization of the Company's net operating loss carryforwards and tax credits could be limited.
The Company evaluates tax positions for recognition using a more-likely-than-not recognition threshold, and those tax positions eligible for recognition
are measured as the largest amount of tax benefit that is greater than 50% likely of being realized upon the effective settlement with a taxing authority that has
full knowledge of all relevant information.
F-24
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
A reconciliation of the beginning and ending amount of the gross recognized tax benefit is as follows (in thousands):
Balance at beginning of year
Increase based on the tax positions in the current year
Decrease for tax positions of prior year
Balance at end of year
As of December 31,
2019
2018
$
$
1,760 $
177
157
2,094 $
1,747
29
(16)
1,760
As of December 31, 2019, all unrecognized tax benefits are subject to a full valuation allowance and, if recognized, will not affect the Company’s tax
rate.
The Company does not anticipate that the total amounts of unrecognized tax benefits will significantly increase or decrease in the next twelve months.
The Company's policy is to include interest and penalties related to unrecognized tax benefits within its provision for income taxes. Due to the Company's
net operating loss position, the Company has not recorded an accrual for interest or penalties related to uncertain tax positions for the years ended December
31, 2019 or 2018.
12. Related-Party Transactions
In October 2015, the Company entered into an agreement with Consensys Imaging Service (“Consensys”) to provide field engineers to assist the
Company with the installation, service and maintenance of its Lightbox consoles. Jeffrey M. Soinski, the Company’s President, Chief Executive Officer and a
member of its Board of Directors was also a member of the Board of Directors of Consensys until October 2017. For the years ended December 31, 2019 and
2018, Consensys provided services to the Company of $80,000 and $84,000, respectively. As of December 31, 2019 and 2018, amounts due to Consensys
included in accounts payable and accrued liabilities, were $27,000 and $12,000, respectively.
13. 401(k) Plan
The Company has a qualified retirement plan under section 401(k) of the Internal Revenue Code (“IRC”) under which participants may contribute up to
90% of their eligible compensation, subject to maximum deferral limits specified by the IRC. The Company may make a discretionary matching contribution to
the 401(k) plan, and may make a discretionary employer contribution to each eligible employee each year. Eligible employees vest in the Company’s
contributions over a graded four year schedule. To date, the Company has made no contributions to the 401(k) plan.
14. Subsequent Events
On January 31, 2020, we completed a public offering of 6,428,572 shares of common stock at an offering price of $0.70 per share. As a result, we
received net proceeds of approximately $3.7 million after underwriting discounts, commissions, legal and accounting fees, and other ancillary expenses. Due to
anti-dilution provisions, the conversion price of the outstanding shares of Series B preferred stock, which was issued in our February 2018 offering, was reduced
to $0.70 per share.
On March 2, 2020, Avinger, Inc. (the “Company”) entered into Amendment No. 3 to Term Loan Agreement (the “Amendment”) with CRG Partners III
L.P. and certain of its affiliated funds, as lenders (the “Lenders”), which amended the Term Loan Agreement, dated as of September 22, 2015, by and among the
Company, certain of its subsidiaries from time to time party thereto as guarantors and the Lenders (as amended, the “Term Loan Agreement”). The Amendment
amended the Term Loan Agreement to, among other things:
•
•
•
•
Extend the period that the Company can make interest payments in payment in kind (PIK) to June 30, 2020;
Lower the Minimum Revenue Covenants to $10 million for 2020, $12 million for 2021, and $15 million for 2022;
Insert certain terms to clarify that all fees, including the prepayment premium, are due if the obligations are accelerated; and
Insert a new provision to make clear that to the extent the Company divides its assets/liabilities into divisions, such assets/liabilities will be treated as
transferred to a third party.
The foregoing description of the Amendment is qualified in its entirety by reference to the full text of the Amendment, a copy of which is included as
Exhibit 10.41 in our Annual Report on Form 10-K filed on March 5, 2020, and which is incorporated herein in its entirety by reference.
F-25
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
Pursuant to the requirements of Section 13 and 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this Annual Report on
Form 10-K to be signed on its behalf by the undersigned thereunto duly authorized.
SIGNATURES
Date: March 5, 2020
Date: March 5, 2020
Avinger, Inc.
(Registrant)
/s/ Jeffrey M. Soinski
Jeffrey M. Soinski
Chief Executive Officer
(Principal Executive Officer)
/s/ Mark Weinswig
Mark Weinswig
Chief Financial Officer
(Principal Financial and Accounting Officer)
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Jeffrey Soinski and Mark
Weinswig, jointly and severally, as his or her true and lawful attorneys-in-fact and agents, with full power of substitution and resubstitution, for him or her, and in
his or her name, place and stead, in any and all capacities, to sign any and all amendments to this Annual Report on Form 10-K, and to file the same, with all
exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents
full power and authority to do and perform each and every act and thing requisite or necessary to be done in and about the premises hereby ratifying and
confirming all that said attorneys-in-fact and agents, or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this Annual Report on Form 10-K has been signed below by the
following persons on behalf of the registrant and in the capacities and on the dates indicated.
Signature
Title
/s/ Jeffrey M. Soinski
Jeffrey M. Soinski
/s/ Mark Weinswig
Mark Weinswig
/s/ James B. McElwee
James B. McElwee
/s/ James G. Cullen
James G. Cullen
/s/ Tamara Elias
Tamara Elias
Date
March 5, 2020
President and Chief Executive Officer (Principal Executive Officer);
Director
Chief Financial Officer (Principal Financial and Accounting Officer)
March 5, 2020
Director
Director
Director
77
March 5, 2020
March 5, 2020
March 5, 2020
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
DESCRIPTION OF THE REGISTRANT’S SECURITIES
REGISTERED PURSUANT TO SECTION 12 OF THE SECURITIES
EXCHANGE ACT OF 1934
EXHIBIT 4.5
Avinger, Inc. (“Avinger,” “we,” “our,” or “us”) has one class of securities registered under Section 12 of the Securities Exchange Act of 1934, as amended: our
common stock.
DESCRIPTION OF CAPITAL STOCK
The following summary of the terms of our capital stock is based upon our Amended and Restated Certificate of Incorporation (as amended by that certain
Certificate of Amendment to the Amended and Restated Certificate of Incorporation , the “Certificate of Incorporation”) and our Amended and Restated Bylaws
(the “Bylaws”). The summary is not complete, and is qualified by reference to our Certificate of Incorporation and our Bylaws, which are filed as exhibits to this
Annual Report on Form 10-K and are incorporated by reference herein. We encourage you to read our Certificate of Incorporation, our Bylaws and the applicable
provisions of the Delaware General Corporation Law for additional information.
Authorized Shares of Capital Stock
Our authorized capital stock consists of 100,000,000 shares of common stock, $0.001 par value per share, and 5,000,000 shares of preferred stock, $0.001 par
value per share. Of our 5,000,000 shares of authorized preferred stock, 60,000 shares have been designated as Series A preferred stock and 178 have been
designated as Series B preferred stock.
Outstanding Shares
COMMON STOCK
On December 31, 2019, there were 10,364,663 shares of common stock outstanding, held of record by 126 stockholders. Our board of directors is authorized,
without stockholder approval, to issue additional shares of our capital stock. As of December 31, 2019, there were 2,753,999 shares of common stock subject to
outstanding warrants and 7,401 shares of common stock subject to outstanding options.
Dividend Rights
Subject to preferences that may be applicable to any then outstanding preferred stock, holders of our common stock are entitled to receive dividends, if any, as
may be declared from time to time by our board of directors out of legally available funds. We have never declared or paid cash dividends on any of our capital
stock and currently do not anticipate paying any cash dividends after this offering or in the foreseeable future.
Voting Rights
Each holder of our common stock is entitled to one vote for each share on all matters submitted to a vote of stockholders; provided, however, that, except as
otherwise required by law, holders of our common stock, as such, shall not be entitled to vote on any amendment to our Certificate of Incorporation that relates
solely to the terms of one or more outstanding series of preferred stock if the holders of such affected series are entitled, either separately or together with the
holders of one or more other such series, to vote thereon. Corporate actions can generally be taken by a majority of our board and/or stockholders holding a
majority of our outstanding shares, except as otherwise indicated in the section entitled “Anti-takeover Effects of Delaware Law and Our Certificate of
Incorporation and Bylaws,” where certain amendments to our Certificate of incorporation and Bylaws require the vote of at least 66 and 2/3% of our then
outstanding voting securities. Additionally, our stockholders do not have cumulative voting rights in the election of directors. Accordingly, holders of a plurality of
the votes cast at a meeting of stockholders will be able to elect all of the directors then standing for election.
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
Right to Receive Liquidation Distributions
In the event of our liquidation, dissolution or winding up, holders of our common stock are entitled to share ratably in the net assets legally available for
distribution to stockholders after the payment of all of our debts and other liabilities and the satisfaction of any liquidation preference granted to the holders of
any then outstanding shares of preferred stock.
Rights and Preferences
Holders of our common stock have no preemptive, conversion, subscription or other rights, and there are no redemption or sinking fund provisions applicable to
our common stock. The rights, preferences and privileges of the holders of our common stock are subject to, and may be adversely affected by, the rights of the
holders of our outstanding preferred stock and shares of any series of our preferred stock that we may designate in the future.
Transfer Agent and Registrar
The transfer agent and registrar for our common stock is American Stock Transfer & Trust Company, LLC. The transfer agent and registrar’s address is 6201
15th Avenue, Brooklyn, NY 11219. Our shares of common stock are issued in uncertificated form only, subject to limited circumstances.
Market Listing
Our common stock is listed on the Nasdaq Capital Market under the symbol “AVGR”.
Certain Anti-Takeover Effects
Certain provisions of Delaware law, our Certificate of Incorporation and our Bylaws may have the effect of delaying, deferring or discouraging another person
from acquiring control of our company. These provisions, which are summarized below, may have the effect of discouraging takeover bids. They are also
designed, in part, to encourage persons seeking to acquire control of us to negotiate first with our board of directors. We believe that the benefits of increased
protection of our potential ability to negotiate with an unfriendly or unsolicited acquirer outweigh the disadvantages of discouraging a proposal to acquire us
because negotiation of these proposals could result in an improvement of their terms.
Delaware Law.
We are governed by the provisions of Section 203 of the Delaware General Corporation Law. In general, Section 203 prohibits a public Delaware corporation
from engaging in a “business combination” with an “interested stockholder” for a period of three years after the date of the transaction in which the person
became an interested stockholder, unless the business combination is approved in a prescribed manner. A “business combination” includes mergers, asset
sales or other transactions resulting in a financial benefit to the stockholder. An “interested stockholder” is a person who, together with affiliates and associates,
owns, or within three years of the date on which it is sought to be determined whether such person is an “interested stockholder,” did own, 15% or more of the
corporation’s outstanding voting stock. These provisions may have the effect of delaying, deferring or preventing a change in our control.
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
Certificate of Incorporation and Bylaw Provisions
Our Certificate of Incorporation and our Bylaws include a number of provisions that could deter hostile takeovers or delay or prevent changes in control of our
management team, including the following:
• Board of directors vacancies. Our Certificate of Incorporation and Bylaws authorize only our board of directors to fill vacant directorships, including
newly created seats. In addition, the number of directors constituting our board of directors is permitted to be set only by a resolution adopted by our board of
directors. These provisions prevent a stockholder from increasing the size of our board of directors and then gaining control of our board of directors by filling the
resulting vacancies with its own nominees. This makes it more difficult to change the composition of our board of directors but promotes continuity of
management.
• Classified board. Our Certificate of Incorporation and Bylaws provide that our board is classified into three classes of directors. A third party may be
discouraged from making a tender offer or otherwise attempting to obtain control of us as it is more difficult and time consuming for stockholders to replace a
majority of the directors on a classified board of directors.
• Stockholder action; special meeting of stockholders . Our Certificate of Incorporation provides that our stockholders may not take action by written
consent, but may only take action at annual or special meetings of our stockholders. As a result, a holder controlling a majority of our capital stock may not be
able to amend our Bylaws or remove directors without holding a meeting of our stockholders called in accordance with our Bylaws. Our Bylaws further provide
that special meetings of our stockholders may be called only by our board of directors, the Chairman of our Board of Directors, our Chief Executive Officer or our
President, thus prohibiting a stockholder from calling a special meeting. These provisions might delay the ability of our stockholders to force consideration of a
proposal or for stockholders controlling a majority of our capital stock to take any action, including the removal of directors.
• Advance notice requirements for stockholder proposals and director nominations . Our Bylaws provide advance notice procedures for stockholders
seeking to bring business before our annual meeting of stockholders or to nominate candidates for election as directors at our annual meeting of stockholders.
Our amended and restated bylaws also specify certain requirements regarding the form and content of a stockholder’s notice. These provisions might preclude
our stockholders from bringing matters before our annual meeting of stockholders or from making nominations for directors at our annual meeting of stockholders
if the proper procedures are not followed. We expect that these provisions may also discourage or deter a potential acquirer from conducting a solicitation of
proxies to elect the acquirer’s own slate of directors or otherwise attempting to obtain control of our company.
• No cumulative voting . The Delaware General Corporation Law provides that stockholders are not entitled to the right to cumulate votes in the
election of directors unless a corporation’s certificate of incorporation provides otherwise. Our Certificate of Incorporation does not provide for cumulative voting.
• Directors removed only for cause . Our Certificate of Incorporation provides that stockholders may remove directors only for cause.
• Amendment of charter provisions. Any amendment of the above provisions in our Certificate of Incorporation would require approval by holders of at
least 66 and 2/3% of the voting power of our then outstanding voting securities.
• Issuance of undesignated preferred stock. Our board of directors will have the authority, without further action by the stockholders, to issue up to
5,000,000 shares of undesignated preferred stock with rights and preferences, including voting rights, designated from time to time by our board of directors. The
existence of authorized but unissued shares of preferred stock would enable our board of directors to render more difficult or to discourage an attempt to obtain
control of us by means of a merger, tender offer, proxy contest or other means.
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
AMENDMENT NO. 1 TO AMENDED AND RESTATED OFFICER AND DIRECTOR SHARE PURCHASE PLAN
WHEREAS, on August 22, 2018, Avinger, Inc. (the “ Company”) adopted an Officer and Director Share Purchase Plan, which plan was amended and
restated on August 28, 2019 (the “Plan”); and
WHEREAS, the Company wishes to amend the Plan to increase the number of shares of the Company’s Common Stock reserved for issuance
Exhibit 10.40
thereunder, effective as of the date hereof (the “Effective Date ”).
The Plan is hereby amended as of the Effective Date as follows:
Amendments to Plan.
Section 4.1 of the Plan is hereby amended and restated to read in its entirety as follows:
“4.1 Subject to adjustment as provided in Section 4.2, the total number of Shares available for issuance under the Plan shall equal one hundred
eighty-five thousand (185,000). Shares granted under the Plan may be either authorized but unissued Shares or treasury Shares.”
Effect of this Amendment . Except as expressly amended hereby, the Plan shall continue in full force and effect in accordance with the provisions
thereof.
(signature page follows)
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
IN WITNESS WHEREOF, the Company, by its duly authorized officer, has executed this Amendment No. 1 to Amended and Restated Officer and
Director Share Purchase Plan on the date indicated below.
Date: March 2, 2020
AVINGER, INC.
By:
/s/ Jeffrey M. Soinski
Jeffrey M. Soinski
President and Chief Executive Officer
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
AMENDMENT 3 TO TERM LOAN AGREEMENT
Exhibit 10.41
THIS AMENDMENT 3 TO TERM LOAN AGREEMENT, dated as of March 2, 2020 (this “ Amendment”) is made among Avinger, Inc., a Delaware
corporation (“Borrower”), and the Lenders listed on the signature pages hereof under the heading “LENDERS” (each a “ Lender” and, collectively, the
“Lenders”).
RECITALS
WHEREAS, the Borrower, the Subsidiary Guarantors from time to time party thereto, the lenders from time to time party thereto (each a “ Lender” and,
collectively, the “Lenders”) are parties to a Term Loan Agreement, dated as of September 22, 2015, as amended by Amendment 1 to Term Loan Agreement,
dated as of October 28, 2016, as further amended by Amendment No. 2 to Term Loan Agreement, dated as of February 14, 2018, and as modified by the Waiver
and Consent, dated as of December 14, 2017, the Waiver and Consent, dated as of January 24, 2018 , the Waiver and Consent, dated as of April 5, 2019, and
the Waiver and Consent, dated as of July 24, 2019 (as amended, restated, modified or otherwise supplemented from time to time, the “Loan Agreement”).
WHEREAS, the parties hereto desire to amend the Term Loan Agreement on the terms and subject to the conditions set forth herein.
AGREEMENT
NOW, THEREFORE, in consideration of the mutual agreements, provisions and covenants contained herein, the parties hereto agree as follows:
SECTION 1. Definitions; Interpretation.
(a) Terms Defined in Loan Agreement . All capitalized terms used in this Amendment (including in the recitals hereof) and not otherwise defined
herein shall have the meanings assigned to them in the Loan Agreement.
(b) Interpretation. The rules of interpretation set forth in Section 1.03 of the Loan Agreement shall be applicable to this Amendment and are
incorporated herein by this reference.
SECTION 2. Amendments to Loan Agreement. Subject to Section 3, the Loan Agreement is hereby amended as follows:
(a) The following definitions are hereby added to Section 1.01 of the Loan Agreement in appropriate alphabetical order:
“acceleration” and “Acceleration” have the meanings set forth in Section 11.02.
“Acceleration Premium” has the meaning set forth in Section 11.02(c).
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
“Back-End Facility Fee” means the fee payable pursuant to Section 2 of the Fee Letter.
(b) The following definitions in Section 1.01 of the Loan Agreement are hereby amended and restated in their entirety:
“Prepayment Premium” means, if the prepayment occurs:
(A) on or prior to the fourteenth (14th) Payment Date, the Prepayment Premium shall be an amount equal to 5.00% of the aggregate
outstanding principal amount of the Loans being prepaid on such Redemption Date;
(B) after the fourteenth (14th) Payment Date and on or prior to the eighteenth (18th) Payment Date, the Prepayment Premium shall be an
amount equal to 4.00% of the aggregate outstanding principal amount of the Loans being prepaid on such Redemption Date;
(C) after the eighteenth (18th) Payment Date and on or prior to the twenty-second (22nd) Payment Date, the Prepayment Premium shall
be an amount equal to 3.00% of the aggregate outstanding principal amount of the Loans being prepaid on such Redemption Date;
(D) after the twenty-second (22nd) Payment Date and on or prior to the twenty-sixth (26th) Payment Date, the Prepayment Premium shall
be an amount equal to 2.00% of the aggregate outstanding principal amount of the Loans being prepaid on such Redemption Date;
(E) after the twenty-sixth (26th) Payment Date and on or prior to the thirtieth (30th) Payment Date, the Prepayment Premium shall be an
amount equal to 1.00% of the aggregate outstanding principal amount of the Loans being prepaid on such Redemption Date;
(F) after the thirtieth (30th) Payment Date, the Prepayment Premium shall be an amount equal to 0.00% of the aggregate outstanding
principal amount of the Loans being prepaid on such Redemption Date;
provided that, to determine the aggregate outstanding principal amount of the Loans, and how many Payment Dates have occurred, as of
any Redemption Date for purposes of this definition:
(i) if, as of such Redemption Date, Borrower shall have made only one Borrowing, the number of Payment Dates shall be deemed to be
the number of Payment Dates that shall have occurred following the first Borrowing Date; and
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
(ii) if, as of such Redemption Date, Borrower shall have made more than one Borrowing, then the Prepayment Premium shall equal the
sum of multiple Prepayment Premiums calculated with respect to the Loans of each Borrowing, each of which Prepayment Premiums shall be
calculated based on solely the aggregate outstanding principal amount of the Loans borrowed in such Borrowing (and PIK Loans subsequently
borrowed in respect of interest payments thereon), as though the applicable number of Payment Dates equals the number of Payment Dates
that shall have occurred following the applicable Borrowing Date. In the case of any partial prepayment, the amount of such prepayment shall be
allocated to Loans made in the various Borrowings (and PIK Loans in respect thereof) in the order in which such Borrowings were made.
The Prepayment Premium payable upon any prepayment shall be in addition to any payments required pursuant to the Fee Letter.
“Redemption Date” means, as the context may require, (i) the Payment Date on which an optional prepayment is made pursuant to
Section 3.03(a), (ii) the date of an Asset Sale or Change of Control in connection with which a prepayment pursuant to Section 3.03(b), (iii) the
date mandated by a Requirement of Law as described in Section 5.02(b) and (iv) in the event that Loans become due and payable prior to the
Stated Maturity Date for any reason not related to the foregoing clauses (i) through (iii) (other than by reason of the Loans becoming due and
payable pursuant to an Acceleration), the date on which a prepayment is due.
“Redemption Price” means an amount equal to the aggregate principal amount of the Loans being prepaid plus the Prepayment
Premium plus any accrued but unpaid interest and any fees then due and owing (including the Back-End Facility Fee).
(c) The following Section 1.05 is hereby added to the Loan Agreement immediately following Section 1.04 of the Loan Agreement:
1.05 Divisions. For all purposes under the Loan Documents, in connection with any division or plan of division under Delaware law (or
any comparable event under a different jurisdiction’s laws): (a) if any asset, right, obligation or liability of any Person becomes the asset, right,
obligation or liability of a different Person, then it shall be deemed to have been transferred from the original Person to the subsequent Person,
and (b) if any new Person comes into existence, such new Person shall be deemed to have been organized on the first date of its existence by
the holders of its Equity Interests at such time.
(d) The first sentence of Section 3.02(d) of the Loan Agreement shall be amended to add a proviso at the end thereof as follows:
“provided that, for the Payment Dates commencing with the eleventh (11th) Payment Date following the Closing Date and continuing
through and including the twenty-fourth (24th) Payment Date following the Closing Date, Borrower may elect to pay such interest on the
outstanding principal amount of the Loans entirely in the form of PIK Loans provided further that no Default shall have occurred and be
continuing as of each such Payment Date.”
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
(e) The following Section 3.02(e) is hereby added to the Loan Agreement immediately following Section 3.02(d) of the Loan Agreement:
( e ) Redemption Price. For the avoidance of doubt, in the event any Loans shall become due and payable for any reason, interest
pursuant to Sections 3.02(a) and (b) shall accrue on the Redemption Price for such Loans from and after the date such Redemption Price is
due and payable until paid in full.
(f) Section 3.03(a) of the Loan Agreement is hereby amended and restated in its entirety as follows:
(a) Optional Prepayments . Upon prior written notice to Administrative Agent delivered pursuant to Section 4.03, Borrower shall have
the right to optionally prepay in whole or in part the outstanding principal amount of the Loans on any Business Day for the Redemption Price.
No partial prepayment shall be made under this Section 3.03(a) in connection with any event described in Section 3.03(b).
(g) Section 10.02 of the Loan Agreement shall be amended and restated to amend and restate clauses (f) through (h) in their entirety as follows:
“(f) during the twelve month period beginning on January 1, 2020, and every calendar year thereafter, of at least $10,000,000;
(g) during the twelve month period beginning on January 1, 2021, of at least $12,000,000; and
(h) during the twelve month period beginning on January 1, 2022, of at least $15,000,000.”
(h) Section 11.02 of the Loan Agreement is hereby amended and restated in its entirety as follows:
11.02 Remedies.
(a) Upon the occurrence of any Event of Default, then, and in every such event (other than an Event of Default described in Section
11.01(i), (j) or (k)), and at any time thereafter during the continuance of such event, the Majority Lenders may, by notice to Borrowers, take
either or both of the following actions, at the same or different times: (i) terminate the Commitments, and thereupon the Commitments shall
terminate immediately, and (ii) declare the Loans then outstanding to be due and payable in whole (or in part, in which case any principal not so
declared to be due and payable may thereafter be declared to be due and payable) (an “acceleration”), and thereupon the principal of the Loans
so declared to be due and payable, together with accrued interest thereon and all fees and other Obligations shall become due and payable
immediately and the Obligors shall immediately pay all Obligations, including the Back-End Facility Fee and an Acceleration Premium as
calculated below, all without presentment, demand, protest or other notice of any kind, all of which are hereby waived by each Obligor.
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
(b) Upon the occurrence of any Event of Default described in Section 11.01(i), (j) or (k), the Commitments shall automatically
terminate and the principal of the Loans then outstanding, together with accrued interest thereon and all fees and other Obligations, shall
automatically become due and payable immediately (an “acceleration” and, together with any acceleration defined in Section 11.02(a), each,
an “Acceleration”) and the Obligors shall immediately pay all Obligations, including the Back-End Facility Fee and an Acceleration Premium as
calculated below, all without presentment, demand, protest or other notice of any kind, all of which are hereby waived by each Obligor.
(c) Acceleration Premium Calculation. The applicable “Acceleration Premium” shall be an amount calculated as follows:
(i) If the date of Acceleration occurs:
(A) on or prior to the fourteenth (14th) Payment Date, the Acceleration Premium shall be an amount equal to 5.00% of the aggregate
outstanding principal amount of the Loans subject to the Acceleration;
(B) after the fourteenth (14th) Payment Date and on or prior to the eighteenth (18th) Payment Date, the Acceleration Premium shall
be an amount equal to 4.00% of the aggregate outstanding principal amount of the Loans subject to the Acceleration;
(C) after the eighteenth (18th) Payment Date and on or prior to the twenty-second (22nd) Payment Date, the Acceleration Premium
shall be an amount equal to 3.00% of the aggregate outstanding principal amount of the Loans subject to the Acceleration;
(D) after the twenty-second (22nd) Payment Date and on or prior to the twenty-sixth (26th) Payment Date, the Acceleration Premium
shall be an amount equal to 2.00% of the aggregate outstanding principal amount of the Loans subject to the Acceleration;
(E) after the twenty-sixth (26th) Payment Date and on or prior to the thirtieth (30th) Payment Date, the Acceleration Premium shall be
an amount equal to 1.00% of the aggregate outstanding principal amount of the Loans subject to the Acceleration; and
(F) after the thirtieth (30th) Payment Date, the Acceleration Premium shall be an amount equal to 0.00% of the aggregate principal
amount of the Loans subject to the Acceleration.
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
(ii) To determine the aggregate outstanding principal amount of the Loans subject to the Acceleration, and how many Payment Dates
have occurred, as of any date of Acceleration, for purposes of this Section 11.02(c):
(A) if, as of such date of Acceleration, Borrowers shall have made only one Borrowing, the number of Payment Dates shall be deemed
to be the number of Payment Dates that shall have occurred following the first Borrowing Date; and
(B) if, as of such date of Acceleration, Borrowers shall have made more than one Borrowing, then the Acceleration Premium shall
equal the sum of multiple Acceleration Premiums calculated with respect to the Loans of each Borrowing, each of which Acceleration Premiums
shall be calculated based on solely the aggregate outstanding principal amount of the Loans borrowed in such Borrowing (and PIK Loans
subsequently borrowed in respect of interest payments thereon), as though the applicable number of Payment Dates equals the number of
Payment Dates that shall have occurred following the applicable Borrowing Date. In the case that the Loans subject to Acceleration does not
equal the full principal amount of Loans outstanding, the amount of such payment shall be allocated to Loans made in the various Borrowings
(and PIK Loans in respect thereof) in the order in which such Borrowings were made.
(d) (i) For the avoidance of doubt, the Acceleration Premium and the Back-End Facility Fee that are payable upon Acceleration of the
Loans shall be due and payable at any time the Loans become due and payable prior to the Stated Maturity Date due to Acceleration pursuant
to the terms of this Agreement (in which case it shall be due immediately, upon the giving of notice to Borrowers in accordance with Section
11.02(a), or automatically, in accordance with Section 11.02(b)), whether by operation of law or otherwise (including where bankruptcy filings or
the exercise of any bankruptcy right or power, whether in any plan of reorganization or otherwise, ☒results or would result in a payment,
discharge, modification or other treatment of the Loans or Loan Documents that would otherwise evade, avoid, or otherwise disappoint the
expectations of Lenders in receiving the full benefit of their bargained-for Acceleration Premium and their bargained-for Back-End Facility Fee as
provided herein and in the Fee Letter). The Obligors and Lenders acknowledge and agree that any Acceleration Premium and the Back-End
Facility Fee due and payable in accordance with the Loan Documents shall not constitute unmatured interest, whether under section 502(b)(2) of
the Bankruptcy Code or otherwise, but instead is reasonably calculated to ensure that the Lenders receive the benefit of their bargain under the
terms of this Agreement, whether in a bankruptcy case or otherwise.
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
(ii) Each Obligor acknowledges and agrees that, prior to executing this Agreement, it has had the opportunity to review, evaluate and
negotiate the Acceleration Premium calculation and the Back-End Facility Fee with its advisors and acknowledges that the Acceleration
Premium is a reasonable approximation of Lenders’ liquidated damages upon Acceleration and, accordingly, each Obligor will not contest or
object to the reasonableness thereof. Each Obligor understands and acknowledges that Lenders have entered into this Agreement in reliance
upon the Acceleration Premium and the Back-End Facility Fee. Each Obligor acknowledges and agrees that the Lenders shall be entitled to
recover the full amount of the Obligations, including the Acceleration Premium and the Back-End Facility Fee in each and every circumstance in
which such amount is due pursuant to or in connection with this Agreement and the Fee Letter, including in the case of any Obligor’s bankruptcy
filing, so that the Lenders shall receive the benefit of their bargain hereunder and otherwise receive full recovery of the agreed-upon return under
every possible circumstance, and each Borrower hereby waives any defense to payment, whether such defense may be based in public policy,
ambiguity, or otherwise. Each Obligor further acknowledges and agrees, and waives any argument to the contrary, that payment of such
amounts does not constitute a penalty or an otherwise unenforceable or invalid obligation. Any damages that the Lenders may suffer or incur
resulting from or arising in connection with any breach by any Borrower shall constitute secured obligations owing to the Lenders.
(iii) For the avoidance of doubt, in the event of any Acceleration, interest pursuant to Sections 3.02(a) and (b) shall accrue on all
Obligations, including the Back-End Facility Fee and any Acceleration Premium, from and after the date such Obligations are due and payable
until paid in full.
(e) In the event of an Acceleration under this Section 11.02, no Prepayment Premium will be due and payable; provided that the
Acceleration Premium will be due and payable as aforesaid.
(i) The following Section 13.10 is hereby added to the Loan Agreement immediately following Section 13.09 of the Loan Agreement:
13.10 Redemption Price.
(a) For the avoidance of doubt, the Prepayment Premium (as a component of the Redemption Price) and Back-End Facility Fee shall be
due and payable whenever so stated in this Agreement (and the Fee Letter, as applicable), or by any applicable operation of law, regardless of
the circumstances causing any related payment prior to the Stated Maturity Date (other than an Acceleration, in which case the Acceleration
Premium instead shall be payable).
(b) The Obligors and the Lenders acknowledge and agree that any Prepayment Premium due and payable in accordance with the Loan
Documents shall not constitute unmatured interest, whether under section 502(b)(2) of the Bankruptcy Code or otherwise, but instead is
reasonably calculated to ensure that the Lenders receive the benefit of their bargain under the terms of this Agreement.
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
(c) Each Obligor acknowledges and agrees that, prior to executing this Agreement, it has had the opportunity to review, evaluate and
negotiate the Prepayment Premium calculation with its advisors and acknowledges that the Prepayment Premium is a reasonable approximation
of the Lenders’ liquidated damages upon repayment on any Redemption Date or other day on which payment is due or made prior to the Stated
Maturity Date and, accordingly, each Obligor will not contest or object to the reasonableness thereof. Each Obligor understands and
acknowledges that the Lenders have entered into this Agreement in reliance upon the Prepayment Premium. Each Obligor acknowledges and
agrees that the Lenders shall be entitled to recover the full amount of the Obligations, including the Prepayment Premium in each and every
circumstance in which such amount is due pursuant to or in connection with this Agreement, so that the Lenders shall receive the benefit of their
bargain hereunder and otherwise receive full recovery of the agreed-upon return under every possible circumstance, and each Borrower hereby
waives any defense to payment, whether such defense may be based in public policy, ambiguity, or otherwise. Each Obligor further
acknowledges and agrees, and waives any argument to the contrary, that payment of such amounts does not constitute a penalty or an
otherwise unenforceable or invalid obligation. Any damages that the Lenders may suffer or incur resulting from or arising in connection with any
breach by any Borrower shall constitute secured obligations owing to the Lenders.
(j) Annex B of Exhibit E of the Loan Agreement is hereby replaced in its entirety by Annex B to Compliance Certificate attached hereto.
SECTION 3. Conditions of Effectiveness. The effectiveness of Section 2 shall be subject to the following conditions precedent:
(a) Borrower and all of the Lenders shall have duly executed and delivered this Amendment pursuant to Section 12.04 of the Loan Agreement;
provided, however, that this Amendment shall have no binding force or effect unless all conditions set forth in this Section 3 have been satisfied;
(b) No Default or Event of Default under the Loan Agreement shall have occurred and be continuing; and
(c) The Borrower shall have paid or reimbursed Lenders for Lenders’ reasonable out of pocket costs and expenses incurred in connection with this
Amendment, including Lenders’ reasonable and documented out of pocket legal fees and costs, pursuant to Section 12.03(a)(i)(z) of the Loan Agreement.
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
SECTION 4. Representations and Warranties; Reaffirmation.
(a) The Borrower hereby represents and warrants to each Lender as follows:
(i) The Borrower has full power, authority and legal right to make and perform this Amendment. This Amendment is within the Borrower’s
corporate powers and has been duly authorized by all necessary corporate and, if required, by all necessary shareholder action. This Amendment has been duly
executed and delivered by the Borrower and constitutes a legal, valid and binding obligation of the Borrower, enforceable against the Borrower in accordance
with its terms, except as such enforceability may be limited by (a) bankruptcy, insolvency, reorganization, moratorium or similar laws of general applicability
affecting the enforcement of creditors’ rights and (b) the application of general principles of equity (regardless of whether such enforceability is considered in a
proceeding in equity or at law). This Amendment (x) does not require any consent or approval of, registration or filing with, or any other action by, any
Governmental Authority or any third party, except for such as have been obtained or made and are in full force and effect and the filing of a copy of this
Amendment with the SEC following its effectiveness, (y) will not violate any applicable law or regulation or the charter, bylaws or other organizational
documents of the Borrower and its Subsidiaries or any order of any Governmental Authority, other than any such violations that, individually or in the aggregate,
could not reasonably be expected to have a Material Adverse Effect, (z) will not violate or result in an event of default under any material indenture, agreement or
other instrument binding upon the Borrower and its Subsidiaries or assets, or give rise to a right thereunder to require any payment to be made by any such
Person.
(ii) No Default has occurred or is continuing or will result after giving effect to this Amendment.
(iii) The representations and warranties made by or with respect to the Borrower in Section 7 of the Loan Agreement are (A) in the case of
representations qualified by “materiality,” “Material Adverse Effect” or similar language, true and correct in all respects and (B) in the case of all other
representations and warranties, true and correct in all material respects (except that the representation regarding representations and warranties that refer to a
specific earlier date are true and correct on the basis set forth above as of such earlier date), in each case taking into account any changes made to schedules
updated in accordance with Section 7.21 of the Loan Agreement or attached hereto.
(iv) There has been no Material Adverse Effect since the date of the Loan Agreement.
(b) The Borrower hereby ratifies, confirms, reaffirms, and acknowledges its obligations under the Loan Documents to which it is a party and agrees that
the Loan Documents remain in full force and effect, undiminished by this Amendment, except as expressly provided herein. By executing this Amendment, the
Borrower acknowledges that it has read, consulted with its attorneys regarding, and understands, this Amendment.
SECTION 5. GOVERNING LAW; SUBMISSION TO JURISDICTION; WAIVER OF JURY TRIAL .
(a) Governing Law. This Amendment and the rights and obligations of the parties hereunder shall be governed by, and construed in accordance with,
the law of the State of New York, without regard to principles of conflicts of laws that would result in the application of the laws of any other jurisdiction; provided
that Section 5-1401 of the New York General Obligations Law shall apply.
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
(b) Submission to Jurisdiction. The Borrower agrees that any suit, action or proceeding with respect to this Amendment or any other Loan
Document to which it is a party or any judgment entered by any court in respect thereof may be brought initially in the federal or state courts in Houston, Texas
or in the courts of its own corporate domicile and irrevocably submits to the non-exclusive jurisdiction of each such court for the purpose of any such suit, action,
proceeding or judgment. This Section 5 is for the benefit of the Lenders only and, as a result, no Lender shall be prevented from taking proceedings in any other
courts with jurisdiction. To the extent allowed by applicable Laws, the Lenders may take concurrent proceedings in any number of jurisdictions.
(c) Waiver of Jury Trial. The Borrower and each Lender hereby irrevocably waives, to the fullest extent permitted by applicable law, any and all right
to trial by jury in any suit, action or proceeding arising out of or relating to this Amendment, the other Loan Documents or the transactions contemplated hereby
or thereby.
SECTION 6. Miscellaneous.
(a) No Waiver. Nothing contained herein shall be deemed to constitute a waiver of compliance with any term or condition contained in the Loan
Agreement or any of the other Loan Documents or constitute a course of conduct or dealing among the parties. Except as expressly stated herein, the Lenders
reserve all rights, privileges and remedies under the Loan Documents. Except as amended hereby, the Loan Agreement and other Loan Documents remain
unmodified and in full force and effect. All references in the Loan Documents to the Loan Agreement shall be deemed to be references to the Loan Agreement
as amended hereby.
(b) Severability. In case any provision of or obligation under this Amendment shall be invalid, illegal or unenforceable in any jurisdiction, the validity,
legality and enforceability of the remaining provisions or obligations, or of such provision or obligation in any other jurisdiction, shall not in any way be affected
or impaired thereby.
(c) Headings. Headings and captions used in this Amendment (including the Exhibits, Schedules and Annexes hereto, if any) are included for
convenience of reference only and shall not be given any substantive effect.
(d) Integration. This Amendment constitutes a Loan Document and, together with the other Loan Documents, incorporates all negotiations of the
parties hereto with respect to the subject matter hereof and is the final expression and agreement of the parties hereto with respect to the subject matter hereof.
(e) Counterparts. This Amendment may be executed in any number of counterparts, all of which taken together shall constitute one and the same
instrument and any of the parties hereto may execute this Amendment by signing any such counterpart.
(f) Controlling Provisions. In the event of any inconsistencies between the provisions of this Amendment and the provisions of any other Loan
Document, the provisions of this Amendment shall govern and prevail. Except as expressly modified by this Amendment, the Loan Documents shall not be
modified and shall remain in full force and effect.
[Remainder of page intentionally left blank]
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
IN WITNESS WHEREOF, the parties hereto have duly executed this Amendment, as of the date first above written.
BORROWER:
AVINGER, INC.
By:
/s/ Mark Weinswig
Name: Mark Weinswig
Title: Chief Financial Officer
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
LENDERS:
CRG PARTNERS III L.P.
By Crg PARTNERS III GP L.P., its General Partner
By Crg PARTNERS III GP LLC, its General Partner
By /s/ Nathan Hukill__________________
Name: Nathan Hukill
Title: Authorized Signatory
Address for Notices:
1000 Main Street, Suite 2500
Houston, TX 77002
Attn: General Counsel
Tel.: 713.209.7350
Fax: 713.209.7351
Email: adorenbaum@crglp.com
CRG PARTNERS III – PARALLEL FUND “A” L.P.
By Crg PARTNERS III – PARALLEL FUND “A” GP L.P., its General Partner
By Crg PARTNERS III GP LLC, its General Partner
By /s/ Nathan Hukill__________________
Name: Nathan Hukill
Title: Authorized Signatory
Address for Notices:
1000 Main Street, Suite 2500
Houston, TX 77002
Attn:
Tel.:
Fax:
Email: adorenbaum@crglp.com
General Counsel
713.209.7350
713.209.7351
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
CRG PARTNERS III – PARALLEL FUND “B” (CAYMAN) L.P.
By Crg PARTNERS III (Cayman) GP L.P., its General Partner
By Crg PARTNERS III GP LLC, its General Partner
By /s/ Nathan Hukill__________________
Name: Nathan Hukill
Title: Authorized Signatory
WITNESS: /s/ Nicole Nesson
Name: Nicole Nesson
Address for Notices:
1000 Main Street, Suite 2500
Houston, TX 77002
Attn:
Tel.:
Fax:
Email: adorenbaum@crglp.com
General Counsel
713.209.7350
713.209.7351
CRG PARTNERS III (CAYMAN) LEV AIV L.P.
By Crg PARTNERS III (Cayman) GP L.P., its General Partner
By Crg PARTNERS III GP LLC, its General Partner
By /s/ Nathan Hukill__________________
Name: Nathan Hukill
Title: Authorized Signatory
WITNESS: /s/ Nicole Nesson
Name: Nicole Nesson
Address for Notices:
1000 Main Street, Suite 2500
Houston, TX 77002
Attn:
Tel.:
Fax:
Email: adorenbaum@crglp.com
General Counsel
713.209.7350
713.209.7351
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
I.
A.
II.
B.
A.
B.
C.
D.
E.
F.
G.
H.
Annex [B] to Compliance Certificate
CALCULATIONS OF FINANCIAL COVENANT COMPLIANCE
Section 10.01: Minimum Liquidity
Amount of unencumbered (other than Liens securing the Obligations and Liens permitted
pursuant to Section 9.02(c) and 9.02(j), provided that with respect to cash subject to a Permitted
Priority Lien in connection with Permitted Priority Debt, there is no event of default under the
documentation governing the Permitted Priority Debt) cash and Permitted Cash Equivalent
Investments (which for greater certainty shall not include any undrawn credit lines), in each case,
to the extent held in an account over which the Lenders (or the Control Agent on behalf of the
Lenders) have (or has) a perfected security interest:
$__________
$3,500,000
Is Line IA equal to or greater than Line IB?:
$3,500,000
Yes: In compliance; No: Not in
compliance
Section 10.02(a)-(h): Minimum Revenue—Subsequent Periods
Revenues during the twelve month period beginning on January 1, 2015
$__________
[Is line II.A equal to or greater than $7,000,000?
Yes: In compliance; No: Not in
compliance]1
Revenues during the twelve month period beginning on January 1, 2016
$__________
[Is line II.B equal to or greater than $18,000,000?
Revenues during the twelve month period beginning on January 1, 2017
Revenues during the twelve month period beginning on January 1, 2018
Revenues during the twelve month period beginning on January 1, 2019
Revenues during the twelve month period beginning on January 1, 2020
[Is line I I.E equal to or greater than $10,000,000?
Revenues during the twelve month period beginning on January 1, 2021
[Is line II.E equal to or greater than $12 ,000,000?
Revenues during the twelve month period beginning on January 1, 2022
[Is line II.E equal to or greater than $15 ,000,000?
Yes: In compliance; No: Not in
compliance]2
N/A
N/A
N/A
Yes: In compliance; No: Not in
compliance]3
Yes: In compliance; No: Not in
compliance]4
Yes: In compliance; No: Not in
compliance]5
1 Include bracketed entry only on the Compliance Certificate to be delivered within 90 days of the end of 2015 pursuant to Section 8.01(b) of the Loan
Agreement.
2 Include bracketed entry only on the Compliance Certificate to be delivered within 90 days of the end of 2016 pursuant to Section 8.01(b) of the Loan
Agreement.
3 Include bracketed entry only on the Compliance Certificate to be delivered within 90 days of the end of 2020 pursuant to Section 8.01(b) of the Loan
Agreement.
4 Include bracketed entry only on the Compliance Certificate to be delivered within 90 days of the end of 2021 pursuant to Section 8.01(b) of the Loan
Agreement.
5 Include bracketed entry only on the Compliance Certificate to be delivered within 90 days of the end of 2022 pursuant to Section 8.01(b) of the Loan
Agreement.
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
AMENDMENT NO. 1 TO THE
CHANGE OF CONTROL AND SEVERANCE AGREEMENT
Exhibit 10.42
This Amendment No. 1 (this “ Amendment”) to the Agreement (defined below) is entered into and made effective on March 4, 2020 (“ Effective Date ”),
by Jeffrey M. Soinski (“Executive”) and Avinger, Inc. (“ Company”). This Amendment amends the Change of Control and Severance Agreement entered into
between Executive and Company on March 29, 2018 (the “Agreement”).
WHEREAS, the Agreement may be amended or modified by a written instrument executed by Company and Executive;
WHEREAS, Company and Executive desire to amend certain provisions of the Agreement;
NOW, THERFORE, Company and Executive intending to be legally bound hereby enter into this Amendment and agree as follows:
1. Termination for other than Cause, Death or Disability or Good Reason in the Event of a Change of Control. Section 1(a) of the Agreement is
hereby amended and restated to read as follows:
(a) Termination for other than Cause, Death or Disability or Good Reason in the Event of a Change of Control
. If upon or within eighteen (18) months
following a Change of Control (i) the Company (or any parent or subsidiary or successor of the Company) terminates Executive’s employment with the
Company other than for Cause, death or disability, or (ii) the Executive resigns from such employment for Good Reason, then, subject to Section 2,
Executive will be entitled to: (A) receive continuing payments of severance pay at a rate equal to Executive’s monthly base salary and pro rated target
bonus, as then in effect, for a period of twelve (12) months plus one (1) month for every year of service completed (measured from Executive’s date of
hire until the Change of Control) for the Company (or any parent or subsidiary or successor of the Company); provided that, such severance period shall
not exceed eighteen (18) months and such continuing payments will be paid in accordance with the Company’s regular payroll procedures; (B) if
Executive timely elects continuation coverage pursuant to the Consolidated Omnibus Budget Reconciliation Act of 1985, as amended (“COBRA”) for
Executive and Executive’s dependents, within the time period prescribed pursuant to COBRA, the Company will reimburse Executive for the COBRA
premiums for such coverage for Executive and his covered dependents for twelve (12) months from the date of Executive’s termination of employment or
such earlier date if Executive no longer constitutes a “Qualified Beneficiary” (as such term is defined in Section 4980B(g) of the Code); (C) accelerated
vesting as to 100% of Executive’s outstanding unvested stock options and/or restricted stock; and (D) the extension of the post-termination exercise
period for any options held by Executive for a period of one (1) year. Notwithstanding the foregoing, Executive will not be entitled to any payment under
Section 1(a)(A) if Executive has received a bonus pursuant to Section 1(e).
2. Stay Bonus. Section 1(e) of the Agreement is hereby added and will read as follows:
( e ) Stay Bonus. If upon the date that is twelve (12) months following a Change of Control Executive is employed by the Company (or any parent or
subsidiary or successor of the Company), then Executive will be entitled to receive a lump sum bonus payment in an amount equal to what Executive
would be entitled to receive under Section 1(a)(A) had Executive been terminated other than for Cause, death or disability. Any bonus payable pursuant
to this Section 1(e) shall be paid upon the date that is twelve (12) months following a Change of Control. If payment is made pursuant to this Section
1(e), Executive will not be entitled to any payment under Section 1(a)(A).
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
3 . Amendment. This Amendment shall be binding upon and inure to the benefit of the parties hereto, and their respective heirs, executors,
administrators, successors, and assigns, who are obligated to take any action which may be necessary or proper to carry out the purpose and intent hereof.
4 . Effect on Agreement; Capitalized Terms. Except as expressly modified or amended by this Amendment, the Agreement shall continue in full
force and effect in accordance with its terms. All capitalized terms not otherwise defined herein shall have the meaning set forth in the Agreement.
5. Counterparts. This Amendment may be executed in any number of counterparts, each of which shall be deemed an original and all of which taken
together shall constitute a single instrument.
6. Governing Law. This Amendment shall be construed and enforced with, and governed by, the laws of the State of California.
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
IN WITNESS WHEREOF, the following, being Company and Executive, have executed this Amendment to be effective as of the Effective Date.
COMPANY:
AVINGER, INC.
By: /s/ Mark Weinswig
Name: Mark Weinswig
Title: Chief Financial Officer
EXECUTIVE:
/s/ Jeffrey M. Soinski
Jeffrey M. Soinski
[Signature Page to Amendment to Change of Control and Severance Agreement ]
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
AMENDMENT NO. 1 TO THE
CHANGE OF CONTROL AND SEVERANCE AGREEMENT
Exhibit 10.43
This Amendment No. 1 (this “ Amendment”) to the Agreement (defined below) is entered into and made effective on March 4, 2020 (“ Effective Date ”),
by Himanshu Patel (“Executive”) and Avinger, Inc. (“ Company”). This Amendment amends the Change of Control and Severance Agreement entered into
between Executive and Company on October 10, 2013 (the “Agreement”).
WHEREAS, the Agreement may be amended or modified by a written instrument executed by Company and Executive;
WHEREAS, Company and Executive desire to amend certain provisions of the Agreement;
NOW, THERFORE, Company and Executive intending to be legally bound hereby enter into this Amendment and agree as follows:
1. Termination for other than Cause, Death or Disability or Good Reason in the Event of a Change of Control. Section 1(a) of the Agreement is
hereby amended and restated to read as follows:
(a) Termination for other than Cause, Death or Disability or Good Reason in the Event of a Change of Control
. If upon or within eighteen (18) months
following a Change of Control (i) the Company (or any parent or subsidiary or successor of the Company) terminates Executive’s employment with the
Company other than for Cause, death or disability, or (ii) the Executive resigns from such employment for Good Reason, then, subject to Section 2,
Executive will be entitled to: (A) receive continuing payments of severance pay at a rate equal to Executive’s monthly base salary and pro rated target
bonus, as then in effect, for a period of twelve (12) months plus one (1) month for every year of service completed (measured from Executive’s date of
hire until the Change of Control) for the Company (or any parent or subsidiary or successor of the Company); provided that, such severance period shall
not exceed eighteen (18) months and such continuing payments will be paid in accordance with the Company’s regular payroll procedures; (B) if
Executive timely elects continuation coverage pursuant to the Consolidated Omnibus Budget Reconciliation Act of 1985, as amended (“COBRA”) for
Executive and Executive’s dependents, within the time period prescribed pursuant to COBRA, the Company will reimburse Executive for the COBRA
premiums for such coverage for Executive and his covered dependents for twelve (12) months from the date of Executive’s termination of employment or
such earlier date if Executive no longer constitutes a “Qualified Beneficiary” (as such term is defined in Section 4980B(g) of the Code); (C) accelerated
vesting as to 100% of Executive’s outstanding unvested stock options and/or restricted stock; and (D) the extension of the post-termination exercise
period for any options held by Executive for a period of one (1) year. Notwithstanding the foregoing, Executive will not be entitled to any payment under
Section 1(a)(A) if Executive has received a bonus pursuant to Section 1(e).
2. Stay Bonus. Section 1(e) of the Agreement is hereby added and will read as follows:
( e ) Stay Bonus. If upon the date that is twelve (12) months following a Change of Control Executive is employed by the Company (or any parent or
subsidiary or successor of the Company), then Executive will be entitled to receive a lump sum bonus payment in an amount equal to what Executive
would be entitled to receive under Section 1(a)(A) had Executive been terminated other than for Cause, death or disability. Any bonus payable pursuant
to this Section 1(e) shall be paid upon the date that is twelve (12) months following a Change of Control. If payment is made pursuant to this Section
1(e), Executive will not be entitled to any payment under Section 1(a)(A).
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
3 . Amendment. This Amendment shall be binding upon and inure to the benefit of the parties hereto, and their respective heirs, executors,
administrators, successors, and assigns, who are obligated to take any action which may be necessary or proper to carry out the purpose and intent hereof.
4 . Effect on Agreement; Capitalized Terms. Except as expressly modified or amended by this Amendment, the Agreement shall continue in full
force and effect in accordance with its terms. All capitalized terms not otherwise defined herein shall have the meaning set forth in the Agreement.
5. Counterparts. This Amendment may be executed in any number of counterparts, each of which shall be deemed an original and all of which taken
together shall constitute a single instrument.
6. Governing Law. This Amendment shall be construed and enforced with, and governed by, the laws of the State of California.
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
IN WITNESS WHEREOF, the following, being Company and Executive, have executed this Amendment to be effective as of the Effective Date.
COMPANY:
AVINGER, INC.
By: /s/ Jeffrey Soinski
Name: Jeffrey Soinski
Title: President and Chief Executive Officer
EXECUTIVE:
/s/ Himanshu Patel
Himanshu Patel
[Signature Page to Amendment to Change of Control and Severance Agreement ]
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
AMENDMENT NO. 1 TO THE
CHANGE OF CONTROL AND SEVERANCE AGREEMENT
Exhibit 10.44
This Amendment No. 1 (this “ Amendment”) to the Agreement (defined below) is entered into and made effective on March 4, 2020 (“ Effective Date ”),
by Mark Weinswig (“Executive”) and Avinger, Inc. (“ Company”). This Amendment amends the Change of Control and Severance Agreement entered into
between Executive and Company on June 25, 2018 (the “Agreement”).
WHEREAS, the Agreement may be amended or modified by a written instrument executed by Company and Executive;
WHEREAS, Company and Executive desire to amend certain provisions of the Agreement;
NOW, THERFORE, Company and Executive intending to be legally bound hereby enter into this Amendment and agree as follows:
1. Termination for other than Cause, Death or Disability or Good Reason in the Event of a Change of Control. Section 1(a) of the Agreement is
hereby amended and restated to read as follows:
(a) Termination for other than Cause, Death or Disability or Good Reason in the Event of a Change of Control
. If upon or within eighteen (18) months
following a Change of Control (i) the Company (or any parent or subsidiary or successor of the Company) terminates Executive’s employment with the
Company other than for Cause, death or disability, or (ii) the Executive resigns from such employment for Good Reason, then, subject to Section 2,
Executive will be entitled to: (A) receive continuing payments of severance pay at a rate equal to Executive’s monthly base salary and pro rated target
bonus, as then in effect, for a period of twelve (12) months plus one (1) month for every year of service completed (measured from Executive’s date of
hire until the Change of Control) for the Company (or any parent or subsidiary or successor of the Company); provided that, such severance period shall
not exceed eighteen (18) months and such continuing payments will be paid in accordance with the Company’s regular payroll procedures; (B) if
Executive timely elects continuation coverage pursuant to the Consolidated Omnibus Budget Reconciliation Act of 1985, as amended (“COBRA”) for
Executive and Executive’s dependents, within the time period prescribed pursuant to COBRA, the Company will reimburse Executive for the COBRA
premiums for such coverage for Executive and his covered dependents for twelve (12) months from the date of Executive’s termination of employment or
such earlier date if Executive no longer constitutes a “Qualified Beneficiary” (as such term is defined in Section 4980B(g) of the Code); (C) accelerated
vesting as to 100% of Executive’s outstanding unvested stock options and/or restricted stock; and (D) the extension of the post-termination exercise
period for any options held by Executive for a period of one (1) year. Notwithstanding the foregoing, Executive will not be entitled to any payment under
Section 1(a)(A) if Executive has received a bonus pursuant to Section 1(e).
2. Stay Bonus. Section 1(e) of the Agreement is hereby added and will read as follows:
( e ) Stay Bonus. If upon the date that is twelve (12) months following a Change of Control Executive is employed by the Company (or any parent or
subsidiary or successor of the Company), then Executive will be entitled to receive a lump sum bonus payment in an amount equal to what Executive
would be entitled to receive under Section 1(a)(A) had Executive been terminated other than for Cause, death or disability. Any bonus payable pursuant
to this Section 1(e) shall be paid upon the date that is twelve (12) months following a Change of Control. If payment is made pursuant to this Section
1(e), Executive will not be entitled to any payment under Section 1(a)(A).
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
3 . Amendment. This Amendment shall be binding upon and inure to the benefit of the parties hereto, and their respective heirs, executors,
administrators, successors, and assigns, who are obligated to take any action which may be necessary or proper to carry out the purpose and intent hereof.
4 . Effect on Agreement; Capitalized Terms. Except as expressly modified or amended by this Amendment, the Agreement shall continue in full
force and effect in accordance with its terms. All capitalized terms not otherwise defined herein shall have the meaning set forth in the Agreement.
5. Counterparts. This Amendment may be executed in any number of counterparts, each of which shall be deemed an original and all of which taken
together shall constitute a single instrument.
6. Governing Law. This Amendment shall be construed and enforced with, and governed by, the laws of the State of California.
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
IN WITNESS WHEREOF, the following, being Company and Executive, have executed this Amendment to be effective as of the Effective Date.
COMPANY:
AVINGER, INC.
By: /s/ Jeffrey Soinski
Name: Jeffrey Soinski
Title: President and Chief Executive Officer
EXECUTIVE:
/s/ Mark Weinswig
Mark Weinswig
[Signature Page to Amendment to Change of Control and Severance Agreement ]
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
Consent of Independent Registered Public Accounting Firm
We consent to the incorporation by reference in the Registration Statements on Form S-1 (Nos. 333-222517, 333-227308, and 333-227689), Form S-3 (No.
333-230124) and Form S-8 (Nos. 333-201928, 333-209364, 333-216695, 333-227072 and 333-233498) pertaining to the 2015 Equity Incentive Plan and the
Officer and Director Share Purchase Plan of Avinger, Inc., of our report dated March 5, 2020, relating to the financial statements of Avinger, Inc., which report
expresses an unqualified opinion and includes explanatory paragraphs relating to a going concern emphasis, a change in the method of accounting for leases
and a change in the method of accounting for revenue recognition, appearing in this Annual Report on Form 10-K for the year ended December 31, 2019.
Exhibit 23.1
/s/ Moss Adams LLP
San Francisco, California
March 5, 2020
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
CERTIFICATION OF THE CHIEF EXECUTIVE OFFICER
Pursuant to
Securities Exchange Act Rules 13a-14(a) and 15d-14(a),
As Adopted Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002
Exhibit 31.1
I, Jeffrey Soinski, hereby certify that:
1. I have reviewed this Annual Report on Form 10-K of Avinger, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this Annual Report on Form 10-K, fairly present in all
material respects the financial condition, results of operations, and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the
registrant and have:
a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, is made known to us by others within those entities, particularly during the period in which
this report is being prepared;
b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting principles;
c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this Annual Report on Form 10-K based on such
evaluation; and
d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during registrant’s most recent
fiscal quarter (the registrant’s fourth quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the
registrant’s internal control over financial reporting;
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the
registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a) all significant deficiencies and material weakness in the design or operation of internal control over financial reporting which are reasonably
likely to adversely affect the registrant’s ability to record, process, summarize, and report financial information; and
b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control
over financial reporting.
Dated: March 5, 2020
/s/ Jeffrey M. Soinski
Jeffrey M. Soinski
Chief Executive Officer
(Principal Executive Officer)
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
CERTIFICATION OF THE CHIEF FINANCIAL OFFICER
Pursuant to
Securities Exchange Act Rules 13a-14(a) and 15d-14(a),
As Adopted Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002
Exhibit 31.2
I, Mark Weinswig, hereby certify that:
1. I have reviewed this Annual Report on Form 10-K of Avinger, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the
financial condition, results of operations, and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the
registrant and have:
a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, is made known to us by others within those entities, particularly during the period in which
this report is being prepared;
b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting principles;
c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report; and
d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during registrant’s most recent
fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect,
the registrant’s internal control over financial reporting;
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the
registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a) all significant deficiencies and material weakness in the design or operation of internal control over financial reporting which are reasonably
likely to adversely affect the registrant’s ability to record, process, summarize, and report financial information; and
b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control
over financial reporting.
Dated: March 5, 2020
/s/ Mark Weinswig
Mark Weinswig
Chief Financial Officer
(Principal Financial and Accounting Officer)
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.
CERTIFICATIONS OF CHIEF EXECUTIVE OFFICER
AND CHIEF FINANCIAL OFFICER
PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
Exhibit 32.1
In connection with the Annual Report of Avinger, Inc. (the “Company”) on Form 10-K for the period ended December 31, 2019, as filed with the Securities and
Exchange Commission (the “Report”), Jeffrey Soinski, as Chief Executive Officer of the Company, and Mark Weinswig, Chief Financial Officer of the
Company, each hereby certifies, pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. Section 1350), to his knowledge:
1.
2.
The Report fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934; and
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
IN WITNESS WHEREOF, the undersigned have set their hands hereto as of the 5th day of March, 2020.
/s/ Jeffrey M. Soinski
Jeffrey M. Soinski
Chief Executive Officer
(Principal Executive Officer)
/s/ Mark Weinswig
Mark Weinswig
Chief Financial Officer
(Principal Financial and Accounting Officer)
This certification accompanies the Form 10-K to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be
incorporated by reference into any filing of the Registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended
(whether made before or after the date of the Form 10-K), irrespective of any general incorporation language contained in such filing.
EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.