UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549
FORM 10-K
(Mark One)
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For the fiscal year ended January 2, 2021
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITY EXCHANGE ACT OF 1934
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITY EXCHANGE ACT OF 1934
or
For the transition period from to .
Commission File Number 0-27598
IRIDEX CORPORATION
(Exact name of Registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation or organization)
77-0210467
(I.R.S. Employer Identification No.)
1212 Terra Bella Avenue
Mountain View, CA
(Address of principal executive offices)
Title of each class
Common Stock, par value $0.01 per share
(650) 940-4700
(Registrant’s telephone number, including area code)
94043
(Zip Code)
Securities registered pursuant to Section 12(b) of the Act:
Trading Symbol
IRIX
Name of Exchange on Which Registered
Nasdaq Global 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 of 1933. 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 Securities Exchange Act of 1934 (the “Exchange 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 Exchange Act 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 (§ 232.405 of this chapter)
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 the
definition of “large accelerated filer”, “accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.:
Large accelerated filer
Non-accelerated filer
Emerging growth company
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☑
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Accelerated filer
Smaller reporting company
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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 has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting
under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☑
The aggregate market value of the voting common equity held by non-affiliates of the Registrant was approximately $16,966,496 as of June 26, 2020, the last business day of the Registrant’s most
recently completed second fiscal quarter, based on the closing price reported for such date on the Nasdaq Global Market. The registrant did not have any non-voting common equity outstanding. For purposes
of this disclosure, shares of common stock held by each executive officer and director and by each holder of 5% or more of the outstanding shares of common stock have been excluded from this calculation,
because such persons may be deemed to be affiliates. This determination of affiliate status is not necessarily a conclusive determination for other purposes.
As of March 15, 2021, Registrant had 15,521,058 shares of common stock outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
Certain parts of the Proxy Statement for the Registrant’s 2021 Annual Meeting of Stockholders (the “Proxy Statement”) are incorporated by reference into Part III of this Annual Report on Form 10-
K.
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which statements involve substantial risks and uncertainties. Forward-
looking statements generally relate to future events or our future financial or operating performance. In some cases, you can identify forward-looking
statements because they contain words such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,”
“contemplates,” “believes,” “estimates,” “predicts,” “potential,” or “continue” or the negative of these words or other similar terms or expressions that
concern our expectations, strategy, plans, or intentions. Forward-looking statements contained in this Annual Report on Form 10-K include, but are not
limited to, statements about:
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our future financial performance, including our expectations regarding our revenue, cost of revenue, gross profit or gross margin, operating
expenses (including changes in sales and marketing, research and development and general and administrative expenses), and our ability to
achieve and maintain future profitability;
the impact of the COVID-19 pandemic and related responses of business and governments to the pandemic on our operations and personnel,
and on commercial activity and demand of our products, business operations, and results of operations;
our ability to raise additional capital;
customer acceptance and purchase of our existing products and new products;
our ability to maintain and expand our customer base;
competition from other products;
the impact of foreign currency exchange rate and interest rate fluctuations on our results and sales;
the pace of change and innovation in the markets in which we participate and the competitive nature of those markets;
our business strategy and our plan to build our business;
our ability to effectively manage our growth;
our costs of manufacturing and reliance on third party manufacturers;
our ability to forecast and meet product demand;
our ability to discover defects in our products and systems;
our international expansion and sales strategy;
our operating results and cash flows;
our beliefs and objectives for future operations;
our relationships with third parties;
our ability to maintain, protect, and enhance our intellectual property rights;
our ability to maintain, protect, and enhance our information technology systems and data;
our ability to maintain our facilities in good working order;
our ability to recover the carrying value of goodwill;
the impact of expensing stock options and other equity awards;
our ability to successfully defend litigation brought against us;
our ability to indemnify our directors and officers;
our ability to repay indebtedness and have indebtedness forgiven;
our ability to successfully expand in our existing markets and into new markets;
sufficiency of cash to meet cash needs for at least the next 12 months;
our ability to comply with laws, policies, and regulations that currently apply or become applicable to our business both in the United States
and internationally;
our ability to attract and retain qualified employees and key personnel, and source suppliers;
the future trading prices of our common stock; and
our ability to pay dividends in the future.
In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based
upon information available to us as of the date of this Annual Report on Form 10-K, and while we believe such information forms a reasonable basis for
such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive
inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly
rely upon these statements.
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You should not rely upon forward-looking statements as predictions of future events. We have based the forward-looking statements contained in
this Annual Report on Form 10-K primarily on our current expectations and projections about future events and trends that we believe may affect our
business, financial condition, results of operations, and prospects. The outcome of the events described in these forward-looking statements is subject to
risks, uncertainties, and other factors described in the section titled “Risk Factors” and elsewhere in this Annual Report on Form 10-K. Moreover, we
operate in a very competitive and rapidly changing environment. New risks and uncertainties emerge from time to time, and it is not possible for us to
predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this Annual Report on Form 10-K. We cannot
assure you that the results, events, and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events, or
circumstances could differ materially from those described in the forward-looking statements.
The forward-looking statements made in this Annual Report on Form 10-K relate only to events as of the date on which such statements are made.
We undertake no obligation to update any forward-looking statements made in this Annual Report on Form 10-K to reflect events or circumstances after
the date of this Annual Report on Form 10-K or to conform such statements to actual results or revised expectations, except as required by law. We may not
actually achieve the plans, intentions, or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-
looking statements. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, or
investments we may make.
As used in this Annual Report on Form 10-K, the terms “Company,” “IRIDEX,” “we,” “us” and “our” refer to IRIDEX Corporation, and its
consolidated subsidiaries.
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Table of Contents
Part I
Item 1. Business
Item 1A. Risk Factors
Item 1B. Unresolved Staff Comments
Item 2. Properties
Item 3. Legal Proceedings
Item 4. Mine Safety Disclosures
Part II
Item 5. Market for Registrant’s Common Equity and Related Stockholder Matters, and Issuer Purchases of Equity Securities
Item 6. Selected Financial Data
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
Item 8. Financial Statements and Supplementary Data
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
Signatures
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Item 1. Business
Overview
PART I
IRIDEX Corporation is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products
and procedures used to treat sight-threatening eye conditions, including glaucoma and retinal diseases. Certain of our laser products are powered by our
proprietary MicroPulse® technology, which is a method of delivering laser energy using a mode which chops the continuous wave laser beam into short,
microsecond-long laser pulses. Our products consist of laser consoles, delivery devices and consumable instrumentation, including laser probes.
Our laser consoles consist of the following product lines:
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Glaucoma – This product line includes our Cyclo G6® laser system used for the treatment of glaucoma;
Medical Retina – Our medical retina product line includes our IQ 532® and IQ 577® laser photocoagulation systems, which are used for
the treatment of diabetic macular edema and other retinal diseases; and
Surgical Retina – Our surgical retina line of products includes our OcuLight® TX, OcuLight SL, OcuLight SLx, OcuLight GL and
OcuLight GLx laser photocoagulation systems. These systems are often used in vitrectomy procedures, which are used to treat proliferative
diabetic retinopathy, macular holes, retinal tears and detachments.
Our business generates recurring revenues through sales of consumable products, predominantly single-use laser probe devices and other
instrumentation, as well as repair, servicing and extended service contracts for our laser systems. Our laser probes consist of the following product lines:
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Glaucoma – Probes used in our glaucoma product line include our patented MicroPulse P3® Probe, G-Probe® and G-Probe Illuminate®;
and
Surgical Retina – Our surgical retina probes include our EndoProbe® family of products used in vitrectomy procedures.
Ophthalmologists typically use our laser systems in hospital operating rooms (“ORs”) and ambulatory surgical centers (“ASCs”), as well as their
offices and clinics. In ORs and ASCs, ophthalmologists use our laser systems with either an indirect laser ophthalmoscope or a consumable, single use
MicroPulse P3 probe, G-Probe, G-Probe Illuminate or EndoProbe.
In 2020 and 2019, our products were sold in the United States and Germany predominantly through a direct sales force and internationally (aside
from Germany) primarily through independent distributors. Total revenues in 2020 and 2019 were $36.3 million and $43.4 million, respectively. We
generated net losses of $6.3 million and $8.8 million in 2020 and 2019, respectively.
IRIDEX Corporation was incorporated in California in February 1989 as IRIS Medical Instruments, Inc. In January 1996, we changed our name to
IRIDEX Corporation and reincorporated in Delaware. Our executive offices are located at 1212 Terra Bella Avenue, Mountain View, California 94043-
1824, and our telephone number is (650) 940-4700. We can also be reached at our website at www.IRIDEX.com, however, the information on, or that can
be accessed through, our website is not part of this report.
Impact of COVID-19 to our Business
The COVID-19 pandemic continues to create significant uncertainty in global markets, which has disrupted and harmed, and may continue to
disrupt and harm, the Company's business, financial condition, and results of operations. Beginning in the middle of March 2020, the pandemic and
responses thereto contributed to a decrease in the demand for our products, primarily due to most hospitals ceasing elective surgical procedures. This
impact continued through the fourth quarter of 2020. The extent of the impact of COVID-19 on the Company's operational and financial performance will
depend on certain developments, including but not limited to the duration and spread of the outbreak, duration of local, state and federal issued public
health orders, impact on our customers and our sales cycles, impact on our employees and impact on regional and worldwide economies and markets in
general, all of which are uncertain and cannot be predicted.
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For more information on risks associated with the COVID-19 pandemic, see the section titled “Risk Factors” in Item 1A of Part I. For more
information on the impact of COVID-19 on our business, see the section titled “Management’s Discussion and Analysis of Financial Condition and Results
of Operation” in Item 7 of Part II.
Our Market Opportunity
Ophthalmology is a large and growing global market that is driven by the aging world population and the onset of chronic diseases. We currently
target the glaucoma and retina disease markets.
Glaucoma
Glaucoma is a leading cause of blindness in the world. Glaucoma is a progressive, chronic disease and vision loss resulting from glaucoma
currently cannot be regained. According to Market Scope’s 2020 Laser Market Report, an estimated 101.6 million people worldwide suffer from glaucoma
and an additional 42.2 million people suffer from ocular hypertension, for a total of almost 143.8 million candidates for glaucoma treatment. Market Scope
expects this to grow at a compounded rate of 2.6 percent through 2025. Glaucoma is most commonly associated with elevated levels of pressure within the
eye, or intraocular pressure (“IOP”). Elevated IOP often occurs when aqueous humor, the thin watery fluid that fills the front of the eye, is not circulating
normally and draining properly. Currently, reducing IOP is the only proven treatment for glaucoma with treatments primarily focused on improving the
flow of aqueous humor through the eye’s trabecular meshwork and uveoscleral outflow pathways. Global sales of products used to diagnose and treat
glaucoma were expected to total $5.8 billion in 2018, according to Market Scope’s 2018 Global Glaucoma Surgical Device Report.
Pharmaceutical products represent a majority of this revenue estimate but have significant shortcomings. Pharmaceuticals are typically the first
treatment method prescribed for glaucoma. These pharmaceutical treatments are commonly self-administered in drop form by the patients. Patients often
have difficulties applying the pharmaceutical drops properly and may fail to appropriately or timely apply the medication, which may significantly reduce
the effectiveness of the eye drops. This poor adherence to and lack of persistence with glaucoma medication regimens have been documented in numerous
independent studies, which often place the incidence of patient noncompliance up to or above 50%, particularly in patients on two or more prescription eye
drops. Even when administered correctly, pharmaceuticals have demonstrated reduced efficacy over time.
When pharmaceuticals lose their effectiveness, appropriate treatment options are determined based on the progression and severity of the disease
and include traditional laser therapy (e.g. selective laser trabeculoplasty (“SLT”), minimally invasive stents/shunts (e.g. MIGS), and open surgery (e.g.
trabeculectomy)). These treatment alternatives also have significant shortcomings due to treatment effects that dissipate over time, repeat procedures that
are less effective or not clinically advised, limited indications of use, and significant complication risks.
We believe that because of the limitations of these traditional treatment alternatives, a clear unmet medical need exists in the management of
glaucoma patients.
Medical Retina
Per Market Scope estimates in 2016, global sales of retinal surgical products will increase to $2.7 billion in 2021. Our medical retina business
focuses on the treatment of diabetic macular edema (“DME”) which is part of a broader disease state called diabetic retinopathy. Diabetic retinopathy is a
common complication of diabetes which impairs vision over time and, if left untreated, can lead to blindness. An estimated 463 million people worldwide
had diabetes in 2019, according to the International Diabetes Federation. The federation predicts that there will be 578 million people with diabetes by
2030, and as many as 700 million will have diabetes globally by 2045. Previous clinical publications, such as an article cited at the U.S. National Institutes
of Health’s National Library of Medicine, indicated 28.5% of diabetic patients can develop some form of diabetic retinopathy. Traditional laser
photocoagulation and a regimen of injected pharmaceuticals are currently the standard treatment for this disease and are associated with significant
shortcomings. Traditional laser photocoagulation can stabilize the patient’s vision over the long term but presents a risk of varying degrees of vision loss to
the patient. Pharmaceuticals can stabilize vision in the near term but require repeated injections. The injections are painful and the patients may experience
side effects including increased risk of eye infections. Furthermore, a regimen of repeated pharmaceutical injections is very demanding to the physician
and patient in terms of time and to the healthcare system at large with regard to dollars spent on treatment.
The shortcomings in treating retinal diseases have led to a renewed interest in alternative approaches that may provide better or comparable patient
outcomes at lower costs.
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Our Solution
Our traditional laser technology was developed to perform laser photocoagulation by using a mode that delivers continuously-on laser light, which
is referred to as continuous wave (“CW”) mode. Laser photocoagulation generates a local healing response and has been demonstrated to be a safe and
effective therapy with long-term benefits for certain ophthalmic procedures. However, use of the CW mode typically leads to local tissue damage and can
cause loss of visual function, which limits the applications of the technology.
We developed our proprietary MicroPulse technology with the goal of harnessing the clinical benefits of CW mode while minimizing the associated
tissue damage. MicroPulse is a method of delivering laser energy using a mode which chops the CW beam into short, microsecond long laser pulses. The
laser pulses are intended to generate the desired therapeutic response while the time in between laser pulses is believed to enable the tissue to cool and
thereby minimize tissue damage. This is analogous to holding one’s hand continuously over a candle versus waving it back and forth. When held
continuously, the candle would cause burning and scar tissue. However, when exposed intermittently the candle only heats the tissue without burning.
There is a growing body of clinical evidence that has been published over the past 10 years that demonstrates that MicroPulse therapy is clinically
effective with limited tissue damage for the treatment of glaucoma and retinal diseases. Currently, we have developed three applications of our MicroPulse
technology for the treatment of eye diseases:
MicroPulse Applications
Description
Glaucoma – uveoscleral outflow
Glaucoma - trabecular meshwork outflow
Medical Retina - DME
Treats glaucoma using our Cyclo G6 laser system and MicroPulse P3 delivery device. MicroPulse
P3 is IRIDEX’s proprietary, single-use, disposable probe. It delivers MicroPulse laser energy
transsclerally (through the white of the eye) to target the ciliary body inside the eye. The ciliary body
controls various ocular functions including aqueous humor production, and it helps facilitate the
reduction of aqueous humor via outflow channels.
MicroPulse transscleral laser therapy (“TLT”) is a non-incisional treatment that reduces IOP primarily
through uveoscleral outflow. Numerous peer-reviewed published clinical studies have demonstrated
MicroPulse TLT as a safe and clinically effective treatment to lower patients’ IOP and reduce the
number of topical eye drops and oral medications across a wide spectrum of glaucoma types and
disease severity. Glaucoma specialists and comprehensive ophthalmologists incorporate MicroPulse
TLT prior to, concurrent with, and after other surgical therapies. It’s a repeatable procedure which does
not impact the patients’ quality of life nor does it inhibit future interventions.
Treats glaucoma with our IQ laser systems. MicroPulse laser is delivered through a mechanical and
optical delivery device and targets the trabecular meshwork. Physicians describe the technique as
MicroPulse Laser Trabeculoplasty (“MLT”). It is believed that the MLT procedure improves trabecular
meshwork outflow and thus lowers IOP. According to studies, MLT procedure provides incremental
clinical benefits relative to other laser trabeculoplasty procedures such as SLT.
Treats DME with our IQ laser systems. MicroPulse laser is administered through a mechanical and
optical delivery device that rapidly delivers multiple treatment spots on the retina. Our MicroPulse
laser is uniquely believed to be “fovea friendly” in that the laser can be used to treat the fovea, the
center of the field of vision in the retina, without any loss of visual function. Instead of causing
thermal damage like traditional lasers, MicroPulse laser is believed to induce a therapeutic response
through the recruitment of biological factors such as heat shock proteins. We believe that the treatment
of DME with MicroPulse laser therapy has several competitive advantages over alternate therapies
with respect to long term vision stability, visual function, and cost effectiveness.
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Our Strategy
We are a worldwide leader in developing, manufacturing, marketing, selling and servicing innovative medical laser systems and associated
instrumentation for the treatment of sight-threatening eye diseases. Our strategy is to leverage our existing brand and distribution channel in the
ophthalmology market to promote the adoption of MicroPulse as a viable treatment alternative for glaucoma and retinal diseases and consequently to
commercialize a broad array of products that:
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Improve therapeutic outcomes for patients suffering from sight-threatening eye diseases;
Improve the efficiency of physicians and reduce their costs; and
Provide economic benefits to healthcare systems.
To achieve these goals, we are pursuing a number of organic initiatives that we anticipate will be supplemented from time to time by acquisitions,
such as the asset acquisition recently completed with one of the subsidiaries for Topcon Corporation. We anticipate that the successful execution of this
strategy will lead to profitable growth and enhanced shareholder value.
Our Products
Our current product portfolio utilizes a system approach. Each system includes a laser console, which generates the laser energy, and a number of
interchangeable delivery devices or disposable probes for use in specific clinical applications. This approach allows our customers to purchase a basic laser
system and add additional delivery devices or disposable probes as their therapeutic needs expand or as new applications develop. We currently offer three
basic product categories: 1) laser consoles, 2) delivery devices which are optical-mechanical products that mount to ophthalmologists’ diagnostic
equipment and transmit the laser and 3) single-use disposable probes that transmit the laser light to a targeted region inside the eye.
Laser Consoles
Our laser consoles, which are identified below, incorporate the economic and technical benefits of solid state and semiconductor laser technology.
Glaucoma: Cyclo G6 Laser System. The Cyclo G6® is an infrared (810nm) laser designed to treat patients diagnosed with a range of glaucoma
disease states. The Cyclo G6 system is sold with a family of probes that are disposable, including our patented MicroPulse P3 Probe that utilizes our
MicroPulse technology, our G-Probe and our G-Probe Illuminate.
Medical retina: IQ laser systems. Our IQ laser systems offer our MicroPulse technology but also have CW capabilities. Our IQ 577® delivers
visible yellow (577nm) laser light and our IQ 532® delivers visible green (532nm) laser light. Our IQ laser systems are typically used with our TxCell®
Scanning Laser Delivery System and our Slit Lamp Adapters when used to treat DME with MicroPulse.
Surgical retina: OcuLight laser systems. Our OcuLight® TX, OcuLight GL, and OcuLight GLx lasers deliver visible green (532nm) laser light. Our
OcuLight SL and OcuLight SLx lasers deliver infrared (810 nm) laser light.
Delivery Devices
The following delivery devices are typically used with our IQ and OcuLight laser systems:
TxCell Scanning Laser Delivery System (“TxCell”). TxCell® allows the physician to perform multi-spot pattern scanning for efficient delivery of
our MicroPulse laser.
Slit Lamp Adapter (“SLA”). These adapters allow the physician to utilize a standard slit lamp in both diagnosis and treatment procedures.
Physicians can install an SLA in a few minutes and convert standard diagnostic slit lamps into a therapeutic laser delivery system. SLAs are used in
treatment procedures for both retinal diseases and glaucoma.
Laser Indirect Ophthalmoscope (“LIO”). The indirect ophthalmoscope is designed to be worn on the physician’s head and to be used in procedures
to treat peripheral retinal disorders, particularly in infants or adults requiring treatment in the supine position. This product can be used in both diagnosis
and treatment procedures at the point-of-care.
Single-use disposable probes
MicroPulse P3 Probe. The MicroPulse P3® Probe is used with our Cyclo G6 laser system to perform MicroPulse TLT. The MicroPulse P3 Probe is
used on an anesthetized eye in the doctor’s office or in the OR. The non-incisional procedure takes just a few minutes and results in minimal post-operative
recovery for the patient. MicroPulse TLT may be used to treat a wide variety of glaucoma types, including open-angle and closed-angle glaucoma, and a
broad range of disease severity.
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Since the launch of the MicroPuls P3 Probe, we have worked with physicians to optimize treatment techniques and clinical outcomes. During our
collaborations, we learned that minor ergonomic probe modifications could facilitate easier use and result in more consistent clinical outcomes. In the
fourth quarter of fiscal year 2019, we released a revised MicroPulse P3 Probe that reflects these modifications. Initial feedback from approximately 150
physicians has been very positive in terms of better viewing of the treatment area, ease of treating small eyes and deep-set eyes, more intuitive probe
orientation and placement, better stabilization of the probe on the eye, and improved light coupling to the tissue. In addition, physicians have continued to
observe excellent safety profiles and good preliminary clinical results.
G-Probe. The G-Probe® is used in procedures to treat uncontrolled glaucoma, typically described as “refractory glaucoma”. The G-Probe delivers
CW laser to the ciliary body and is believed to stop the production of aqueous humor, thus reducing IOP. The G-Probe’s non-invasive procedure takes
approximately ten minutes and is performed on an anesthetized eye in the doctor’s office or OR. The G-Probe is a sterile disposable product.
G-Probe Illuminate. The G-Probe Illuminate® is also used in procedures to treat refractory glaucoma. The proprietary illumination feature allows
for more targeted treatment and may offer additional clinical benefits. The G-Probe Illuminate is a sterile disposable product.
EndoProbe. Our EndoProbe® family of products are used for endophotocoagulation, a retinal treatment procedure performed in the hospital OR or
surgery center during a vitrectomy procedure. Vitrectomy procedures are performed to treat proliferative diabetic retinopathy, macular holes, retinal tears
and detachments. These disposable probes are available in tapered, angled, stepped, aspirating, illuminating, and adjustable styles, as well as a wide variety
of sizes. The EndoProbe is a sterile disposable product.
Research and Development
We have close working relationships with researchers, clinicians and practicing physicians around the world who provide new ideas, evaluate
prototypes and assist us in validating new products and new applications before they are introduced.
Our internal research and development (“R&D”) activities are performed by a current team of eight engineers and regulatory professionals with
experience in various aspects of medical products, laser systems, delivery devices, clinical techniques, and regulatory affairs with a focus on introducing
innovative products which satisfy the unmet and emerging needs of our customers. The core competencies of the team include: mechanical engineering,
electrical engineering, optics, lasers, fiber optics, software, and industrial designs. The R&D process integrates all necessary disciplines of the Company
from product inception through customer acceptance. This process facilitates reliable new product innovations and a consistent pipeline of innovative
products for our customers.
Our research activities are managed internally by our R&D staff. We supplement our internal R&D staff by hiring consultants or partnering with
physicians known for their expertise. Research efforts are directed toward the development of new products, as well as the identification of markets not
currently addressed by our products.
We believe that it is important to make a substantial contribution to improving clinical outcomes. For instance, we have made substantial
investments in improving the treatment of serious eye diseases such as glaucoma and retinal disease. The objectives of developing new treatments and
applications are to expand the patient population, to better and more economically treat diseases, to treat patients earlier in the treatment regimen and to
reduce the side effects of treatment.
We consider clinical projects to be a component of our R&D efforts and they may or may not result in additional commercial opportunities.
Customers and Customer Support
Our products are currently sold for use by ophthalmologists specializing in the treatment of eye disease in retina, glaucoma and pediatric eye
diseases. Other customers include research and teaching hospitals, government installations, surgical centers, hospitals, veterinary practices, and office
clinics (outpatient).
We seek to provide superior customer support and service and believe that our customer service and technical support distinguish our product
offerings from those of our competitors. We provide depot service at our Mountain View facility for our products. Our customer support representatives
assist customers with orders, warranty returns and other administrative functions. Our technical support engineers provide customers with answers to
technical and product-related questions. We maintain an “around-the-clock” telephone service line to service our customers. If a problem with a depot
serviceable product cannot be diagnosed and resolved by telephone, a service loaner is shipped overnight to domestic customers under warranty or service
contract, and by the most rapid delivery means available to our international customers, and the problem unit is returned to us. The small size and rugged
design of our products allows for economical shipment and quick response to customers worldwide.
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Sales and Marketing
In 2020 and 2019, we sold and marketed our products in the United States and Germany predominantly through our direct sales force and
internationally (aside from Germany) primarily through independent distributors. Currently we have a direct sales force of 16 employees who are engaged
in sales efforts within the United States, 1 in Germany and 5 personnel engaged in managing our distribution sales efforts internationally. Our sales are
administered through our corporate headquarters in Mountain View, California.
International revenues represented 46.9% and 48.7% of our revenues in 2020 and 2019, respectively. We believe that our international sales will
continue to represent a significant portion of our revenues for the foreseeable future. Our international sales are made principally to customers in Europe,
Asia, the Pacific Rim, the Middle East, Russia, Africa and Latin America. Our distribution agreements with our international distributors are generally
exclusive and typically can be terminated by either party without cause with 90 days’ notice. International sales may be adversely affected by currency
fluctuations, the imposition of governmental controls, restrictions on export technology, political instability, trade restrictions, changes in tariffs, tax treaties
and the economic condition in each country in which we sell our products.
To support our sales process, we conduct marketing programs which include: our website, clinical education, social media, email marketing, trade
shows, public relations, market research, key opinion leader collaborations and advertising in trade and academic journals and newsletters. We typically
participate in over 85 trade shows worldwide on an annual basis. These meetings allow us to present our products to existing and prospective buyers.
Through marketing, we collaborate with our customers to identify new products and applications which help meet their needs, and in turn provides
us with new product concepts, enhances our ability to identify new applications for our products and validates new procedures using our products.
Customers include key opinion leaders who are often the heads of the departments in which they work or professors at universities. We believe that these
luminaries in the field of ophthalmology are key to the successful introduction of new products and the subsequent acceptance of these new products by the
general market. Acceptance of our products by these early adopters is key to our strategy in the validation and commercialization of our new products.
Clinical Affairs
Our clinical affairs group was established to support clinical research opportunities, provide specialized ophthalmic surgeon training and
credentialing for our proprietary MicroPulse products, establish strong relationships with prominent key opinion leaders and assure the accuracy and
consistency our messaging to the market. We believe that a strong research program underlying marketing initiatives and professional level training for our
customers are key to driving the application of our technology for more widespread and consistent use.
Operations
The manufacture of our visible light and infrared laser consoles and the related delivery devices is a highly complex and precise process. Completed
systems must pass quality control and reliability tests before shipment. Our manufacturing activities consist of specifying, sourcing, assembling and testing
of components and certain subassemblies for assembly into our final product. Currently we have a total of 11 employees engaged in manufacturing
activities for these products.
The medical devices we manufacture are subject to extensive regulation by numerous governmental authorities, including federal, state, and foreign
governmental agencies. The principal regulators in the United States are the Food and Drug Administration (“FDA”) and the California Department of
Public Health, Food and Drug Branch. In April 1998, we received certification for ISO 9001/EN 46001, which is an international quality system standard
that documents compliance to the European Medical Device Directives. In February 2004, we were certified to ISO 13485:2003, which replaced ISO
9001/EN46001 as the international standard for quality systems as applied to medical devices. In December 2018, we were certified to ISO 13485:2016,
which superseded the 2003 version of the standard. In August 2008, we received FDA 510(k) clearance on our family of IRIDEX IQ laser systems. This
clearance covers the IRIDEX IQ 532 and IQ 577 laser systems and their associated delivery devices to deliver laser energy in either CW or MicroPulse
mode. In January 2015, we received FDA 510(k) clearance for Cyclo G6. These laser systems are intended for a wide range of specific applications in the
medical specialties of ophthalmology.
International regulatory bodies often establish varying product standards, packaging requirements, labeling requirements, tariff regulations, duties
and tax requirements. As a result of our sales in Europe, we are required to have all products “CE” marked, an international symbol affixed to all products
demonstrating compliance to the European Medical Device Directives and all applicable standards. In July 1998, we received CE mark certification under
Annex II guidelines, the most stringent path to CE certification. With Annex II CE mark certification, we have demonstrated our ability to both understand
and comply with all applicable standards under the European Medical Device Directives. Currently, all of our released products are CE marked. Continued
certification is based on successful review of the process by our European
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Registrar during its annual audit. Any loss of certification could have a material adverse effect on our business, results of operations and financial
condition. We rely on third parties to manufacture substantially all of the components used in our products, although we assemble critical subassemblies
and the final product at our facility in Mountain View, California. Some of these suppliers and manufacturers are sole source. We have some long-term or
volume purchase agreements with our suppliers but currently purchase most components on a purchase order basis. These components may not be available
in the quantities required, on reasonable terms, or at all. Financial or other difficulties faced by our suppliers or significant changes in demand for these
components or materials could limit their availability. Any failures by our third-party suppliers to adequately perform may delay the submission of products
for regulatory approval, impair our ability to deliver products on a timely basis or otherwise impair our competitive position.
Competition
Competition in the market for laser systems and delivery devices used for ophthalmic treatment procedures is intense and is expected to increase.
This market is also characterized by technological innovation and change. We compete by providing features and services that are valued by our customers
such as: enhanced product performance, and clinical outcomes, ease of use, durability, versatility, customer training services and rapid repair of equipment.
Our principal ophthalmic laser competitors are Alcon, Inc., Novartis AG, Bausch Health Companies Inc., Carl Zeiss Meditec AG, Ellex Medical
Lasers, Ltd., Lumenis Ltd, Nidek Co. Ltd., Quantel Medical SA, OD-OS GmbH and A.R.C. Laser GmbH. We also compete with alternative glaucoma
surgical device companies such as Alcon, Inc., Allergan, Inc., Glaukos Corporation, New World Medical, Inc. and Ivantis, Inc. Pharmaceuticals represent
alternative treatments to our laser procedures. Some of our principal pharmaceutical competitors are Alcon, Inc., Allergan, Inc., Astellas Pharma Inc.,
Pfizer Inc., Regeneron Pharmaceuticals, Inc., Roche Holding Ltd. (Genentech) and Bausch Health Companies Inc. Some of our competitors have
substantially greater financial, engineering, product development, manufacturing, marketing and technical resources than we do. Some companies also have
greater name recognition than us and long-standing customer relationships. In addition, other medical companies, academic and research institutions, or
others, may develop new technologies or therapies, including medical devices, surgical procedures or pharmacological treatments and obtain regulatory
approval for products utilizing such techniques that are more effective in treating the conditions targeted by us, or are less expensive than our current or
future products. Our technologies and products could be rendered obsolete by such developments. Any such developments could have a material adverse
effect on our business, financial condition and results of operations.
Patents and Proprietary Rights
Our success and ability to compete is dependent in part upon our proprietary information. We rely on a combination of patents, trade secrets,
copyright and trademark laws, nondisclosure and other contractual agreements and technical measures to protect our intellectual property rights. These are
either developed internally or obtained from acquisitions such as RetinaLabs. We file patent applications to protect technology, inventions and
improvements that are significant to the development of our business. Our patent portfolio includes 25 active United States patents and 7 active foreign
patents on the technologies related to our products and processes. In addition, we have 7 patent applications pending in the United States and 12 foreign
patent applications pending. Our patent applications may not be approved.
In addition to patents, we rely on trade secrets and proprietary know-how which we seek to protect, in part, through proprietary information
agreements with employees, consultants and other parties. Our proprietary information agreements with our employees and consultants contain provisions
requiring such individuals to assign to us, without additional consideration, any inventions conceived or reduced to practice by them while employed or
retained by us, subject to customary exceptions. We can provide no assurance that our employees and consultants will abide by the provisions of these
agreements and that our confidential information and trade secrets will be protected.
Government Regulation
The medical devices marketed and manufactured by us are subject to extensive regulation by numerous governmental authorities, including federal,
state, and foreign governmental agencies. Pursuant to the Federal Food, Drug, and Cosmetic Act (“FD&C Act”), as amended, and the regulations
promulgated thereunder, the FDA serves as the principal federal agency within the United States with authority over medical devices and regulates the
research, clinical testing, manufacture, labeling, distribution, sale, marketing and promotion of such devices. Noncompliance with applicable requirements
can result in, among other things, warning letters, fines, injunctions, civil penalties, recall or seizures of products, total or partial suspension of production,
failure of the government to grant pre-market clearance or approval for devices, withdrawal of marketing approvals, and criminal prosecution. The FDA
also has the authority to request repair, replacement or refund of the cost of any medical device manufactured or distributed by us.
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In the United States, medical devices are classified into one of three classes - Class I, II or III. The class to which the device is assigned determines,
among other things, the type of pre-marketing submission/application required for FDA clearance to market. If the device is classified as Class I or II, and
if it is not exempt, a 510(k) pre-market notification will be required for marketing. Under FDA regulations, Class I devices are subject to general controls
(for example, labeling, pre-market notification and adherence to Quality System Regulations (“QSRs”) requirements). Class II devices receive marketing
clearance through a 510(k) pre-market notification. For Class III devices, a pre-market approval (“PMA”) application will be required unless the device is a
pre-amendments device (on the market prior to the passage of the medical device amendments in 1976, or substantially equivalent to such a device) and
PMAs have not been called for. In that case, a 510(k) will be the route to market. A 510(k) clearance will be granted if the submitted information
establishes that the proposed device is substantially equivalent to a legally marketed Class I or II medical device, or to a Class III medical device for which
the FDA has not called for a PMA. The FDA may determine that a proposed device is not substantially equivalent to a legally marketed device or that
additional information or data are needed before a substantial equivalence determination can be made. A request for additional data may require that
clinical studies of the device’s safety and efficacy be performed.
In the United States, commercial distribution of a device for which a 510(k) notification is required can begin only after the FDA issues an order
finding the device to be substantially equivalent to a previously cleared device. The FDA has recently been requiring a more rigorous demonstration of
substantial equivalence than in the past. Even in cases where the FDA grants a 510(k) clearance, it can take the FDA between three and six months from
the date of submission to grant a 510(k) clearance, but it may take longer.
A “not substantially equivalent” determination, or a request for additional information, could delay the market introduction of new products that fall
into this category and could have a material adverse effect on our business, financial condition and results of operations. For any of our products that are
cleared through the 510(k) process, modifications or enhancements that could significantly affect the safety or effectiveness of the device or that constitute
a major change to the intended use of the device will require new 510(k) submissions.
We have obtained 510(k) clearances for all of our products marketed within the United States that require 510(k) clearance. We have also modified
aspects of our products since receiving regulatory clearance, and we have submitted 510(k)s for those modifications as required by FDA regulations. After
a device receives a 510(k) clearance or a PMA, any modification that could significantly affect its safety or effectiveness, or that would constitute a major
change in its intended use, will require a new clearance or approval. The FDA requires each manufacturer to make this determination initially, but the FDA
can review any such decision and can disagree with a manufacturer’s determination. If the FDA disagrees with our determination not to seek a new 510(k)
clearance or PMA, the FDA may retroactively require us to seek 510(k) clearance or pre-market approval. The FDA could also require us to cease
marketing and distribution and/or recall the modified device until a 510(k) clearance or a PMA approval is obtained. Also, in these circumstances, we may
be subject to significant regulatory fines or penalties.
Any products manufactured or distributed by us pursuant to FDA clearances or approvals are subject to pervasive and continuing regulation by the
FDA, including record keeping requirements and reporting of adverse experiences with the use of the device. Device manufacturers are required to register
their establishments and list their devices with the FDA and certain state agencies, and are subject to periodic inspections by the FDA and certain state
agencies. The FD&C Act requires devices to be manufactured to comply with applicable QSR regulations which impose certain procedural and
documentation requirements upon us with respect to design, development, manufacturing and quality assurance activities. We are subject to unannounced
inspections by the FDA and the Food and Drug Branch of the California Department of Public Health, to determine our compliance with the QSR and other
regulations, and these inspections may include the manufacturing facilities of our subcontractors.
Labeling and promotion activities are subject to scrutiny by the FDA and in certain instances, by the Federal Trade Commission. The FDA actively
enforces regulations prohibiting marketing of products for unapproved uses. We and our products are also subject to a variety of state laws and regulations
in those states or localities where our products are or will be marketed. Any applicable state or local regulations may hinder our ability to market our
products in those states or localities. Manufacturers are also subject to numerous federal, state and local laws relating to such matters as safe working
conditions, manufacturing practices, environmental protection, fire hazard control and disposal of hazardous or potentially hazardous substances. We may
be required to incur significant costs to comply with such laws and regulations now or in the future. Such laws or regulations may have a material adverse
effect upon our ability to do business.
Export of our products is regulated by the FDA and subject to the FD&C Act, 21 U.S.C. §§321-397, and other statutes FDA administers, which
greatly expanded the export of approved and unapproved United States medical devices. However, some foreign countries require manufacturers to provide
a specific type of FDA export certificate (such as a Certificate to Foreign Government or Certificate of Exportability) which requires the device
manufacturer to certify to the FDA that the product has been granted pre-market clearance in the United States and that the manufacturing facilities
appeared to be in compliance with QSR at the time of the last QSR inspection. The FDA will refuse to issue any export certificate if significant outstanding
QSR violations exist.
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We are also regulated under the Radiation Control provisions (originally enacted as the Radiation Control for Health and Safety Act of 1968) which
are located in Sections 531 through 542 of the FD&C Act, which requires laser products to comply with performance standards, including design and
operation requirements, and manufacturers to certify in product labeling and in reports to the FDA that their products comply with all such standards. The
law also requires laser manufacturers to file new product and annual reports, maintain manufacturing, testing and sales records and report product defects.
Various warning labels must be affixed and certain protective devices installed, depending on the class of the product.
The introduction of our products in foreign markets will also subject us to foreign regulatory clearances which may impose substantial additional
costs and burdens. International sales of medical devices are subject to the regulatory requirements of each country. The regulatory review process varies
from country to country. Many countries also impose product standards, packaging requirements, labeling requirements and import restrictions on devices.
In addition, each country has its own tariff regulations, duties and tax requirements. The approval by the FDA and foreign government authorities is
unpredictable and uncertain. The necessary approvals or clearances may not be granted on a timely basis, if at all. Delays in receipt of, or a failure to
receive, such approvals or clearances, or the loss of any previously received approvals or clearances, could have a material adverse effect on our business,
financial condition and results of operations. There are a number of major regulatory changes occurring in the regulation of medical devices in the
European Union. A new revision of the quality system regulation (ISO 13485:2016) has been released that substantially increases the requirements for a
medical device quality system. The Medical Device Regulation (“MDR”) will replace the current medical device directives (93/42/EEC), and it
substantially changes the way that medical devices are brought to market in the European Union and how they maintain compliance throughout the
product’s life cycle. Additionally, the new revision 4 of the clinical evaluation report guidance document (MEDDEV 2.7.1) severely restricts the use of
substantial equivalence for new products, resulting in the need for formal clinical trial data for most new products. These changes will increase the cost for
compliance and for product development, and they lengthen product introduction cycles. Failure to comply with these changes can have an adverse effect
on our ability to release new products in a timely manner.
In order to maintain a Canadian Medical Device License (MDL), which is needed to sell a medical device in Canada, the holder of the MDL (the
“regulatory manufacturer”) must obtain an ISO 13485:2016 certificate through the Medical Device Single Audit Program (MDSAP). The MDSAP
requirement is new to Canada, and manufacturers that received a MDL prior to adoption of this requirement are required to transition to the MDSAP. To
address this Canadian medical device licensing requirement, Iridex transferred its MDLs to Salient Medical Solutions (Salient), Iridex’s distributor in
Canada and an entity that is certified under MDSAP. Iridex continues to fabricate the devices as Salient’s contract manufacturer. Salient is now the
regulatory manufacturer, and has the licenses necessary to import and sell Iridex’s products into Canada.
Changes in existing requirements or adoption of new requirements or policies by the FDA or other foreign and domestic regulatory authorities
could adversely affect our ability to comply with regulatory requirements. Failure to comply with regulatory requirements could have a material adverse
effect on our business, financial condition and results of operations. We may be required to incur significant costs to comply with laws and regulations in
the future. These laws or regulations may have a material adverse effect upon our business, financial condition or results of operations.
Reimbursement
The cost of a significant portion of medical care in the United States is funded by government programs, health maintenance organizations and
private insurance plans. Our ophthalmology products are typically purchased by doctors, clinics, hospitals and other users, which bill various third-party
payers, such as government programs and private insurance plans, for the health care services provided to their patients. Government imposed limits on
reimbursement of hospitals and other health care providers have significantly affected the spending budgets of doctors, clinics and hospitals to acquire new
equipment, including our products. Under certain government insurance programs, a health care provider is reimbursed for a fixed sum for services
rendered in treating a patient, regardless of the actual charge for such treatment. The Center for Medicare and Medicaid Services reimburses hospitals on a
prospectively-determined fixed amount basis for the costs associated with an in-patient hospitalization based on the patient’s discharge diagnosis,
regardless of the actual costs incurred by the hospital or physician in furnishing the care and regardless of the specific devices used in that procedure.
Private third-party reimbursement plans are also developing increasingly sophisticated methods of controlling health-care costs by imposing
limitations on reimbursable procedures and the exploration of more cost-effective methods of delivering health care. In general, these government and
private measures have caused health care providers, including our customers, to be more selective in the purchase of medical products. In addition, changes
in government regulation or in private third-party payers’ policies may limit or eliminate reimbursement for procedures employing our products, which
could have a material adverse effect on our business, results of operations and financial condition.
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Doctors, clinics, hospitals and other users of our products may not obtain adequate reimbursement for use of our products from third-party payers.
While we believe that the laser procedures using our products have generally been reimbursed, payers may deny coverage and reimbursement for our
products if they determine that the device was not reasonable and necessary for the purpose used, was investigational or was not cost-effective.
Backlog and Seasonality
We generally do not maintain a material level of backlog. As a result, we do not believe that our backlog at any particular time is indicative of
future sales levels. Our quarterly results have been, and are expected to continue to be, affected by seasonal factors. For example, our European sales
during the third quarter are generally lower due to many businesses being closed for the summer vacation season.
Human Capital
Our employees are our human capital and they are our greatest strength and most valuable resource. As of January 2, 2021, we had a total of 89
full-time equivalent employees engaged in our ongoing operations, including 37 in operations (including manufacturing, quality, logistics and service), 33
in sales and marketing which does not include four consultants and one independent sales representative, eight in R&D and 11 in finance and
administration. We also employ, from time to time, a number of temporary and part-time employees as well as consultants on a contract basis. As of
January 2, 2021, we had 39 such persons serving in such roles.
Our human capital resources objectives include identifying, recruiting, retaining, incentivizing and integrating our existing and new employees,
advisors and consultants. We continuously invest in our workforce by seeking to create a diverse, inclusive, and safe work environment where our
employees can learn, innovate, and deliver their best. We are committed to being inclusive to enable our workforce and customers to succeed.
Our employees are not represented by a collective bargaining organization, and we have never experienced a work stoppage or strike. We consider
our employee relations to be good.
Available Information
Our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to reports pursuant to Section
13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, are available, free of charge, through the U.S. Securities and Exchange Commission’s
(“SEC”) website. These periodic reports and amendments are also available, free of charge, on our website, as soon as reasonably practicable after such
reports are electronically filed with the SEC.
Investors and others should note that we announce material financial information to our investors using SEC filings, press releases, our investor
relations website, public conference calls and webcasts. We use these channels as well as social media to communicate with investors, customers and the
public about our company, our products and other issues. It is possible that the information we post on social media channels could be deemed to be
material information. We encourage investors, our customers, and others interested in IRIDEX to review the information we post on our Facebook page
(www.facebook.com/IRIDEX) and Twitter feed (https://twitter.com/IRIDEX). Any information on, or that can be accessed through, our website and social
media channels is not part of this report.
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Item 1A. Risk Factors
Risk Factor Summary
Our business operations are subject to numerous risks, factors and uncertainties outside of our control that could cause our actual results to be
harmed, including risks regarding the following:
General economic factors
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the COVID-19 pandemic and responsive measures; and
natural disasters, economic downturns, public health crises or political crises.
Operational factors
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our relationship with our strategic partner and distributor, Topcon Corporation;
quality control and production issues;
the complexity of our laser systems;
defects in our laser systems;
costs, sales volumes, results of operations, and revenues;
direct and independent sales forces and a network of international distributors to sell our products;
our growth;
dependence on international sales;
new products and applications and improving existing products;
fluctuations in our sales and operating results;
the ophthalmology market;
competition in our industry;
the collaborative relationships used to enhance products and applications;
the loss of key personnel;
meeting product demand;
dependence on sole source and limited source suppliers;
disruptions to our information technology system and breaches of data security;
maintaining relationships with health care providers;
the misuse of our products;
our reputation and brand;
the inability of our customers to obtain credit or material increases in interest rates; and
recalls of our products.
Regulatory and Legal factors
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healthcare reform measures;
third-party coverage and reimbursement policies;
compliance with healthcare laws;
our compliance with potential governmental, regulatory and other legal proceedings relative to advertising, promotion and marketing;
patents and proprietary rights related to our intellectual property;
compliance with government regulations, including the FDA’s quality system regulation and laser performance standards;
regulatory approval for clinical trials;
compliance with product liability claims;
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•
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developments in trade policies;
tax laws;
federal, state and foreign laws; and
environmental requirements.
Financing and Transactional Risks
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our ability to repay indebtedness and have indebtedness forgiven;
efforts to acquire additional companies or product lines;
divestitures of our businesses or product lines;
raising additional capital; and
provisions in our charter documents, Delaware law and contractual provisions that could delay or prevent an acquisition or sale of our company.
Governance Risks and Risks related to Ownership of our Common Stock
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the volatility of the trading price of our common stock;
our intention not to pay dividends for the foreseeable future;
the publication of research about us by analysts;
the concentration of ownership of our common stock; and
our ability to maintain an effective system of internal control over financial reporting.
Factors That May Affect Future Results
In addition to the other information contained in this Annual Report Form 10-K, we have identified the following risks and uncertainties that may
have a material adverse effect on our business, common stock price, financial condition or results of operations. You should carefully consider the risks
described below before making an investment decision.
Risks Relating to our Business
The effects of the COVID-19 pandemic have disrupted, and may continue to significantly disrupt, our operations, including our ability to
manufacture and supply products and perform research and development activities, our customers’ usage of our products as demand declines in
elective surgeries in response to COVID-19, all of which have had and expected to continue to have a material and adverse effect on our business,
future revenues and financial condition. We are unable to predict the extent to which the pandemic and related impacts will continue to adversely
impact our business operations, financial performance, results of operations, financial position and the achievement of our strategic objectives.
Our business, results of operation and financial performance have been negatively impacted by the COVID-19 pandemic and related public health
responses, such as shelter-in-place orders, social distancing protocols, and travel restrictions in many of the countries and regions in which we have
operations or manufacturing partners. Due to these impacts and measures, we have experienced and may continue to experience significant and
unpredictable reductions in the demand for our products as healthcare customers divert medical resources and priorities towards the treatment of diseases
related to COVID-19. In addition, our customers may delay, cancel or redirect planned capital expenditures in order to focus resources on COVID-19 or in
response to economic disruption related to COVID-19. For example, during the fiscal year ended January 2, 2021, we experienced significant decline in
treatment and procedure volume worldwide, as healthcare systems diverted resources to meet the increasing demands of managing COVID-19. In addition,
the American College of Surgeons, U.S. surgeon general, and medical societies are evaluating the risks of minimally invasive surgeries in the presence of
infectious diseases, which we expect will continue to negatively impact the usage of our products and the number of ophthalmic treatments and procedures
performed. If these recommendations continue to remain in place and the volume of elective procedures remains low, our results of operations and financial
condition will continue to be adversely affected.
As a result of the COVID-19 outbreak around the world, we have adopted several measures including instructing employees to work from home
while under shelter-in-place orders, slowing our manufacturing operations, and restricting non-critical business travel by our employees. In April and May
of 2020, following shelter-in-place orders, the Company operated with limited personnel at our facilities to continue essential operations. In June 2020, we
implemented return-to-work phases in conjunction with a social distancing protocol to safely continue essential operations to best meet customer demands
in light of the pandemic. This pandemic has caused disruption and delays in our ability to operate and manufacture, test and assemble products in our
internal facilities, particularly in our Mountain View, California facility, and has limited our ability to continue certain research and development activities
which could materially and adversely affect our ability to develop new products and technologies on the timelines we previously anticipated.
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The COVID-19 pandemic has created economic uncertainty and volatility in the financial markets around the world, resulting in an economic
downturn that has affected and will likely continue to affect demand for our products and impact our results of operations. As a result, this may lead to a
period of regional, national, and global economic slowdown or regional, national, or global recessions that would curtail or delay spending by hospitals and
affect demand for our products as well as increase the risk of customer defaults or delays in payments. Our customers may terminate or amend their
agreements for the purchase, lease, or service of our products due to bankruptcy, lack of liquidity, lack of funding, operational failures, or other reason. The
ultimate impact of the COVID-19 pandemic on our operations and financial performance depends on many factors that are not within our control,
including, but not limited, to: the recommendations by medical authorities on whether hospitals should and may perform elective surgical procedures;
hospitals abilities and willingness to devote resources to elective surgical procedures; governmental, business and individuals’ actions that have been and
continue to be taken in response to the pandemic (including restrictions on travel and transport and workforce pressures); the impact of the pandemic and
actions taken in response on global and regional economies, travel, and economic activity; the availability of federal, state, local or non-U.S. funding
programs; general economic uncertainty in key global markets and financial market volatility; global economic conditions and levels of economic growth;
and the pace of recovery when the COVID-19 pandemic subsides. Although the magnitude of the impact of COVID-19 on our business operations remains
uncertain and difficult to predict, and this remains a highly dynamic situation, we have experienced and will continue to experience in subsequent periods,
disruptions to our business that will likely continue to adversely impact our business, financial condition and results of operations.
We may not be successful in our strategic partnership with Topcon Corporation and the relationship may divert resources away from existing
operations or expose us to liabilities, which could adversely affect our business, results of operations and financial condition.
On March 2, 2021, we entered into a series of strategic transactions with Topcon Corporation (“Topcon”) Topcon America Corporation (the
“Investor”) and Topcon Medical Laser Systems, Inc., a subsidiary of Topcon (the “Seller”), which included an asset purchase agreement with the Seller,
pursuant to which we acquired substantially all the assets (except for cash and cash equivalents) of the Seller, including rights to the Seller’s PASCAL
product (the “Asset Purchase Agreement”), (ii) Topcon and our company entered into a distribution agreement dated March 2, 2021, pursuant to which we
granted Topcon the exclusive right to distribute our retina and glaucoma products in certain geographies outside the United States (the “Distribution
Agreement”), (iii) pursuant to an investment agreement dated March 2, 2021 (the “Investment Agreement”) the Investor acquired 1,618,122 shares of the
our Common Stock for an aggregate purchase price of $10 million (the “Shares”).
Pursuant to the Asset Purchase Agreement, the transferred assets include substantially all of the Seller’s assets including the rights to the Seller’s
PASCAL product (the “Transferred Assets”). We assumed only those liabilities arising after the closing in connection with the Transferred Assets. In the
Asset Purchase Agreement, our company and the Seller made certain customary representations and warranties and agreed to certain customary covenants.
The Agreement provides that our company and the Seller will each indemnify the other for losses arising from certain breaches of the Agreement and for
certain other liabilities subject to customary caps and deductibles. If there are claims under the indemnification provisions for which we are liable we will
need to use some or all our cash to settle those claims.
Pursuant to the Distribution Agreement, we appointed Topcon as the exclusive distributor of our glaucoma and retina products, including Seller’s
PASCAL product, in certain countries outside of the United States. Topcon agreed to use commercially reasonable efforts to commercialize our products in
each region throughout the territory, including achieving certain sales baselines by product category and region. If Topcon fails to achieve the baselines in a
region, we will have the right to, subject to payment of a fee, terminate Topcon’s appointment in such region. The Distribution Agreement and Topcon’s
appointment will, unless terminated earlier, continue on a country-by-country basis for a period of ten (10) years from the date exclusivity is granted. The
Distribution Agreement includes customary termination rights and effects of termination, including a termination for convenience right in favor of Topcon
and, subject to payment of a fee, a termination right in our favor upon a change of control of our company.
As a result of the Distribution Agreement, we anticipate terminating our relationships with our current distributors in certain geographies and using
Topcon as our exclusive distributor. If we are unable to terminate our existing relationships with current distributors, or if Topcon is unable to generate as
much revenue under the Distribution Agreement as we receive from our current distributors, our business, results of operations and financial condition
could be adversely affected. If there are claims under the indemnification provisions of the Distribution Agreement for which we are liable or we are
unable to terminate our relationships with our current distributors, we will need to use some or all our cash to settle those claims or make payments to
Topcon pursuant to the terms of the Distribution Agreement.
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We are investing a substantial amount of time, resources and efforts in connection with our relationship with Topcon, including commercializing
our products in certain geographies and working to achieve certain sales baselines by product category and region. All of these actions divert resources
away from our other initiatives and operations particularly with respect to product sales in the United States. These efforts may not result in the anticipated
additional products, efficiencies or revenues for our company, which could adversely affect our business, operating results and financial condition as a
result.
We have incurred indebtedness under the CARES Act which may be subject to audit, may not be forgivable and may eventually have to be
repaid. Any repayment of such indebtedness may limit the funds available to us and may restrict our flexibility in operating our business or otherwise
adversely affect our results of operations.
In April 2020, the Company received an aggregate principal amount of approximately $2.5 million U.S. Small Business Administration Loan (the
“SBA Loan”) pursuant to the Payroll Protection Program (“PPP”), established under the CARES Act. The SBA Loan is subject to forgiveness under the
PPP upon the Company’s request to the extent that the proceeds are used to pay expenses permitted by the PPP, including payroll costs, covered rent and
mortgage obligations, and covered utility payments. In September 2020, the Company submitted an application for forgiveness of the entire amount due on
the loan. Amounts outstanding under the loan will bear a fixed interest rate of 1.00% per annum with a maturity date of April 22, 2022, two years from
commencement date. All payments are deferred for 18 months for the Company with interest accruing over the entire period of the SBA Loan. The U.S.
Department of the Treasury has announced that it will conduct audits for PPP loans that exceed $2 million. Should we be audited or reviewed by the U.S.
Department of the Treasury or the U.S. Small Business Administration as a result of the SBA Loan or filing an application for forgiveness or otherwise,
such audit or review could result in the diversion of management’s time and attention, generate negative publicity and cause us to incur legal and
reputational costs. If we were to be audited and receive an adverse outcome in such an audit, we could be required to return the full amount of the SBA
Loan and may potentially be subject to civil and criminal fines and penalties. We may not have the resources to repay the SBA Loan if required to do so by
the federal government.
The Company cannot provide assurance that the principal and interest amounts under the PPP Loan will be forgiven. If all or substantially all of the
SBA Loan is not forgiven or it is subsequently determined that it must be repaid, we may be required to use a substantial portion of our cash flows from
operations to pay interest and principal on the SBA Loan. Although we currently have no intention of repaying the SBA Loan, we may decide to repay it in
the future. Any such repayment of the SBA Loan will reduce the funds available to us for working capital, capital expenditures, and other corporate
purposes and may limit our ability to obtain additional financing for working capital, capital expenditures, expansion plans, and other investments or divert
funds that are otherwise necessary to run our business. We cannot assure you that our business will generate sufficient cash flow from operations or that
future financing will be available to us in amounts sufficient to enable us to make required and timely repayments on our indebtedness, or to fund our
operations. To date, we have used a substantial amount of cash for operating activities, and we cannot assure you when we will begin to generate cash from
operating activities in amounts sufficient to service our debt. Additionally, though we believe we are eligible for the SBA Loan under the PPP, our receipt
of the SBA Loan could result in negative publicity, or expose us to liability under the federal False Claims Act, which prohibits the known filing of a false
claim or the known use of false statements to obtain payment from the federal government, if it is determined that we were in fact not eligible to take the
SBA Loan in the first instance.
In addition, although we are reviewing and may seek additional available benefits under the CARES Act, we cannot predict the manner in which
such benefits will be allocated or administered and we cannot assure you that we will be able to access such benefits in a timely manner or at all. Certain of
the benefits under the CARES Act have not previously been administered on the present scale or at all. Government or third party program administrators
may be unable to cope with the volume of applications in the near term and any benefits we receive may not be as extensive as those for which we apply,
may impose additional conditions and restrictions on our operations or may otherwise provide less relief than we contemplate. If the U.S. government or
any other governmental authority agrees to provide additional crisis relief assistance that we accept, it may impose certain requirements on the recipients of
the aid, including restrictions on executive officer compensation, dividends, prepayment of debt, limitations on debt and other similar restrictions that will
apply for a period of time after the aid is repaid or redeemed in full. We cannot assure you that any such government crisis relief assistance will not
significantly limit our corporate activities or be on terms that are favorable to us. Such restrictions and terms could adversely impact our business and limit
our operations and revenue as a result.
We face quality control and other production issues that could materially and adversely impact our sales and financial results and the
acceptance of our products.
The manufacture of our infrared and visible laser consoles and related delivery devices is a highly complex and precise process. We may experience
manufacturing difficulties, quality control issues or assembly constraints.
If our sales increase substantially, we may need to increase our production capacity and may not be able to do so in a timely, effective or cost-
efficient manner. We may not be able to manufacture sufficient quantities of our products, which
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may require that we qualify other manufacturers for our products. Furthermore, we may experience delays, disruptions, capacity constraints or quality
control problems in our manufacturing operations.
In the past several years, we have experienced supply chain, production and training issues as we have expanded our product lines and sales
volumes, and may experience similar issues in the future as we continue to grow our business. For example, we have contracted with a manufacturing
company located in Wuhan, China for certain laser systems scheduled for release in the first half of 2021. Due to the COVID-19 outbreak, release of our
manufacturing process and launch of these new laser systems may be delayed or disrupted, and we may need to incur costs to replace or shift this
manufacturing process elsewhere. These issues have caused, and may in the future cause, us to reduce or delay the shipment of our products and incur costs
to service or replace products already shipped to customers. We have also incurred, and may in the future incur, additional costs to rectify or prevent similar
issues in the future. Our efforts to address these supply chain, production and training issues may not be successful, and if we are unable to address these
issues in a timely and cost-effective manner, product shipments to our customers could be delayed, our sales levels may suffer and manufacturing and
operational costs may increase, any of which would negatively impact our business, results of operations and financial condition.
Some of our laser systems are complex in design and may contain defects that are not detected until deployed by our customers, which could
increase our costs and reduce our revenues.
Laser systems are inherently complex in design and require regular maintenance. The manufacture of our lasers, laser products and systems
involves a highly complex and precise process. As a result of the technical complexity of our products, changes in our or our suppliers’ manufacturing
processes or the inadvertent use of defective materials by us or our suppliers could result in a material adverse effect on our ability to achieve acceptable
manufacturing yields and product reliability. To the extent that we do not achieve such yields or product reliability, our business, operating results, financial
condition and customer relationships would be adversely affected. We provide warranties on certain of our product sales, and allowances for estimated
warranty costs are recorded during the period of sale. The determination of such allowances requires us to make estimates of failure rates and expected
costs to repair or replace the products under warranty. We currently establish warranty reserves based on historical warranty costs. If actual return rates
and/or repair and replacement costs differ significantly from our estimates, adjustments to recognize additional cost of revenues may be required in future
periods.
Our customers may discover defects in our products after the products have been fully deployed and operated under peak stress conditions. In
addition, some of our products are combined with products from other vendors, which may contain defects. As a result, should problems occur, it may be
difficult to identify the source of the problem. If we are unable to identify and fix defects or other problems, we could experience, among other things:
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loss of customers;
increased costs of product returns and warranty expenses;
damage to our brand reputation;
failure to attract new customers or achieve market acceptance;
diversion of development and engineering resources; and
legal actions by our customers.
The occurrence of any one or more of the foregoing factors could seriously harm our business, financial condition and results of operations.
We rely on our direct and independent sales forces and international distributors to sell our products and if we lose our sales force or distributor
relationships, it could harm our business.
Our ability to sell our products and generate revenues depends upon our direct and independent sales forces within the United States, direct sales
force in Germany and relationships with independent international distributors. Currently our direct and independent sales forces within the United States
consist of approximately 16 employees and one independent representative, respectively and our direct sales force in Germany consists of one employee.
Our international independent distributors are managed by a team of five people. We generally grant our distributors exclusive territories for the sale of our
products in specified countries. The amount and timing of resources dedicated by our distributors to the sales of our products is not within our control. Our
international sales are largely dependent on the efforts of these third parties. If any distributor breaches the terms of its distribution agreement with us or
fails to generate sales of our products, we may be forced to replace the distributor and our ability to sell our products into that exclusive sales territory could
be adversely affected.
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We do not have any long-term employment contracts with the members of our direct sales force. We may be unable to replace our direct sales force
personnel with individuals of equivalent technical expertise and qualifications, which may harm our revenues and our ability to maintain market share.
Similarly, our independent contractor and distributor agreements are generally terminable at will by either party and independent contractors and
distributors may terminate their relationships with us, which would affect our sales and results of operations. Any loss of the members of our existing direct
or indirect sales organizations, or any failure to execute on our plans to further develop our sales function, could have an adverse impact on our business,
results of operations and financial condition. Additionally, our sales forces’ operations have been disrupted by the COVID-19 pandemic, as many are no
longer allowed to travel and must instead perform their services from home, which could have an impact on their ability to sell and distribute our products.
Growth in our sales and marketing organization may create operational challenges without immediately offsetting benefits.
We have increased and continue to increase our internal sales and marketing functions. This growth may place a significant strain on our
management, operating and financial systems and our sales, marketing, training and administrative resources. As a result of our growth, our operating costs
may escalate even faster than planned, and some of our internal systems may need to be enhanced or replaced. For example, if we are unable to provide
adequate training for our expanding sales force, our ability to fully utilize new sales and marketing resources may be adversely impacted, we could suffer
reputational harm and our ability to maintain our installed base of customers may be negatively impacted. If we cannot effectively manage our expanding
operations and our costs, we may not be able to grow effectively or we may grow at a slower pace, and our business could be adversely affected.
It can take six months or longer before our internal sales representatives are fully trained and productive in selling our product to prospective
clients. This ramp up period presents a number of operational challenges as the cost of recruiting, hiring and carrying new sales representatives cannot be
offset by the revenue such new sales representatives produce until after they complete their ramp up periods. If we cannot reliably develop our sales
representatives to a productive level, or if we lose productive representatives in whom we have heavily invested, our future growth rates and revenue may
suffer.
We depend on international sales for a significant portion of our operating results.
We derive, and expect to continue to derive, a large portion of our revenues from international sales. For the fiscal year 2020, our international sales
were $17.0 million, or 46.9% of total revenues. We anticipate that international sales will continue to account for a significant portion of our revenues in
the foreseeable future. All of our international revenues and costs for the fiscal year 2020 have been denominated in U.S. dollars except for sales transacted
through our German subsidiary. As a result, an increase in the value of the U.S. dollar relative to foreign currencies makes our U.S. dollar-denominated
products more expensive and thus less competitive in foreign markets and may negatively affect our reported revenue in any particular reporting period.
Our international operations and sales are subject to a number of risks and potential costs, including:
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the impact of the COVID-19 pandemic on the global economy and financial markets;
fluctuations in foreign currency exchange rates;
product and production issues;
performance of our international channel of distributors;
longer accounts receivable collection periods;
impact of recessions in global economies and availability of credit;
political and economic instability;
change in international regulatory agreements and requirements;
trade sanctions and embargoes;
impact of international conflicts, terrorist and military activity, civil unrest;
foreign certification requirements, including continued ability to use the “CE” mark in Europe, and other local regulatory requirements;
differing local product preferences and product requirements;
cultural differences;
changes in foreign medical reimbursement and coverage policies and programs;
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reduced or limited protections of intellectual property rights in jurisdictions outside the United States;
potentially adverse tax consequences, such as those related to changes in tax laws or tax rates or their interpretations;
protectionist, adverse and changing foreign governmental laws and regulations;
greater risk of our employees failing to comply with both U.S. and foreign laws, including anti-trust regulations, the U.S. Foreign Corrupt
Practices Act, the U.K. Bribery Act of 2010 and any trade regulations designed to ensure fair trade practices; and
compliance costs and risks of non-compliance with multiple regulatory regimes governing the production, marketing, sale and use of our
products.
Any one or more of these factors stated above could have a material adverse effect on our business, financial condition or results of operations.
As we expand our existing international operations, we may encounter new risks in addition to the above factors. For example, as we focus on
building our international sales and distribution networks in new geographic regions, we must continue to develop relationships with qualified local
distributors and trading companies. If we are not successful in developing these relationships, we may not be able to grow sales in these geographic
regions. These or other similar risks could adversely affect our revenues, profitability and the price of our common stock.
If we fail to develop and successfully introduce new products and applications or fail to improve our existing products, our business prospects
and operating results may suffer.
Our ability to generate incremental revenue growth will depend, in part, on the successful outcome of research and development activities, which
may include clinical trials that lead to the development of new products and new applications using our products. Our research and development process is
expensive, prolonged, and entails considerable uncertainty. Due to the complexities and uncertainties associated with ophthalmic research and
development, products we are currently developing may not complete the development process or obtain the regulatory approvals required to market such
products successfully. In addition, our research and development process has been slowed by the impact of COVID-19, and should the COVID-19
economic restrictions worsen, it could delay and disrupt our research and development processes even further.
Successful commercialization of new products and new applications will require that we effectively transfer production processes from research and
development to manufacturing and effectively coordinate with our suppliers. In addition, we must successfully sell and achieve market acceptance of new
products and applications and enhanced versions of existing products. The extent of, and rate at which, market acceptance and penetration are achieved by
future products is a function of many variables, which include, among other things, price, safety, efficacy, reliability, marketing and sales efforts, the
development of new applications for these products, the availability of third-party reimbursement of procedures using our new products, the existence of
competing products and general economic conditions affecting purchasing patterns.
Our ability to market and sell new products is subject to government regulation, including approval or clearance by the FDA and foreign
government agencies. Any failure in our ability to successfully develop and introduce new products or enhanced versions of existing products and achieve
market acceptance of new products and new applications could have a material adverse effect on our operating results and would cause our net revenues to
decline.
We are exposed to risks associated with worldwide economic slowdowns and related uncertainties.
We are subject to macro-economic fluctuations in the U.S. and worldwide economy. Concerns about consumer and investor confidence, volatile
corporate profits and reduced capital spending, international conflicts, terrorist and military activity, civil unrest and pandemic illness could reduce
customer orders or cause customer order cancellations. For example, the COVID-19 pandemic has and may continue to cause adverse impacts on global
economic activity which could negatively impact our business. In addition, political and social turmoil related to international conflicts and terrorist acts
may put further pressure on economic conditions in the United States and abroad.
Weak economic conditions and declines in consumer spending and consumption may harm our operating results. Purchases of our products are
often discretionary. During uncertain economic times, customers or potential customers may delay, reduce or forego their purchases of our products and
services, which may impact our business in a number of ways, including lower prices for our products and services and reducing or delaying sales. There
could be a number of follow-on effects from economic uncertainty on our business, including insolvency of key suppliers resulting in product delays,
delays in customer payments of outstanding accounts receivable and/or customer insolvencies, counterparty failures negatively impacting our operations,
and increasing expense or inability to obtain future financing.
If economic uncertainty persisted, or if the economy entered a prolonged period of decelerating growth, our results of operations may be harmed.
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Our operating results may fluctuate from quarter to quarter and year to year.
Our sales and operating results may vary significantly from quarter to quarter and from year to year in the future. Our operating results are affected
by a number of factors, many of which are beyond our control. Factors contributing to these fluctuations include the following:
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general economic uncertainties and political concerns, including the impact of COVID-19;
changes in the prices at which we can sell our products, including the impact of changes in exchange rates;
introduction of new products, product enhancements and new applications by our competitors, including new drugs, entry of new
competitors into our markets, pricing pressures and other competitive factors;
any delays or reductions in product shipments, or product recalls, resulting from manufacturing, distribution or other operational issues;
the timing of the introduction and market acceptance of new products, product enhancements and new applications;
changes in demand for our existing line of ophthalmology products;
the cost and availability of components and subassemblies, including the willingness and ability of our sole or limited source suppliers to
timely deliver components at the times and prices that we have planned;
our ability to maintain sales volumes at a level sufficient to cover fixed manufacturing and operating costs;
fluctuations in our product mix within ophthalmology products and foreign and domestic sales;
the effect of regulatory approvals and changes in domestic and foreign regulatory requirements;
our long and highly variable sales cycle;
changes in customers’ or potential customers’ budgets as a result of, among other things, reimbursement policies of government programs
and private insurers for treatments that use our products;
variances in shipment volumes as a result of product, supply chain and training issues; and
increased product innovation costs.
In addition to these factors, our quarterly results have been, and are expected to continue to be, affected by seasonal factors. For example, our
European sales during the third quarter are generally lower due to many businesses being closed for the summer vacation season.
Our expense levels are based, in part, on expected future sales. If sales levels in a particular quarter do not meet expectations, we may be unable to
adjust operating expenses quickly enough to compensate for the shortfall of sales, and our results of operations may be adversely affected. In addition, we
have historically made a significant portion of each quarter’s product shipments near the end of the quarter. If that pattern continues, any delays in shipment
of products could have a material adverse effect on results of operations for such quarters. Due to these and other factors, we believe that quarter to quarter
and year to year comparisons of our past operating results may not be meaningful. You should not rely on our results for any quarter or year as an
indication of our future performance. Our operating results in future quarters and years may be below expectations, which would likely cause the price of
our common stock to fall.
We rely on continued market acceptance of our existing products and any decline in sales of our existing products would adversely affect our
business and results of operations.
We currently market visible and infrared medical laser systems and delivery devices to the ophthalmology market. We believe that continued and
increased sales, if any, of these medical laser systems is dependent upon a number of factors including the following:
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the impact of COVID-19 pandemic on timing of ophthalmic treatment procedures;
acceptance of product performance, features, ease of use, scalability and durability, including with respect to our MicroPulse laser
photocoagulation systems;
recommendations and opinions by ophthalmologists, other clinicians, and their associated opinion leaders;
marketing and clinical study outcomes;
price of our products and prices of competing products and technologies, particularly in light of the current macro-economic environment
where healthcare systems and healthcare operators are becoming increasingly price sensitive;
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availability of competing products, technologies and alternative treatments; and
level of reimbursement for treatments administered with our products.
In addition, we derive a meaningful portion of our sales in the form of recurring revenues from selling consumable instrumentation, including our
Cyclo G6 probe and EndoProbe devices. Our ability to increase recurring revenues from the sale of consumable products will depend primarily upon the
features of our current products and product innovation, the quality of, ease of use and prices of our products, including the relationship to prices of
competing products. The level of our service revenues will depend on the quality of service we provide and the responsiveness and the willingness of our
customers to request our services rather than purchase competing products or services. Any significant decline in market acceptance of our products or our
revenues derived from the sales of laser consoles, delivery devices, consumables or services may have a material adverse effect on our business, results of
operations and financial condition.
We face strong competition in our markets and expect the level of competition to grow in the foreseeable future.
Competition in the market for laser systems and delivery devices used for ophthalmic treatment procedures is intense and is expected to increase.
This market is also characterized by technological innovation and change. We compete by providing features and services that are valued by our customers
such as: enhanced product performance and clinical outcomes, ease of use, durability, versatility, customer training services and rapid repair of equipment.
Our principal ophthalmic laser competitors are Alcon, Inc., Novartis AG, Bausch Health Companies Inc., Carl Zeiss Meditec AG, Ellex Medical
Lasers, Ltd., Lumenis Ltd., Nidek Co. Ltd., Quantel Medical SA, OD-OS GmbH and A.R.C. Laser GmbH. We also compete with alternative glaucoma
surgical device companies such as Alcon, Inc., Allergan, Inc., Glaukos Corporation, New World Medical, Inc. and Ivantis, Inc. Pharmaceuticals represent
alternative treatments to our laser procedures. Some of our principal pharmaceutical competitors are Alcon, Inc., Allergan, Inc., Astellas Pharma Inc.,
Pfizer Inc., Regeneron Pharmaceuticals, Inc., Roche Holdings Ltd. (Genentech) and Bausch Health Companies Inc. Some of our competitors have
substantially greater financial, engineering, product development, manufacturing, marketing and technical resources than we do. Some companies also have
greater name recognition than us and long-standing customer relationships. In addition, other medical device companies, academic and research
institutions, or others, may develop new technologies or therapies, including medical devices, surgical procedures or pharmacological treatments and obtain
regulatory approval for products utilizing such techniques that are more effective in treating the conditions targeted by us, or are less expensive than our
current or future products. Our technologies and products could be rendered obsolete by such developments. Any such developments could have a material
adverse effect on our business, financial condition and results of operations.
Our ability to raise capital in the future may be limited, and future sales and issuances of securities could negatively affect our stock price and
dilute the ownership interest of our existing investors.
Our business and operations may consume resources faster than we anticipate. We may need in the future 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 and may
subsequently require additional fundraising. Additional financing may not be available on favorable terms, if at all. If adequate funds are not available on
acceptable terms, we may be unable to invest in future growth opportunities, which could seriously harm our business and operating results. Future sales or
issuances of securities by us could decrease the value of our common stock, dilute stockholders’ voting power and reduce future potential earnings per
share.
To raise capital, we may sell common stock, convertible securities or other equity-linked securities in one or more transactions at prices and in a
manner we determine from time to time. If we sell additional equity securities, our existing stockholders may be materially diluted. Additionally, new
investors could gain rights, preferences and privileges senior to those of existing holders of our common stock. We may also issue debt securities, which
may impose restrictive covenants on our operations or otherwise adversely affect the holdings or the rights of our stockholders.
We may sell shares or other securities in any offering at a price per share that is less than the price per share paid by existing investors, and investors
purchasing shares or other securities in the future could have rights superior to existing stockholders. The price per share at which we sell additional shares
of our common stock, or securities convertible or exchangeable into common stock, in future transactions may be higher or lower than the price per share
paid by existing investors.
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Our operating results may be adversely affected by uncertainty regarding healthcare reform measures and changes in third-party coverage and
reimbursement policies.
Our products are typically purchased by doctors, clinics, hospitals and other users, which bill various third-party payers, such as governmental
programs and private insurance plans, for the health care services provided to their patients. Changes in government legislation or regulation or in private
third-party payers’ policies toward reimbursement for procedures employing our products may prohibit adequate reimbursement. There have been a
number of legislative and regulatory proposals to change the healthcare system, reduce the costs of healthcare and change medical reimbursement policies.
Doctors, clinics, hospitals and other users of our products may decline to purchase our products to the extent there is uncertainty regarding reimbursement
of medical procedures using our products and any healthcare reform measures. Further proposed legislation, regulation and policy changes affecting third-
party reimbursement are likely. Among other things, Congress has in the past proposed changes to and the repeal of the Patient Protection and Affordable
Care Act and the Health Care and Education Reconciliation Act of 2010, collectively, the “Affordable Care Act”, and the current U.S. presidential
administration has announced certain policy changes that could impact the availability of benefits under the Affordable Care Act. For example, tax reform
legislation enacted at the end of 2017 eliminated the tax penalty for individuals who did not maintain sufficient health insurance coverage beginning in
2019 (the “individual mandate”). We anticipate continued Congressional interest in modifying provisions of the Affordable Care Act. At this time, it
remains unclear whether there will be any changes made to or any repeal of the Affordable Care Act, with respect to certain of its provisions or in its
entirety or related administrative policies. Various healthcare reform proposals have also emerged at the state level.
We are unable to predict what legislation or regulation, if any, relating to the health care industry or third-party coverage and reimbursement may be
enacted in the future at the state or federal level, or what effect such legislation or regulation may have on us. Furthermore, existing legislation and
regulation related to the health care industry and third-party coverage reimbursement, including the Affordable Care Act, has been subject to judicial
challenge, and may be subject to similar challenges from time to time in the future (such as the ongoing California v. Texas case). Denial of coverage and
reimbursement of our products, or the revocation or changes to coverage and reimbursement policies, could have a material adverse effect on our business,
results of operations and financial condition.
Third-party payers are increasingly scrutinizing and continue to challenge the coverage of new products and the level of reimbursement for covered
products. Doctors, clinics, hospitals and other users of our products may not obtain adequate reimbursement for use of our products from third-party
payers. While we believe that the laser procedures using our products have generally been reimbursed, payers may deny coverage and reimbursement for
our products if they determine that the device was not reasonable and necessary for the purpose used, was investigational or was not cost-effective.
If we fail to comply with healthcare laws, we could face substantial penalties and financial exposure, and our business, operations and financial
condition could be adversely affected.
While we do not bill directly to Medicare, Medicaid or other third-party payors, because payment is in many cases available for our products from
such payors, many healthcare laws place limitations and requirements on the manner in which we conduct our business (including our sales and
promotional activities and interactions with healthcare professionals and facilities) and could result in liability and exposure for us. The laws that may
affect our ability to operate include (i) the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully
soliciting, receiving, offering or paying 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 Medicare or
Medicaid, (ii) federal false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented,
claims for payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent, and which may apply to entities like us if we provide
coding and billing advice to customers, or under theories of “implied certification” where the government and qui tam relators may allege that device
companies are liable where a product that was paid for by the government in whole or in part was promoted “off-label,” lacked necessary clearance or
approval, or failed to comply with good manufacturing practices or other laws; (iii) transparency laws and related reporting and disclosures requirements
such as the federal Sunshine Act, now known as Open Payments; and/or (iv) state law equivalents of each of the above federal laws, including, without
limitation anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers,
many of which differ from their federal counterparts in significant ways, thus complicating compliance efforts.
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If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us, we may be
subject to penalties, including civil and criminal penalties, exclusion from participation in government healthcare programs, damages, fines and the
curtailment or restructuring of our operations. Any penalties, damages, fines, curtailment or restructuring of our operations could adversely affect our
ability to operate our business and our financial results. The risk of our being found in violation of these laws is increased by the fact that their provisions
are open to a variety of evolving interpretations and enforcement discretion. Compliance with Open Payments, commonly known as the Sunshine Act, has
presented a number of challenges to companies such as ours, in terms of interpretation of the law and its implementation. Under the Sunshine Act, Centers
for Medicare & Medicaid Services (“CMS”) has the potential to impose penalties of up to $1.15 million per year for violations, depending on the
circumstances, although enforcement has been negligible to date. Payments reported under the Sunshine Act also have the potential to draw scrutiny on
payments to and relationships with physicians, which may have implications under the Anti-Kickback Statute and other healthcare laws. The risk that we
are our being found in violation of these laws may be increased by the fact that we do not have a formal healthcare compliance program in place. Further,
while safe harbors may in some instances be available and utilized by companies to reduce risks associated with the Anti-Kickback Statute and certain
other healthcare laws, we have not necessarily utilized such safe harbors nor fully followed all elements required to claim the benefit of such safe harbors in
all possible instances. Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal
expenses and divert our management’s attention from the operation of our business.
We depend on collaborative relationships to develop, introduce and market new products, product enhancements and new applications.
We depend on both clinical and commercial collaborative relationships. We have entered into collaborative relationships with academic medical
centers and physicians in connection with the research and innovation and clinical testing of our products. Commercially, we currently have a distribution
and licensing agreement with Alcon for our GreenTip SoftTip Cannula. Sales of and royalties from the GreenTip SoftTip Cannula are dependent upon the
sales performance of Alcon, which depends on their efforts and is beyond our control. The failure to obtain any additional future clinical or commercial
collaborations and the resulting failure or success of such collaboration relationships could have a material adverse effect on our ability to introduce new
products or applications and therefore could have a material adverse effect on our business, results of operations and financial condition.
If we cannot increase our sales volumes, reduce our costs or introduce higher margin products to offset potential reductions in the average unit
price of our products, our operating results may suffer.
The average unit price of our products may decrease in the future in response to changes in product mix, competitive pricing pressures, new product
introductions by our competitors or other factors. If we are unable to offset the anticipated decrease in our average selling prices by increasing our sales
volumes or through new product introductions, our net revenues will decline. In addition, to maintain our gross margins we must continue to reduce the
manufacturing cost of our products. If we cannot maintain our gross margins our business could be seriously harmed, particularly if the average selling
price of our products decreases significantly without a corresponding increase in sales.
Our promotional practices are subject to extensive government scrutiny. We may be subject to governmental, regulatory and other legal
proceedings relative to advertising, promotion and marketing that could have a significant negative effect on our business.
We are subject to governmental oversight and associated civil and criminal enforcement relating to drug and medical device advertising, promotion,
and marketing, and such enforcement is evolving and intensifying. In the United States, we are subject to potential enforcement from the FDA, the U.S.
Federal Trade Commission, the Department of Justice, the CMS, other divisions of the Department of Health and Human Services and state and local
governments. Other parties, including private plaintiffs, also are commonly bringing suit against pharmaceutical and medical device companies, alleging
off-label marketing and other violations. We may be subject to liability based on the actions of individual employees and contractors carrying out activities
on our behalf, including sales representatives who may interact with healthcare professionals.
If we fail to manage growth effectively, our business could be disrupted which could harm our operating results.
We have experienced and may in the future experience growth in our business, both organically and through the acquisition of businesses and
products. We have made and expect to continue to make significant investments to enable our future growth through, among other things, new product
innovation and clinical trials for new applications and products. We must also be prepared to expand our work force and to train, motivate and manage
additional employees as the need for additional personnel arises. Our personnel, systems, procedures and controls may not be adequate to support our
future operations. Any failure to effectively manage future growth could have a material adverse effect on our business, results of operations and financial
condition.
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We rely on patents and proprietary rights to protect our intellectual property and business.
Our success and ability to compete is dependent, in part, upon our proprietary information. We rely on a combination of patents, trade secrets,
copyright and trademark laws, nondisclosure and other contractual agreements and technical measures to protect our intellectual property rights. We file
patent applications to protect technology, inventions and improvements that are significant to the development of our business. As of January 2, 2021, our
patent portfolio includes 25 active United States patents and seven active foreign patents on the technologies related to our products and processes. In
addition, as of January 2, 2021, we have seven patent applications pending in the United States and 12 foreign patent applications pending. Our patent
applications may not be approved. Any patents granted now or in the future may offer only limited protection against potential infringement and
development by our competitors of competing products. Moreover, our competitors, many of which have substantial resources and have made substantial
investments in competing technologies, may seek to apply for and obtain patents that will prevent, limit or interfere with our ability to make, use or sell our
products either in the United States or in international markets. Patents have a limited lifetime and once a patent expires competition may increase.
In addition to patents, we rely on trade secrets and proprietary know-how which we seek to protect, in part, through proprietary information
agreements with employees, consultants and other parties. Our proprietary information agreements with our employees and consultants contain industry
standard provisions requiring such individuals to assign to us, without additional consideration, any inventions conceived or reduced to practice by them
while employed or retained by us, subject to customary exceptions. Proprietary information agreements with employees, consultants and others may be
breached, and we may not have adequate remedies for any breach. Also, our trade secrets may become known to or independently developed by
competitors.
The laser and medical device industry is characterized by frequent litigation regarding patent and other intellectual property rights. Companies in
the medical device industry have employed intellectual property litigation to gain a competitive advantage.
Numerous patents are held by others, including academic institutions and our competitors. Patent applications filed in the United States generally
will be published eighteen months after the filing date. However, since patent applications continue to be maintained in secrecy for at least some period of
time, both within the United States and internationally, we cannot provide assurance that our technology does not infringe any patents or patent applications
held by third parties. We have, from time to time, been notified of, or have otherwise been made aware of, claims that we may be infringing upon patents or
other proprietary intellectual property owned by others. If it appears necessary or desirable, we may seek licenses under such patents or proprietary
intellectual property. Although patent holders commonly offer such licenses, licenses under such patents or intellectual property may not be offered or the
terms of any offered licenses may not be reasonable.
Any claims, with or without merit, and regardless of whether we are successful on the merits, would be time-consuming, result in costly litigation
and diversion of technical and management personnel, cause shipment delays or require us to develop non-infringing technology or to enter into royalty or
licensing agreements. An adverse determination in a judicial or administrative proceeding and failure to obtain necessary licenses or develop alternate
technologies could prevent us from manufacturing and selling our products, which would have a material adverse effect on our business, results of
operations and financial condition.
If we lose key personnel or fail to integrate replacement personnel successfully, our ability to manage our business could be impaired.
Our future success depends upon the continued service of our key management, technical, sales, and other critical personnel. Our officers and other
key personnel are employees-at-will, and we cannot provide assurance that we will be able to retain them. Key personnel have left our company in the past,
and there likely will be additional departures of key personnel from time to time in the future. The loss of any key employee could result in significant
disruptions to our operations, including adversely affecting the timeliness of product releases, the successful implementation and completion of company
initiatives, and the results of our operations. Competition for these individuals is intense, and we may not be able to attract, assimilate or retain highly
qualified personnel. Competition for qualified personnel in our industry and the San Francisco Bay Area, as well as other geographic markets in which we
recruit, is intense and characterized by increasing salaries, which may increase our operating expenses or hinder our ability to recruit qualified candidates.
In addition, the integration of replacement personnel could be time consuming, may cause additional disruptions to our operations, and may be
unsuccessful.
Efforts to acquire additional companies or product lines may divert our managerial resources away from our business operations, and if we
complete additional acquisitions, we may incur or assume additional liabilities or experience integration problems.
As part of our growth strategy, we seek to acquire businesses or product lines for various reasons, including adding new products, adding new
customers, increasing penetration with existing customers, adding new manufacturing capabilities or expanding into new geographic markets. Our ability to
successfully grow through acquisitions depends upon our ability to
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identify, negotiate, complete and integrate suitable acquisitions and to obtain any necessary financings. These efforts could divert the attention of our
management and key personnel from our business operations. If we complete future acquisitions, we may also experience:
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difficulties integrating any acquired products into our existing business;
difficulties in integrating an acquired company’s technologies, services, employees, customers, partners, business operations and
administrative and software management systems with ours;
delays in realizing the benefits of the acquired products;
diversion of our management’s time and attention from other business concerns;
adverse customer reaction to the product acquisition; and
increases in expenses.
Moreover, we cannot assure you that the anticipated benefits of any acquisition or investment would be realized or that we would not be exposed to
unknown liabilities. In connection with these types of transactions, we may issue additional equity securities that would dilute the ownership interest of
existing investors or earnings per share, use cash that we may need in the future to operate our business, incur debt on terms unfavorable to us or that we
are unable to repay, incur large charges or substantial liabilities, encounter difficulties integrating diverse business cultures and become subject to adverse
tax consequences, substantial depreciation or deferred compensation charges. These challenges related to acquisitions or investments could adversely affect
our business, operating results and financial condition.
If we fail to accurately forecast demand for our product and component requirements for the manufacture of our product, we could incur
additional costs or experience manufacturing delays and may experience lost sales or significant inventory carrying costs.
We use quarterly and annual forecasts based primarily on our anticipated product orders to plan our manufacturing efforts and determine our
requirements for components and materials. It is very important that we accurately predict both the demand for our product and the lead times required to
obtain or manufacture the necessary components, materials, and fully assembled products. Lead times for components and fully assembled products vary
significantly and depend on numerous factors, including the specific supplier, the size of the order, contract terms and current market demand for such
products. If we overestimate the demand for our product, we may have excess inventory, which would increase our costs. If we underestimate demand for
our product and consequently, our components, materials and fully assembled products requirements, we may have inadequate inventory, which could
interrupt our manufacturing, delay delivery of our product to our customers and result in the loss of customer sales. Any of these occurrences would
negatively impact our business and operating results.
We depend on sole source or limited source suppliers.
We rely on third parties to manufacture substantially all of the components used in our products, including optics, laser diodes and crystals. We have
some long term or volume purchase agreements with our suppliers and currently purchase components and fully-assembled products on a purchase order
basis. Some of our suppliers and manufacturers are sole or limited source suppliers. In addition, some of these suppliers are relatively small private
companies whose operations may be disrupted or discontinued at any time. There are risks associated with the use of independent manufacturers, including
the following:
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the impact of COVID-19 on global supply chains and market stability;
unavailability of shortages or limitations on the ability to obtain supplies of components and products in the quantities that we require, or
that satisfy the environmental requirements to which we are subject;
delays in delivery or failure of suppliers to deliver critical components and products on the dates we require;
failure of suppliers to manufacture and assemble components and products to our specifications, and potentially reduced quality; and
inability to obtain components and products at acceptable prices.
Our business and operating results may suffer from the lack of alternative sources of supply for critical sole and limited source components and
fully-assembled products. The process of qualifying suppliers is complex, requires extensive testing with our products, and may be lengthy, particularly as
new products are introduced. New suppliers would have to be educated in our production processes. In addition, the use of alternate components may
require design alterations to our products and additional product testing under FDA and relevant foreign regulatory agency guidelines, which may delay
sales and increase product costs. Any failures by our vendors to adequately supply limited and sole source components or products may impair our ability
to offer our existing products, delay the submission of new products for regulatory approval and market introduction, materially harm our business and
financial condition and cause our stock price to decline. Establishing our own
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capabilities to manufacture these components or products would be expensive and could significantly decrease our profit margins. Our business, results of
operations and financial condition would be adversely affected if we are unable to continue to obtain components or fully-assembled products in the
quantity and quality desired and at the prices we have budgeted.
If our facilities were to experience catastrophic loss, our operations would be seriously harmed.
Our facilities could be subject to catastrophic loss such as fire, flood, unpredictable power outages, or earthquake. All of our research and
development activities, manufacturing, our corporate headquarters and other critical business operations are located near major earthquake faults in
Mountain View, California. California can experience earthquakes, catastrophic wildfires, and intermittent power outages. Any such loss at any of our
facilities caused by fires, flooding, power outages, or earthquakes could disrupt our operations, delay production, shipments and revenue and result in large
expense to repair and replace our facilities.
If we experience a significant disruption in our information technology systems or breaches of data security, our business could be adversely
affected.
We rely on information technology systems to keep financial records and corporate records, communicate with staff and external parties and operate
other critical functions, including sales and manufacturing processes. Our information technology systems are potentially vulnerable to disruption due to
breakdown or malicious intrusion and computer viruses. If we were to experience a prolonged system disruption in our information technology systems, it
could negatively impact the coordination of our sales, planning and manufacturing activities, which could adversely affect our business. In addition, in
order to maximize our information technology efficiency, we have physically consolidated our primary corporate data and computer operations. This
concentration, however, exposes us to a greater risk of disruption to our internal information technology systems. Although we maintain offsite back-ups of
our data, if operations at our facilities were disrupted, it may cause a material disruption in our business if we are not capable of restoring function on an
acceptable time frame.
In addition, our information technology systems are potentially vulnerable to cyber-attacks or other data security breaches-whether by employees or
others-which may expose sensitive data to unauthorized persons. Such data security breaches could lead to the loss of trade secrets or other intellectual
property, or could lead to the public exposure of sensitive and confidential information of our employees, customers, suppliers and others, any of which
could have a material adverse effect on our business, financial condition and results of operations.
While we have implemented a number of protective measures, including firewalls, antivirus and malware detection tools, patches, log monitors,
routine back-ups, system audits, routine password modifications and disaster recovery procedures, such measures may not be adequate or implemented
properly to prevent or fully address the adverse effect of such events, and in some cases we may be unaware of an incident or its magnitude and effects. If
we are unable to prevent such security breaches or privacy violations or implement satisfactory remedial measures, our operations could be disrupted, and
we may suffer loss of reputation, financial loss and other regulatory penalties because of lost or misappropriated information. In addition, these breaches
and other inappropriate access can be difficult to detect, and any delay in identifying them may lead to increased harm of the type described above.
If we fail to maintain our relationships with health care providers, customers may not buy our products and our revenue and profitability may
decline. At the same time, relationships with these individuals and entities are the subject of heightened scrutiny and may present the potential for
healthcare compliance risks.
We market our products to numerous health care providers, including physicians, hospitals, ambulatory surgery centers, government affiliated
groups and group purchasing organizations. We have developed and strive to maintain close relationships with members of each of these groups who assist
in product research and development and advise us on how to satisfy the full range of surgeon and patient needs. We rely on these groups to recommend
our products to their patients and to other members of their organizations. The failure of our existing products and any new products we may introduce to
retain the support of these various groups could have a material adverse effect on our business, financial condition and results of operations. In addition,
our interactions, communications, and financial relationships with these individuals and entities present potential healthcare compliance risks.
We are subject to government regulations which may cause us to delay or withdraw the introduction of new products or new applications for
our products.
The medical devices that we market and manufacture are subject to extensive regulation by the FDA and by foreign and state governments. Under
the FD&C Act and the related regulations, the FDA regulates the design, development, clinical testing, manufacture, labeling, sale, distribution and
promotion of medical devices. Before a new device can be introduced into the market, the product must be shown to meet regulatory requirements
established by the FD&C Act and implemented by the FDA. Unless otherwise exempt, a device manufacturer must obtain marketing “clearance” through
the 510(k) premarket notification process, or “approval” through the lengthier premarket approval application (“PMA”) process. Not all devices are eligible
for the 510(k) clearance process. Depending upon the type, complexity and novelty of the device and the nature of the disease or disorder to be treated, the
PMA process can take several years, require extensive clinical testing and result in significant expenditures. Even if regulatory clearance or approval is
obtained, later discovery of previously unknown safety issues may result in restrictions on the product, including withdrawal of the product from the
market. Other countries also have extensive regulations regarding clinical trials and testing prior to new product introductions. Our failure to obtain
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government approvals or any delays in receipt of such approvals would have a material adverse effect on our business, results of operations and financial
condition.
The FDA imposes a broad range of additional requirements on medical device companies. Our products must be produced in compliance with the
Quality System Regulation (“QSR”) and our manufacturing facilities are subject to establishment registration and device listing requirements from the
FDA, and similar requirements from certain state authorities, and ongoing periodic inspections by the FDA, including unannounced inspections for
compliance with applicable requirements. We are subject to monitoring, recordkeeping, and reporting obligations for medical device adverse events and
malfunctions; notification of our products’ defects or failure to comply with the FDA’s laser regulations; and reporting of recalls, corrections, or removals
of our products. The FDA also imposes requirements for the labeling of our products, and places limitations on claims we are permitted to make about our
products in promotional labeling. The Federal Trade Commission has jurisdiction over the advertising of all of our products, which are non-restricted
devices, and exercises oversight in coordination with the FDA.
Noncompliance with the applicable requirements can result in, among other things, regulatory citations (including “483 Observations”) and
Warning Letters, fines, injunctions, civil penalties, recall or seizure of products, total or partial suspension of production, withdrawal of marketing
approvals, and criminal prosecution. The FDA also has the authority to request repair, replacement or refund of the cost of any device we manufacture or
distribute. Any of these actions by the FDA would materially and adversely affect our ability to continue operating our business and the results of our
operations. Such enforcement action can also result in negative publicity.
In addition, we are also subject to varying product standards, packaging requirements, labeling requirements, tariff regulations, duties and tax
requirements. As a result of our sales in Europe, we are required to have all products “CE” marked, an international symbol affixed to all products
demonstrating compliance with the European Medical Device Directives and all applicable standards. While currently all of our released products are CE
marked, continued certification is based on the successful review of our quality system by our European Registrar during their annual audit. Any loss of
certification would have a material adverse effect on our business, results of operations and financial condition. There are a number of major regulatory
changes occurring in the regulation of medical devices in the EU. A new revision of the quality system regulation (ISO 13485:2016) has been released that
substantially increases the requirements for a medical device quality system. The Medical Device Regulation (“MDR”) will replace the current medical
device directives (93/42/EEC), and it substantially changes the way that medical devices are brought to market in the EU and how they maintain
compliance throughout the product’s life cycle. Due to the UK’s exit from EU (“Brexit”), different rules will apply in Great Britain (England, Wales and
Scotland), Northern Ireland and the EU after the Brexit transition period, which began January 1, 2021. Additionally, the new revision 4 of the clinical
evaluation report guidance document (MEDDEV 2.7.1) severely restricts the use of substantial equivalence for new products, resulting in the need for
formal clinical trial data for most new products. These changes will increase the cost for compliance and for product development, and they lengthen
product introduction cycles. Failure to comply with these changes can have an adverse effect on our ability to release new products in a timely manner.
Any clinical trials necessary that we may undertake for regulatory approval or marketing reasons will be an expensive, lengthy, costly, and
uncertain process, and could result in delays in new product introductions or even an inability to release a product.
We may be required to undertake clinical trials often required to obtain regulatory approvals or may choose to undertake such trials for marketing or
other reasons. Clinical trials for products such as ours are complex and expensive and their outcomes are uncertain. Any clinical trials that we may
undertake would require the investment of significant financial and administrative resources. Moreover, the results of clinical trials are uncertain, and
inconclusive or negative results may not support, or may impair, the sale and adoption of our products. We may suffer significant setbacks in clinical trials,
even after earlier clinical trials showed promising results. Any of our products could produce undesirable side effects that could cause us or regulatory
authorities to interrupt, delay or halt clinical trials of a product candidate. We, the FDA, or another regulatory authority could suspend or terminate clinical
trials at any time if they or we believed the trial participants faced unacceptable health risks.
If we fail to comply with the FDA’s quality system regulation and laser performance standards, our manufacturing operations could be halted,
and our business would suffer.
We are currently required to demonstrate and maintain compliance with the FDA’s QSR. The QSR is a complex regulatory scheme that covers the
methods and documentation of the design, testing, control, manufacturing, labeling, quality assurance, packaging, storage and shipping of our products.
Because our products involve the use of lasers, our products also are covered by a performance standard for lasers set forth in FDA regulations. The laser
performance standard imposes specific record-keeping, reporting, product testing and product labeling requirements. These requirements include affixing
warning labels to laser products, as well as incorporating certain safety features in the design of laser products. The FDA enforces the QSR and laser
performance standards through periodic unannounced inspections. We have been, and anticipate in the future being, subject to such inspections. Our failure
to take satisfactory corrective action in response to an adverse QSR inspection or our failure to comply with applicable laser performance standards could
result in enforcement actions, including a public warning letter, a shutdown of our manufacturing operations, a recall of our products, civil or criminal
penalties, or other sanctions, which would cause our sales and business to suffer.
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If we modify one of our FDA cleared devices, we may need to submit a new 510(k), or potentially a PMA, and if clearance or approval is not
obtained, it would prevent us from selling our modified products or cause us to redesign our products.
Any modifications to an FDA-cleared device that would significantly affect its safety or effectiveness or that would constitute a major change in its
intended use would require a new 510(k) clearance or possibly a PMA. We may not be able to obtain additional 510(k) clearances or premarket approvals
for new products or for modifications to, or additional indications for, our existing products in a timely fashion, or at all. Delays in obtaining future
clearances would adversely affect our ability to introduce new or enhanced products in a timely manner, which in turn would harm our revenues and future
profitability. We have made modifications to our devices in the past and may 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 marketing the modified devices, which could harm our operating results and require us to redesign our products.
Our products may be misused, which could harm our reputation and our business.
We market and sell our products for use by highly skilled physicians with specialized training and experience in the treatment of eye-related
disorders. We, and our distributors, generally offer but do not require purchasers or operators of our products to attend training sessions, nor do we
supervise the procedures performed with our products. The physicians who operate our products are responsible for their use and the treatment regime for
each individual patient. In addition, non-physicians, particularly in countries outside of the United States, or poorly trained or inexperienced physicians,
may make use of our products. Our efforts to market our MicroPulse systems as a fovea-friendly alternative to traditional continuous wavelength systems
or alternative treatment methods may result in users failing to implement adequate safety precautions and thereby increase the risks associated with the
misuse of our product. The lack of training and the purchase and use of our products by non-physicians or poorly trained or inexperienced physicians may
result in product misuse and adverse treatment outcomes, which could harm our reputation and expose us to costly product liability litigation, or otherwise
cause our business to suffer.
Inability of customers to obtain credit or material increases in interest rates may harm our sales.
Some of our products are sold to health care providers in general practice. Many of these health care providers purchase our products with funds
they secure through various financing arrangements with third-party financial institutions, including credit facilities and short-term loans. If availability of
credit becomes more limited, or interest rates increase, these financing arrangements may be harder to obtain or become more expensive for our customers,
which may decrease demand for our products. Any reduction in the sales of our products would cause our business to suffer.
Our products could be subject to recalls even after receiving FDA approval or clearance. A recall would harm our reputation and adversely
affect our operating results.
The FDA and similar governmental authorities in other countries in which we market and sell our products have the authority to require the recall of
our products in the event of material deficiencies or defects in the design or manufacture of our products, or in other cases we may determine that we will
recall a product because we have determined that the product is violative, in order to avoid further enforcement action and protect the public health.
A government mandated recall, or a voluntary recall by us, could occur as a result of actual or potential component failures, adverse event reports,
manufacturing errors or design defects, including defects in labeling. Furthermore, we may from time to time initiate a recall of a component or set of
components comprising a portion of our laser systems, which could increase customer returns, warranty claims and associated reserve levels. A recall could
divert management’s attention, cause us to incur significant expenses, harm our reputation with customers and negatively affect our future sales and
financial results.
For example, on February 23, 2018, we initiated a worldwide voluntary recall of a specific laser accessory called the TruFocus LIO Premiere®
(“LIO”). The LIO is a head-mounted indirect ophthalmoscope that connects to our laser console and is used to view and perform laser treatment on a
patient’s retina. This recall was prompted after we received reports of three adverse events from one physician in the U.S., resulting in focal cataracts and
iris burns occurring during procedures in which the TruFocus LIO Premiere was used. We identified several potential root causes for the adverse events,
including use error. On March 22, 2019, we provided the FDA with a request for termination of Recall Number Z-1075-2018. Our termination request is
pending.
We obtained FDA clearance for an updated TruFocus LIO Premiere® device. The updated device includes expanded user instructions and minor
design changes. Use of the updated LIO may result in adverse events, including those observed with the prior LIO device. If physician use of our updated
LIO results in serious adverse events, we may have to initiate another recall or utilize additional resources to further evaluate the design of the LIO device.
Furthermore, in light of the recall, we cannot provide any assurance that the updated LIO, once launched, will achieve market acceptance. We will be
required to devote significant resources to launch and market the updated LIO and cannot provide any assurance that these activities will generate revenue
as anticipated. If our revenue grows more slowly than we expect because of a delay in or a lack of market acceptance for our updated LIO, our business and
financials will be adversely affected.
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If product liability claims are successfully asserted against us, we may incur substantial liabilities that may adversely affect our business or
results of operations.
We may be subject to product liability claims from time to time. Our products are highly complex and the risk of significant patient injury is more
likely with products and procedures involving the eye. Use of our products incorrectly can result in temporary or permanent loss in vision, burns, scarring,
blind spots or other injuries of the eye and we may periodically become subject to product liability lawsuits as a result. We believe we maintain adequate
levels of product liability insurance to cover such claims subject to certain deductibles. However, product liability insurance is expensive and we might not
be able to obtain product liability insurance in the future on acceptable terms or in sufficient amounts to protect us, if at all. A successful claim brought
against us in excess of our insurance coverage could have a material adverse effect on our business, results of operations and financial condition.
Significant developments resulting from recent and potential changes in United States trade policies could have a material adverse effect on us.
Certain of our materials may be subject to the effects of various trade agreements, treaties and tariffs. The recent U.S. presidential administration
has imposed tariffs on various goods from various countries, including China, Canada and the European Union (“EU”), and announced intentions to impose
furthermore significant tariffs on certain United States imports. As a result, Canada, the EU, China and other countries have responded with retaliatory
tariffs on certain United States exports. We cannot predict the effect these and potential additional tariffs will have on our business, including in the context
of escalating trade tensions. Further tariffs, additional taxes, or trade barriers, both domestically and internationally, may affect our selling and/or
manufacturing costs and margins, the competitiveness of our products, or our ability to sell products or purchase necessary equipment and supplies, and
consequently affect our business, results of operations, or financial conditions. To the extent that trade tariffs and other restrictions imposed by the United
States increase the price of, or limit the amount of, raw materials and finished goods imported into the United States, the costs of our raw materials may be
adversely affected and the demand from our customers for products and services may be diminished, which could adversely affect our revenues and
profitability.
In addition, these potential developments and any market perceptions concerning these and related issues and the attendant regulatory uncertainty
regarding, for example, the posture of governments with respect to international trade, could have a material adverse effect on global trade and economic
growth which, in turn can adversely affect our business. Furthermore, changes in United States trade policy have resulted and could result in additional
reactions from United States trading partners and other countries, including adopting responsive trade policies that make it more difficult or costly for us to
export our products to those countries. We sell a significant majority of our products into countries outside the United States and we purchase a significant
portion of equipment and supplies from suppliers outside the United States. These measures could also result in increased costs for goods imported into the
U.S. or may cause us to adjust our worldwide supply chain. Any of these effects could require us to increase prices to our customers which may reduce
demand, or, if we are unable to increase prices, may result in lowering our margin on products sold.
We cannot predict future trade policy or the terms of any renegotiated trade agreements and their impacts on our business. The adoption and
expansion of trade restrictions, the occurrence of a trade war, or other governmental action related to tariffs or trade agreements or policies has the potential
to adversely impact demand for our products, our costs, our customers, our suppliers, and the United States economy, which in turn could adversely impact
our business, financial condition and results of operations.
Changes in U.S. tax laws could have a material adverse effect on our business, cash flow, results of operations or financial conditions.
The comprehensive tax legislation commonly referred to as the Tax Cuts and Jobs Act (the “Tax Act”) was enacted in the United States on
December 22, 2017 and includes, among other items, a reduction in the federal corporate income tax rate from 35% to 21%, certain interest expense
deduction limitations and changes in the timing of certain taxable income. We are required to recognize the effect of the tax law changes in the period of
enactment, such as re-measuring our U.S. deferred tax assets and liabilities and reassessing the net realizability of our deferred tax assets and liabilities.
On December 22, 2017, the SEC staff issued Staff Accounting Bulletin No. 118 (“SAB 118”) which provides guidance on accounting for the tax
effects of the Tax Act. We have completed our analysis and accounting with respect the Tax Act, and identified no additional changes from amounts
previously recorded. However, changes in law, interpretations, and facts may result in adjustments to these amounts. Based on the our net operating loss
carryovers and valuation allowance, there is no impact to its consolidated financial statements as a result of the accounting for the tax effects of the Tax
Act.
Subsequent legislations, guidance, regulations or audits that differ from our prior assumptions and interpretations, or other factors which were not
anticipated at the time we estimated our tax provision could have a material adverse effect on our business, cash flow, results of operations or financial
condition.
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We are subject to federal, state and foreign laws governing our business practices which, if violated, could result in substantial penalties.
Additionally, challenges to or investigation into our practices could cause adverse publicity and be costly to respond to and thus could harm our
business.
The Dodd-Frank Wall Street Reform and Consumer Protection Act requires us to track and disclose the source of certain metals used in
manufacturing which may stem from minerals (so called “conflict minerals”) which originate in the Democratic Republic of the Congo or adjoining
regions. These metals include tantalum, tin, gold and tungsten. These metals are central to the technology industry and are present in some of our products
as component parts. In most cases no acceptable alternative material exists which has the necessary properties. It is not possible to determine the source of
the metals by analysis but instead a good faith description of the source of the intermediate components and raw materials must be obtained. The
components which incorporate those metals may originate from many sources and we purchase fabricated products from manufacturers who may have a
long and difficult-to-trace supply chain. As the spot price of these materials varies, producers of the metal intermediates can be expected to change the mix
of sources used, and components and assemblies which we buy may have a mix of sources as their origin. We are required to carry out a diligent effort to
determine and disclose the source of these materials. There can be no assurance we can obtain this information from intermediate producers not willing or
not able to provide this information or further identify their sources of supply or to notify us if these sources change. These metals are subject to price
fluctuations and shortages which can affect our ability to obtain the manufactured materials we rely on at favorable terms or from consistent sources. These
changes could have an adverse impact on our ability to manufacture and market our devices and products.
Divestitures of some of our businesses or product lines may materially and adversely affect our financial condition, results of operations or cash
flows and require us to raise additional capital to replace revenue from those business units or product lines.
We evaluate the performance and strategic fit of all of our businesses and may sell businesses or product lines. Divestitures involve risks, including
difficulties in the separation of operations, services, products and personnel, the diversion of management's attention from other business concerns, the
disruption of our business, the potential loss of key employees and the retention of uncertain environmental or other contingent liabilities related to the
divested business. In addition, divestitures may result in significant asset impairment charges, including those related to goodwill and other intangible
assets, and the loss of revenue which could have a material adverse effect on our financial condition and results of operations. In addition, we may need to
raise additional capital to replace the revenue generated from the business or product line that is divested and we can provide no assurance that such capital
will be available or available on terms that are acceptable to us. We cannot assure you that we will be successful in managing these or any other significant
risks that we encounter in divesting a business or product line, and any divestiture we undertake could materially and adversely affect our business,
financial condition, results of operations and cash flows, and may also result in a diversion of management attention, operational difficulties and losses.
If we fail to comply with environmental requirements, our business, financial condition, operating results and reputation could be adversely
affected.
Our products and operations are subject to various federal, state, local and foreign environmental laws and regulations, including those governing
the use, storage, handling, exposure to, and disposal of hazardous materials and a large and growing body of international standards which govern the
design, manufacture, materials content and sourcing, testing, certification, packaging, installation, use and disposal of our products. We must continually
keep abreast of these standards and requirements and integrate compliance to these with the development and regulatory documentation for our products.
Failure to meet these standards could limit the ability to market our products in those regions which require compliance with such standards or subject us to
fines and penalties. Examples of such standards include laws governing the hazardous material content of our devices and products, such as the EU
Directive 2015/863 which is known as “RoHS 3” and that relates to Restrictions on the Use of Certain Hazardous Substances and the EU Directive
2012/19/EU on Waste Electrical and Electronic Equipment. Similar laws and regulations have been passed or are pending in several other jurisdictions and
may be enacted in other regions, including in the United States, and we are, or may in the future be, subject to these laws and regulations.
Our failure to comply with past, present and future similar laws could result in reduced sales of our devices and products, inventory write-offs,
reputational damage, penalties and other sanctions, any of which could harm our business and financial condition. We also expect that our devices and
products will be affected by new environmental laws and regulations on an ongoing basis. New environmental laws and regulations will likely result in
additional costs and may increase penalties associated with violations or require us to change the content of our devices and products or how they are
manufactured, which could have a material adverse effect on our business, operating results and financial condition.
Risks Relating to Ownership of Our Common Stock
Our stock price has been and may continue to be volatile and an investment in our common stock could suffer a decline in value.
The trading price of our common stock has been subject to wide fluctuations in response to a variety of factors, some of which are beyond our
control, including changes in foreign currency exchange rates, quarterly variations in our operating
32
results, announcements by us or our competitors of new products or of significant clinical achievements, changes in market valuations of other similar
companies in our industry and general market conditions. During the fourth quarter of fiscal year 2020, the trading price of our common stock fluctuated
from a low of $1.62 per share to a high of $2.91 per share. During the fiscal year 2020, the trading price of our common stock fluctuated from a low of
$1.40 per share to a high of $3.64 per share. On March 10, 2021, our stock price closed at $7.30 per share. There can be no assurance that our common
stock trading price will not suffer declines. Our common stock may experience an imbalance between supply and demand resulting from low trading
volumes and therefore broad market fluctuations could have a significant impact on the market price of our common stock regardless of our performance.
Because we do not intend to pay dividends, stockholders will benefit from an investment in our common stock only if it appreciates in value.
We expect to retain any earnings for use to further develop our business, and do not expect to declare cash dividends on our common stock in the
foreseeable future. The declaration and payment of any such dividends in the future depends upon our earnings, financial condition, capital needs and other
factors deemed relevant by the board of directors, and may be restricted by future agreements with lenders. As a result, the success of an investment in our
common stock will depend entirely upon any future appreciation. There is no guarantee that our common stock will appreciate in value or even maintain
the price at which stockholders have purchased their shares.
If securities or industry analysts do not continue to publish research or publish incorrect or unfavorable research about our business, our stock
price and trading volume could decline.
The trading market for our common stock depends in part on the research and reports that securities or industry analysts publish about us, our
market and our competitors. If no or few securities or industry analysts cover our company, the trading price for our stock could be negatively impacted. If
one or more of the analysts who covers us downgrades our stock or publishes incorrect or unfavorable research about our business, our stock price could
decline. If one or more of these analysts ceases coverage of our company or fails to publish reports on us regularly, demand for our stock could decrease,
which could cause our stock price or trading volume to decline.
Ownership of our common stock is concentrated among a few investors, which may affect the ability of a third party to acquire control of us.
Substantial sales by such investors could cause our stock price to decline.
Our directors, executive officers, current five percent or greater stockholders and affiliated entities together beneficially own a significant portion of
our common stock outstanding. Having such a concentration of ownership may have the effect of making it more difficult for a third party to acquire, or of
discouraging a third party from seeking to acquire, a majority of our outstanding common stock or control of our board of directors through a proxy
solicitation.
As a public company, we are obligated to develop and maintain proper and effective internal control over financial reporting. We may not
complete our analysis of our internal control over financial reporting in a timely manner, or these internal controls may not be determined to be
effective, which may adversely affect investor confidence in our company and, as a result, the value of our common stock.
We are required, pursuant to Section 404 of the Sarbanes-Oxley Act, to furnish a report by management on, among other things, the effectiveness of
our internal control over financial reporting. This assessment must include disclosure of any material weaknesses identified by our management in our
internal control over financial reporting. We may experience difficulty in meeting these reporting requirements in a timely manner, particularly if material
weaknesses or significant deficiencies were to persist. Our independent registered public accounting firm will not be required to formally attest to the
effectiveness of our internal control over financial reporting pursuant to Section 404 while we are a “smaller reporting company” as defined in the
Exchange Act. If we are unable to comply with the requirements of Section 404 in a timely manner, the market price of our stock could decline and we
could be subject to sanctions or investigations by the Nasdaq Stock Market, the SEC or other regulatory authorities, which could require additional
financial and management resources.
Any failure to develop or maintain effective controls, or any difficulties encountered in their implementation or improvement, could harm our
operating results or cause us to fail to meet our reporting obligations. Any failure to implement and maintain effective internal controls also could adversely
affect the results of periodic management evaluations regarding the effectiveness of our internal control over financial reporting. Ineffective disclosure
controls and procedures or internal control over financial reporting could also cause investors to lose confidence in our reported financial and other
information, which could likely have a negative effect on the trading price of our common stock.
Implementing any appropriate changes to our internal controls may require specific compliance training of our directors, officers and employees,
entail substantial costs in order to modify our existing accounting systems, and take a significant period of time to complete. Such changes may not,
however, be effective in maintaining the adequacy of our internal controls, and any failure to maintain that adequacy, or consequent inability to produce
accurate financial statements on a timely basis, could increase our operating costs and could materially impair our ability to operate our business. In the
event that we are not able to demonstrate compliance with Section 404 of the Sarbanes-Oxley Act in a timely manner, that
33
our internal controls are perceived as inadequate or that we are unable to produce timely or accurate financial statements, investors may lose confidence in
our operating results and our stock price could decline.
Our charter documents, anti-takeover provisions of Delaware law, and contractual provisions could delay or prevent an acquisition or sale of
our company.
Our certificate of incorporation empowers the board of directors to establish and issue a class of preferred stock, and to determine the rights,
preferences and privileges of the preferred stock. These provisions give the board of directors the ability to deter, discourage or make more difficult a
change in control of our company, even if such a change in control could be deemed in the interest of our stockholders or if such a change in control would
provide our stockholders with a substantial premium for their shares over the then-prevailing market price for the common stock. Our certificate of
incorporation and bylaws contain other provisions that could have an anti-takeover effect, including the following:
•
•
•
•
•
the authorized number of directors may be changed only by resolution of our board of directors;
only our board of directors is authorized to fill vacant directorships, including newly created seats;
special meetings of our stockholders may be called only by our board of directors, the chairman of the board, chief executive officer or
president, thus prohibiting a stockholder from calling a special meeting;
stockholders must give advance notice to nominate directors or propose other business; and
stockholders are not permitted to cumulate votes in the election of directors.
In addition, we are generally subject to the anti-takeover provisions of Section 203 of the Delaware General Corporation Law, which regulates
corporate acquisitions. These provisions could discourage potential acquisition proposals and could delay or prevent a change in control transaction. They
could also have the effect of discouraging others from making tender offers for our common stock or prevent changes in our management.
Item 1B. Unresolved Staff Comments
None.
Item 2. Properties
We lease a 37,166 square feet facility in Mountain View, California pursuant to a lease that is scheduled to expire in February 2022.
This facility is being substantially utilized for all of our manufacturing, research and development efforts and also serves as our corporate
headquarters. Management believes that these facilities are adequate for our current needs and that suitable additional space or an alternative space would
be available as needed in the future on commercially reasonable terms.
Item 3. Legal Proceedings
From time to time, we may be involved in legal proceedings arising in the ordinary course of business. Although the results of litigation and claims
cannot be predicted with certainty, we currently believe that the final outcome of these ordinary course matters will not have a material adverse effect on
our business, operating results, financial condition or cash flows. Regardless of the outcome, litigation can have an adverse impact on us because of defense
and settlement costs, diversion of management resources and other factors. We are not currently party to any material legal proceedings.
Item 4. Mine Safety Disclosures
Not applicable.
34
PART II
Item 5. Market for Registrant’s Common Equity and Related Stockholder Matters, and Issuer Purchases of Equity Securities
Market Information for Common Equity
Our common stock is currently quoted on the Nasdaq Global Market under the symbol “IRIX”.
As of March 15, 2021, there were approximately 33 holders of record (not in street name) of our common stock. Because many of our shares of
common stock are held by brokers and other institutions on behalf of our stockholders, we are unable to estimate the total number of stockholders
represented by these record holders.
Dividend Policy
We have never paid cash dividends on our common stock. We currently intend to retain any earnings for use in our business and do not anticipate
paying cash dividends in the foreseeable future.
Sales of Unregistered Securities
None.
Purchases of Equity Securities by the Issuer and Affiliated Purchasers
Not applicable.
Item 6. Selected Financial Data
As a “smaller reporting company,” as defined in Rule 12b-2 of the Exchange Act, we are not required to provide the information called for by this
Item.
35
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Overview
IRIDEX Corporation is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products
and procedures used to treat sight-threatening eye conditions, including glaucoma and retinal diseases. Certain of our laser products are powered by our
proprietary MicroPulse technology, which is a method of delivering laser energy using a mode which chops the continuous wave laser beam into short,
microsecond-long laser pulses. Our products consist of laser consoles, delivery devices and consumable instrumentation, including laser probes.
Our laser consoles consist of the following product lines:
•
•
•
Glaucoma – This product line includes our Cyclo G6® laser system used for the treatment of glaucoma;
Medical Retina – Our medical retina product line includes our IQ 532® and IQ 577® laser photocoagulation systems, which are used for
the treatment of diabetic macular edema and other retinal diseases; and
Surgical Retina – Our surgical retina line of products includes our OcuLight® TX, OcuLight SL, OcuLight SLx, OcuLight GL and
OcuLight GLx laser photocoagulation systems. These systems are often used in vitrectomy procedures, which are used to treat proliferative
diabetic retinopathy, macular holes, retinal tears and detachments.
Our business generates recurring revenues through sales of consumable products, predominantly single-use laser probe devices and other
instrumentation, as well as repair, servicing and extended service contracts for our laser systems. Our laser probes consist of the following product lines:
•
•
Glaucoma – Probes used in our glaucoma product line include our recently patented MicroPulse P3® Probe, G-Probe® and G-Probe
Illuminate®; and
Surgical Retina – Our surgical retina probes include our EndoProbe® family of products used in vitrectomy procedures.
Ophthalmologists typically use our laser systems in hospital ORs and ambulatory surgical centers (“ASCs”), as well as their offices and clinics. In
ORs and ASCs, ophthalmologists use our laser systems with either an indirect laser ophthalmoscope or a consumable, single use MicroPulse P3 Probe, G-
Probe, G-Probe Illuminate or EndoProbe.
In 2020 and 2019, our products were sold in the United States and Germany predominantly through a direct sales force and internationally (aside
from Germany) primarily through independent distributors. Total revenues in 2020 and 2019 were $36.3 million and $43.4 million, respectively. We
generated net losses of $6.3 million and $8.8 million in 2020 and 2019, respectively.
Cost of revenues consists primarily of the cost of components and sub-systems, assembling, packaging, shipping and testing components at our
facility, direct labor and associated overhead, warranty, royalty and amortization of intangible assets and depot service costs.
Research and development expenses consist primarily of personnel costs, materials to support new product development and research support
provided to clinicians at medical institutions developing new applications which utilize our products and regulatory expenses. Research and development
costs have been expensed as incurred.
Sales and marketing expenses consist primarily of costs of personnel, sales commissions, travel expenses, advertising and promotional expenses.
General and administrative expenses consist primarily of costs of personnel, legal, accounting and other public company costs, insurance and other
expenses not allocated to other departments.
Impact of COVID-19 to our Business
The outbreak of the COVID-19 has been declared a pandemic by the World Health Organization and continues to spread globally. The spread of
COVID-19 has caused public health officials to recommend, and governments to enact, precautions to mitigate the spread of the virus, including travel
restrictions and bans, extensive social distancing guidelines and issuing a “shelter-in-place” order in many regions of the world. The pandemic and these
related responses have caused, and are expected to continue to cause a global slowdown of economic activity (including the decrease in demand for a broad
variety of goods and services), disruptions in global supply chains and significant volatility and disruption of financial markets. We have adopted several
measures in response to the COVID-19 outbreak including instructing employees to work from home while under shelter-in-place orders, slowing our
manufacturing operations, and restricting non-critical business travel by our employees. Furthermore, we cannot be certain that these actions will mitigate
some or all of the negative effects of the pandemic on our business. The extent of the negative effects of COVID-19 on our financial condition or results of
operations remains uncertain. Any actual effects on our financial condition or results of operations may differ from any estimates reflected in our financial
statements, and such effects may not be fully reflected in our financial condition or results of operations until future periods, if at all.
36
The Company has been deemed an essential business and therefore, has continued to operate in a more limited capacity during the pandemic. In
April and May 2020, following shelter-in-place orders, the Company operated with limited personnel at our facilities to continue essential operations. In
June 2020, we implemented return-to-work phases in conjunction with a social distancing protocol to safely continue essential operations to best meet
customer demands in light of the pandemic. We will continue to actively monitor the situation and may take further actions altering our business operations
that we determine are in the best interests of our employees, customers, communities, business partners, suppliers, and shareholders, or as required by
federal, state, or local authorities.
Our total revenues decreased $7.1 million or 16.3% from $43.4 million in 2019 to $36.3 million in 2020. This decrease was primarily attributed to
the decrease in surgical elective procedures using our products, in part caused by limitations on the availability of such procedures and hospitals’ capacities
to provide them and delays in capital purchases caused by the general uncertainty in the near term business environment. The extent to which our
operations will be impacted by the outbreak will depend largely on future developments, which are highly uncertain and cannot be accurately predicted,
including new information which may emerge concerning the severity of the outbreak and actions by government authorities, hospitals and private
businesses to contain the outbreak or recover from its impact, among other things. Due to the nature of our business, the availability of elective surgical
procedures and customers’ ability to make capital purchases directly impacts our revenue and operations. We are actively monitoring the ongoing impact of
the COVID-19 pandemic and its impact on elective surgical procedures throughout the U.S.
We expect our results of operations to be impacted for so long as the COVID-19 pandemic continues.
For more information on risks associated with the COVID-19 outbreak, see the section titled “Risk Factors” in Item 1A of Part I.
Results of Operations - 2020 and 2019
Our fiscal year ends on the Saturday closest to December 31. Fiscal 2020 ended on January 2, 2021 and fiscal 2019 ended on December 28, 2019.
Fiscal years 2020 and 2019 included 53 weeks and 52 of operations, respectively.
The following table sets forth certain operating data as a percentage of revenue for the periods indicated.
Revenues
Cost of revenues
Gross margin
Operating expenses:
Research and development
Sales and marketing
General and administrative
Total operating expenses
Loss from operations
Other income, net
Loss from operations before provision for income taxes
Provision for income taxes
Net loss
Percentage of Revenue
Years Ended
FY 2020
January 2, 2021
FY 2019
December 28, 2019
100.0%
57.2%
42.8%
9.0%
33.7%
18.2%
60.9%
(18.1%)
0.8%
(17.3%)
0.1%
(17.4%)
100.0%
58.7%
41.3%
8.5%
34.2%
19.3%
62.0%
(20.7%)
0.5%
(20.2%)
0.1%
(20.3%)
Comparison of 2020 and 2019
Revenues.
(in thousands)
G6
Retina
Other
Total revenues
FY 2020
FY 2019
Change in $
Change in %
$
$
11,273 $
18,087
6,987
36,347 $
37
13,070 $
22,879
7,498
43,447 $
(1,797)
(4,792)
(511)
(7,100)
(13.7%)
(20.9%)
(6.8%)
(16.3%)
Our total revenues decreased $7.1 million or 16.3% from $43.4 million in 2019 to $36.3 million in 2020. Our business was impacted by the onset of
the COVID-19 pandemic at the beginning of the year with sales of our retina products most impacted. Revenues from G6 products decreased 13.7% with a
decrease in both Cyclo G6 systems and probes sales. Revenues from retina products decreased by 20.9% driven by a decrease in both domestic and
international sales as capital equipment sales were especially impacted by the pandemic. Other revenues, comprised of service, royalty, freight and legacy
G probes, decreased 6.8% due mainly to a decrease in legacy G probes and royalty revenues.
While we believe that demand for our products remains and our revenue will recover, overall capital expenditures within hospitals, surgi-centers
and physician offices has been impacted by the general level of uncertainty brought about by COVID-19. Until this stabilizes, we anticipate capital
expenditures may continue to be deferred.
Gross Profit.
Gross profit decreased $2.4 million or 13.3% from $17.9 million in 2019 to $15.5 million in 2020. Gross margin increased 1.5% from 41.3% in
2019 to 42.8% in 2020. The increase in gross margin was primarily attributable to favorable geographic and product mix, partially offset by an increase in
manufacturing overhead rate as a result of fixed overhead expenditures being absorbed over a lower sales volume.
Gross margins are expected to continue to fluctuate due to changes in the relative proportions of domestic and international sales, the product mix
of sales, manufacturing variances, total unit volume changes that lead to greater or lesser production efficiencies, sales return and a variety of other factors.
Research and Development.
R&D expenses decreased $0.4 million or 10.9% from $3.7 million in 2019 to $3.3 million in 2020. The decrease was attributable primarily to a
decrease in consulting expenses and a decrease in personnel costs due to reduction in headcount.
Sales and Marketing.
Sales and marketing expenses decreased $2.6 million or 17.6%, from $14.9 million in 2019 to $12.2 million in 2020. The decrease was primarily
attributable to a decrease in personnel costs as a result of a reduction in headcount, lower commission expense due to lower sales, lower travel expenses
and lower marketing program expenses as a consequence of the COVID-19 pandemic reducing business activity.
General and Administrative.
General and administrative expenses decreased $1.8 million or 21.0% from $8.4 million in 2019 to $6.6 million in 2020. The decrease was
primarily attributable to a decrease in personnel costs as a result of a reduction in headcount and lower legal expenses.
Management anticipates operating with the reduction in headcount and consequently lower costs for the foreseeable future as it continues to focus
on managing expenses.
Other Income, Net.
Other income, net amounted to $0.3 million in 2020 and $0.2 million in 2019. Other income, net, consisted primarily of interest income or expense,
foreign currency gain or loss and the change in expense associated with the re-measurement of contingent liabilities.
Income Taxes.
We recorded a provision for income taxes of $26 thousand for the year ended January 2, 2021 compared to $48 thousand for the year ended
December 28, 2019. The effective tax rate for the year ended December 2, 2021 was negative 0.41% compared to an effective tax rate of negative 0.46%
for the year ended December 28, 2019. The income tax valuation allowance was $18.8 million at the end of 2020 compared to $17.4 million at the end of
2019.
Liquidity and Capital Resources
Liquidity is our ability to generate sufficient cash flows from operating activities to meet our obligations and commitments. In addition, liquidity
includes the ability to obtain appropriate financing or to raise capital.
Comparison of 2020 and 2019
As of January 2, 2021, we had cash and cash equivalents of $11.6 million and working capital of $16.7 million compared to cash and cash
equivalents of $12.7 million and working capital of $20.8 million as of December 28, 2019.
Net cash used in operating activities was $3.2 million in 2020 compared to $7.9 million in 2019. The decrease in net cash used in operating
activities, expressed in direct cash flow terms, was primarily due to lower vendor payments and lower employee compensation, partially offset by a
reduction in cash receipts from customers.
38
During 2020, net cash used in investing activities was $0.1 million, which consisted of capital expenditures. Net cash used in investing activities
during 2019 was $0.5 million, which consisted of $0.1 million for capital expenditures and $0.4 million for payment of the contingent earn-out liability.
During 2020, net cash provided by financing activities was $2.5 million, primarily from the proceeds from a U.S. Small Business Association Loan
(the “SBA Loan”) pursuant to the Payroll Protection Program (“PPP”) established under the CARES Act. Net cash used in financing activities during 2019
was $0.2 million, which consisted of payroll taxes related to net share settlement of equity awards.
We have historically funded our operations primarily through sales of our products to customers, and through common stock and borrowing
arrangements. As of January 2, 2021, our principal sources of liquidity consisted of cash and cash equivalents of $11.6 million. We have incurred net losses
over the last several years, and as of January 2, 2021, have an accumulated deficit of approximately $56.9 million. We expect to continue to incur operating
losses and negative cash flows from operations at least through January 1, 2022.
We believe our existing cash and cash equivalents will be sufficient to meet our anticipated cash needs over the next 12 months. Our future capital
requirements will depend on many factors, including our growth rate, the timing and extent of our spending to support research and development activities,
the timing and cost of establishing additional sales and marketing capabilities, the introduction of new and enhanced products and our costs to implement
new manufacturing technologies.
Critical Accounting Policies
Revenue Recognition.
Our revenues arise from the sale of laser consoles, delivery devices, consumables, service, and support activities. We also derive revenue from
royalties from third parties which are typically based on licensees’ net sales of products that utilize our technology. Our revenue is recognized in
accordance with Accounting Standards Codification (“ASC”) 606, “Revenue from Contracts with Customers.”
We have the following revenue transaction types: (1) Product Sale Only, (2) Laser Advantage Program (LAP), (3) Service Contracts, (4) System
Repairs (outside of warranty) and (5) Royalty Revenue.
(1)
(2)
Product Sale Only: Our products consist of laser consoles, delivery devices and consumable instrumentation, including laser probes. Our
products are currently sold for use by ophthalmologists specializing in the treatment of glaucoma and retinal diseases. Inside the United
States and Germany the products are sold directly to the end users. In other countries outside of the United States and Germany, we utilize
independent, third-party distributors to market and sell our products. There is no continuing obligation subsequent to the shipment to these
distributors.
We recognize revenue from product sale at a point in time. When a system or disposables are sold without any additional deliverables, we
recognize revenue using the five-step model: (1) identifying the contract with the customer, (2) identifying the performance obligations in
the contract, (3) determining expected transaction price, (4) allocating the transaction price to the distinct performance obligations in the
contract, and (5) recognizing revenue when (or as) the performance obligations are satisfied.
LAP Program (Discontinued in the second quarter of fiscal year 2019): We entered into LAP contracts with certain customers. Under the
LAP program, the system is given away free of charge and title is transferred after the customer purchases the minimum required number of
boxes of probes (classified as disposables). Customers with older machines have the ability to trade in their old machines for the most
current laser equipment offered in the program (Cyclo G6 Laser) and receive a discount on the program’s minimum purchase requirements.
Under ASC 606, this non-cash consideration must be included in the transaction price. However, we have determined that there is no value
associated with the old machines and the trade-in is essentially offered to encourage customers to purchase more consumables under the
program.
We recognize revenue from product sales under the LAP program at a point in time. We allocate the transaction price of the distinct
performance obligations in the contract by determining stand-alone selling price using historical pricing net of any variable consideration or
discounts to specifically allocate to a particular performance obligation.
(3)
Service Contracts: We offer a standard two-year warranty on all system sales. We also offer a service contract which is sold to customers in
incremental, one-year periods which begin subsequent to the expiration of the standard two-year warranty. The customer can opt to purchase
the service contract at the time of the system sale or after the initial system sale.
We recognize revenue from service contracts ratably over the service period. Revenue recognition for the sale of a service contract is largely
dependent on the timing of the sale as follows:
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a.
b.
Service Contract Sale in Conjunction with System Sale: If the customer opts to purchase a service contract at the time of the system
sale, we allocate the transaction price of the distinct performance obligations in the contract by determining stand-alone selling price
using historical pricing net of any variable consideration or discounts to specifically allocate to a particular performance obligation.
Service Contract Sale Subsequent to System Sale: If the customer opts to purchase a service contract after the initial system sale, we
determine the amount of time that has elapsed since the initial system sale. If the service contract is purchased within 60 days of the
initial sale, we consider this sale to be an additional element of the original sale and allocates the transaction price of the distinct
performance obligations in the contract by determining stand-alone selling price using historical pricing net of any variable
consideration or discounts to specifically allocate to a particular performance obligation. If the service contract is purchased
subsequent to sixty days after the initial sale, the sale of the service contract is deemed a separate contract and is deferred at the
selling price and recognized ratably over the extended warranty period as the performance obligation is satisfied.
(4)
System Repairs (outside of warranty): Customers will occasionally request repairs from us subsequent to the expiration of the standard
warranty and outside of a service contract.
We recognize revenue from system repairs (outside of warranty) at a point in time. When the customer requests repairs from us subsequent
to the expiration of the standard warranty and outside of a service contract, these repair contracts are considered separate from the initial
sale, and as such, revenue is recognized as the repair services are rendered and the performance obligation satisfied.
(5)
Royalty Revenue: We have royalty agreements with two customers related to sale of our intellectual property. Under the terms of these
agreements, the customer is to remit a percentage of sales to us.
Since these arrangements are for sales-based licenses of intellectual property, for which the guidance in paragraph ASC 606-10-55-65
applies, we recognize revenue only as the subsequent sale occurs. However, we note that such sales being reported by the licensee with a
quarter in arrears, such revenue is recognized at the time it is reported and paid by the licensee given that any estimated variable
consideration would have to be fully constrained due to the unpredictability of such estimate and the unavoidable risk that it may lead to
significant revenue reversals.
We elected the practical expedient allowing it to not recognize as a contract asset the commission paid to its salesforce on the sale of its products as
an incremental cost of obtaining a contract with a customer but rather recognize such commission as expense when incurred as the amortization period of
the asset that we would have otherwise recognized is one year or less.
Inventories.
Inventories are stated at the lower of cost or net realizable value and include on-hand inventory physically held at our facility, sales demo inventory
and service loaner inventory. Cost is determined on a standard cost basis which approximates actual cost on a first-in, first-out (“FIFO”) method. Lower of
cost or net realizable value is evaluated by considering obsolescence, excessive levels of inventory, deterioration and other factors. Adjustments to reduce
the cost of inventory to its net realizable value, if required, are made for estimated excess, obsolete or impaired inventory and are charged to cost of
revenues. Once the cost of the inventory is reduced, a new lower-cost basis for that inventory is established, and subsequent changes in facts and
circumstances do not result in the restoration or increase in that newly established cost basis. Factors influencing these adjustments include changes in
demand, product life cycle and development plans, component cost trends, product pricing, physical deterioration and quality issues. Revisions to these
adjustments would be required if these factors differ from our estimates.
Sales Returns Allowance and Allowance for Doubtful Accounts.
We estimate future product returns related to current period product revenue. We analyze historical returns, and changes in customer demand and
acceptance of our products when evaluating the adequacy of the sales returns allowance. Significant management judgment and estimates must be made
and used in connection with establishing the sales returns allowance in any accounting period. Material differences may result in the amount and timing of
our revenue for any period if management made different judgments or utilized different estimates. Our provision for sales returns is recorded net of the
associated costs.
Similarly, management must make estimates regarding the uncollectibility of accounts receivable. We are exposed to credit risk in the event of non-
payment by customers to the extent of amounts recorded on the consolidated balance sheets. As sales increase the level of accounts receivable would likely
also increase. In addition, in the event that customers were to delay their payments to us, the levels of accounts receivable would likely also increase. We
maintain allowances for doubtful accounts for estimated losses resulting from the inability of our customers to make required payments. The allowance for
40
doubtful accounts is based on past payment history with the customer, analysis of the customer’s current financial condition, the aging of the accounts
receivable balance, customer concentration and other known factors.
Warranty.
We provide reserves for the estimated cost of product warranties at the time revenue is recognized based on historical experience of known product
failure rates and expected material and labor costs to provide warranty services. We generally provide a two-year warranty on our products. Additionally,
from time to time, specific warranty accruals may be made if unforeseen technical problems arise. Alternatively, if estimates are determined to be greater
than the actual amounts necessary, we may reverse a portion of such provisions in future periods. Our warranty policy is applicable to products which are
considered defective in their performance or fail to meet the product specifications. Warranty costs are reflected in the consolidated statements of
operations as cost of revenues.
Income Taxes.
We account for income taxes in accordance with ASC 740, “Income Taxes” (“ASC 740”), which requires that deferred tax assets and liabilities be
recognized using enacted tax rates for the effect of temporary differences between the book and tax bases of recorded assets and liabilities. Under ASC 740,
the liability method is used in accounting for income taxes. Deferred tax assets and liabilities are determined based on the differences between financial
reporting and the tax basis of assets and liabilities, and are measured using the enacted tax rates and laws that will be in effect when the differences are
expected to reverse. ASC 740 also requires that deferred tax assets be reduced by a valuation allowance if it is more likely than not that some or all of the
deferred tax asset will not be realized. We annually evaluate the realizability of our deferred tax assets by assessing our valuation allowance and by
adjusting the amount of such allowance, if necessary. The factors used to assess the likelihood of realization include our forecast of future taxable income
and available tax planning strategies that could be implemented to realize the net deferred tax assets. As of January 2, 2021, based on our recent history of
losses and its forecasted losses, management believes on the more likely than not basis that a full valuation allowance is required. Accordingly, as of
January 2, 2021, we provided a full valuation allowance on our federal and state deferred tax assets.
Accounting for Uncertainty in Income Taxes.
We account for uncertain tax positions in accordance with ASC 740. ASC 740 seeks to reduce the diversity in practice associated with certain
aspects of measurement and recognition in accounting for income taxes. ASC 740 prescribes a recognition threshold and measurement attribute for the
financial statement recognition and measurement of a tax provision that an entity takes or expects to take in a tax return. Additionally, ASC 740 provides
guidance on de-recognition, classification, interest and penalties, accounting in interim periods, disclosures, and transition. Under ASC 740, an entity may
only recognize or continue to recognize tax positions that meet a "more-likely-than-not" threshold. In accordance with our accounting policy, we recognize
accrued interest and penalties related to unrecognized tax benefits as a component of income tax expense. There was no accrued interest and penalties
during the year ended January 2, 2021.
Accounting for Stock-Based Compensation.
We account for stock-based compensation granted to employees and directors, including employees’ stock option awards and restricted stock units
at grant date, based on the fair value of the award. Stock-based compensation is recognized as expense on a ratable basis over the requisite service period of
the award.
We value options using the Black-Scholes option pricing model. Time-based restricted stock units are valued at the grant date fair value of the
underlying common shares. Performance-based restricted stock units without market conditions are valued at grant date fair value of the underlying
common shares. Performance-based RSUs granted with market conditions and performance-based stock options with market conditions are valued using
the Monte Carlo simulation model. The Black-Scholes option pricing model requires the use of highly subjective and complex assumptions which
determine the fair value of stock-based awards, including the option’s expected term and the price volatility of the underlying stock. The Monte Carlo
simulation model incorporates assumptions for the holding period, risk-free interest rate, stock price volatility and dividend yield.
41
Leases.
We determine if an arrangement is a lease at inception. Operating leases are included in Operating lease right-of-use (“ROU”) assets, net and
Operating lease liabilities in our consolidated balance sheets. As of January 2, 2021, we were not a party to finance lease arrangements.
ROU assets represent our right to use an underlying asset for the lease term and lease liabilities represent our obligation to make lease payments
arising from the lease. Operating lease ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over
the lease term. As most of our leases do not provide an implicit rate, we use our incremental borrowing rate based on information available at
commencement date in determining the present value of lease payments. We use the implicit rate when readily determinable. The operating lease ROU
asset also includes any lease payments made and excludes lease incentives. Our lease terms may include options to extend or terminate the lease when it is
reasonably certain that we will exercise that option. Lease expense for lease payments is recognized on a straight-line basis over the lease term.
Under the available practical expedient, we account for the lease and non-lease components as a single lease component.
Recent Accounting Standards Not Yet Adopted.
In December 2019, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2019-12, “Income Taxes
(Topic 740): Simplifying the Accounting for Income Taxes” as part of its initiative to reduce complexity in the accounting standards. The standard
eliminates certain exceptions related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period and
the recognition of deferred tax liabilities for outside basis differences. The standard also clarifies and simplifies other aspects of the accounting for income
taxes. The standard is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020. The Company is
currently evaluating the impact that this guidance will have on its financial position and results of operations, if any.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk.
As a “smaller reporting company,” as defined in Rule 12b-2 of the Exchange Act, we are not required to provide the information called for by this
Item.
Item 8. Financial Statements and Supplementary Data.
Our consolidated balance sheets as of January 2, 2021 and December 28, 2019 and the consolidated statements of operations, comprehensive
income, stockholders’ equity and cash flows for each of our fiscal years 2020 and 2019 together with the related notes and the report of our independent
registered public accounting firm, are on the following pages. Additional required financial information is described in Item 15.
42
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Stockholders of IRIDEX Corporation
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of IRIDEX Corporation (a Delaware corporation) and its subsidiaries (the
“Company”) as of January 2, 2021 and December 28, 2019, and the related consolidated statements of operations, comprehensive loss, stockholders’
equity, and cash flows for each of the two years in the period ended January 2, 2021, and the related notes (collectively referred to as the “consolidated
financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as
of January 2, 2021 and December 28, 2019, and the results of its operations and its cash flows for each of the two years in the period ended January 2,
2021, in conformity with accounting principles generally accepted in the United States of America.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the
Company’s consolidated 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 consolidated 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 consolidated 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 consolidated 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 consolidated financial statements. We believe that our audits provide a reasonable
basis for our opinion.
Critical Audit Matters
The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was
communicated or required to be communicated to the audit committee and that (1) relates to accounts or disclosures that are material to the consolidated
financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not
alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below,
providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
Inventory Valuation - Adjustments for Excess or Obsolete Inventories
As described in Notes 2 and 4 to the consolidated financial statements, the Company has inventories with a carrying value of $5.7 million as of
January 2, 2021. The Company’s inventories are stated at the lower of cost or net realizable value. Cost is determined on a standard cost basis which
approximates actual cost on a first-in, first-out (“FIFO”) method. Lower of cost or net realizable value is evaluated by considering obsolescence, excessive
levels of inventory, deterioration, and other factors. Adjustments to reduce the cost of inventory to its net realizable value, if required, are made for
estimated excess, obsolescence or impaired inventory and are charged to cost of revenues. The Company’s inventories include demonstration units
(“demos”) to facilitate the sale of products to prospective customers and loaners for existing customers to use while their product is under repair.
The principal considerations for our determination that performing procedures relating to net realizable value adjustments to inventories is a
critical audit matter are the significant amount of judgement by management in developing the assumptions of the forecasted changes in demand, product
life cycle and development plans, component cost trends, product pricing, physical deterioration and quality issues, which in turn led to significant auditor
judgement, subjectivity, and effort in performing audit procedures and evaluating audit evidence relating to these factors. Additionally, for certain new
product launches there may be limited historical data with which to evaluate forecasts.
43
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the
consolidated financial statements. These procedures included obtaining an understanding of the Company’s inventory reserve review process, including the
assumptions and data underlying the excess and obsolete inventory valuation. The procedures also included, among others, testing management’s process
for developing the estimate of the adjustments for excess or obsolete inventories, testing the completeness and accuracy of the underlying data used in the
estimate, and evaluating management’s assumptions of forecasted product demand. Evaluating management’s demand forecast for reasonableness involved
considering historical sales by product, comparing prior period estimates to actual results, and determining whether the demand forecast used was
consistent with evidence obtained in other areas of the audit.
/s/ BPM LLP
We have served as the Company’s auditor since 2007.
San Jose, California
March 23, 2021
44
IRIDEX Corporation
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
FY 2020
January 2, 2021
FY 2019
December 28, 2019
$
11,626 $
Current assets:
ASSETS
Cash and cash equivalents
Accounts receivable, net of allowance for doubtful accounts of $244 as of January 2, 2021 and $187
as of December 28, 2019
Inventories
Prepaid expenses and other current assets
Total current assets
Property and equipment, net
Intangible assets, net
Goodwill
Operating lease right-of-use assets, net
Other long-term assets
Total assets
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
Accrued compensation
Accrued expenses
Current portion of PPP loan
Accrued warranty
Deferred revenue
Operating lease liabilities
Total current liabilities
Long-term liabilities:
PPP loan
Accrued warranty
Deferred revenue
Operating lease liabilities
Other long-term liabilities
$
$
Total liabilities
Commitments and contingencies (Note 10)
Stockholders’ equity:
Preferred stock, $0.01 par value, 2,000,000 shares authorized, no shares issued and outstanding
Common stock, $0.01 par value:
Authorized: 30,000,000 shares;
Issued and outstanding 13,899,683 and 13,785,233 shares as of January 2, 2021 and December 28,
2019, respectively
Additional paid-in capital
Accumulated other comprehensive income (loss)
Accumulated deficit
Total stockholders’ equity
Total liabilities and stockholders’ equity
$
7,289
5,714
730
25,359
449
68
533
1,428
132
27,969 $
1,148 $
1,965
1,806
1,249
166
938
1,409
8,681
1,248
81
289
282
22
10,603
12,653
9,323
8,174
401
30,551
730
84
533
2,764
151
34,813
2,592
2,398
1,544
—
380
1,450
1,414
9,778
—
156
360
1,795
19
12,108
—
—
148
74,181
(19)
(56,944)
17,366
27,969 $
147
73,093
80
(50,615)
22,705
34,813
The accompanying notes are an integral part of these consolidated financial statements.
45
IRIDEX Corporation
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
Total revenues
Cost of revenues
Gross profit
Operating expenses:
Research and development
Sales and marketing
General and administrative
Total operating expenses
Loss from operations
Other income, net
Loss from operations before provision for income taxes
Provision for income taxes
Net loss
Net loss per share:
Basic
Diluted
Weighted average shares used in computing net loss per common share:
Basic
Diluted
$
$
$
$
FY 2020
Year Ended
January 2, 2021
FY 2019
Year Ended
December 28, 2019
36,347 $
20,789
15,558
3,282
12,239
6,620
22,141
(6,583)
280
(6,303)
26
(6,329) $
(0.46) $
(0.46) $
13,842
13,842
43,447
25,508
17,939
3,682
14,852
8,379
26,913
(8,974)
209
(8,765)
48
(8,813)
(0.64)
(0.64)
13,707
13,707
The accompanying notes are an integral part of these consolidated financial statements.
46
IRIDEX Corporation
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(in thousands)
Net loss
Change in foreign currency translation adjustments
Comprehensive loss
FY 2020
Year Ended
January 2, 2021
FY 2019
Year Ended
December 28, 2019
$
$
(6,329) $
(99)
(6,428) $
(8,813)
10
(8,803)
The accompanying notes are an integral part of these consolidated financial statements.
47
IRIDEX Corporation
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(in thousands, except share data)
FY 2018: Balances, December 29, 2018
Issuance of common stock under stock option plan
Employee stock-based compensation expense
Release of restricted stock, including net share
settlement
Other comprehensive income
Net loss
FY 2019: Balances, December 28, 2019
Employee stock-based compensation expense
Release of restricted stock, including net share
settlement
Other comprehensive income
Net loss
FY 2020: Balances, January 2, 2021
Common Stock
Amount
Shares
13,602,052 $
210
Additional
Paid-in
Capital
Accumulated
Other
Comprehensive
Income (Loss)
Accumulated
Deficit
Total
145 $
71,548 $
70 $
(41,802) $
182,971
2
(158)
1,703
13,785,233
147
73,093
1,119
114,450
1
(31)
10
80
(99)
13,899,683 $
148 $
74,181 $
(19) $
(8,813)
(50,615)
(6,329)
(56,944) $
29,961
—
1,703
(156)
10
(8,813)
22,705
1,119
(30)
(99)
(6,329)
17,366
The accompanying notes are an integral part of these consolidated financial statements.
48
IRIDEX Corporation
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
Operating activities:
Net loss
Adjustments to reconcile net loss to net cash used in operating activities:
Loss on disposal of property and equipment
Depreciation and amortization
Change in fair value of earn-out liability
Stock-based compensation
Provision for doubtful accounts
Changes in operating assets and liabilities:
Accounts receivable
Inventories
Prepaid expenses and other current assets
Operating lease right-of-use assets
Other long-term assets
Accounts payable
Accrued compensation
Accrued expenses
Accrued warranty
Deferred revenue
Operating lease liabilities
Other long-term liabilities
Net cash used in operating activities
Investing activities:
Acquisition of property and equipment
Proceeds from sale of property and equipment
Payment on earn-out liability
Net cash used in investing activities
Financing activities:
Proceeds from PPP loan
Taxes paid related to net share settlements of equity awards
Net cash provided by (used in) financing activities
Effect of foreign exchange rate changes
Net decrease in cash and cash equivalents
Cash and cash equivalents, beginning of year
Cash and cash equivalents, end of year
Supplemental disclosure of cash flow information:
Cash (received) paid during the year for:
Income taxes
Supplemental disclosure of non-cash activities:
Transfer of inventory to property and equipment
FY 2020
Year Ended
January 2, 2021
FY 2019
Year Ended
December 28, 2019
$
(6,329) $
(8,813)
17
504
—
1,119
181
1,861
2,382
(328)
1,342
27
(1,445)
(434)
259
(289)
(583)
(1,524)
3
(3,237)
(97)
4
—
(93)
2,497
(30)
2,467
(164)
(1,027)
12,653
11,626 $
(74) $
129 $
2
688
47
1,703
25
(271)
545
145
1,219
47
76
(563)
(752)
(324)
(415)
(1,274)
2
(7,913)
(128)
—
(381)
(509)
—
(156)
(156)
37
(8,541)
21,194
12,653
14
67
$
$
$
The accompanying notes are an integral part of these consolidated financial statements.
49
IRIDEX Corporation
Notes to Consolidated Financial Statements
1. Organization
Description of Business.
IRIDEX Corporation (“IRIDEX”, the “Company”, “we”, “us”, or “our”) is a leading worldwide provider of therapeutic based laser systems,
delivery devices and consumable instrumentation used to treat sight-threatening eye diseases in ophthalmology. Our ophthalmology products are sold in the
United States and Germany predominantly through a direct sales force and internationally (aside from Germany) primarily through independent
distributors.
2. Summary of Significant Accounting Policies
Financial Statement Presentation.
The consolidated financial statements include the accounts of IRIDEX and our wholly owned subsidiaries. All significant intercompany accounts
and transactions have been eliminated in consolidation.
Our fiscal year always ends on the Saturday closest to December 31. Fiscal 2020 ended on January 2, 2021 (“FY 2020”) and Fiscal 2019 ended on
December 28, 2019 (“FY 2019”). Fiscal years 2020 and 2019 included 53 weeks and 52 weeks of operations, respectively.
Use of Estimates.
The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States of America
(“U.S. GAAP”) requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues, and expenses and the related
disclosure of contingent assets and liabilities. We base our estimates on historical experience and on various other assumptions that we believe 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. Actual results may differ from these estimates. In addition, any change in these estimates or their related assumptions
could have an adverse effect on our operating results.
Cash and Cash Equivalents.
We consider all highly liquid debt instruments with insignificant interest rate risk and an original maturity of three months or less when purchased
to be cash equivalents. Our cash equivalents consist primarily of cash deposits in money market funds that are available for withdrawal without restriction.
Sales Returns Allowance and Allowance for Doubtful Accounts.
When determining the transaction price, we estimate the variable consideration as the most likely amount to which we expect to be entitled, and we
include the estimated amounts in the transaction price to the extent it is probable that a significant reversal of cumulative revenue will not occur when the
uncertainty associated with the variable consideration is resolved. Material differences may result in the amount and timing of our revenue for any period if
management made different judgments or utilized different estimates. Our provision for sales returns is recorded net of the associated costs. There was no
provision for sales returns as of January 2, 2021 and $264 thousand as of December 28, 2019, which was recorded within the deferred revenue accounts in
the consolidated balance sheets.
Similarly management must make estimates regarding the uncollectibility of accounts receivable. We are exposed to credit risk in the event of non-
payment by customers to the extent of amounts recorded on the consolidated balance sheets. As sales levels change, the level of accounts receivable would
likely also change. In addition, in the event that customers were to delay their payments to us, the levels of accounts receivable would likely increase. We
maintain allowances for doubtful accounts for estimated losses resulting from the inability of our customers to make required payments. The allowance for
doubtful accounts is based on past payment history with the customer, analysis of the customer’s current financial condition, the aging of the accounts
receivable balance, customer concentration and other known factors.
50
A reconciliation of the changes in our allowance for doubtful accounts balances for the years ended January 2, 2021 and December 28, 2019 are as
follows (in thousands):
Description
Allowance for doubtful accounts Years ended
January 2, 2021
December 28, 2019
Balance at
Beginning of
the period
Additions
(Deductions)
Balance
at End of
the period
187
213
181
25
(124)
(51)
244
187
Inventories.
Inventories are stated at the lower of cost or net realizable value and include on-hand inventory physically held at our facility, sales demo inventory
and service loaner inventory. Cost is determined on a standard cost basis which approximates actual cost on a first-in, first-out (“FIFO”) method. Lower of
cost or net realizable value is evaluated by considering obsolescence, excessive levels of inventory, deterioration and other factors. Adjustments to reduce
the cost of inventory to its net realizable value, if required, are made for estimated excess, obsolescence or impaired inventory and are charged to cost of
revenues. Once the cost of the inventory is reduced, a new lower-cost basis for that inventory is established, and subsequent changes in facts and
circumstances do not result in the restoration or increase in that newly established cost basis. Factors influencing these adjustments include changes in
demand, product life cycle and development plans, component cost trends, product pricing, physical deterioration and quality issues. Revisions to these
adjustments would be required if these factors differ from our estimates.
As part of our normal business, we generally utilize various finished goods inventory as either sales demos to facilitate the sale of our products to
prospective customers, or as loaners that we allow our existing customers to use while we repair their products. We are amortizing these demos and loaners
over an estimated useful life of four years. The amortization of the demos is charged to sales and marketing expense while the amortization on the loaners
is charged to cost of revenues. The gross value of demos and loaners was $1.9 million and $2.8 million and the accumulated amortization was $1.7 million
and $1.4 million as of January 2, 2021 and December 28, 2019, respectively. The net book value of demos and loaners is charged to cost of revenues when
such demos or loaners are sold.
Property and Equipment.
Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation and amortization are calculated on a
straight–line basis over the estimated useful lives of the assets, which is generally three years. Leasehold improvements are amortized over the lesser of
their estimated useful lives or the lease term. Repairs and maintenance costs are expensed as incurred.
Leases.
We determine if an arrangement is a lease at inception. Operating leases are included in Operating lease right-of-use (“ROU”) assets, net and
Operating lease liabilities in our consolidated balance sheets. As of January 2, 2021, the Company was not a party to finance lease arrangements.
ROU assets represent our right to use an underlying asset for the lease term and lease liabilities represent our obligation to make lease payments
arising from the lease. Operating lease ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over
the lease term. As most of our leases do not provide an implicit rate, we use our incremental borrowing rate based on information available at
commencement date in determining the present value of lease payments. We use the implicit rate when readily determinable. The operating lease ROU
asset also includes any lease payments made and excludes lease incentives. Our lease terms may include options to extend or terminate the lease when it is
reasonably certain that we will exercise that option. Lease expense for lease payments is recognized on a straight-line basis over the lease term.
Under the available practical expedient, we account for the lease and non-lease components as a single lease component.
51
Valuation of Goodwill and Intangible Assets.
Goodwill represents the excess of the purchase price over the fair value of the net tangible and identifiable intangible assets acquired in a business
combination. The Company reviews goodwill for impairment on an annual basis or whenever events or changes in circumstances indicate the carrying
value may not be recoverable. The Company performs an annual impairment test by comparing the fair value of a reporting unit with its carrying amount.
An impairment charge should be recognized for the amount by which the carrying amount exceeds the reporting unit’s fair value; however, the loss
recognized should not exceed the total amount of goodwill allocated to that reporting unit. In addition, income tax effects from any tax deductible goodwill
carrying amount of the reporting unit should be considered when measuring the goodwill impairment loss, if applicable. The Company has determined that
it has a single reporting unit for purposes of performing its goodwill impairment test. As the Company uses the market approach to assess impairment, its
common stock price is an important component of the fair value calculation. If the Company’s stock price continues to experience significant price and
volume fluctuations, this will impact the fair value of the reporting unit and can lead to potential impairment in future periods. The Company performed its
annual impairment test during the second quarter of fiscal 2020 and determined that its goodwill was not impaired. As of January 2, 2021, we had not
identified any factors that indicated there was an impairment of our goodwill and determined that no additional impairment analysis was then required.
Intangible assets with definite lives are amortized over the useful life of the asset. We review our amortizing intangible assets for impairment
whenever events or changes in circumstances indicate that their carrying value may not be recoverable. An asset is considered impaired if its carrying
amount exceeds the future non-discounted net cash flow the asset is expected to generate. If an asset is considered to be impaired, the impairment to be
recognized is measured by the amount by which the carrying amount of the asset exceeds its fair value. In such circumstances, we conduct an impairment
analysis in accordance with Accounting Standards Codification (“ASC”) 350, “Intangibles – Goodwill and Other” (“ASC 350”).
Revenue Recognition.
Our revenues arise from the sale of laser consoles, delivery devices, consumables, service, and support activities. We also derive revenue from
royalties from third parties which are typically based on licensees’ net sales of products that utilize our technology. Our revenue is recognized in
accordance with ASC 606, “Revenue from Contracts with Customers.”
The Company has the following revenue transaction types: (1) Product Sale Only, (2) Laser Advantage Program (LAP), (3) Service Contracts, (4)
System Repairs (outside of warranty) and (5) Royalty Revenue.
(1)
(2)
Product Sale Only: The Company’s products consist of laser consoles, delivery devices and consumable instrumentation, including laser
probes. The Company’s products are currently sold for use by ophthalmologists specializing in the treatment of glaucoma and retinal
diseases. Inside the United States and Germany the products are sold directly to the end users. In other countries outside of the United
States and Germany, the Company utilizes independent, third-party distributors to market and sell the Company’s products. There is no
continuing obligation subsequent to the shipment to these distributors.
The Company recognizes revenue from product sale at a point in time. When a system or disposables are sold without any additional
deliverables, the Company recognizes revenue using the five-step model: (1) identifying the contract with the customer, (2) identifying the
performance obligations in the contract, (3) determining expected transaction price, (4) allocating the transaction price to the distinct
performance obligations in the contract, and (5) recognizing revenue when (or as) the performance obligations are satisfied.
LAP Program (Discontinued in the second quarter of fiscal year 2019): The Company entered into LAP contracts with certain customers.
Under the LAP program, the system is given away free of charge and title is transferred after the customer purchases the minimum required
number of boxes of probes (classified as disposables). Customers with older machines have the ability to trade in their old machines for the
most current laser equipment offered in the program (Cyclo G6 Laser) and receive a discount on the program’s minimum purchase
requirements. Under ASC 606, this non-cash consideration must be included in the transaction price. However, the Company has determined
that there is no value associated with the old machines and the trade in is essentially offered to encourage customers to purchase more
consumables under the program.
The Company recognizes revenue from product sales under the LAP program at a point in time. The Company allocates the transaction
price of the distinct performance obligations in the contract by determining stand-alone selling price using historical pricing net of any
variable consideration or discounts to specifically allocate to a particular performance obligation.
(3)
Service Contracts: The Company offers a standard two-year warranty on all system sales. The Company also offers a service contract which
is sold to customers in incremental, one-year periods which begin subsequent to the expiration of the standard two-year warranty. The
customer can opt to purchase the service contract at the time of the system sale or after the initial system sale.
52
The Company recognizes revenue from service contracts ratably over the service period. Revenue recognition for the sale of a service
contract is largely dependent on the timing of the sale as follows:
a.
b.
Service Contract Sale in Conjunction with System Sale: If the customer opts to purchase a service contract at the time of the system
sale, the Company allocates the transaction price of the distinct performance obligations in the contract by determining stand-alone
selling price using historical pricing net of any variable consideration or discounts to specifically allocate to a particular performance
obligation.
Service Contract Sale Subsequent to System Sale: If the customer opts to purchase a service contract after the initial system sale, the
Company determines the amount of time that has elapsed since the initial system sale. If the service contract is purchased within 60
days of the initial sale, the Company considers this sale to be an additional element of the original sale and allocates the transaction
price of the distinct performance obligations in the contract by determining stand-alone selling price using historical pricing net of
any variable consideration or discounts to specifically allocate to a particular performance obligation. If the service contract is
purchased subsequent to sixty days after the initial sale, the sale of the service contract is deemed a separate contract and is deferred
at the selling price and recognized ratably over the extended warranty period as the performance obligation is satisfied.
(4)
System Repairs (outside of warranty): Customers will occasionally request repairs from the Company subsequent to the expiration of the
standard warranty and outside of a service contract.
The Company recognizes revenue from system repairs (outside of warranty) at a point in time. When the customer requests repairs from the
Company subsequent to the expiration of the standard warranty and outside of a service contract, these repair contracts are considered
separate from the initial sale, and as such, revenue is recognized as the repair services are rendered and the performance obligation satisfied.
(5)
Royalty Revenue: The Company has royalty agreements with two customers related to sale of the Company’s intellectual property. Under
the terms of these agreements, the customer is to remit a percentage of sales to the Company.
Since these arrangements are for sales-based licenses of intellectual property, for which the guidance in paragraph ASC 606-10-55-65
applies, the Company recognizes revenue only as the subsequent sale occurs. However, the Company notes that such sales being reported by
the licensee with a quarter in arrear, such revenue is recognized at the time it is reported and paid by the licensee given that any estimated
variable consideration would have to be fully constrained due to the unpredictability of such estimate and the unavoidable risk that it may
lead to significant revenue reversals.
The Company elected the practical expedient allowing it to not recognize as a contract asset the commission paid to its salesforce on the sale of its
products as an incremental cost of obtaining a contract with a customer but rather recognize such commission as expense when incurred as the amortization
period of the asset that the Company would have otherwise recognized is one year or less.
Taxes Collected from Customers and Remitted to Governmental Authorities.
Taxes collected from customers and remitted to governmental authorities are recognized on a net basis in the accompanying consolidated statements
of operations as well as accrued expenses to the degree which is appropriate.
Deferred Revenue.
Deferred revenue represents contract liabilities. Revenue related to extended service contracts is deferred and recognized on a straight-line basis
over the period of the applicable service period. Costs associated with these service arrangements are recognized as incurred.
A reconciliation of the changes in our deferred revenue balances for the years ended January 2, 2021 and December 28, 2019 are as follows (in
thousands):
FY 2018: Balance as of December 29, 2018
Additions to deferral
Revenue recognized
Deductions from reserves
FY 2019: Balance as of December 28, 2019
Additions to deferral
Revenue recognized
Deductions from reserves
FY 2020: Balance as of January 2, 2021
53
$
$
2,225
2,168
(2,564)
(19)
1,810
1,610
(2,190)
(3)
1,227
During each of the twelve months ended January 2, 2021 and December 28, 2019, approximately $1.3 million was recognized pertaining to
amounts deferred as of both December 28, 2019 and December 29, 2018.
Warranty.
We provide reserves for the estimated cost of product warranties at the time revenue is recognized based on historical experience of known product
failure rates and expected material and labor costs to provide warranty services. We generally provide a two-year warranty on our products. The Company’s
warranty policy is applicable to products which are considered defective in their performance or fail to meet the product specifications. Additionally, from
time to time, specific warranty accruals may be made if unforeseen technical problems arise. If estimates are determined to be greater than the actual
amounts necessary, we may reverse a portion of such provisions in future periods. Warranty costs are reflected in the consolidated statements of operations
as costs of revenues.
A reconciliation of the changes in our warranty liability for the years ended January 2, 2021 and December 28, 2019 are as follows (in thousands):
FY 2018: Balance as of December 29, 2018
Accruals for product warranties
Cost of warranty claims
Adjustment to pre-existing warranties
FY 2019: Balance as of December 28, 2019
Accruals for product warranties
Cost of warranty claims
Adjustment to pre-existing warranties
FY 2020: Balance as of January 2, 2021
Shipping and Handling Costs.
$
$
860
283
(296)
(311)
536
128
(108)
(309)
247
Our shipping and handling costs billed to customers are included in revenues and the associated expense is recorded in cost of revenues for all
periods presented. Shipping and handling costs billed to customers amounted to $0.2 million during each of fiscal years 2020 and 2019.
Research and Development.
Research and development expenditures are charged to operations as incurred.
Advertising.
Advertising and promotion costs are expensed as they are incurred; such costs were approximately $0.1 million in 2020 and $0.3 million in 2019
and are included in sales and marketing expenses in the accompanying consolidated statements of operations.
Income Taxes.
We account for income taxes in accordance with ASC 740, “Income Taxes” (“ASC 740”), which requires that deferred tax assets and liabilities be
recognized using enacted tax rates for the effect of temporary differences between the book and tax bases of recorded assets and liabilities. Under ASC 740,
the liability method is used in accounting for income taxes. Deferred tax assets and liabilities are determined based on the differences between financial
reporting and the tax basis of assets and liabilities, and are measured using the enacted tax rates and laws that will be in effect when the differences are
expected to reverse. ASC 740 also requires that deferred tax assets be reduced by a valuation allowance if it is more likely than not that some or all of the
deferred tax asset will not be realized. We annually evaluate the realizability of our deferred tax assets by assessing our valuation allowance and by
adjusting the amount of such allowance, if necessary. The factors used to assess the likelihood of realization include our forecast of future taxable income
and available tax planning strategies that could be implemented to realize the net deferred tax assets. As of January 2, 2021, based on the Company's recent
history of losses and its forecasted losses, management believes on the more likely than not basis that a full valuation allowance is required. Accordingly,
as of January 2, 2021, the Company provided a full valuation allowance on its federal and states deferred tax assets.
54
Accounting for Uncertainty in Income Taxes.
We account for uncertain tax positions in accordance with ASC 740. ASC 740 seeks to reduce the diversity in practice associated with certain
aspects of measurement and recognition in accounting for income taxes. ASC 740 prescribes a recognition threshold and measurement attribute for the
financial statement recognition and measurement of a tax provision that an entity takes or expects to take in a tax return. Additionally, ASC 740 provides
guidance on de-recognition, classification, interest and penalties, accounting in interim periods, disclosures, and transition. Under ASC 740, an entity may
only recognize or continue to recognize tax positions that meet a "more-likely-than-not" threshold. In accordance with our accounting policy, we recognize
accrued interest and penalties related to unrecognized tax benefits as a component of income tax expense. There were no accrued interest and penalties
during the years ended January 2, 2021 and December 28, 2019.
Accounting for Stock-Based Compensation.
We account for stock-based compensation granted to employees and directors, including employees stock option awards and restricted stock units
in accordance with ASC 718, “Compensation – Stock Compensation” (“ASC 718”). Accordingly, stock-based compensation cost is measured at grant date,
based on the fair value of the award. Stock-based compensation is recognized as expense on a ratable basis over the requisite service period of the award.
We value options using the Black-Scholes option pricing model. Time-based restricted stock units are valued at the grant date fair value of the
underlying common shares. Performance-based restricted stock units without market conditions are valued at grant date fair value of the underlying
common shares. Performance-based RSUs granted with market conditions and performance-based stock options with market conditions are valued using
the Monte Carlo simulation model. The Black-Scholes option pricing model requires the use of highly subjective and complex assumptions which
determine the fair value of stock-based awards, including the option’s expected term and the price volatility of the underlying stock. The Monte Carlo
simulation model incorporates assumptions for the holding period, risk-free interest rate, stock price volatility and dividend yield.
Concentration of Credit Risk and Other Risks and Uncertainties.
Our cash and cash equivalents are deposited in demand and money market accounts. Deposits held with banks may exceed the amount of insurance
provided on such deposits. Generally, these deposits may be redeemed upon demand and therefore, bear minimal risk.
We market our products to distributors and end-users throughout the world. Sales to international distributors are generally made on open credit
terms and letters of credit. Management performs ongoing credit evaluations of our customers and maintains an allowance for potential credit losses.
Historically, we have not experienced any significant losses related to individual customers or a group of customers in any particular geographic area. For
the years ended January 2, 2021 and December 28, 2019, no single customer accounted for greater than 10% of total revenues. As of January 2, 2021, one
customer accounted for over 10% of our accounts receivable, representing 13%. As of December 28, 2019, one customer accounted for more than 10% of
accounts receivable balance, representing 11%.
Our products require approvals from the Food and Drug Administration and international regulatory agencies prior to commercialized sales. Our
future products may not receive required approvals. If we were denied such approvals, or if such approvals were delayed, it would have a material adverse
impact on our business, results of operations and financial condition.
Reliance on Certain Suppliers.
Certain components and services used to manufacture and develop our products are presently available from only one or a limited number of
suppliers or vendors. The loss of any of these suppliers or vendors would potentially require a significant level of hardware and/or software development
efforts to incorporate the products or services into our products.
Net Income (Loss) per Share.
Basic net income (loss) per share is based upon the weighted average number of common shares outstanding during the period. Diluted net income
per share is based upon the weighted average number of common shares outstanding and dilutive common stock equivalents outstanding during the period.
Common stock equivalents consist of incremental common shares issuable upon the exercise of stock options and release (vesting) of restricted stock units
and awards and are calculated under the treasury stock method. Common stock equivalent shares from unexercised stock options and unvested restricted
stock units are excluded from the computation for periods in which we incur a net loss or if the exercise price of such options is greater than the average
market price of our common stock for the period as their effect would be anti-dilutive. See Note 16 - Computation of Basic and Diluted Net Loss Per
Common Share.
55
Reclassifications
Certain reclassifications have been made to the prior year consolidated financial statements included in these consolidated financial statements to
conform to the current year presentation. The reclassifications had no impact on previously reported net loss, accumulated deficit, total assets, or total
liabilities.
Recent Accounting Standards Not Yet Adopted.
In December 2019, the FASB issued ASU 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes” as part of its
initiative to reduce complexity in the accounting standards. The standard eliminates certain exceptions related to the approach for intraperiod tax allocation,
the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. The standard
also clarifies and simplifies other aspects of the accounting for income taxes. The standard is effective for fiscal years, and interim periods within those
fiscal years, beginning after December 15, 2020. Early adoption is permitted. The Company is currently evaluating the impact that this guidance will have
on its financial position and results of operations, if any.
3. Fair Value Measurement
Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market
participants at the measurement date. The fair value hierarchy distinguishes between (1) market participant assumptions developed based on market data
obtained from independent sources (observable inputs) and (2) an entity’s own assumptions about market participant assumptions developed based on the
best information available in the circumstances (unobservable inputs). The fair value hierarchy consists of three broad levels, which gives the highest
priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1) and the lowest priority to unobservable inputs (Level 3).
The three levels of the fair value hierarchy are described below:
•
•
•
Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities.
Level 2: Directly or indirectly observable inputs as of the reporting date through correlation with market data, including quoted prices for
similar assets and liabilities in active markets and quoted prices in markets that are not active. Level 2 also includes assets and liabilities that
are valued using models or other pricing methodologies that do not require significant judgment since the input assumptions used in the
models, such as interest rates and volatility factors, are corroborated by readily observable data from actively quoted markets for
substantially the full term of the financial instrument.
Level 3: Unobservable inputs that are supported by little or no market activity and reflect the use of significant management judgment.
These values are generally determined using pricing models for which the assumptions utilize management’s estimates of market participant
assumptions.
In determining fair value, we utilize valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs
to the extent possible as well as considers counterparty credit risk in our assessment of fair value.
The carrying amounts of our financial assets and liabilities, including cash and cash equivalents, accounts receivable, accounts payable, and accrued
expenses as of January 2, 2021 and December 28, 2019, approximate fair value because of the short maturity of these instruments. The carrying amount of
the Company’s PPP loan as of January 2, 2021, approximates its fair value based on the specified interest rate.
As of January 2, 2021 and December 28, 2019, financial assets and liabilities measured and recognized at fair value on a recurring basis and
classified under the appropriate level of the fair value hierarchy as described above was as follows (in thousands):
(in thousands)
Assets:
As of January 2, 2021
Fair Value Measurements
Level 3
Level 2
Level 1
Total
Level 1
As of December 28, 2019
Fair Value Measurements
Level 3
Level 2
Total
Money market funds
$ 11,051 $
— $
— $
11,051 $
10,711 $
— $
— $
10,711
The Company’s Level 1 financial assets are money market funds whose fair values are based on quoted market prices. The Company does not have
any Level 2 and Level 3 financial assets or liabilities.
56
4. Inventories
The components of our inventories are as follows (in thousands):
Raw materials
Work in process
Finished goods
Total inventories
5. Property and Equipment
The components of our property and equipment are as follows (in thousands):
Equipment
Leasehold improvements
Less: accumulated depreciation and amortization
Property and equipment, net
FY 2020
January 2, 2021
FY 2019
December 28, 2019
2,236 $
548
2,930
5,714 $
2,043
1,111
5,020
8,174
FY 2020
January 2, 2021
FY 2019
December 28, 2019
10,760 $
2,464
(12,775)
449 $
10,594
2,490
(12,354)
730
$
$
$
$
Depreciation expense related to property and equipment was $488 thousand and $672 thousand for the fiscal years 2020 and 2019, respectively.
6. Goodwill
The carrying value of goodwill was $533 thousand as of January 2, 2021 and December 28, 2019, respectively.
Goodwill is tested for impairment at least annually or whenever there is a change in circumstances that indicates the carrying value of these assets
may be impaired. The determination of whether any potential impairment of goodwill exists is based upon an impairment test performed in accordance
with ASC 350. There was no impairment of goodwill recognized during fiscal years 2020 and 2019.
7. Intangible Assets
The components of our purchased intangible assets as of January 2, 2021 are as follows (in thousands):
Customer relations
Patents
Useful
Lives
15 Years
Varies
$
$
FY 2020
Annual
Amortization
Gross
Carrying
Value
Accumulated
Amortization
Net
Carrying
Value
16 $
—
16 $
240 $
600
840 $
172 $
600
772 $
The components of our purchased intangible assets as of December 28, 2019 are as follows (in thousands):
Customer relations
Patents
Useful
Lives
15 Years
Varies
$
$
FY 2019
Annual
Amortization
Gross
Carrying
Value
Accumulated
Amortization
Net
Carrying
Value
16 $
—
16 $
240 $
600
840 $
156 $
600
756 $
Useful Lives
Remaining
4.25 Years
Varies
Useful Lives
Remaining
5.25 Years
Varies
68
—
68
84
—
84
Aggregate amortization expense for each of the fiscal years 2020 and 2019 was $16 thousand. The amortization of customer relations was charged
to sales and marketing expense.
57
Estimated future amortization expense for purchased intangible assets is as follows (in thousands):
Fiscal Year:
2021
2022
2023
2024
2025
Total
$
$
16
16
16
16
4
68
8. Accrued Expenses
The components of our accrued expenses are as follows (in thousands):
Customer deposits
Royalties payable
Sales and marketing expenses
Professional fees
Legal expenses
Accrued rent
Other accrued expenses
Total accrued expenses
FY 2020
January 2, 2021
FY 2019
December 28, 2019
$
$
802 $
89
116
125
201
169
304
1,806 $
775
89
100
147
120
—
313
1,544
In July 2020, the Company agreed with its landlord for its Mountain View, California operating facility to defer rent for six weeks in August and
September 2020 totaling approximately $169 thousand without interest to be paid in equal monthly installments from September 2021 to February
2022. In accordance with the “SEC Staff Q&A – Topic 842 and Topic 840: Accounting for lease concessions related to the effects of the COVID-19
pandemic”, the Company has accounted for this transaction as if no changes to the lease contract were made, and therefore not as a modification to the
original lease. As such, the Company has recorded the rent expense during the deferral period.
9. PPP Loan
On April 23, 2020, the Company qualified for and received a loan pursuant to the Paycheck Protection Program, a program implemented by the
U.S. Small Business Administration under the Coronavirus Aid, Relief, and Economic Security Act, from a qualified lender (the “PPP Lender”), for an
aggregate principal amount of approximately $2.5 million (the "PPP Loan"). The PPP Loan bears interest at a fixed rate of 1.0% per annum, with the first
six months of interest deferred, has a term of two years, and is unsecured and guaranteed by the U.S. Small Business Administration. The principal amount
of the PPP Loan is subject to forgiveness under the Paycheck Protection Program upon the Company’s request to the extent that the PPP Loan proceeds are
used to pay expenses permitted by the Paycheck Protection Program, including payroll costs, covered rent and mortgage obligations, and covered utility
payments incurred by the Company. On September 22, 2020, the Company submitted the PPP Loan forgiveness application for the entire amount of
approximately $2.5 million. The accrued interest is $17 thousand as of January 2, 2021. The Company cannot provide assurance that principal and interest
amounts under the PPP Loan will be forgiven. To the extent that all or part of the PPP Loan is not forgiven, the Company will be required to pay interest on
the PPP Loan at a rate of 1.0% per annum, and starting in September 2021 principal and interest payments will be required through the maturity date in
April 2022. The terms of the PPP Loan provide for customary events of default including, among other things, payment defaults, breach of representations,
and insolvency events.
The U.S. Department of the Treasury has announced that it will conduct audits for PPP loans that exceed $2 million. Should we be audited or
reviewed by the U.S. Department of the Treasury or the U.S. Small Business Administration as a result of the SBA Loan or filing an application for
forgiveness or otherwise and receive an adverse outcome in such an audit, we could be required to return the full amount of the SBA Loan and may
potentially be subject to civil and criminal fines and penalties.
10. Commitments and Contingencies
Operating Lease Commitments.
We lease our operating facilities in Mountain View, California, under a non-cancelable operating lease through February 28, 2022. There are no
remaining options to extend or renew the terms of this lease.
58
Our operating lease commitments consist of facility and office equipment leases. Operating lease expense for fiscal years 2020 and 2019 was
approximately $1.3 million and $1.4 million, respectively. The weighted average discount rate used in calculating the present value of lease payments was
5.4%. As of January 2, 2021, the weighted average remaining lease term for our operating leases was 1.2 years.
The following represents maturities of operating lease liabilities as of January 2, 2021 (in thousands):
Fiscal Year
2021
2022
2023
2024
2025
Total lease payments
Less: Imputed interest
Total future minimum lease payments
Operating
Lease Payments
1,467
268
16
—
—
1,751
(60)
1,691
$
$
Purchase Commitments.
Our purchase commitments consist primarily of non-cancellable purchase orders with vendors to manufacture certain components and ophthalmic
instruments. Future minimum payments for our purchase commitments as of January 2, 2021 are summarized as follows (in thousands):
Fiscal Year
2021
License Agreements.
Purchase
Commitments
$
9,160
We are obligated to pay royalties equivalent to 5% of sales on certain products under certain license agreements with termination dates through the
end of 2021. Royalty expense, charged to cost of revenues, was approximately $0.3 million and $0.4 million for fiscal years 2020 and 2019, respectively.
Indemnification Arrangements.
We enter into standard indemnification arrangements in our ordinary course of business. Pursuant to these arrangements, we indemnify, hold
harmless, and agree to reimburse the indemnified parties for losses suffered or incurred by the indemnified parties (generally our business partners or
customers) in connection with any trade secret, copyright, patent or other intellectual property infringement claim by any third-party with respect to our
products. The term of these indemnification agreements is generally perpetual any time after the execution of the agreement. The maximum potential
amount of future payments we could be required to make under these agreements is not determinable. We have never incurred costs to defend lawsuits or
settle claims related to these indemnification agreements. As a result, we believe the estimated fair value of these agreements is minimal.
We have entered into indemnification agreements with our directors and officers that may require us to indemnify our directors and officers against
liabilities that may arise by reason of their status or service as directors or officers, other than liabilities arising from willful misconduct of a culpable
nature. These agreements also require us to advance their expenses incurred as a result of any proceeding against them as to which they could be
indemnified and to make good faith determination whether or not it is practicable for us to obtain directors and officers insurance. We currently have
directors and officers liability insurance.
Legal Proceedings.
From time to time, we may be involved in legal proceedings arising in the ordinary course of business. In general, management believes that
ordinary course of business matters will not have a material adverse effect on our financial position or results of operations and are adequately covered by
our liability insurance. However, it is possible that cash flows or results of operations could be materially affected in any particular period by the
unfavorable resolution of one of more of these contingencies or because of the diversion of management’s attention and the incurrence of significant
expenses.
59
11. Stockholders’ Equity
2008 Equity Incentive Plan.
On June 11, 2008, the shareholders approved the adoption of the 2008 Equity Incentive Plan, (the “Incentive Plan”). There are no material changes
in the Incentive Plan from the 1998 Plan. In 2014, 2017, 2018 and 2019, the stockholders approved an amendment to the Incentive Plan for purposes of
complying with Section 162(m) of the Internal Revenue Code of 1986, as amended, to increase the share reserve under the Incentive Plan, and to make
certain other amendments to the terms of the Incentive Plan. The maximum aggregate number of shares that may be awarded and sold under the Incentive
Plan is 3,850,000 shares plus any shares subject to stock options or similar awards granted under the 1998 Plan that expire or otherwise terminate without
having been exercised in full and shares issued pursuant to awards granted under the 1998 Stock Plan (the “1998 Plan”) that are forfeited to us on or after
February 23, 2008, which was the date the 1998 Plan expired.
The following table represents the shares activity and the total number of shares available for grant under the Incentive Plan:
Balances as of December 29, 2018
Additional shares reserved
Options granted
Restricted stock granted
Options cancelled or forfeited
Awards cancelled
Balances as of December 28, 2019
Options granted
Restricted stock granted
Options cancelled or forfeited
Awards cancelled
Balances as of January 2, 2021
Shares
Available
for Grant
700,962
1,000,000
(853,650)
(443,036)
314,786
388,461
1,107,523
(523,650)
(557,816)
257,662
194,303
478,022
Awards (RSU, PSU, RSA) with a per share or unit purchase price lower than 100% of the fair market value of the Company's common stock on the
date of grant under the 2008 Equity Incentive Plan, as amended, are counted against shares authorized under the plan as one and one-half shares of
common stock for each share. When cancelled, these shares are added back to the Plan as one and one-half shares.
The following table shows stock-based compensation expenses by functional area in the consolidated statements of operations for 2020 and 2019
(in thousands):
Cost of revenues
Research and development
Sales and marketing
General and administrative
Total stock-based compensation expense
FY 2020
Year Ended
January 2, 2021
FY 2019
Year Ended
December 28, 2019
$
$
133 $
(4)
429
561
1,119 $
75
174
409
1,045
1,703
Stock-based compensation expense capitalized to inventory was immaterial for 2020 and 2019.
As of January 2, 2021, there was $2.0 million of total unrecognized compensation cost related to non-vested share-based compensation
arrangements under the Incentive Plan. The cost is expected to be recognized over a weighted-average period of 2.05 years.
60
Summary of Stock Options
The following table summarizes information regarding activity in our stock option plans during the fiscal years ended 2020 and 2019 (in thousands
except share and per share data):
Balances as of December 29, 2018
Options granted
Options exercised
Options cancelled or forfeited
Balances as of December 28, 2019
Options granted
Options exercised
Options cancelled or forfeited
Balances as of January 2, 2021
Outstanding Options
Number
of Shares
844,898 $
853,650
(210)
(314,786)
1,383,552 $
523,650
—
(257,662)
1,649,540 $
Weighted
Average
Exercise
Price
8.84
4.55
3.49
9.20
6.11
2.13
—
7.23
4.67
The following table summarizes information with respect to stock options outstanding and exercisable as of January 2, 2021:
Range of Exercise Prices
$1.70 - $2.12
$2.13 - $2.13
$2.18 - $4.33
$4.60 - $4.85
$4.92 - $4.92
$4.98 - $8.29
$8.33 - $11.16
$12.85 - $12.85
$14.61 - $14.61
$16.29 - $16.29
$1.70 - $16.29
Number of
Shares
Outstanding
Options Outstanding
Weighted
Average
Remaining
Contractual
Life (years)
Options Vested and Exercisable
Weighted
Average
Exercise
Price
Number of
Shares
Exercisable
Weighted
Average
Exercise
Price
32,400
434,950
174,200
30,000
600,000
168,100
174,428
15,000
20,000
462
1,649,540
6.01 $
6.67 $
5.73 $
5.28 $
5.38 $
4.36 $
2.15 $
2.81 $
3.18 $
2.56 $
5.27 $
1.85
2.13
2.75
4.73
4.92
5.76
9.67
12.85
14.61
16.29
4.67
5,018 $
— $
41,016 $
12,813 $
237,500 $
98,921 $
162,989 $
15,000 $
18,751 $
462 $
592,470 $
1.82
—
3.12
4.72
4.92
5.94
9.69
12.85
14.61
16.29
6.76
The determination of the fair value of options granted is computed using the Black-Scholes option pricing model with the following weighted
average assumptions:
Average risk free interest rate
Expected life (in years)
Dividend yield
Average volatility
Employee Stock Option Plan
FY 2020
FY 2019
0.25%
4.55 years
—
62.4%
1.75%
4.55 years
—
45.6%
The weighted average grant date fair value of options granted as calculated using the Black-Scholes option pricing was $1.06 and $1.65 per share
for the fiscal years 2020 and 2019, respectively.
61
Option pricing models require the input of various subjective assumptions, including the option’s expected life and the price volatility of the
underlying stock. The expected stock price volatility is based on analysis of our stock price history over a period commensurate with the expected term of
the options, trading volume of our stock, look-back volatilities and Company specific events that affected volatility in a prior period. The expected term of
employee stock options represents the weighted average period the stock options are expected to remain outstanding and is based on the history of
exercises and cancellations on all past option grants made, the contractual term, the vesting period and the expected remaining term of the outstanding
options. The risk-free interest rate is based on the U.S. Treasury interest rates whose term is consistent with the expected life of the stock options. No
dividend yield is included as we have not issued any dividends and does not anticipate issuing any dividends in the future.
Information regarding stock options outstanding, exercisable and expected to vest as of January 2, 2021 is summarized below:
Options outstanding
Options vested and expected to vest
Options exercisable
Number of
Shares
Weighted Average
Exercise Price
1,649,540
1,454,695
592,470
$
$
$
4.67
4.86
6.76
Weighted
Average
Remaining
Contractual
Life (years)
Aggregate
Intrinsic
Value
(thousands)
5.27 $
5.17 $
4.10 $
217
175
9
The aggregate intrinsic value in the table above represents the total pretax intrinsic value (the difference between our closing stock price on the last
trading day of fiscal 2020 and the exercise price, multiplied by the number of in-the-money options) that would have been received by the option holders
had all option holders exercised their options on January 2, 2021. This amount is subject to change due to changes to the fair market value of our common
stock. The total intrinsic value of options exercised for each of fiscal years 2020 and 2019 was approximately $0 thousand.
Restricted Stock Units
Effective for the 2018 fiscal year and thereafter, each non-employee member of the Board of Directors receives an annual equity award of either
restricted stock or RSU, at the election of such Board member, in each case equal to $40 thousand worth of our common stock (determined at the fair
market value of the shares at the time such award is granted) under our Incentive Plan. The Lead Independent Director or the Chairman of the Board of
Directors receives an additional annual equity award of either restricted stock or RSU, equal to $10 thousand worth of our common stock. Each equity
award vests in full on the earlier of the one-year anniversary of the date of grant or the Company’s next annual meeting of stockholders, provided that the
non-employee member continues to serve on the Board through such date.
Summary of Restricted Stock Units
We recognize the estimated compensation expense of restricted stock units, net of estimated forfeitures, over the vesting term. The estimated
compensation expense is based on the fair value of our common stock on the date of grant.
Information regarding the restricted stock units outstanding, vested and expected to vest as of January 2, 2021 is summarized below:
Restricted stock units outstanding
Restricted stock units vested and expected to vest
Number of
Shares
524,851
467,764
Weighted
Average
Remaining
Contractual
Life (years)
Aggregate
Intrinsic
Value (thousands)
0.70 $
0.64 $
1,317
1,174
The intrinsic value of the restricted stock units is calculated based on the closing price of our shares as quoted on the Nasdaq Global Market on the
last trading day of the fiscal year, December 31, 2020, of $2.51.
The majority of the restricted stock units that were released in fiscal year 2020 were net-share settled such that we withheld shares with value
equivalent to the employees’ minimum statutory obligation for the applicable income and other employment taxes, and remitted the cash to the appropriate
taxing authorities. The total shares withheld were based on the value of the restricted stock units on their release date as determined by our closing stock
price. These net-share settlements had the effect of share repurchases as they reduced and retired the number of shares that would have otherwise been
issued as a result of the release and did not represent an expense to us. For the fiscal year ended January 2, 2021, 128,624 shares of
62
restricted stock units were released with an intrinsic value of approximately $0.3 million. We withheld 14,174 shares to satisfy approximately $30 thousand
of employees’ minimum tax obligation on the released restricted stock units.
Information regarding the RSU activity during the years ended January 2, 2021 and December 28, 2019 is summarized below:
Outstanding as of December 29, 2018
Restricted stock units granted
Restricted stock units released
Restricted stock units forfeited
Outstanding as of December 28, 2019
Restricted stock units granted
Restricted stock units released
Restricted stock units forfeited
Outstanding as of January 2, 2021
Number of
Shares
Weighted
Average
Grant Date Fair
Value
597,121 $
295,357 $
(222,371) $
(258,974) $
411,133 $
371,877 $
(128,624) $
(129,535) $
524,851 $
9.08
2.28
4.32
8.41
7.19
1.90
2.14
5.48
5.10
During the year ended January 2, 2021, the Company awarded 371,877 restricted stock units at a weighted average grant date fair value of $1.90 per
share. There were no grants for performance-based shares that are subject to service and performance vesting conditions.
12. Employee Benefit Plan
We have a plan known as the Iridex Corporation Profit Sharing/401(k) Plan to provide retirement benefits through the deferred salary deductions for
substantially all U.S. employees. Employees may contribute up to 15% of their annual compensation to the plan, limited to a maximum amount set by the
Internal Revenue Service. The plan also provides for Company contributions at the discretion of the Company. The Company did not make matching
contributions during 2020. In 2019, total matching contributions made by the Company was $219 thousand.
13. Income Taxes
Loss from operations before provision for income taxes was comprised of the following:
United States
Foreign
Total
The provision for income taxes includes:
Current:
Federal
State
Foreign
Deferred:
Federal
State
Provision for income taxes
FY 2020
Year Ended
January 2, 2021
FY 2019
Year Ended
December 28, 2019
(6,486) $
183
(6,303) $
(8,711)
(54)
(8,765)
FY 2020
Year Ended
January 2, 2021
FY 2019
Year Ended
December 28, 2019
— $
12
11
23
1
2
3
26 $
—
19
27
46
1
1
2
48
$
$
$
$
63
Our effective tax rate differs from the statutory federal income tax rate as shown in the following schedule:
Income tax provision at statutory rate
State income taxes, net of federal benefit
Permanent differences
Research and development credits
Change in valuation allowance
Foreign rate differential
Other
Effective tax rate
FY 2020
Year Ended
January 2, 2021
FY 2019
Year Ended
December 28, 2019
21.0%
0.9%
(2.8)%
0.4%
(23.3)%
0.4%
3.0%
(0.4)%
21.0%
2.8%
(3.4)%
0.4%
(21.3)%
(0.3)%
0.3%
(0.5)%
The tax effect of temporary differences and carryforwards that give rise to significant portions of the net deferred tax assets are presented below (in
thousands):
Net operating losses
Research and development credits
Accruals and reserves
Deferred revenue
Property and equipment
Intangible assets
Stock compensation
Net deferred tax asset
Valuation allowance
Net deferred tax liabilities
FY 2020
Year Ended
January 2, 2021
FY 2019
Year Ended
December 28, 2019
11,769 $
3,273
2,382
81
307
328
658
18,798
(18,820)
(22) $
10,426
3,175
2,334
54
316
370
657
17,332
(17,351)
(19)
$
$
Our accounting for deferred taxes involves the evaluation of a number of factors concerning the realizability of our deferred tax assets. Assessing
the realizability of deferred tax assets is dependent upon several factors, including the likelihood and amount, if any, of future taxable income in relevant
jurisdictions during the periods in which those temporary differences become deductible. Our management forecasts taxable income by considering all
available positive and negative evidence including our history of operating income or losses and our financial plans and estimates which are used to
manage the business. These assumptions require significant judgment about future taxable income. The amount of deferred tax assets considered realizable
is subject to adjustment in future periods if estimates of future taxable income are reduced.
As of January 2, 2021, based on the Company's recent history of losses and its forecasted losses, management believes on the more likely than not
basis that a full valuation allowance is required. Accordingly, in the fourth quarter of fiscal year 2020, the Company provided a full valuation allowance on
its federal and state deferred tax assets. As of January 2, 2021, the Company had federal and state net operating loss (“NOL”) carry forwards of $47.7
million and $23.3 million, respectively. The federal NOL will begin to expire in 2033 and the state NOL will begin to expire in 2021.
The Company has federal and state research credit carry forwards of approximately $2.0 million and $2.9 million, respectively. The federal research
credit will begin to expire in 2027 and the state research credit can be carried forward indefinitely. In the event of a change in ownership as defined by IRC
sections 382 and 383, the usage of the above mentioned NOLs and credits may be limited.
The Company accounts for uncertain tax positions in accordance with ASC 740, “Income Taxes”. ASC 740 seeks to reduce the diversity in practice
associated with certain aspects of measurement and recognition in accounting for income taxes. ASC 740 prescribes a recognition threshold and
measurement attribute for the financial statement recognition and measurement of a tax provision that an entity takes or expects to take in a tax return.
Additionally, ASC 740 provides guidance on de-recognition, classification, interest and penalties, accounting in interim periods, disclosures, and transition.
Under ASC 740, an entity may only recognize or continue to recognize tax positions that meet a "more likely than not" threshold. In accordance with our
accounting policy, we recognize accrued interests and penalties related to unrecognized tax benefits as a component of income tax expense. There is no
accrued interest and penalty during the year ended January 2, 2021.
64
A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows (in thousands):
Balance at the beginning of the year
Additions based upon tax positions related to the current year
Balance at the end of the year
FY 2020
Year Ended
January 2, 2021
FY 2019
Year Ended
December 28, 2019
$
$
1,192 $
28
1,220 $
1,155
37
1,192
If the ending balance of $1.2 million of unrecognized tax benefits at January 2, 2021 were recognized, $0 of the recognition would affect the
income tax rate. The Company does not anticipate any material change in our unrecognized tax benefits over the next twelve months. The unrecognized tax
benefits may change during the next year for items that arise in the ordinary course of business.
The Company files U.S. federal and state returns. The tax years 2012 to 2020 remain open in several jurisdictions, none of which have individual
significance.
14. Loan and Security Agreement
In November 2016, the Company entered into a Loan and Security Agreement (“Loan Agreement”) with Silicon Valley Bank providing for up to
$15.0 million secured revolving loan facility (“Revolving Loan Facility”), with availability subject to an accounts receivable borrowing base formula.
Borrowings under the Revolving Loan Facility accrue interest at a per annum rate equal to the Wall Street Journal Prime Rate as in effect from time to time,
plus 1.5%. The Loan Agreement does not include any financial covenants. The Loan Agreement expired in November 2, 2019 and was amended (First
Amendment to the Loan Agreement) to extend through January 1, 2020.
In January 2020, the Company reduced the credit line to match its expected borrowing base, which is reflected in the Second Amendment to the
Loan Agreement providing for up to $8.0 million Revolving Loan Facility through January 1, 2021. The Third Amendment to the Loan Agreement was
executed in December 2020 to extend the term through April 1, 2022.
As of January 2, 2021 and December 28, 2019, there were no amounts outstanding.
15. Business Segments and Geographical Information
We operate in one segment, ophthalmology. We develop, manufacture and market medical devices. Our revenues arise from the sale of consoles,
delivery devices, consumables, service and support activities.
Revenue information shown by product is as follows (in thousands):
G6
Retina
Other(1)
Total revenues
FY 2020
Year Ended
January 2, 2021
FY 2019
Year Ended
December 28, 2019
$
$
11,272 $
18,088
6,987
36,347 $
13,070
22,879
7,498
43,447
(1) Other includes service contract revenues of $1,263 and $1,363 recognized during fiscal years 2020 and 2019, respectively. Other also
includes revenues from paid service, royalty, freight and legacy G probes.
Revenue information shown by geographic region is as follows (in thousands):
United States
Europe
Americas, excluding the U.S.
Asia/Pacific Rim
FY 2020
Year Ended
January 2, 2021
FY 2019
Year Ended
December 28, 2019
19,312 $
8,006
1,967
7,062
36,347 $
22,270
9,894
2,857
8,426
43,447
$
$
65
Revenues are attributed to countries based on location of end customers. For fiscal years 2020 and 2019 no individual country accounted for more
than 10% of our sales, except for the United States, which accounted for 53.1% and 51.3% of revenues in 2020 and 2019, respectively.
16. Computation of Basic and Diluted Net Loss Per Common Share
A reconciliation of the numerator and denominator of basic and diluted net income per common share is provided as follows (in thousands, except
per share amounts):
Numerator:
Net loss
Denominator:
Weighted average shares of common stock
(basic)
Weighted average shares of common stock
(diluted)
Per share data:
Basic net loss per share
Diluted net loss per share
$
$
$
FY 2020
Year Ended
January 2, 2021
FY 2019
Year Ended
December 28, 2019
(6,329)
$
(8,813)
13,842
13,842
(0.46)
(0.46)
$
$
13,707
13,707
(0.64)
(0.64)
As of January 2, 2021 and December 28, 2019, stock options, restricted stock units and restricted stock awards of 1,407,410 and 1,162,049 shares,
respectively, were excluded from the computation of diluted weighted average shares outstanding because to do so would have been anti-dilutive.
17. Subsequent Events
On March 2, 2021, the Company entered into a series of strategic transactions with Topcon Corporation (“Topcon”), Topcon America Corporation
(the “Investor”) and Topcon Medical Laser Systems, Inc. (the “Seller”), pursuant to which (i) the Company and the Seller entered into an asset purchase
agreement dated March 2, 2021, pursuant to which the Company acquired substantially all the assets (except for cash and cash equivalents) of the Seller
(the “Transferred Assets”) (the “Asset Purchase Agreement”), (ii) Topcon and the Company entered into a distribution agreement dated March 2, 2021,
pursuant to which the Company granted Topcon the exclusive right to distribute the Company’s retina and glaucoma products in certain geographies
outside the United States (the “Distribution Agreement”), (iii) pursuant to an investment agreement dated March 2, 2021 (the “Investment Agreement”) the
Investor acquired 1,618,122 shares of the Company’s Common Stock for an aggregate purchase price of $10 million (the “Shares”) and (iv) the Company
and Investor entered into a registration rights agreement dated March 2, 2021 (the “Registration Rights Agreement”) with respect to the registration of the
Shares for resale.
Pursuant to the Asset Purchase Agreement, the transferred assets include substantially all of the Seller’s assets including the rights to the Seller’s
PASCAL product (the “Transferred Assets”). The Company assumed only those liabilities arising after the closing in connection with the Transferred
Assets. In the Asset Purchase Agreement, the Company and the Seller made certain customary representations and warranties and agreed to certain
customary covenants. The Agreement provides that the Company and the Seller will each indemnify the other for losses arising from certain breaches of
the Agreement and for certain other liabilities subject to customary caps and deductibles. The Company plans to offer employment to certain of the
employees of the Seller and sublease the Seller’s current Livermore facility from Topcon. The Closing occurred on March 10, 2021.
66
Pursuant to the Distribution Agreement, the Company appointed Topcon as the exclusive distributor of the Company’s glaucoma and retina
products, including Seller’s PASCAL product, in certain countries outside of the United States. Topcon agreed to use commercially reasonable efforts to
commercialize the Company’s products in each region throughout the territory, including achieving certain sales baselines by product category and
region. If Topcon fails to achieve the baselines in a region, the Company will have the right to, subject to payment of a fee, terminate Topcon’s appointment
in such region. The Distribution Agreement and Topcon’s appointment will, unless terminated earlier, continue on a country-by-country basis for a period
of ten (10) years from the date exclusivity is granted. The Distribution Agreement includes customary termination rights and effects of termination,
including a termination for convenience right in favor of Topcon and, subject to payment of a fee, a termination right in favor of the Company upon a
change of control of the Company. The net proceeds to the Company from the transactions reflected in the Asset Purchase Agreement and the Distribution
Agreement are $9.5 million.
Pursuant to the Investment Agreement, Shares are subject to a six-month lockup. In the six months following the purchase of the Shares, the
Investor shall have the right to participate on a pro rata basis in subsequent issuances of Common Stock or equivalents by the Company or any of its
subsidiaries. Pursuant to the Registration Rights Agreement the Company has committed to register the Shares for resale within the same period of time
and there are standard penalty provisions if the Company fails to register the Shares for resale within such period. The Investment Agreement and the
Registration Rights Agreement are subject to customary representations and warranties, covenants and indemnification provisions.
67
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Not applicable.
Item 9A. Controls and Procedures
Evaluation of Disclosure Controls and Procedures.
Our management, with the participation of our Principal Executive Officer and Principal Financial Officer, evaluated the effectiveness of our
disclosure controls and procedures pursuant to Rule 13a-15 under the Exchange Act. In designing and evaluating our disclosure controls and procedures,
management recognizes that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute,
assurance that the objectives of the disclosure controls and procedures are met. Additionally, in designing disclosure controls and procedures, our
management was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of
any disclosure controls and procedures 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.
Based on management’s evaluation, our Principal Executive Officer and Principal Financial Officer concluded that, as of January 2, 2021, our
disclosure controls and procedures are designed at a reasonable assurance level and are effective to provide reasonable assurance that information we are
required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified
in SEC 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 timely decisions regarding required disclosure.
Management’s Report on Internal Control over Financial Reporting.
Our management is responsible for establishing and maintaining adequate internal control over the Company’s financial reporting. There are
inherent limitations in the effectiveness of any internal control, including the possibility of human error and the circumvention or overriding of controls.
Accordingly, even any effective internal control can provide only reasonable assurance with respect to financial statement preparation. Further, because of
changes in conditions, the effectiveness of any internal control may vary over time. Our management assessed the effectiveness of the company’s internal
control over financial reporting as of January 2, 2021. In making this assessment, we used the criteria set forth by the Committee of Sponsoring
Organizations of the Treadway Commission (COSO) in Internal Control-Integrated Framework (2013). Based on our assessment using those criteria, our
management concluded that, as of January 2, 2021, our internal control over financial reporting is effective.
This Annual Report on Form 10-K does not include an attestation report of our independent registered public accounting firm regarding internal
control over financial reporting. Management’s report is not subject to attestation by our independent registered public accounting firm.
Changes in Internal Control over Financial Reporting.
There were no changes in our internal control over financial reporting that occurred during the fourth quarter of fiscal year 2020 that has materially
affected, or is reasonably likely to materially affect, our internal control over financial reporting, as defined in Rule 13a-15(f) and 15(d)-15(f) under the
Exchange Act.
Inherent Limitations on Effectiveness of Controls
Our management, including our Principal Executive Officer and Principal 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 persons 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.
Item 9B. Other Information
Not applicable.
68
PART III
Certain information required by Part III has been omitted from this Form 10-K. This information is instead incorporated herein by reference to our
definitive Proxy Statement, which we will file within 120 days after the end of our fiscal year pursuant to Regulation 14A in time for our Annual Meeting
of Stockholders to be held in 2021.
Item 10. Directors, Executive Officers and Corporate Governance
The information required by this item will be contained in our definitive proxy statement to be filed with the SEC in connection with our 2021
Annual Meeting of Stockholders (the “Proxy Statement”), which is expected to be filed not later than 120 days after the end of our fiscal year ended
January 2, 2021 and is incorporated in this report by reference.
Item 11. Executive Compensation
The information required by this item will be set forth in the Proxy Statement and is incorporated herein by reference.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The information required by this item will be set forth in the Proxy Statement and is incorporated herein by reference.
Item 13. Certain Relationships and Related Transactions, and Director Independence
The information required by this item will be set forth in the Proxy Statement and is incorporated herein by reference.
Item 14. Principal Accountant Fees and Services.
The information required by this item will be set forth in the Proxy Statement and is incorporated herein by reference.
69
Item 15. Exhibits and Financial Statement Schedules
(a)
The following documents are filed in Part II of this Annual Report on Form 10-K:
PART IV
1. Index to Financial Statements
Report of Independent Registered Public Accounting Firm
Consolidated Balance Sheets as of January 2, 2021 and December 28, 2019
Consolidated Statements of Operations for the years ended January 2, 2021 and December 28, 2019
Consolidated Statements of Comprehensive Loss for the years ended January 2, 2021 and December 28, 2019
Consolidated Statements of Stockholders’Equity for the years ended January 2, 2021 and December 28, 2019
Consolidated Statements of Cash Flows for the years ended January 2, 2021 and December 28, 2019
Notes to Consolidated Financial Statements
2. Financial Statement Schedule
Page in
Form 10-K
Report
43
45
46
47
48
49
50
Schedules have been omitted because they are either not required, not applicable, or the required information is included in the consolidated
financial statements or notes thereto.
3. Exhibits
Exhibits
Exhibit Title
3.1(1) (P)
Amended and Restated Certificate of Incorporation of Registrant.
Exhibit Index
3.2(2)
4.1(3)
Amended and Restated Bylaws of Registrant.
Investor Rights Agreement, dated as of August 31, 2007, by and among the Registrant, BlueLine Capital Partners, LP; BlueLine Capital
Partners III, LP and BlueLine Capital Partners II, LP.
4.2(4)
Amendment No. 1 to Investor Rights Agreement, dated as of March 31, 2009.
4.3(25)
Description of Capital Stock.
10.1(17)
Fourth Amendment to Lease Agreement dated February 9, 2016 by and between Zappettini Investment Co. and the Registrant.
10.2(19)
Form of Indemnification Agreement with directors and officers.
10.3(5)
Lease Agreement dated December 6, 1996 by and between Zappettini Investment Co. and the Registrant, as amended pursuant to
Amendment No. 1 dated September 15, 2003 and Amendment No. 2 dated December 22, 2008.
10.3.1(13)
Third Amendment to Lease Agreement dated August 4, 2014 by and between Zappettini Investment Co. and the Registrant.
10.3.2(21)
Fourth Amendment to Lease Agreement dated January 31, 2016 by and between ZIC 12112 Terra Bella LLC and the Registrant.
10.3.3(22)
Triple Net Lease dated April 26, 2017 by and between ZIC 12112 Terra Bella LLC and the Registrant.
10.6(8)*
2005 Employee Stock Purchase Plan.
10.7(9)*
2008 Equity Incentive Plan, as amended.
10.8(10)*
Form of 2008 Equity Incentive Plan Option Agreement.
10.9(11)*
Form of Stand-Alone Stock Option Agreement.
10.10(3)
Securities Purchase Agreement, dated August 31, 2007, by and among BlueLine Capital Partners, LP, BlueLine Capital Partners III, LP,
BlueLine Capital Partners II, LP and the Registrant.
10.11(12)*
Form of 2008 Equity Incentive Plan Restricted Stock Award Agreement.
70
Exhibits
10.12(12)*
Exhibit Title
Form of 2008 Equity Incentive Plan Restricted Stock Unit Award Agreement.
10.13(14)*
Restricted Stock Unit Award Agreement granted to William M. Moore under the Company’s 2008 Equity Incentive Plan, as amended.
10.14(15)*
Restricted Stock Unit Award Agreement granted to William M. Moore under the Company’s 2008 Equity Incentive Plan, as amended.
10.15(16)*
Change in Control Severance Agreement dated March 30, 2015, between the Registrant and William M. Moore.
10.16(18)*
Change in Control Severance Agreement dated as of December 6, 2017 by and between the Company and George Marcellino
10.17(19)*
Offer Letter between the Company and Mr. Mokari effective as of May 13, 2016.
10.18(19)*
Change in Control Severance Agreement, between the Company and Mr. Mokari.
10.19(20)
Loan and Security Agreement, dated as of November 2, 2016, between IRIDEX Corporation and Silicon Valley Bank.
10.19.1(25)
First Amendment to Loan and Security Agreement between IRIDEX Corporation and Silicon Valley Bank, executed on December 3,
2019.
10.19.2(25)
Second Amendment to Loan and Security Agreement between IRIDEX Corporation and Silicon Valley Bank, executed on January 8,
2020.
10.19.3
Third Amendment to Loan and Security Agreement between IRIDEX Corporation and Silicon Valley Bank, executed on December 31,
2020.
10.20(23)*
Offer Letter between the Company and Mr. Bruce effective as of May 20, 2019.
10.21(24)*
Change in Control Severance Agreement dated as of October 25, 2019, between the Company and Mr. Bruce.
10.22(24)*
Change in Control Severance Agreement dated as of October 25, 2019, between the Company and Mr. Mercer.
21.1 (1) (P)
Subsidiaries of Registrant
23.1
24.1
31.1
31.2
32.1
32.2
Consent of BPM LLP, Independent Registered Public Accounting Firm.
Power of Attorney (included on signature page).
Certification of Principal Executive and Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
Certification of Principal Accounting Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
Certification of Principal Executive and Financial Officer pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
Certification of Principal Accounting Officer pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-
Oxley Act of 2002.
101.INS
XBRL Instance Document.
101.SCH
XBRL Taxonomy Extension Schema Document.
101.CAL
XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF
XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB
XBRL Taxonomy Extension Labels Linkbase Document.
101.PRE
XBRL Taxonomy Extension Presentation Linkbase Document.
*
(1)
Indicates a management contract or compensatory plan or arrangement.
Incorporated by reference to the Exhibits filed with the Registration Statement on Form SB-2 (No. 333-00320-LA) which was declared effective on
February 15, 1996.
71
(2)
(3)
(4)
(5)
(8)
(9)
(10)
(11)
(12)
(13)
(14)
(15)
(16)
(17)
(18)
(19)
(20)
(21)
(22)
(23)
(24)
(25)
(P)
Incorporated by reference to the Exhibits filed with the Registrant’s Report on Form 8-K on April 1, 2019.
Incorporated by reference to the Exhibits filed with the Registrant’s Report on Form 8-K on September 7, 2007.
Incorporated by reference to the Exhibits filed with the Registrant’s Report on Form 8-K on April 6, 2009.
Incorporated by reference to the Exhibits filed with the Registrant’s Report on Form 10-K for the year ended January 3, 2009.
Incorporated by reference to the appendix filed with the Registrant’s Proxy Statement for the Registrant’s 2004 Annual Meeting of Stockholders
which was filed on April 30, 2004.
Incorporated by reference to the appendix filed with the Registrant’s Proxy Statement for the Registrant’s 2019 Annual Meeting of Stockholders
which was filed on June 12, 2019.
Incorporated by reference to Exhibit 99.1 filed with Registrant’s Registration Statement on Form S-8 on November 21, 2008.
Incorporated by reference to Exhibit 99.(d)(5) filed with the Registration Statement on Form SC TO-I July 30, 2009.
Incorporated by reference to the Exhibits filed with the Registrant’s Report on Form 10-Q for the quarter ended July 2, 2011.
Incorporated by reference to the Exhibit 10.1 filed with the Registrant’s Report on Form 10-Q filed on November 3, 2014.
Incorporated by reference to the Exhibit 10.1 filed with the Registrant’s Report on Form 8-K on March 27, 2013.
Incorporated by reference to the Exhibit 10.1 filed with the Registrant’s Report on Form 8-K on January 9, 2014.
Incorporated by reference to the Exhibits filed with the Registrant’s Report on Form 10-Q on May 12, 2015.
Incorporated by reference to the Exhibit 10.1 filed with the Registrant’s Report on Form 10-K on March 31, 2016.
Incorporated by reference to the Exhibit 10.1 filed with the Registrant’s Report on Form 8-K on December 6, 2017.
Incorporated by reference to the Exhibits filed with the Registrant’s Report on Form 8-K on July 11, 2016,
Incorporated by reference to Exhibit 10.1 filed with the Registrant’s Report on Form 8-K on November 3, 2016.
Incorporated by reference to Exhibit 10.1 filed with the Registrant’s Report on Form 10-K on March 31, 2016.
Incorporated by reference to Exhibit 10.1 filed with the Registrant’s Report on Form 8-K on May 1, 2017.
Incorporated by reference to Exhibit 10.1 filed with the Registrant’s Report on Form 8-K/A on June 14, 2019.
Incorporated by reference to Exhibits filed with the Registrant’s Report on Form 8-K on October 28, 2019.
Incorporated by reference to Exhibits filed with the Registrant’s Report on Form 10-K on March 13, 2020.
Print filing.
Trademark Acknowledgments
IRIDEX, the IRIDEX logo, IRIS Medical, MicroPulse, OcuLight, EndoProbe, MicroPulse P3, G-Probe, G-Probe Illuminate, TruFocus LIO
Premiere, IQ 577, IQ532, Cyclo G6, and TxCell are our registered trademarks. All other trademarks or trade names appearing in this Annual Report on
Form 10-K are the property of their respective owners.
72
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed
on its behalf by the undersigned, thereunto duly authorized, in the City of Mountain View, State of California, on the 23rd day of March 2021.
SIGNATURES
IRIDEX CORPORATION
By:
/s/ David I. Bruce
David I. Bruce
President and Chief Executive Officer
/s/ Fuad Ahmad
Fuad Ahmad
Interim Chief Financial Officer
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints David I. Bruce and
Fuad Ahmad, jointly and severally, their attorney-in-fact, each with full power of substitution, for him in any and all capacities, to sign on behalf of the
undersigned any amendments to this Annual Report on Form 10-K, and to file the same, with exhibits thereto and other documents in connection therewith,
with the Securities and Exchange Commission, and each of the undersigned does hereby ratifying and confirming all that each of said attorneys-in-fact, or
his substitutes, may do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Act of 1934, this report has been signed by the following persons in the capacities and on the dates
indicated.
/s/ David I. Bruce
(David I. Bruce)
/s/ Fuad Ahmad
(Fuad Ahmad)
/s/ Robert Gunst
(Robert Gunst)
/s/ Doris Engibous
(Doris Engibous)
/s/ Robert Grove
(Robert Grove)
/s/ Kenneth E. Ludlum
(Kenneth E. Ludlum)
/s/ (Scott Shuda)
(Scott Shuda)
Signature
Title
President and Chief Executive Officer
(Principal Executive Officer)
Interim Chief Financial Officer
(Principal Financial Officer)
Date
March 23, 2021
March 23, 2021
Chairman of the Board
March 23, 2021
Director
Director
Director
Director
73
March 23, 2021
March 23, 2021
March 23, 2021
March 23, 2021
THIRD AMENDMENT
TO
LOAN AND SECURITY AGREEMENT
Exhibit 10.19.3
THIS THIRD AMENDMENT TO LOAN AND SECURITY AGREEMENT (this “Amendment”) is entered into
this 31st day of December, 2020, by and between SILICON VALLEY BANK, a California corporation (“Bank”), and IRIDEX
CORPORATION, a Delaware corporation (“Borrower”).
RECITALS
A.
Bank and Borrower have entered into that certain Loan and Security Agreement dated as of November 2,
2016 (as the same may from time to time be further amended, modified, supplemented or restated, the “Loan Agreement”).
B.
C.
Bank has extended credit to Borrower for the purposes permitted in the Loan Agreement.
Borrower has requested that Bank amend the Loan Agreement to (i) extend the Revolving Line Maturity
Date, and (ii) make certain other revisions to the Loan Agreement as more fully set forth herein.
D.
Bank has agreed to so amend certain provisions of the Loan Agreement, but only to the extent, in accordance
with the terms, subject to the conditions and in reliance upon the representations and warranties set forth below.
AGREEMENT
NOW, THEREFORE, in consideration of the foregoing recitals and other good and valuable consideration, the receipt and
adequacy of which is hereby acknowledged, and intending to be legally bound, the parties hereto agree as follows:
1.
Definitions. Capitalized terms used but not defined in this Amendment shall have the meanings given to
them in the Loan Agreement.
2.
Amendments to Loan Agreement.
2.1
clause (f) as clause (g):
Section 2.6 (Fees). Section 2.6 of the Loan Agreement is amended by adding the following after
Anniversary Fee. A fully earned, non-refundable anniversary fee of Five Thousand
Dollars ($5,000) due on the earlier of (a) January 1, 2022 or (b) termination of the Revolving Line for any reason prior
to the Revolving Line Maturity Date.
(g)
deleting clause (a) thereof in its entirety and replacing it with the following:
2.2
Section 6.8 (Operating Accounts). Section 6.8 of the Loan Agreement is hereby amended by
operating accounts and excess cash with Bank or Bank’s Affiliates.
(a)
Borrower, any Subsidiary of Borrower and any Guarantor shall maintain all of its
Borrower, any Subsidiary of Borrower and any Guarantor shall obtain any business credit card exclusively from Bank.
Section 13.1 of the Loan Agreement is hereby deleted in its entirety and replaced with the following:
2.3
Section 13 (Definitions). The definition of “Revolving Line Maturity Date” as set forth in
“Revolving Line Maturity Date” is April 1, 2022.
3.
Limitation of Amendments.
3.1
The amendments set forth in Section 2, above, are effective for the purposes set forth herein and
shall be limited precisely as written and shall not be deemed to (a) be a consent to any amendment, waiver or modification of any
other term or condition of any Loan Document, or (a) otherwise prejudice any right or remedy which Bank may now have or may
have in the future under or in connection with any Loan Document.
This Amendment shall be construed in connection with and as part of the Loan Documents and all
terms, conditions, representations, warranties, covenants and agreements set forth in the Loan Documents, except as herein
amended, are hereby ratified and confirmed and shall remain in full force and effect.
3.2
4.
Representations and Warranties. To induce Bank to enter into this Amendment, Borrower hereby
represents and warrants to Bank as follows:
4.1
Immediately after giving effect to this Amendment (a) the representations and warranties contained
in the Loan Documents are true, accurate and complete in all material respects as of the date hereof (except to the extent such
representations and warranties relate to an earlier date, in which case they are true and correct as of such date), and (a) no Event
of Default has occurred and is continuing;
obligations under the Loan Agreement, as amended by this Amendment;
4.2
Borrower has the power and authority to execute and deliver this Amendment and to perform its
accurate and complete and have not been amended, supplemented or restated and are and continue to be in full force and effect;
4.3
The organizational documents of Borrower delivered to Bank on the Effective Date remain true,
its obligations under the Loan Agreement, as amended by this Amendment, have been duly authorized;
4.4
The execution and delivery by Borrower of this Amendment and the performance by Borrower of
4.5
The execution and delivery by Borrower of this Amendment and the performance by Borrower of
its obligations under the Loan Agreement, as amended by this Amendment, do not and will not contravene (a) any law or
regulation binding on or affecting Borrower, (a) any contractual restriction with a Person binding on Borrower, (a) any order,
judgment or decree of any court or other governmental or public body or authority, or subdivision thereof, binding on Borrower,
or (a) the organizational documents of Borrower;
2
4.6
The execution and delivery by Borrower of this Amendment and the performance by Borrower of
its obligations under the Loan Agreement, as amended by this Amendment, do not require any order, consent, approval, license,
authorization or validation of, or filing, recording or registration with, or exemption by any governmental or public body or
authority, or subdivision thereof, binding on Borrower, except as already has been obtained or made; and
4.7
This Amendment has been duly executed and delivered by Borrower and is the binding obligation
of Borrower, enforceable against Borrower in accordance with its terms, except as such enforceability may be limited by
bankruptcy, insolvency, reorganization, liquidation, moratorium or other similar laws of general application and equitable
principles relating to or affecting creditors’ rights.
5.
Ratification of Perfection Certificate. Borrower hereby ratifies, confirms and reaffirms, all and singular, the
terms and disclosures contained in a certain Perfection Certificate dated as of the Effective Date, and acknowledges, confirms and
agrees that the disclosures and information Borrower provided to Bank in such Perfection Certificate have not changed, as of the
date hereof.
6.
Integration. This Amendment and the Loan Documents represent the entire agreement about this subject
matter and supersede prior negotiations or agreements. All prior agreements, understandings, representations, warranties, and
negotiations between the parties about the subject matter of this Amendment and the Loan Documents merge into this
Amendment and the Loan Documents.
7.
Counterparts. This Amendment may be executed in any number of counterparts and all of such counterparts
taken together shall be deemed to constitute one and the same instrument.
8.
Effectiveness. This Amendment shall be deemed effective upon (a) the due execution and delivery to Bank
of this Amendment by each party hereto, and (a) Borrower’s payment of (i) a fully-earned, non-refundable commitment fee in an
amount equal to Twenty Thousand Dollars ($20,000), and (i) Bank’s legal fees and expenses incurred in connection with the
negotiation and preparation of this Amendment.
[Signature page follows.]
3
IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be duly executed and delivered as of the date
first written above.
BANK
SILICON VALLEY BANK
By:
Name:
Title:
/s/ Sheetal Kapani
Sheetal Kapani
Vice President
BORROWER
IRIDEX CORPORATION
By:
Name:
Title:
/s/ David I. Bruce
David I. Bruce
President and Chief Executive Officer
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We hereby consent to the incorporation by reference in the Registration Statements on Form S-3 (333-213094) and Form S-8 (333-233628, 333-
226358, 333-219448, 333-197934, 333-183513, 333-161630, 333-155598, 333-147866, 333-135822, 333-127716, 333-117885, 333-107700, 333-97541,
333-67480, 333-45736, 333-86091, 333-57573, 333-32161) of our report dated March 23, 2021 relating to the consolidated financial statements of IRIDEX
Corporation as of January 2, 2021, which appears in this Annual Report on Form 10-K.
Exhibit 23.1
/s/ BPM LLP
San Jose, California
March 23, 2021
CERTIFICATION OF PRINCIPAL EXECUTIVE AND FINANCIAL OFFICER
PURSUANT TO SECTION 13(a) or 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934
AS ADOPTED PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, David I. Bruce, certify that:
EXHIBIT 31.1
1.
2.
3.
4.
I have reviewed this annual report on Form 10-K of IRIDEX Corporation;
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;
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;
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)
b)
c)
d)
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, including its consolidated subsidiaries, is made known to us
by others within those entities, particularly during the period in which this report is being prepared;
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;
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 based on such evaluation;
and
Disclosed in this report any changes in the registrant’s internal control over financial reporting that occurred during the 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; and
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)
b)
All significant deficiencies and material weaknesses 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
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.
Date: March 23, 2021
By: /s/ DAVID I. BRUCE
Name: David I. Bruce
Title: President and Chief Executive Officer
(Principal Executive Officer)
CERTIFICATION OF PRINCIPAL ACCOUNTING OFFICER
PURSUANT TO SECTION 13(a) or 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934
AS ADOPTED PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Fuad Ahmad, certify that:
EXHIBIT 31.2
1.
2.
3.
4.
I have reviewed this annual report on Form 10-K of IRIDEX Corporation;
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;
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;
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)
b)
c)
d)
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, including its consolidated subsidiaries, is made known to us
by others within those entities, particularly during the period in which this report is being prepared;
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;
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 based on such evaluation;
and
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the 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; and
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)
b)
All significant deficiencies and material weaknesses 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
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.
Date: March 23, 2021
By: /s/ FUAD AHMAD
Name: Fuad Ahmad
Title: Interim Chief Financial Officer
(Principal Financial Officer)
CERTIFICATION OF PRINCIPAL EXECUTIVE AND 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
I, David I. Bruce, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, certify that the
Annual Report of IRIDEX Corporation on Form 10-K for the fiscal year ended January 2, 2021 (i) fully complies with the requirements of Section 13(a) or
15(d) of the Securities Exchange Act of 1934 and (ii) that information contained in such Annual Report on Form 10-K fairly presents, in all material
respects, the financial condition and results of operations of IRIDEX Corporation.
Date: March 23, 2021
By: /s/ DAVID I. BRUCE
Name: David I. Bruce
Title: President and Chief Executive Officer
(Principal Executive Officer)
CERTIFICATION OF PRINCIPAL ACCOUNTING OFFICER
PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
EXHIBIT 32.2
I, Fuad Ahmad, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, certify that the Annual
Report of IRIDEX Corporation on Form 10-K for the fiscal year ended January 2, 2021 (i) fully complies with the requirements of Section 13(a) or 15(d)
of the Securities Exchange Act of 1934 and (ii) that information contained in such Annual Report on Form 10-K fairly presents, in all material respects, the
financial condition and results of operations of IRIDEX Corporation.
Date: March 23, 2021
By: /s/ FUAD AHMAD
Name: Fuad Ahmad
Title: Interim Chief Financial Officer
(Principal Financial Officer)