ITEM
1A. RISK FACTORS.
Risks
Relating to Our Financial Condition
We
have limited working capital and a history of losses that raise substantial doubts as to whether we will be able to continue as
a goding concern.
We
have prepared our Condensed Consolidated Financial Statements on the basis that we would continue as a going concern. However,
we have incurred losses in each year since our inception and will need to raise additional capital prior to the end of the first
quarter of 2018, and cannot assure you that we will be able to do so. We do not currently have any available borrowing under our
term loan or credit facility.
Our
Condensed Consolidated Financial Statements do not include any adjustments relating to the recoverability and classification of
recorded asset amounts or the amounts and classification of liabilities that might be necessary if we were not able to continue
as a going concern. If we are unable to generate positive cash flows from operations, we would need to undertake a review of potential
business alternatives, which may include, but are not limited to, a merger or sale of the company or ceasing operations and winding
down the business.
We
have incurred losses since inception and anticipate that we will incur continued losses for the foreseeable future.
We
have incurred losses in each year since our inception. As of June 30, 2017, we had an accumulated deficit of $521.0 million. Our
losses have resulted primarily from expenses incurred in research and development of our product candidates from the former retina
and glaucoma business divisions. We do not know when or if we will successfully commercialize the TearLab® Osmolarity System
in the United States or in international markets. As a result, and because of the numerous risks and uncertainties facing us,
it is difficult to provide the extent of any future losses or the time required to achieve profitability, if at all. Any failure
to become and remain profitable would require us to undertake a review of the potential business alternatives discussed above.
We
will need to raise additional capital in the near future. Such capital, may not be available to us on reasonable terms, if at
all, when or as we require additional funding. If we issue additional shares of our common stock or other securities that may
be convertible into, or exercisable or exchangeable for, our common stock, our existing stockholders, would experience further
dilution.
We
expect that we will need to raise additional capital prior to the end of the first quarter of 2018. Such financings may involve
the issuance of debt, equity and/or securities convertible into or exercisable or exchangeable for our equity securities. These
financings may not be available to us on reasonable terms or at all when and as we require funding. Any failure to obtain additional
working capital when required would have a material adverse effect on our business and financial condition, our ability to continue
as a going concern and would be expected to result in a decline in our stock price. If we consummate such financings, the terms
of such financings may adversely affect the interests of our existing stockholders. Any issuances of our common stock, preferred
stock, or securities such as warrants or notes that are convertible into, exercisable or exchangeable for, our capital stock,
would have a dilutive effect on the voting and economic interest of our existing stockholders.
We
may not be able to generate sufficient cash to service our indebtedness, which currently consists of our credit facility with
CRG. We may not be able to satisfy our minimum revenue and cash covenants, as required by the CRG term loan. If our annual sales
revenue levels do not meet or exceed the levels required by the CRG covenants, we will be required to raise additional equity
or subordinated debt, with the proceeds paid to reduce the outstanding principal of the CRG term loan. This financing could dilute
existing shareholders and impact the value of their investment.
TearLab
Corporation
On
March 4, 2015, we executed a term loan agreement with CRG as lenders (the “Term Loan Agreement”) providing us with
access of up to $35.0 million under the Term Loan Agreement. We entered into an amendment of the Term Loan Agreement with CRG
on August 6, 2015. We received $25.0 million in gross proceeds during 2015. We can make no assurance that we will be able to raise
either additional debt financing or additional equity capital. There can be no assurances that there will be adequate financing
available to us on acceptable terms or at all.
Our
ability to make scheduled payments or to refinance our debt obligations depends on numerous factors, including the amount of our
cash reserves and our actual and projected financial and operating performance. These amounts and our performance are subject
to certain financial and business factors, as well as prevailing economic and competitive conditions, some of which may be beyond
our control. We cannot assure you that we will maintain a level of cash reserves or cash flows from operating activities sufficient
to permit us to pay the principal, premium, if any, and interest on our existing or future indebtedness. If our cash flows and
capital resources are insufficient to fund our debt service obligations, we may be forced to reduce or delay capital expenditures,
sell assets or operations, seek additional capital or restructure or refinance our indebtedness. We cannot assure you that we
would be able to take any of these actions, or that these actions would permit us to meet our scheduled debt service obligations.
In addition, in the event of our breach of the Term Loan Agreement with CRG, we may not be allowed to draw additional amounts
under the agreement, we may be required to repay any outstanding amounts earlier than anticipated, and the lenders may foreclose
on their security interest in our assets.
The
CRG loan is collateralized by all our assets. Additionally, the terms of the Term Loan Agreement contain various affirmative and
negative covenants agreed to by the Company. Among them, we must attain minimum annual revenue and minimum cash threshold levels.
The minimum annual revenue threshold levels required by the Term Loan are $31.0 million, $36.0 million, $45.0 million and $55.0
million for calendar years 2017, 2018, 2019 and 2020, respectively. The minimum cash balance required is $5.0 million, subject
to certain conditions.
If
we do not have annual revenue greater or equal to the annual revenue covenant in a calendar year, we will have the right to cure
by raising subordinated debt or equity equal to twice the difference between the annual revenue and the revenue covenant, with
the total proceeds from this financing to be used to reduce the principal of the Term Loan Agreement. We cannot assure you that
we will be able to achieve the annual revenue thresholds and the daily cash threshold. We cannot assure you that we would be able
to raise the financing described above, if required. In addition, in the event of our breach of the Term Loan Agreement with CRG,
we may not be allowed to draw additional amounts under the Term Loan Agreement, we may be required to repay any outstanding amounts
earlier than anticipated, and the lenders may foreclose on their security interest in our assets.
Borrowings
under the Term Loan Agreement are subject to certain conditions, including the non-occurrence of a material adverse change in
our business or operations (financial or otherwise), or a material impairment of the prospect of repayment of obligations.
Our
existing Term Loan Agreement contains restrictive and financial covenants that may limit our operating flexibility.
Our
existing Term Loan Agreement with CRG contains certain restrictive covenants that limit our ability to incur additional indebtedness
and liens, merge with other companies or consummate certain changes of control, acquire other companies, engage in new lines of
business, make certain investments, pay dividends, transfer or dispose of assets, amend certain material agreements or enter into
various specified transactions. We therefore may not be able to engage in any of the foregoing transactions unless we obtain the
consent of the lender or terminate the Term Loan Agreement. There is no guarantee that we will be able to generate sufficient
cash flow or sales to meet the financial covenants or pay the principal and interest under the agreement. Furthermore, there is
no guarantee that future working capital, borrowings or equity financing will be available to repay or refinance the amounts outstanding
under the Term Loan Agreement.
TearLab
Corporation
Our
financial results may vary significantly from year-to-year [and quarter-to-quarter] due to a number of factors, which may lead
to volatility in the trading price of our common stock.
Our
annual and quarterly revenue and results of operations have varied in the past and may continue to vary significantly from year-to-year
and quarter-to-quarter. The variability in our annual and quarterly results of operations may lead to volatility in our stock
price as research analysts and investors respond to these annual fluctuations. These fluctuations are due to numerous factors
that are difficult to forecast, including:
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fluctuations
in demand for our products;
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changes
in customer budget cycles and capital spending;
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seasonal
variations in customer operations that could occur during holiday or summer vacation periods;
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tendencies
among some customers to defer purchase decisions until the end of the quarter;
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the
unit value of our systems;
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changes
in our pricing and sales policies or the pricing and sales policies of our competitors;
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changes
in reimbursement levels that might negatively impact our pricing policies;
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our
ability to design, manufacture and deliver products to our customers in a timely and cost effective manner;
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quality
control or yield problems in our manufacturing suppliers;
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our
ability to timely obtain adequate quantities of the components used in our products;
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new
product introductions or enhancements by us and our competitors;
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unanticipated
increases in costs or expenses;
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our
complex, variable and, at times, lengthy sales cycle;
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global
economic conditions; and
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fluctuations
in foreign currency exchange rates.
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In
addition, we may experience seasonal variations in our customer operations such as could occur during holiday vacation periods.
For example, one of our principal target markets consists of private ophthalmic and optometric practices, and our quarterly operating
results could be adversely affected by summer or holiday vacation periods. The foregoing factors, as well as other factors, could
materially and adversely affect our quarterly and annual results of operations. In addition, a significant amount of our operating
expenses are relatively fixed due to our manufacturing, research and development, and sales and general administrative efforts.
Any failure to adjust spending quickly enough to compensate for a revenue shortfall could magnify the adverse impact of such revenue
shortfall on our results of operations. We expect that our sales will continue to fluctuate on a quarterly basis and our financial
results for some periods may differ from those projected by securities analysts, which could significantly decrease the price
of our common stock.
TearLab
Corporation
Risks
Related to Our Business
Our
near-term success is highly dependent on the success of the TearLab® Osmolarity System, and we cannot be certain that it will
be successfully commercialized in the United States.
The
TearLab® Osmolarity System is currently our only product. Our product is currently sold outside of the United States pursuant
to CE mark approval; in Canada pursuant to a Health Canada Medical Device License; and in the United States as a result of having
received 510(k) approval from the FDA to market the TearLab® Osmolarity System to those reference and physician operated laboratories
with CLIA waiver certifications. Even though the TearLab® Osmolarity System has received all regulatory approvals in the United
States, it may never be successfully commercialized. If the TearLab® Osmolarity System is not as successfully commercialized
as expected, we may not be able to generate revenue, become profitable or continue our operations. Any failure of the TearLab®
Osmolarity System to be successfully commercialized in the United States would have a material adverse effect on our business,
operating results, financial condition and cash flows and could result in a substantial decline in the price of our common stock.
Our
near-term success is highly dependent on increasing sales of the TearLab® Osmolarity System outside the United States, and
we cannot be certain that we will successfully increase such sales.
Our
product is currently sold outside of the United States pursuant to CE mark approval and Health Canada Approval in Canada. Our
near-term success is highly dependent on increasing our international sales. We may also be required to register our product with
health departments in our foreign market countries. A failure to successfully register in such markets would negatively affect
our sales in any such markets. In addition, import taxes are levied on our product in certain foreign markets. Other countries
may adopt taxation codes on imported products. Increases in such taxes or other restrictions on our product could negatively affect
our ability to import, distribute and price our product.
We
have outstanding liabilities, which could adversely affect our ability to adjust our business to respond to competitive pressures
and to obtain sufficient funds to satisfy our future research and development needs, and to defend our intellectual property.
As
of June 30, 2017, our total liabilities were $33.7 million including $27.4 million of long-term obligations under our Term Loan
Agreement. Our significant liability service requirements could adversely affect our ability to operate our business and may limit
our ability to take advantage of potential business opportunities. For example, our liabilities present the following risks:
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our
liabilities increase our vulnerability to economic downturns and adverse competitive and industry conditions and could place
us at a competitive disadvantage compared to those of our competitors that are less leveraged;
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our
liabilities could limit our flexibility in planning for, or reacting to, changes in our business and our industry and could
limit our ability to pursue other business opportunities, borrow money for operations or capital in the future and implement
our business strategies; and
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our
liabilities may restrict us from raising additional funds on satisfactory terms to fund working capital, capital expenditures,
product development efforts, strategic acquisitions, investments and alliances, and other general corporate requirements.
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If
we are at any time unable to generate sufficient cash flow to service our liabilities when payment is due, we may be required
to attempt to renegotiate the terms of the instruments relating to the liabilities, seek to refinance all or a portion of the
liabilities or obtain financing. There can be no assurance that we will be able to successfully renegotiate such terms, that any
such refinancing would be possible or that any additional financing could be obtained on terms that are favorable or acceptable
to us.
TearLab
Corporation
We
will face challenges in bringing the TearLab® Osmolarity System to market in the United States and may not succeed in executing
our business plan.
There
are numerous risks and uncertainties inherent in the development of new medical technologies. In addition to our requirement for
additional capital, our ability to successfully commercialize the TearLab® Osmolarity System in the United States and to execute
our business plan successfully is subject to the following risks, among others:
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Our clinical trials
may not succeed. Clinical testing is expensive and can take longer than originally anticipated. The outcomes of clinical trials
are uncertain, and failure can occur at any stage of the testing. We could encounter unexpected problems, which could result
in a delay in efforts to complete clinical trials supporting our commercialization efforts.
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The TearLab®
Osmolarity System is rated under a CLIA waiver certification which requires our customers to be certified under the CLIA waiver
requirements to be reimbursed under Medicare, including certain parallel state requirements. If our customers are unwilling
or unable to comply with such requirements, it could have an adverse effect on their acceptance of and on our ability to market
the TearLab® Osmolarity System.
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Our suppliers and
we will be subject to numerous FDA requirements covering the design, testing, manufacturing, quality control, labeling, advertising,
promotion and export of the TearLab® Osmolarity System and other matters. If our suppliers or we fail to comply with these
regulatory requirements, the TearLab® Osmolarity System could be subject to restrictions or withdrawals.
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Even though we successfully
obtained the sought-after FDA approvals, we may be unable to commercialize the TearLab® Osmolarity System successfully
in the United States. Successful commercialization will depend on a number of factors, including, among other things, achieving
widespread acceptance of the TearLab® Osmolarity System among physicians, establishing adequate sales and marketing capabilities,
addressing competition effectively, the ability to obtain and enforce patents to protect proprietary rights from use by would-be
competitors, key personnel retention and ensuring sufficient manufacturing capacity and inventory.
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Our
business is subject to health care industry cost-containment measures that could result in reduced sales of our TearLab® Osmolarity
System.
Most
of our customers rely on third-party payers, including government programs and private health insurance plans, to reimburse some
or all of the cost of the procedures which use our TearLab® Osmolarity System. The continuing efforts of governmental authorities,
insurance companies, and other health care payers to contain or reduce these costs could lead to patients and providers being
unable to obtain approval for payment from these third-party payers. If patients and providers cannot obtain third-party payer
payment approval, the use of our TearLab® Osmolarity System may decline significantly and our customers may reduce or eliminate
the use of our system. The cost-containment measures that health care providers are instituting, both in the U.S. and internationally,
could harm our ability to operate profitably. For example, managed care organizations have successfully negotiated volume discounts
for pharmaceuticals. While this type of discount pricing does not currently exist for the medical systems we supply, if managed
care or other organizations were able to affect discount pricing for such systems, it could result in lower prices to our customers
from their customers and, in turn, reduce the amounts we can charge our customers for our products.
In
addition to general health care industry cost-containment, the Centers for Medicare and Medicaid Services (CMS) released its final
rule implementing section 216(a) of the Protecting Access to Medicare Act of 2014 (PAMA) that will require reporting entities
to report private payer rates paid to laboratories for lab tests, which will be used to calculate Medicare payment rates. This
final rule also announces CMS’ decision to move the implementation date for the private payer rate-based fee schedule to
January 1, 2018. Reporting entities, which would primarily be certain qualifying customers in the U.S. that derive a certain percentage
and volume of their revenue from laboratory tests from Medicare, will report private payer rates for our laboratory tests which
will serve under the act as a baseline for future reimbursement. Although it is very early to understand if reimbursement for
our product or future products will be impacted, the act does provide a maximum reimbursement reduction of 10% per year for the
years 2018 through 2020. For years 2021 through 2023, the maximum reduction on the reimbursement rate is 15%. Should reimbursement
for our products be reduced as a result of PAMA, this could negatively impact our pricing and commercialization of our products
in the U.S.
TearLab
Corporation
If
we are subject to regulatory enforcement action as a result of our failure to comply with regulatory requirements, our commercial
operations would be harmed.
While
we received the 510(k) clearance and CLIA waiver that we were seeking, we will be subject to significant ongoing regulatory requirements,
and if we fail to comply with these requirements, we could be subject to enforcement action by the FDA or state agencies, including:
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adverse
publicity, warning letters, fines, injunctions, consent decrees and civil penalties;
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repair,
replacement, refunds, recall or seizure of our product;
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operating
restrictions or partial suspension or total shutdown of production
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delay
or refusal of our requests for 510(k) clearance or premarket approval of new products or of new intended uses or modifications
to our existing product;
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refusal
to grant export approval for our products;
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withdrawing
510(k) clearances or premarket approvals that have already been granted; and
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criminal
prosecution
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If
the government initiated any of these enforcement actions, our business could be harmed.
We
are required to demonstrate and maintain compliance with the FDA’s Quality System Regulation, or the 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. The FDA must determine that the facilities which manufacture and assemble
our products that are intended for sale in the United States, as well as the manufacturing controls and specifications for these
products, are compliant with applicable regulatory requirements, including the QSR. The FDA enforces the QSR through periodic
unannounced inspections. The FDA has not yet inspected our facilities, and we cannot assure you that we will pass any future FDA
inspection. Our failure, or the failure of our suppliers, to take satisfactory corrective action in response to an adverse QSR
inspection could result in enforcement actions, including a public warning letter, a shutdown of our manufacturing operations,
a recall of our product, civil or criminal penalties or other sanctions, which would significantly harm our available inventory
and sales and cause our business to suffer.
If
we are unable to fully comply with federal and state “fraud and abuse laws,” we could face substantial penalties,
which may adversely affect our business, financial condition and results of operations.
We
are subject to various laws pertaining to health care fraud and abuse, including the U.S. Anti- Kickback Statute, physician self-referral
laws (the “Stark Law”), the U.S. False Claims Act, the U.S. False Statements Statute, the Physician Payment Sunshine
Act, and state law equivalents to these U.S. federal laws, which may not be limited to government-reimbursed items and may not
contain identical exceptions. Violations of these laws are punishable by criminal and civil sanctions, including, in some instances,
civil and criminal penalties, damages, fines, exclusion from participation in U.S. federal and state health care programs, including
Medicare and Medicaid, and the curtailment or restructuring of operations. Any action against us for violation of these laws could
have a significant impact on our business. In addition, we are subject to the U.S. Foreign Corrupt Practices Act. Any action against
us for violation by us or our agents or distributors of this act could have a significant impact on our business.
TearLab
Corporation
If
we fail to comply with contractual obligations and applicable laws and regulations governing the handling of patient identifiable
medical information, we could suffer material losses or be adversely affected by exposure to material penalties and liabilities.
Many,
if not all of our customers, are covered entities under the Health Insurance Portability and Accountability Act of August 1996
or HIPAA. As part of the operation of our business, we provide reimbursement assistance to certain of our customers and as a result
we act in the capacity of a business associate with respect to any patient-identifiable medical information, or PHI, we receive
in connection with these services. We and our customers must comply with a variety of requirements related to the handling of
patient information, including laws and regulations protecting the privacy, confidentiality and security of PHI. The provisions
of HIPAA require our customers to have business associate agreements with us under which we are required to appropriately safeguard
the PHI we create or receive on their behalf. Further, we and our customers are required to comply with HIPAA security regulations
that require us and them to implement certain administrative, physical and technical safeguards to ensure the confidentiality,
integrity and availability of electronic PHI, or EPHI. We are required by regulation and contract to protect the security of EPHI
that we create, receive, maintain or transmit for our customers consistent with these regulations. To comply with our regulatory
and contractual obligations, we may have to reorganize processes and invest in new technologies. We also are required to train
personnel regarding HIPAA requirements. If we, or any of our employees or consultants, are unable to maintain the privacy, confidentiality
and security of the PHI that is entrusted to us, we and/or our customers could be subject to civil and criminal fines and sanctions
and we could be found to have breached our contracts with our customers. Under the Health Information Technology for Economic
and Clinical Health Act, or HITECH Act, and recent omnibus revisions to the HIPAA regulations, we are directly subject to HIPAA’s
criminal and civil penalties for breaches of our privacy and security obligations and are required to comply with security breach
notification requirements. The direct applicability of the HIPAA privacy and security provisions and compliance with the notification
requirements requires us to incur additional costs and may restrict our business operations.
Our
patents may not be valid, and we may not obtain and enforce patents to protect our proprietary rights from use by would-be competitors.
Companies with other patents could require us to stop using or pay to use required technology.
Our
owned and licensed patents may not be valid, and we may not obtain and enforce patents to maintain trade secret protection for
our technology. The extent to which we are unable to do so could materially harm our business.
We
have applied for, and intend to continue to apply for, patents relating to the TearLab® Osmolarity System, products in development
and related technology and processes. Such applications may not result in the issuance of any patents, and any patents now held
or that may be issued may not provide adequate protection from competition. Furthermore, it is possible that patents issued or
licensed to us may be challenged successfully. In that event, if we have a preferred competitive position because of any such
patents, any preferred position would be lost. If we are unable to secure or to continue to maintain a preferred position, the
TearLab® Osmolarity System could become subject to competition from the sale of generic products.
TearLab
Corporation
Patents
issued or licensed to us may be infringed by the products or processes of others. The cost of enforcing patent rights against
infringers, if such enforcement is required, could be significant and the time demands could interfere with our normal operations.
There has been substantial litigation and other proceedings regarding patent and other intellectual property rights in the pharmaceutical,
biotechnology and medical technology industries. We are currently involved in litigation defending our patent rights in Canada.
Efforts to defend our rights could incur significant costs and may or may not be resolved in our favor. We could become a party
to additional patent litigation and other proceedings. The cost to us of any patent litigation, even if resolved in our favor,
could be substantial. Some of our would-be competitors may sustain the costs of such litigation more effectively than we can because
of their greater financial resources. Litigation also may absorb significant management time.
Unpatented
trade secrets, improvements, confidential know-how and continuing technological innovation are important to our future scientific
and commercial success. Although we attempt, and will continue to attempt, to protect our proprietary information through reliance
on trade secret laws and the use of confidentiality agreements with corporate partners, collaborators, employees and consultants
and other appropriate means, these measures may not effectively prevent disclosure of our proprietary information, and, in any
event, others may develop independently, or obtain access to, the same or similar information.
Certain
of our patent rights are licensed to us by third parties. If we fail to comply with the terms of these license agreements, our
rights to those patents may be terminated, and we will be unable to conduct our business.
It
is possible that a court may find us to be infringing upon validly issued patents of third parties. In that event, in addition
to the cost of defending the underlying suit for infringement, we may have to pay license fees and/or damages and may be enjoined
from conducting certain activities. Obtaining licenses under third-party patents can be costly, and such licenses may not be available
at all.
We
may face future product liability claims.
The
testing, manufacturing, marketing and sale of therapeutic and diagnostic products entail significant inherent risks of allegations
of product liability. Our past use of the RHEO System and the components of the SOLX Glaucoma System in clinical trials and the
commercial sale of those products may have exposed us to potential liability claims. Our use of the TearLab® Osmolarity System
and its commercial sale could also expose us to liability claims. All of such claims might be made directly by patients, health
care providers or others selling the products. We carry clinical trials and product liability insurance to cover certain claims
that could arise, or that could have arisen, during our clinical trials or during the commercial use of our products. We currently
maintain clinical trials and product liability insurance with aggregate annual coverage limits of $2.0 million. Such coverage,
and any coverage obtained in the future, may be inadequate to protect us in the event of successful product liability claims,
and we may not increase the amount of such insurance coverage or even renew it. A successful product liability claim could materially
harm our business. In addition, substantial, complex or extended litigation could result in the incurrence of large expenditures
and the diversion of significant resources.
If
we do not introduce new commercially successful products in a timely manner, our products may become obsolete over time, customers
may not buy our products and our revenue and profitability may decline.
Demand
for our products may change in ways we may not anticipate because of:
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evolving
customer needs;
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the
introduction of new products and technologies; and
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evolving
industry standards.
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TearLab
Corporation
Without
the timely introduction of new commercially successful products and enhancements, our products may become obsolete over time,
in which case our sales and operating results would suffer. The success of our new product offerings will depend on several factors,
including our ability to:
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properly
identify and anticipate customer needs;
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commercialize
new products in a cost-effective and timely manner;
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manufacture
and deliver products in sufficient volumes on time;
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obtain
and maintain regulatory approval for such new products;
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differentiate
our offerings from competitors’ offerings;
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achieve
positive clinical outcomes; and
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provide
adequate medical and/or consumer education relating to new products.
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Moreover,
innovations generally will require a substantial investment in research and development before we can determine the commercial
viability of these innovations and we may not have the financial resources necessary to fund these innovations. In addition, even
if we successfully develop enhancements or new generations of our products, these enhancements or new generations of products
may not produce revenue in excess of the costs of development and they may be quickly rendered obsolete by changing customer preferences
or the introduction by our competitors of products embodying new technologies or features.
We
rely on a limited number of suppliers of each of the key components of the TearLab® Osmolarity System and are vulnerable to
fluctuations in the availability and price of our suppliers
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products and services.
We
purchase each of the key components of the TearLab
®
Osmolarity System from a limited number of third-party suppliers.
Our suppliers may not provide the components or other products needed by us in the quantities requested, in a timely manner or
at a price we are willing to pay. In the event we were unable to renew our agreements with our suppliers or they were to become
unable or unwilling to continue to provide important components in the required volumes and quality levels or in a timely manner,
or if regulations affecting the components were to change, we would be required to identify and obtain acceptable replacement
supply sources. We may not be able to obtain alternative suppliers or vendors on a timely basis, or at all, which could disrupt
or delay, or halt altogether, our ability to manufacture or deliver the TearLab® Osmolarity System. If any of these events
should occur, our business, financial condition, cash flows and results of operations could be materially adversely affected.
We
face intense competition, and our failure to compete effectively could have a material adverse effect on our results of operations.
We
face intense competition in the markets for ophthalmic products and these markets are subject to rapid and significant technological
change. Although we have no direct competitors, we have numerous potential competitors in the United States and abroad. We face
potential competition from industry participants marketing conventional technologies for the measurement of osmolarity and other
in-lab testing technologies, and commercially available methods, such as the Schirmer Test and ocular surface staining. Many of
our potential competitors have substantially more resources and a greater marketing scale than we do. If we are unable to develop
and produce or market our products to effectively compete against our competitors, our operating results will materially suffer.
TearLab
Corporation
If
we lose key personnel, or we do not attract and retain highly qualified personnel on a cost-effective basis, it would be more
difficult for us to manage our existing business operations and to identify and pursue new growth opportunities.
Our
success depends, in large part, upon our ability to attract and retain highly qualified scientific, clinical, manufacturing and
management personnel. In addition, any difficulties in retaining key personnel or managing this growth could disrupt our operations.
Future growth will require us to continue to implement and improve our managerial, operational and financial systems, and to continue
to recruit, train and retain, additional qualified personnel, which may impose a strain on our administrative and operational
infrastructure. The competition for qualified personnel in the medical technology field is intense. We are highly dependent on
our continued ability to attract, motivate and retain highly qualified management, clinical and scientific personnel.
Due
to our limited resources, we may not effectively recruit, train and retain additional qualified personnel. If we do not retain
key personnel or manage our growth effectively, we may not implement our business plan effectively.
Furthermore,
we have not entered into non-competition agreements with all of our key employees. In addition, we do not maintain “key
person” life insurance on any of our officers, employees or consultants. The loss of the services of existing personnel,
the failure to recruit additional key scientific, technical and managerial personnel in a timely manner, and the loss of our employees
to our competitors would harm our research and development programs and our business.
If
we fail to establish and maintain proper and effective internal controls, our ability to produce accurate financial statements
on a timely basis could be impaired, which would adversely affect our consolidated operating results, our ability to operate our
business and our stock price.
Ensuring
that we have adequate internal financial and accounting controls and procedures in place to produce accurate financial statements
on a timely basis is a costly and time-consuming effort that needs to be re-evaluated frequently. Failure on our part to maintain
effective internal financial and accounting controls would cause our financial reporting to be unreliable, could have a material
adverse effect on our business, operating results, financial condition and cash flows, and could cause the trading price of our
common stock to fall dramatically.
Maintaining
proper and effective internal controls will require substantial management time and attention and may result in our incurring
substantial incremental expenses, including with respect to increasing the breadth and depth of our finance organization to ensure
that we have personnel with the appropriate qualifications and training in certain key accounting roles and adherence to certain
control disciplines within the accounting and reporting function. Any failure in internal controls or any errors or delays in
our financial reporting would have a material adverse effect on our business and results of operations and could have a substantial
adverse impact on the trading price of our common stock.
Our
management is responsible for establishing and maintaining adequate internal control over financial reporting to provide reasonable
assurance regarding the reliability of our financial reporting and the preparation of financial statements for external purposes
in accordance with U.S. GAAP. Our management does not expect that our internal control over financial reporting will prevent or
detect all errors and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not
absolute, assurance that the control system’s objectives will be met. Our management has identified control deficiencies
in the past and may identify additional deficiencies in the future.
TearLab
Corporation
We
cannot be certain that the actions we are taking to improve our internal controls over financial reporting will be sufficient
or that any changes in processes and procedures can be completed in a timely manner. In future periods, if the process required
by Section 404 of the Sarbanes-Oxley Act of 2002 reveals material weaknesses or significant deficiencies, the correction of any
such material weaknesses or significant deficiencies could require additional remedial measures which could be costly and time-consuming.
In addition, we may be unable to produce accurate financial statements on a timely basis. Any of the foregoing could cause investors
to lose confidence in the reliability of our condensed consolidated financial statements, which could cause the market price of
our common stock to decline and make it more difficult for us to finance our operations and growth.
Risks
Related to Our Common Stock
Our
common stock may be delisted from The Nasdaq Capital Market if we cannot maintain compliance with NASDAQ’s continued listing
requirements.
In
order to maintain our listing on NASDAQ, we are required to comply with the NASDAQ Listing Requirements, which include, but are
not limited to, maintaining a minimum stockholders’ equity or market capitalization and minimum bid price. In particular,
we are required to maintain a minimum (i) bid price of $1.00 and (ii) market capitalization of $35 million. On March 16, 2016,
we received a notice from NASDAQ stating that we were not in compliance with Nasdaq Listing Rule 5550(a)(2) (the “Minimum
Bid Price Rule”) because our common stock failed to maintain a minimum closing bid price of $1.00 for the prior 30 consecutive
business days. The notice had no immediate effect on the Company’s listing or trading of the Company’s common stock
on NASDAQ.
On
September 16, 2016, we received a letter from the NASDAQ Listing Qualifications Staff (the “Staff”), which indicated
the Staff had determined to delist our securities from The Nasdaq Capital Market due to our continued non-compliance with the
Minimum Bid Price Rule. To regain compliance with the Minimum Bid Price Rule, we filed a certificate of amendment to our amended
and restated certificate of incorporation to effect (i) a reverse stock split of all of the outstanding shares of our common stock
and those shares held by us in treasury stock, if any, at a ratio of one-for ten shares, and (ii) a reduction in the total number
of authorized shares of our common stock from 95,000,000 to 9,500,000. As of May 8, 2017, the last reported sale price of our
common stock was $1.95 per share.
Additionally,
on November 8, 2016, we received notice from the Staff indicating that the Company did not satisfy Nasdaq Listing Rule 5550(b),
insofar as the Company’s market value of listed securities (“MVLS”) had closed below $35 million for the previous
30 consecutive business days, and we did not satisfy either of the alternative criteria under Nasdaq Listing Rule 5550(b) which
requires stockholders’ equity of at least $2.5 million or net income from continuing operations of at least $500,000 in
the most recently completed fiscal year or in two of the three most recently completed fiscal years. The notice had no immediate
effect on the NASDAQ listing or trading of the Company’s common stock.
In
accordance with Nasdaq Listing Rule 5810(c)(3)(C), the Company was granted a 180-calendar day grace period within which to regain
compliance with the MVLS requirement, through May 8, 2017. To evidence compliance with the MVLS requirement, the Company’s
MVLS must close at $35 million or more for a minimum of 10 consecutive business days during the 180-calendar day compliance period
ended May 8, 2017.
On
May 10, 2017, we received notice from the Staff that the Staff had determined to delist our securities from The Nasdaq Capital
Market due to our continued non-compliance with the MVLS requirement, unless the Company timely requested a hearing before the
Nasdaq Hearings Panel (the “Panel”). On June 19, 2017, the Nasdaq Hearings Panel (the “Panel”) granted
the Company’s request for continued listing on The Nasdaq Capital Market, pursuant to an extension and the Company’s
continued progress on the compliance plan presented to the Panel, through October 6, 2017, by which date the Company must evidence
full compliance with all applicable criteria for continued listing on The Nasdaq Capital Market, including the $2.5 million stockholders’
equity requirement.
TearLab
Corporation
If
we fail to regain compliance with one of the applicable requirements, our stock may be delisted. Delisting from The Nasdaq Capital
Market could make trading in our common stock more difficult for investors, potentially leading to declines in our share price
and liquidity. Without The Nasdaq Capital Market listing, stockholders may have a difficult time getting a quote for the sale
or purchase of our stock, the sale or purchase of our stock would likely be made more difficult and the trading volume and liquidity
of our stock could decline. Delisting from The Nasdaq Capital Market could also result in negative publicity and could also make
it more difficult for us to raise additional capital. The absence of such a listing may adversely impact the acceptance of our
common stock as currency or the value accorded by other parties. Further, if we are delisted, we would also incur additional costs
under state blue sky laws in connection with any sales of our securities. These requirements could severely limit the market liquidity
of our common stock and the ability of our stockholders to sell our common stock in the secondary market.
If
our common stock is delisted by NASDAQ, our common stock may be eligible to trade on an over-the-counter quotation system, such
as the OTCQB market, where an investor may find it more difficult to sell our stock or obtain accurate quotations as to the market
value of our common stock. We cannot assure you that our common stock, if delisted from The Nasdaq Capital Market, will be listed
on another national securities exchange or quoted on an over-the counter quotation system.
If
our common stock is delisted, it would fall within the definition of a “penny stock” as defined in the Securities
Exchange Act of 1934, or the Exchange Act, and would be covered by Rule 15g-9 of the Exchange Act. That Rule imposes additional
sales practice requirements on broker-dealers who sell securities to persons other than established customers and accredited investors.
For transactions covered by Rule 15g-9, the broker-dealer must make a special suitability determination for the purchaser and
receive the purchaser’s written agreement to the transaction prior to the sale. Consequently, Rule 15g-9, if it were to
become applicable, would affect the ability or willingness of broker-dealers to sell our securities, and accordingly would affect
the ability of stockholders to sell their securities in the public market. These additional procedures could also limit our ability
to raise additional capital in the future.
The
trading price of our common stock may be volatile.
The
market prices for, and the trading volumes of, securities of medical device companies, such as ours, have been historically volatile.
The market has experienced, from time to time, significant price and volume fluctuations unrelated to the operating performance
of particular companies. The market price of our common shares may fluctuate significantly due to a variety of factors, including:
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our
results of operations;
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the
results of pre-clinical testing and clinical trials by us, our collaborators and/or our competitors;
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technological
innovations or new diagnostic products;
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governmental
regulations and reimbursement levels;
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developments
in patent or other proprietary rights;
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litigation;
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public
concern regarding the safety of products developed by us or others;
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comments
by securities analysts;
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the
issuance of additional shares to obtain financing or for acquisitions;
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general
market conditions in our industry or in the economy as a whole;
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political
instability, natural disasters, war and/or events of terrorism; and
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failure
to maintain our NASDAQ listing.
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TearLab
Corporation
In
addition, the stock market in general has experienced extreme price and volume fluctuations that have often been unrelated or
disproportionate to the operating performance of individual companies. Broad market and industry factors may seriously affect
the market price of our stock, regardless of actual operating performance. In the past, securities class action litigation often
follows periods of volatility in the overall market and market price of a particular company’s securities. This litigation,
if instituted against us, could result in substantial costs and a diversion of our management’s attention and resources.
Because
we do not expect to pay dividends on our common stock, stockholders will benefit from an investment in our common stock only if
it appreciates in value.
We
have never paid cash dividends on our common stock and have no present intention to pay any dividends in the future. We are not
profitable and may not earn sufficient revenue to meet all operating cash needs. As a result, we intend to use all available cash
and liquid assets in the development of our business. Any future determination about the payment of dividends will be made at
the discretion of our board of directors and will depend upon our earnings, if any, our capital requirements, our operating and
financial conditions and on such other factors as our board of directors may deem relevant. As a result, the success of an investment
in our common stock will depend upon any future appreciation in its value. There is no guarantee that our common stock will appreciate
in value or even maintain the price at which stockholders have purchased their shares.
Warrant
holders will not be entitled to any of the rights of common stockholders, but will be subject to all changes made with respect
thereto.
If
you hold warrants, you will not be entitled to any rights with respect to our common stock (including, without limitation, voting
rights and rights to receive any dividends or other distributions on our common stock), but you will be subject to all changes
affecting our common stock. You will have rights with respect to our common stock only if you receive our common stock upon exercise
of the warrants and only as of the date when you become a record owner of the shares of our common stock upon such exercise. For
example, if a proposed amendment to our charter or bylaws requires stockholder approval and the record date for determining the
stockholders of record entitled to vote on the amendment occurs prior to the date that you are deemed to be the owner of the shares
of our common stock due upon exercise of your warrants, you will not be entitled to vote on the amendment; although, you will
nevertheless be subject to any changes in the powers, preferences or special rights of our common stock.
We
can issue shares of preferred stock that may adversely affect the rights of holders of our common stock.
Our
certificate of incorporation authorizes us to issue up to 10.0 million shares of preferred stock with designations, rights, and
preferences determined from time to time by our board of directors. Accordingly, our board of directors is empowered, without
stockholder approval, to issue preferred stock with dividend, liquidation, conversion, voting or other rights superior to those
of holders of our common stock. For example, an issuance of shares of preferred stock could:
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adversely
affect the voting power of the holders of our common stock;
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make
it more difficult for a third party to gain control of us;
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discourage
bids for our common stock at a premium;
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limit
or eliminate any payments that the holders of our common stock could expect to receive upon our liquidation; or
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otherwise
adversely affect the market price or our common stock.
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TearLab
Corporation
