Item 2. Management’s Discussion and Analysis
Item 2. Management’s Discussion and
Analysis of Financial Condition and Results of Operations
As used in this Quarterly Report on Form 10-Q,
“SenesTech,” the “Company,” “we,” “us,” or “our” refer to SenesTech, Inc.,
a Delaware corporation.
The following Management’s Discussion and
Analysis of Financial Condition and Results of Operations should be read in conjunction with our condensed financial statements and related
notes.
Forward-Looking Statements
Some statements and information contained in this
Management’s Discussion and Analysis of Financial Condition and Results of Operations, notes to our condensed financial statements
and elsewhere in this report are not historical facts but are forward-looking statements within the meaning of Section 27A of the Securities
Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange
Act”) and within the meaning of the safe-harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking
statements can often be identified by words such as: “expect,” “believe,” “estimate,” “plan,”
“strategy,” “future,” “potential,” “continue,” “may,” “should,”
“will,” and similar references to future periods. Examples include, among others, statements about:
●
The impacts and implications of the COVID-19 pandemic;
●
Our commercialization and promotion strategy and plans, including key elements of our business strategy, how we commercialize, our sales approach, the tools we use, our hiring and retention strategy; our areas and markets of focus, our pricing strategy, our strategic relationships and which geographic markets we target;
● The
success and effectiveness of our products;
● Our
seeking, obtaining or maintaining regulatory approvals for our products and product candidates;
● Our
expectations regarding the potential market size for our products and how the market may develop;
●
Our estimates or expectations related to our revenue, cash flow, expenses, operating results, capital requirements and need for additional financing;
●
Our ability to, and the expected benefits of, improving our cost structure and gross margins, and limiting our cash burn;
●
Our plans for our business, including for research and development;
●
Our ability to enter into strategic arrangements and to achieve the expected results from such arrangements;
●
The adequacy of our facilities to meet our current needs;
●
The initiation, timing, progress and results of field studies and other studies and trials and our research and development programs;
●
Our financial performance, including our ability to fund operations; and
●
Developments and projections relating to our projects, competitors and our industry, including legislative developments and impacts from those developments.
27
These forward-looking statements are not guarantees
of future performance and involve known and unknown risks, uncertainties and situations that are difficult to predict and that may cause
our own, or our industry’s, actual results to be materially different from the future results that are expressed or implied by these
statements. Accordingly, actual results may differ materially from those anticipated or expressed in such statements as a result of a
variety of factors, including those discussed in Item 1A-“Risk Factors” of Part I of our Annual Report on Form 10-K, for the
year ended December 31, 2020, filed with the SEC on March 29, 2021, and Item 1A of Part II of this Form 10-Q, in each case entitled “Risk
Factors,” and those contained from time to time in our other filings with the Securities and Exchange Commission. Readers are cautioned
not to place undue reliance on the forward-looking statements, which speak only as of the date made. Except as required by law, we undertake
no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Overview
Since our inception, we have sustained significant
operating losses in the course of our research and development activities and commercialization efforts and expect such losses to continue
for the near future. We have generated limited revenue to date from product sales, research grants and licensing fees received under a
former license. We have primarily funded our operations to date through the sale of equity securities, including convertible preferred
stock, common stock and warrants to purchase common stock; and debt financing, consisting primarily of convertible notes.
Through June 30, 2021, we have received net proceeds
of $89.3 million from our sales of common stock, preferred stock and warrant exercises and issuance of convertible and other promissory
notes, an aggregate of $1.7 million from licensing fees and an aggregate of $1.2 million in net product sales. As of June 30, 2021, we
had an accumulated deficit of $107.8 million and cash and cash equivalents of $13.1 million.
On June 18, 2021, the Company received notification
from BMO Harris Bank National Association as the lender in a promissory note pursuant to the Paycheck Protection Program (the “PPP”)
under the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”), that a loan to the Company under this program
in the amount of $645,700 was forgiven in full under the terms of the program. This loan was originally granted and funded on April 15,
2020.
We have incurred significant operating losses
every year since our inception. Our net losses were $1.7 million and $1.6 million for the three months ended June 30, 2021 and 2020, respectively,
and $3.5 million and $4.4 million for the six months ended June 30, 2021 and 2020, respectively. We expect to continue to incur significant
expenses and generate operating losses for at least the next 12 months.
We will need additional funding in order to continue
to fund our operations and achieve profitability and become cash flow positive and will continue to seek additional financing. If such
equity or debt financing is not available at adequate levels or on acceptable terms, we may need to delay, limit or terminate commercialization
and development efforts or discontinue operations.
While it is difficult to measure the effect and
impact of the COVID-19 pandemic on revenue during the six months ended June 30, 2021 and June 30, 2020, the travel and other restrictions
that started in March 2020 resulted in a significant slowdown in our proof-of-concept field studies and sales efforts. While we were
able to resume field studies in some important projects by mid-year 2020 and initially believed that we would re-start all our most significant
field studies as we obtained limited waivers of certain travel bans, we still have delays on certain projects that might remain on hold
until certain businesses and government entities return to more normal operations. Continued delays or new restrictions on travel or
operations as a result of new outbreaks and variants could impact our results in future quarters. Initially, we believed that pest control
would continue through the COVID-19 pandemic as a necessity and we were and have been able to maintain our manufacturing with cautionary,
best practices put in place. However, we have concerns about distributor, pest control operator and individual consumer spending as restrictive
measures related to the COVID-19 pandemic continue. Extended stay at home orders across the world, whether imposed by governments or
individual businesses, have impeded our ability to communicate with current and prospective customers, potentially reducing sales until
the orders are lifted. In addition, federal, state and municipal budgets continue to be severely strained as a result of the COVID-19
pandemic. This may delay or impede their ability to make near term purchases of our products. While we have stocked certain long lead
time inventory raw material ingredients, any prolonged impact on the suppliers we rely on for the purchase of these items by the COVID-19
pandemic could impact future manufacturing operations.
28
Components of our Results of Operations
Sales
Sales are comprised primarily of sales, net of
discounts and promotions, of ContraPest and related components, to our distributors and customers, as well as consulting and implementation
services provided in conjunction with ContraPest deployments.
Cost of Sales
Cost of sales consist primarily of cost of products
sold, including scrap and reserves for obsolescence. We continue to focus on improving our cost structure, with the goals of shifting
resources to commercialization, significantly reducing our year-over-year burn rate and achieving a 50% or greater gross margin. Steps
have included relocating to more cost-efficient space, organizational restructuring, and improving our manufacturing and supply processes
and reducing staffing. We expect to realize the benefits from these steps in the coming quarters.
Operating Expenses
Research and Development Expenses
Research and development expenses consist primarily
of costs incurred in connection with the research and development of ContraPest and our other product candidates, which costs include:
● Employee
related expenses, including salaries, related benefits, travel and stock-based compensation expense for employees engaged in research
and development functions;
● Expenses
incurred in connection with the development of our product candidates; and
● Facilities,
depreciation and other expenses, which include direct and allocated expenses for rent and maintenance of facilities, insurance and supplies.
We expense research and development costs as incurred.
We continue to investigate other applications
of our core technology to other product candidates, which includes laboratory tests and academic collaborations. We also continue to develop
our supply chain, particularly identifying and improving our sourcing of triptolide, a key active ingredient for our product candidates.
At this time, we cannot reasonably estimate the costs for further development of ContraPest or the cost associated with the development
of any of our other product candidates.
Selling, General and Administrative Expenses
Selling, general and administrative expenses consist
primarily of salaries and related costs, including stock-based compensation, for personnel in executive, finance, sales, marketing and
administrative functions. Selling, general and administrative expenses also include direct and allocated facility-related costs as well
as professional fees for legal, consulting, accounting and audit services.
29
We plan to continue to utilize various forms of
stock-based compensation awards in order to attract and retain qualified employees. As a result, we anticipate that stock-based compensation
expense will continue to represent a significant portion of our selling, general and administrative expenses for the foreseeable future.
Interest Income
Interest income consists primarily of interest
income earned on cash and cash equivalents.
Interest Expense
Interest expense consists primarily of interest
accrued on our finance lease and note commitments.
Other Income (Expense), Net
Other income (expense), net, consists primarily
of any recognized gains or losses related to the sale of fixed assets. In 2021, other income also included the reversal of a payroll benefits
accrual from 2019 that was reversed as the liability period had expired.
Income Taxes
Deferred tax assets and liabilities are determined
based on differences between the financial statement and tax basis of assets and liabilities, as well as a consideration of net operating
loss and credit carry forwards, using enacted tax rates in effect for the period in which the differences are expected to impact taxable
income. A valuation allowance is established, when necessary, to reduce deferred tax assets to the amount that is more likely than not
to be realized. The Company’s effective tax rate for the six months ended June 30, 2021, as well as for the year ended December
31, 2020, has been impacted by the full valuation allowance on the Company’s deferred tax assets.
The Company has not recorded any U.S. federal or state income tax benefits
for our net operating losses incurred since inception or for our research and development tax credits generated to date, due to the uncertainty
regarding our ability to realize a benefit from these tax attributes in the future. Based on tax return activity through December 31,
2020, the Company has federal and state net operating loss carryforwards of approximately $69.5 million and $56.1 million, respectively,
not considering any potential Internal Revenue Code of 1986 (“IRC”) Section 382 annual limitation discussed below. The Company
is accruing additional net operating losses in calendar year 2021, which will be added to the carryover net operating loss balance once
the current year is completed. The federal loss carryforwards begin to expire in 2029, unless previously utilized. The state loss carryforwards
begin to expire in 2032, unless previously utilized. Included in the $69.5 million of federal loss carryforwards are approximately $25.1
million of net operating losses that do not expire due to the tax law changes promulgated in conjunction with the Tax Cuts and Jobs Act
of 2017.
Additionally, the utilization of the net operating
loss carryforwards are subject to an annual limitation under Section 382 and 383 of the Internal Revenue Code od 1986, and similar state
tax provisions due to ownership change limitations that have occurred previously or that could occur in the future. These ownership changes
limit the amount of net operating loss carryforwards and other deferred tax assets that can be utilized to offset future taxable income
and tax, respectively. In general, an ownership change, as defined by Section 382 and 383 results from transactions increasing ownership
of certain stockholders or public groups in the stock of the corporation by more than 50 percent points over a three-year period. The
Company has not conducted an analysis of an ownership change under section 382. To the extent that a study is completed and an ownership
change is deemed to occur, the Company’s net operating losses could be limited.
During the current quarter, the Company received
notification that a loan to the Company under the Paycheck Protection Program (the “PPP”) in the amount of $646 thousand was
forgiven in full pursuant to the PPP program under the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”).
Section 1106(i) of the CARES Act specifically requires taxpayers to exclude canceled indebtedness from PPP loans from gross income, and
accordingly, the debt forgiveness amount is nontaxable to the Company. Subsequent to the passage of the CARES Act, the IRS issued Notice
2020-32, which precludes a deduction for an expense that would otherwise be deductible if the payment results in the forgiveness of a
loan, thereby preventing entities from claiming a double tax benefit on the qualifying expenses for PPP loans. On December
27, 2020, the Consolidated Appropriations Act (“CAA”) was signed into law, which reverses existing IRS guidance provided in
Notice 2020-32 by allowing taxpayers to fully deduct any business expenses, regardless of whether the expense was paid for using forgiven
PPP loan proceeds. None of the other provisions of the CARES Act or CAA had a material impact to the Company’s tax accounts.
30
Comparison of the Three Months Ended June 30, 2021 and 2020
The following table summarizes our results of
operations for the three and six months ended June 30, 2021 and 2020:
For the Three Months Ended
For the Six Months Ended
June 30,
June 30,
2021
2020
2021
2020
Revenue:
Sales
$ 160
$ 71
$ 248
$ 108
Cost of sales
119
43
169
65
Gross profit
41
28
79
43
Operating expenses:
Research and development
455
226
910
522
Selling, general and administrative
1,935
1,427
3,357
3,472
Total operating expenses
2,390
1,653
4,267
3,994
Net operating loss
(2,349 )
(1,625 )
(4,188 )
(3,951 )
Other income (expense):
Interest income
1
-
3
2
Interest expense
(3 )
(7 )
(8 )
(15 )
Payroll Protection Program loan forgiveness
650
-
650
-
Other income
1
3
22
18
Total other income
649
(4 )
667
5
Net loss and comprehensive loss
(1,700 )
(1,629 )
(3,521 )
(3,946 )
Deemed dividend-warrant price protection-revaluation adjustment
-
-
-
414
Net loss attributable to common shareholders
$ (1,700 )
$ (1,629 )
$ (3,521 )
$ (4,360 )
Weighted average common shares outstanding - basic and fully diluted
12,178,754
2,760,875
10,169,061
2,186,089
Net loss per common share - basic and fully diluted
$ (0.10 )
$ (0.59 )
$ (0.35 )
$ (1.99 )
Sales
Sales, shown net of sales discounts and promotions,
were $160,000 for the three months ended June 30, 2021, compared to $71,000 for the same period in 2020. Sales increased by $89,000 in
the three months ended June 30, 2021 due, in part, to the continued focus on of our internet sales initiatives, augmenting our existing
pull through sales strategy, where demand from the consumer market encourages, or pulls, resellers and pest management professionals to
offer our products, as well as enhanced strategic partnerships and collaborations with key distributors and PMPs. While these initiatives
continue to progress, we believe the benefits of these initiatives continue to be impacted by reduced spending by customers due to the
COVID-19 pandemic.
31
Cost of Sales
Cost of sales was $119,000 or 74.4% of net sales
for the three months ended June 30, 2021, compared to $43,000 or 60.6% of net sales for the three months ended June, 2020. The increase
in cost of goods sold of $76,000 in 2021 is primarily due to higher sales volume as well as an increase in manufacturing scrap associated
with manufacturing scale up activities. The increase in cost of sales as a percentage of net sales was primarily due to the impact of
increased new customer sales incentives during the quarter ended June 30, 2021.
We continue to focus on manufacturing process
improvement and efficiencies. We anticipate cost of goods sold as a percentage of sales will improve in the future due to manufacturing
efficiencies as a result of scale-up activities.
Gross Profit
Gross profit for the three months ended June 30,
2021 was $41,000 or 25.6% of net sales, compared to a gross profit of $28,000 or 39.4% of net sales, for the same period in 2020. The
decrease in gross profit was a direct result of the impact of increased new customer sales incentives during the quarter ended June 30,
2021.
Research and Development Expenses
Three Months Ended
June 30,
Increase
2021
2020
(Decrease)
(in thousands)
Direct research and development expenses:
Personnel related (including stock-based compensation)
$ 241
$ 82
$ 159
Facility-related
26
55
(29 )
Other
188
89
99
Total research and development expenses
$ 455
$ 226
$ 229
Research and development expenses were $455,000
for the three months ended June 30, 2021, compared to $226,000 for the same period in 2020. The $229,000 increase in research and development
expenses was primarily due to an increase of $159,000 in personnel-related costs, including stock-based compensation expense, due to an
increase in headcount.
Facility-related expenses decreased $29,000 for
the three months ended June 30, 2021, compared to the three months ended June 20, 2020, due primarily to the expiration of a facility
lease of 7,632 square feet of manufacturing space in Flagstaff, Arizona at December 31, 2020.
The increase in other research and development
expenses of $99,000 in the three months ended June 30, 2021 compared to the same period in 2020 was primarily due to increased expenses
related to field and regulatory compliance studies. We also continue to improve our manufacturing process and formulation.
Selling, General and Administrative Expenses
Selling, general and administrative expenses were
approximately $1.9 million for the three months ended June 30, 2021, as compared to approximately $1.4 million for the three months ended
June 30, 2020. The increase of $500,000 in selling, general and administrative expenses was primarily due to an increase of $417,000 in
net salary costs, $55,000 of travel and entertainment expenses and $53,000 in marketing programs, offset be a decrease of $37,000 in professional
service expenses. The increase in net salary costs of $417,000 was due primarily to incentive bonuses to employees of $130,000 in May
2021, severance expense for the elimination of personnel related to in-house marketing programs in June 2021, the hiring of the Chief
Strategy Officer in May 2021, and $40,000 of increased stock compensation due to the issuance of certain common stock option awards.
32
The increase in travel expenses was a direct result
of eased COVID-19 travel restrictions that were put in place at the end of March 2020. The $53,000 increase in marketing expenses is a
result of costs associated with rebranding activities to highlight the commercial focus of the Company and on-line marketing program expansion
in the three months ended June 30, 2021. The decrease in professional services expenses was primarily due to reduced legal expenses related
to a litigation settlement incurred in the three months ended June 30, 2020 that were not incurred in the same period of 2021.
Interest Income/Expense, Net
We recorded interest expense, net of $2,000 for
the three months ended June 30, 2021, as compared to interest expense, net of $7,000 for the same period in 2020. The $5,000 decrease
in interest expense, net for the period was a result of decreased interest expense on certain notes payable and finance leases that expired
after June 30, 2020.
Paycheck Protection Program Loan Forgiveness
PPP loan forgiveness income for the three months
ended June 30, 2021 represents the forgiveness of a promissory note pursuant to the PPP under the CARES Act, that the Company secured
under this program.
Other Income (Expense)
Other income, net, was $1,000 for the three months
ended June 30, 2021 as compared to $3,000 for the same period in 2020. The $2,000 decrease of other income, net for the three
months ended June 30, 2021 was due to recognized gains on the sale of fixed assets during the three months ended June 30, 2020.
Six Months Ended June 30, 2021 compared to Six Months Ended June
30, 2020:
Sales
Sales, shown net of sales discounts and promotions,
were $248,000 for the six months ended June 30, 2021, compared to $108,000 for the same period in 2020. Sales increased by $140,000 in
the six months ended June 30, 2021 due, in part, to the continued focus on of our internet sales initiatives, augmenting our existing
pull through sales strategy, where demand from the consumer market encourages, or pulls, resellers and pest management professionals to
offer our products, as well as enhanced strategic partnerships and collaborations with key distributors and PMPs. We believe the benefits
of these initiatives continue to be impacted by reduced spending by customers due to the COVID-19 pandemic.
Cost of Sales
Cost of sales was $169,000 or 68.1% of net sales
for the six months ended June 30, 2021, compared to $65,000 or 60.2% of net sales for the six months ended June 30, 2020. The increase
in cost of goods sold of $104,000 in the six months ended June 30, 2021 is primarily due to higher sales volume as well as an increase
in manufacturing scrap associated with manufacturing scale up activities. The increase in cost of sales as a percentage of net sales was
primarily due to the impact of increased new customer sales incentives during the six months ended June 30, 2021 as well as the increased
manufacturing scrap noted above.
We continue to focus on manufacturing process
improvement and efficiencies. We anticipate cost of goods sold as a percentage of sales will improve in the future due to manufacturing
efficiencies as a result of scale-up activities.
Gross Profit
Gross profit for the three months ended June 30,
2021 was $79,000 or 31.9% of net sales, compared to a gross profit of $43,000 or 39.8% of net sales for the same period in 2020. The decrease
in gross profit was a direct result of the impact of increased new customer sales incentives during the six months ended June 30, 2021
as well as the increased manufacturing scrap discussed above.
33
Research and Development Expenses
Six Months Ended
June 30,
Increase
2021
2020
(Decrease)
(in thousands)
Direct research and development expenses:
Personnel related (including stock-based compensation)
$ 475
$ 221
$ 254
Facility-related
46
79
(33 )
Other
389
222
167
Total research and development expenses
$ 910
$ 522
$ 388
Research and development expenses were $910,000 for the six months
ended June 30, 2021, compared to $522,000 for the same period in 2020. The $388,000 increase in research and development expenses was
primarily due to an increase of $254,000 in manufacturing personnel-related costs relative to the second quarter of 2020, which was impacted
by the COVID-19 pandemic, in addition to increases in manufacturing and regulatory headcount to meet current and future demand.
Facility-related expenses decreased $33,000 for
the six months ended June 30, 2021, compared to the six months ended June 30, 2020, due primarily to the expiration of a facility lease
of 7,632 square feet of manufacturing space in Flagstaff, Arizona at December 31, 2020.
The increase in other research and development expenses of $167,000
in the six months ended June 30, 2021 compared to the same period in 2020 was primarily due to increased expenses related to field and
regulatory compliance studies.
Selling, General and Administrative Expenses
Selling, general and administrative expenses were
approximately $3.4 million for the six months ended June 30, 2021, as compared to approximately $3.5 million for the six months ended
June 30, 2020. The decrease of $100,000 in selling, general and administrative expenses was primarily due to a decrease of $357,000 in
professional service expenses and a decrease in transfer agent fees of $62,000 offset by an increase of $267,000 in net salary costs,
$31,000 in marketing programs and $27,000 of travel and entertainment expenses. The decrease in professional services expenses was primarily
due to reduced legal expenses related to a litigation settlement incurred in the six months ended June 30, 2020 that were not incurred
in the same period of 2021. The $62,000 decrease in transfer agent fees in the six months ended June 30, 2021 over the same period of
2020 was due to expenses related to a 20-for-1 reverse stock split effected by the Company in February 2020. The increase in net salary
costs of $267,000 was due primarily to incentive bonuses to employees of $130,000 in May 2021, severance expense for the elimination of
in-house marketing programs in June 2021, $40,000 of increased stock compensation due to the issuance of certain common stock option awards
and the hiring of the Chief Strategy Officer in May 2021. The $31,000 increase in marketing expenses is a result of costs associated with
rebranding activities to highlight the commercial focus of the Company and on-line marketing program expansion in the six months ended
June 30, 2021. The $27,000 increase in travel expenses was a direct result of eased COVID-19 travel restrictions that were put in place
at the end of March 2020.
Interest Income/Expense, Net
We recorded interest expense, net of $5,000 for
the six months ended June 30, 2021, as compared to interest expense, net of $13,000 for the same period in 2020. The $8,000 decrease in
interest expense, net for the period was a result of decreased interest expense on certain notes payable and finance leases that expired
after June 30, 2020.
Paycheck Protection Program Loan Forgiveness
PPP loan forgiveness income for the six months
ended June 30, 2021 represents the forgiveness of a promissory note pursuant to the PPP under the CARES Act that the Company secured under
this program.
34
Other Income (Expense)
Other income, net, was $22,000 for the six months
ended June 30, 2021 as compared to $18,000 for the period ended June 30, 2020. Other income, net for the six months ended
June 30, 2021 primarily represented a payroll benefits accrual from 2019 that was reversed as the liability period had expired. The $18,000
other income, net for the six month period ended June 30, 2020 represented recognized gains on the sale of fixed assets during the period.
Liquidity and Capital Resources
Since our inception, we have sustained significant
operating losses in the course of our research and development activities and commercialization efforts and expect such losses to continue
for the near future. We have generated limited revenue to date from product sales, research grants and licensing fees received under a
former license. We have primarily funded our operations to date through the sale of equity securities, including convertible preferred
stock, common stock and warrants to purchase common stock; and debt financing, consisting primarily of convertible notes.
Through June 30, 2021, we have received net proceeds
of $89.3 million from our sales of common stock, preferred stock and warrant exercises and issuance of convertible and other promissory
notes, an aggregate of $1.7 million from licensing fees and an aggregate of $1.2 million in net product sales. As of June 30, 2021, we
had an accumulated deficit of $107.8 million and cash and cash equivalents of $13.1 million.
As discussed in Note 8 - Borrowings, of our Notes
to Condensed Financial Statements, on April 15, 2020, the Company also received cash proceeds of $645,700 from the PPP of the Coronavirus
Aid, Relief, and Economic Security Act. We used the proceeds from the PPP loan to retain employees, maintain payroll and make lease, interest
and utility payments. This loan was fully forgiven, under terms of the PPP, on June 14, 2021.
Our ultimate success depends upon the outcome
of a combination of factors, including: (i) successful commercialization of ContraPest and maintaining and obtaining regulatory approval
of our products and product candidates; (ii) market acceptance, commercial viability and profitability of ContraPest and other products;
(iii) the ability to market our products and establish an effective sales force and marketing infrastructure to generate significant revenue;
(iv) the success of our research and development; (v) the ability to retain and attract key personnel to develop, operate and grow our
business; and (vi) our ability to meet our working capital needs.
Based upon our current operating plan, we expect
that cash and cash equivalents at June 30, 2021, in combination with anticipated revenue and additional sales of our equity securities,
will be sufficient to fund our current operations for at least the next 12 months. We have evaluated and will continue to evaluate our
operating expenses and will concentrate our resources toward the successful commercialization of ContraPest in the United States. However,
if anticipated revenue targets and margin targets are not achieved or expenses are more than we have budgeted, we may need to raise additional
financing before that time. If we need more financing, including within the next 12 months, and we are unable to raise necessary capital
through the sale of our securities, we may be required to take other measures that could impair our ability to be successful and operate
as a going concern. In any event, we may require additional capital in order to fund our operating losses and research and development
activities before we become profitable and may opportunistically raise capital. We may never achieve profitability or generate positive
cash flows, and unless and until we do, we will continue to need to raise capital through equity or debt financing. If such equity or
debt financing is not available at adequate levels or on acceptable terms, we may need to delay, limit or terminate commercialization
and development efforts or discontinue operations.
Additional Funding Requirements
We expect our expenses to continue or increase
in connection with our ongoing activities, particularly as we focus on marketing and sales of ContraPest. Further, the COVID-19 pandemic
will likely continue to delay completion of field studies and achievement of sales, which will further increase our need for financing.
In addition, we will continue to incur costs associated with operating as a public company.
35
In particular, we expect to incur substantial
and increased expenses as we:
●
Work to maximize market acceptance for, and generate sales of, our products;
●
Manage the infrastructure for the sales, marketing and distribution of ContraPest and any other product candidates for which we may receive regulatory approval;
●
Continue the development of ContraPest and our other product candidates, including engaging in any necessary field studies;
●
Seek additional, and to maintain, regulatory approvals for ContraPest and our other product candidates;
●
Scale up manufacturing processes and quantities to meet future demand of ContraPest and any other product candidates for which we receive regulatory approval;
●
Continue product development of ContraPest and advance our research and development activities and advance the research and development programs for other product candidates;
●
Maintain, expand and protect our intellectual property portfolio;
●
Add operational, financial and management information systems and personnel, including personnel to support our product development and commercialization efforts and operations as a public company; and
●
Expand regulatory approvals for ContraPest, with an effort to make the product more user friendly and available for use in an increased number of applications.
We believe we will need additional financing to fund these continuing
and additional expenses.
Cash Flows
The following table summarizes our sources and
uses of cash for each of the periods presented:
Six Months Ended
June 30,
2021
2020
Cash used in operating activities
$ (4,001 )
$ (3,573 )
Cash (used in) provided by investing activities
(83 )
44
Cash provided by financing activities
13,570
6,311
Net increase in cash and cash equivalents
$ 9,486
$ 2,782
Operating Activities .
During the six months ended June 30, 2021, operating activities used
$4.0 million of cash, primarily resulting from our net loss of $3.5 million, changes in our operating assets and liabilities of $317,000
and by non-cash charges of $163,000, consisting primarily of stock-based compensation, depreciation and amortization, offset by the Paycheck
Protection Program loan forgiveness during the period. Our net loss was primarily attributable to research and development activities
and our selling, general and administrative expenses, as we generated limited product revenue during the period. Net cash used by changes
in our operating assets and liabilities for the six months ended June 30, 2021 of $317,000 consisted primarily of a net decrease in accrued
expenses and accounts payable of $51,000, an increase in prepaid expenses of $203,000, an increase in inventory of $24,000 and an increase
in accounts receivable of $49,000, offset by a decrease in other assets of $10,000.
36
During the six months ended June 30, 2020, operating activities used
$3.6 million of cash, primarily resulting from our net loss of $4.0 million and by changes in our operating assets and liabilities of
$48,000, offset by non-cash charges of $421,000, consisting primarily of stock-based compensation, depreciation and amortization. Our
net loss was primarily attributable to research and development activities and our selling, general and administrative expenses, as we
generated limited product revenue during the period. Net cash used by changes in our operating assets and liabilities for the six months
ended June 30, 2020, consisted primarily of a net decrease in accrued expenses and accounts payable of $181,000 and an increase in prepaid
expenses of $27,000 offset by a decrease in inventory of $45,000, a decrease in receivables of $104,000 and a decrease in other assets
of $11,000.
Investing Activities.
For the six months ended June 30, 2021, net cash
used in investing activities was $83,000 due to the purchases of property, plant and equipment and increases in construction in progress.
For the six months ended June 30, 2020, net cash
provided by investing activities was $44,000 due to the sale of property and equipment.
Financing Activities.
During the six months ended June 30, 2021, net
cash provided by financing activities was $13.6 million as a result of $12.4 million in net proceeds from the issuance of common stock
and net proceeds of $1.2 million from the exercise of warrants, offset by $26,000 related to payments of finance lease obligations, $28,000
related to repayments of notes payable and $17,000 for the payment of employee withholding taxes related to share based awards.
During the six months ended June 30, 2020, net
cash provided by financing activities was $6.3 million as a result of $5.7 million in net proceeds from the issuance of common stock and
net proceeds of $646,000 from the issuance of a promissory note pursuant to the Paycheck Protection Program, offset by $29,000 of repayments
related to notes payable and $49,000 in repayments of finance lease obligations.
Critical Accounting Policies and Significant Judgments and Estimates
Our financial statements are prepared in accordance
with generally accepted accounting principles in the United States, or U.S. GAAP. The preparation of our financial statements and related
disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue, costs and expenses,
and the disclosure of contingent assets and liabilities in our financial statements. We base our estimates on historical experience, known
trends and events and various other factors that we believe are 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. We evaluate
our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.
While our significant accounting policies are
described in more detail in Note 2 to our financial statements included elsewhere in this Quarterly Report on Form 10-Q, we believe that
the following accounting policies are those most critical to the judgments and estimates used in the preparation of our financial statements.
Revenue Recognition
Effective January 1, 2018, the Company
adopted Accounting Standards Codification (“ASC”) 606 — Revenue from Contracts with Customers (“ASC
606”) . Under ASC 606, the Company recognizes revenue from the commercial sales of products, licensing agreements and
contracts to perform pilot studies by applying the following steps: (1) identify the contract with a customer; (2) identify the
performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to each performance
obligation in the contract; and (5) recognize revenue when each performance obligation is satisfied. For the comparative periods,
revenue has not been adjusted and continues to be reported under ASC 605 — Revenue Recognition (“ASC
605”) . Under ASC 605, revenue is recognized when the following criteria are met: (1) persuasive evidence of an
arrangement exists; (2) the performance of service has been rendered to a customer or delivery has occurred; (3) the amount of the
fee to be paid by a customer is fixed and determinable; and (4) the collectability of the fee is reasonably assured. The performance
obligations identified by the Company under ASC 606 are straightforward and similar to the unit of account and performance
obligation determination under ASC Topic 605, Revenue Recognition .
37
The Company recognizes revenue when product is
shipped at a fixed selling price on payment terms of 30 to 120 days from invoicing. The Company recognizes other revenue earned from pilot
studies, consulting and implementation services upon the performance of specific services under the respective service contract.
The Company derives revenue primarily from commercial
sales of products, net of discounts and promotions, as well as consulting and implementation services provided in conjunction with our
product deployments.
Stock-Based Compensation
We recognize compensation costs related to stock
options granted to employees based on the estimated fair value of the awards on the date of grant, net of estimated forfeitures, in accordance
with ASC Topic 718 — Stock Compensation . We estimate the grant date fair value of the awards, and the resulting
stock-based compensation expense, using the Black-Scholes option-pricing model. The grant date fair value of stock-based awards is expensed
on a straight-line basis over the vesting period of the respective award.
We recorded stock-based compensation expense of
approximately $182,000 and $140,000 for the three months ended June 30, 2021 and June 30, 2020, respectively, and approximately $337,000
and $291,000 for the six months ended June 30, 2021 and June 30, 2020, respectively. We expect to continue to grant stock options and
other equity-based awards in the future and continue to recognize stock-based compensation expense in future periods.
The Black-Scholes option-pricing model requires
the use of highly subjective and complex assumptions, which determine the fair value of stock-based awards. If we had made different assumptions,
our stock-based compensation expense, net loss and loss per share of common stock could have been significantly different. Our assumptions
are as follows:
●
Expected term . The expected term represents the period that the stock-based awards are expected to be outstanding. Our historical share option exercise experience does not provide a reasonable basis upon which to estimate an expected term because of a lack of sufficient data. Therefore, we estimate the expected term by using the simplified method, which calculates the expected term as the average of the time-to-vesting and the contractual life of the options.
●
Expected volatility . Expected volatility is derived from the average historical volatilities of publicly traded companies within our industry that we consider to be comparable to our business over a period approximately equal to the expected term. We intend to continue to consistently apply this process using the same or similar public companies unless circumstances change such that the identified companies are no longer similar to us, in which case, more suitable companies whose share prices are publicly available would be utilized in the calculation.
●
Risk-free interest rate . The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of grant for zero coupon U.S. Treasury notes with maturities approximately equal to the expected term.
●
Expected dividend . The expected dividend is assumed to be zero as we have never paid dividends and have no current plans to pay any dividends on our common stock.
●
Expected forfeitures . We use historical data to estimate pre-vesting option forfeitures and record stock-based compensation expense only for those awards that are expected to vest. To the extent actual forfeitures differ from the estimates, the difference will be recorded as a cumulative adjustment in the period that the estimates are revised.
38
Significant Factors, Assumptions and Methodologies
Used in Determining Fair Value of Our Common Stock
As noted above, we are required to estimate the
fair value of the common stock underlying our stock-based awards when performing the fair value calculations using the Black-Scholes option-pricing
model. In the absence of an active market for our common stock, we utilized methodologies in accordance with the framework of the American
Institute of Certified Public Accountants’ Technical Practice Aid, Valuation of Privately-Held Company Equity Securities Issued
as Compensation , to estimate the fair value of our common stock. In addition, we have conducted periodic assessments of the valuation
of our common stock.
The assumptions underlying
these valuations represent management’s best estimates, which involve inherent uncertainties and the application of management’s
judgment. If we had made different assumptions than those used, the amount of our stock-based compensation expense, net income and net
income per share amounts could have been significantly different. The fair value per share of our common stock for purposes of determining
stock-based compensation expense is the closing price of our common stock as reported on the applicable grant date. The compensation cost
that has been included in the statements of operations and comprehensive loss for all stock-based compensation arrangements is as follows:
Three Months Ended
June 30,
Six Months Ended
June 30,
2021
2020
2021
2020
Research and development
$ -
$ 2
$ 2
$ 5
Selling, general and administrative
182
138
335
286
Total stock-based compensation expense
$ 182
$ 140
$ 337
$ 291
The intrinsic value of stock options outstanding as of June 30, 2021
was $0.
Emerging Growth Company Status
The Jumpstart Our Business Startups Act of 2012,
or the JOBS Act, permits an “emerging growth company” such as us to take advantage of an extended transition period to comply
with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies.
We have irrevocably elected to “opt out” of this provision and, as a result, we intend to comply with new or revised accounting
standards when they are required to be adopted by public companies that are not emerging growth companies. We will cease to be an
emerging growth company at the end of 2021.
Item
3. Quantitative and Qualitative Disclosures about Market Risk
Not applicable.
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