Item 7. Management’s Discussion and Analysis
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our financial statements and the notes thereto included elsewhere in this Annual Report on Form 10-K. In addition to historical financial information, the following discussion contains forward-looking statements that reflect our plans, estimates, beliefs and expectations that involve risks and uncertainties. Our actual results and the timing of events could differ materially from those discussed in the forward-looking statements. Factors that could cause or contribute to these differences include those discussed below and elsewhere in this Annual Report on Form 10-K, particularly in the sections of this report titled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements.”
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 December 31, 2024, we had received net proceeds of $94.6 million from our sales of common stock, preferred stock and issuance of convertible and other promissory notes, an aggregate of $1.7 million from research grants and licensing fees and an aggregate of $5.6 million in product sales. At December 31, 2024, we had an accumulated deficit of $136.1 million and cash and cash equivalents of $1.3 million.
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We have incurred significant operating losses every year since our inception. Our net losses were $6.2 million and $7.7 million for the years ended December 31, 2024 and 2023, 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 to continue to fund our operations, achieve profitability and become cash flow positive, we 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.
We have historically utilized, and intend to continue to utilize, various forms of stock-based awards in order to hire, retain and motivate talented employees, consultants and directors and encourage them to devote their best efforts to our business and financial success. In addition, we believe that our ability to grant stock-based awards is a valuable and necessary compensation tool that aligns the long-term financial interests of our employees, consultants and directors with the financial interests of our stockholders. As a result, a significant portion of our operating expenses includes stock-based compensation expense. Stock-based compensation expense has been, and will continue to be for the foreseeable future, a significant recurring expense in our business and an important part of our compensation strategy. Specifically, our stock-based compensation expense for the years ended December 31, 2024 and 2023 was $326,000 and $555,000, respectively, which represented 4.5% and 6.7%, respectively, of our total operating expenses for those periods.
Results of Operations
The following tables provide financial and operational information to be considered in conjunction with management’s discussion and analysis of results of operations.
The results of operations are as following for the years presented (dollars in thousands):
Years Ended December 31, % Increase (Decrease)
2024 2023
Revenues, net $ 1,857 $ 1,193 56 %
Cost of sales 853 654 30 %
Gross profit 1,004 539 86 %
Operating expenses:
Research and development 1,712 1,228 39 %
Selling, general and administrative 5,541 7,043 (21) %
Total operating expenses 7,253 8,271 (12) %
Loss from operations (6,249) (7,732) (19) %
Other income, net 65 22 195 %
Net loss $ (6,184) $ (7,710) (20) %
Revenues, net
Sales, which are net of any discounts and promotions, were $1.9 million for the year ended December 31, 2024, compared to $1.2 million for the year ended December 31, 2023. The $664,000, or 56%, increase in 2024 was driven by the launch of our latest Evolve product offerings, partially offset by a decrease in the number of units sold of our existing ContraPest product offerings. Launched in January 2024, and expanded during 2024 with variations in product offerings, Evolve is a soft bait containing the active ingredient, cottonseed oil, and represented approximately 66%, or $1.2 million, of revenue for 2024. Partially offsetting this increase was a decline in the revenue related to our ContraPest product offerings. Limited erosion of demand for ContraPest products is expected as Evolve products are accepted in the marketplace. Also in 2024, we had a shift in our sales channels, with distributors representing approximately 34% of revenues compared to 9% in 2023.
Cost of Sales
Cost of sales, consisting primarily of the cost of products sold, including scrap and reserves for obsolescence, was $853,000, or 45.9% of net sales, for the year ended December 31, 2024, compared with $654,000, or 54.8% of net sales, for the year ended December 31, 2023. The lower cost of net sales is largely due to a shift in the mix of products sold, and declined due to our latest product offering, Evolve, which launched in January 2024. Furthermore, cost of sales in 2024
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was impacted during the first few months of 2024 from the higher cost of a key ingredient for our new Evolve product as we transitioned from development-stage raw materials pricing to production-level raw materials pricing, while cost of sales in 2023 was impacted by the scrapping of defective trays no longer used in our products in the first quarter of 2023.
Gross Profit
Gross profit for the year ended December 31, 2024 was $1,004,000, for a gross profit margin of 54.1%, compared with gross profit of $539,000, or a gross profit margin of 45.2%, for the year ended December 31, 2023. The increase in our gross profit margin was driven by the shift in the mix of our products sold, and increased due to our latest product offering, Evolve, which launched in January 2024. Additionally, the 2024 gross profit margin was impacted by both the higher-than-expected cost of a key ingredient in our new Evolve product during the first quarter, combined with an increased proportion of our sales coming from distributors, who are offered a lower price due to the quantities purchased, while the 2023 gross profit margin was impacted by the higher cost of sales related to the scrapping of defective tanks no longer used in our products.
Research and Development Expenses
Research and development expenses are expensed as incurred and consist primarily of costs incurred in connection with the research and development of ContraPest, Evolve, and our other product candidates. Such costs include the following:
• employee related expenses, including salaries, related benefits, travel and stock-based compensation expense for employees engaged in research and development functions, including that portion of manufacturing not included in cost of goods sold;
• expenses incurred in connection with the development of our product candidates, including related regulatory and production expenses; and
• facilities, depreciation and other expenses, which include direct and allocated expenses for rent and maintenance of facilities, insurance and supplies.
Research and development expenses consisted of the following (in thousands):
Years Ended December 31, Increase
(Decrease)
2024 2023
Personnel-related (including stock-based compensation) $ 1,032 $ 636 $ 396
Facility-related 184 122 62
Stability and animal studies, materials and field costs 133 45 88
Depreciation 127 109 18
Professional fees 99 156 (57)
Supplies and maintenance 69 73 (4)
Other 68 87 (19)
Total $ 1,712 $ 1,228 $ 484
Research and development expenses were $1.7 million for the year ended December 31, 2024, compared to $1.2 million for the year ended December 31, 2023. The $484,000 increase was primarily due to the realignment of the focus of our field development personnel to research and development activities, lower overhead allocation and increased costs related to the expansion of facilities and supplies and maintenance related to research and development efforts, combined with higher expenses overall related to field and product improvement studies in 2024 when compared with 2023. These increases were partially offset by lower consulting and legal fees required for research and development purposes.
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.
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Selling, general and administrative expenses consisted of the following (in thousands):
Years Ended December 31, Increase
(Decrease)
2024 2023
Personnel-related (including stock-based compensation) $ 2,630 $ 3,440 $ (810)
Professional fees 1,240 1,722 (482)
Marketing 288 317 (29)
Insurance 243 350 (107)
Licensed software 232 240 (8)
Travel and entertainment 230 228 2
Facility-related 146 155 (9)
Other 532 591 (59)
Total $ 5,541 $ 7,043 $ (1,502)
Selling, general and administrative expenses were $5.5 million for the year ended December 31, 2024, compared to $7.0 million for the year ended December 31, 2023. The $1.5 million decrease was primarily due to lower personnel-related expenses resulting from a lower headcount and stock-based compensation, the realignment of the focus of our field development personnel to research and development activities in early 2024 and severance costs incurred in 2023 related to the termination of our former Chief Revenue Officer, combined with lower professional fees and insurance costs. Legal fees were lower as a legal matter was settled at the end of 2023, consulting fees related to marketing efforts were lower due to changes in our overall marketing program, and our insurance costs were lower resulting from both policy and rate changes.
Other Income, Net
Other income, net, consists of interest income and expense, as well as any gains or losses related to the sale of property and equipment and any other miscellaneous items. For the year ended December 31, 2024, other income, net largely consisted of interest income of $56,000 and a gain on the sale of equipment of $28,000, partially offset by interest expense of $22,000. For the year ended December 31, 2023, other income, net consisted of interest income of $26,000, partially offset by interest expense of $4,000. Interest expense was higher in 2024 when compared with 2023 due to new financing arrangements entered into for the purchase of new manufacturing equipment beginning in late 2023 and continuing into 2024.
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. While we have generated $1.9 million of revenue in our most recent fiscal year, it is not sufficient to cover our base operating costs. 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 December 31, 2024, we had received net proceeds of $94.6 million from our sales of common stock, preferred stock and issuance of convertible and other promissory notes, an aggregate of $1.7 million from research grants and licensing fees and an aggregate of $5.6 million in product sales. At December 31, 2024, we had an accumulated deficit of $136.1 million and cash and cash equivalents of $1.3 million.
Our ultimate success depends upon the outcome of a combination of factors, including the following: (i) successful commercialization of ContraPest and Evolve and maintaining and obtaining regulatory approval of our products and product candidates; (ii) market acceptance, commercial viability and profitability of ContraPest, Evolve 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 December 31, 2024, in combination with anticipated revenue, will be sufficient to fund our current operations for at least the next three months. We have evaluated and will continue to evaluate our operating expenses and will concentrate our resources toward the successful commercialization of ContraPest and Evolve in the United States, as well as internationally. However, if anticipated
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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 three months, and we are unable to raise the 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 and Evolve. In addition, we will continue to incur costs associated with operating as a public company.
In particular, we expect to incur substantial and increased expenses as we:
• work to maximize market acceptance for, and generate sales of, our products, including by conducting field demonstrations at potential lead customers;
• explore strategic partnerships to enable us to penetrate additional target markets and geographical locations;
• manage the infrastructure for sales, marketing and distribution of ContraPest and Evolve and any other product candidates for which we may receive regulatory approval;
• seek additional regulatory approvals, if any, for our products, including to more fully expand the market and use for ContraPest and Evolve and, if we believe there is commercial viability, for our other product candidates;
• further develop our manufacturing processes to contain costs while being able to scale to meet future demand of ContraPest and Evolve and any other product candidates for which we receive regulatory approval;
• continue product enhancement and evolution of ContraPest and Evolve and advance our research and development activities and, as our operating budget permits, advance the research and development programs for other product candidates;
• maintain and protect our intellectual property portfolio; and
• 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.
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 years presented (in thousands):
Years Ended December 31,
2024 2023
Cash and cash equivalents, beginning of year $ 5,395 $ 4,775
Net cash provided by (used in):
Operating activities (6,033) (7,566)
Investing activities (56) (149)
Financing activities 2,001 8,335
Net change in cash and cash equivalents (4,088) 620
Cash and cash equivalents, end of year $ 1,307 $ 5,395
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Cash Flows from Operating Activities— Cash flows from operating activities are generally determined by the amount and timing of cash received from customers and payments made to vendors, as well as the nature and amount of non-cash items, including depreciation and amortization and stock-based compensation included in operating results during a given period.
During 2024, net cash flows used in operating activities consisted of our net loss of $6.2 million and by changes in our operating assets and liabilities of $305,000, offset by non-cash charges of $456,000. Our net loss was primarily attributed to expenses incurred related to selling, general and administrative as we continue efforts to commercialize our products, as well as research and development activities. Revenue from our product sales did not cover our operating expenses during the year. Net cash used by changes in our operating assets and liabilities largely consisted of increases of $242,000 in accounts receivable and $44,000 in other assets.
During 2023, net cash flows used in operating activities consisted of our net loss of $7.7 million and by changes in our operating assets and liabilities of $544,000, offset by non-cash charges of $688,000. Our net loss was primarily attributed to expenses incurred related to our selling, general and administrative activities. Net cash used by changes in our operating assets and liabilities consisted primarily of a $582,000 decrease in accounts payable and accrued expenses, and increases of $26,000 in deferred revenue and $10,000 in prepaid expenses, offset by decreases of $58,000 in inventory and $20,000 in accounts receivable.
Cash Flows from Investing Activities— Cash flows used in investing activities primarily consist of the purchase of property and equipment, offset by any proceeds received in connection with sales of property and equipment. In 2024, the cash outlay for our property and equipment purchases were $65,000 lower than 2023. In 2024, we had proceeds received of $28,000 related to the sale of certain equipment.
Cash Flows from Financing Activities— Financing activities provide cash for both day-to-day operations and capital requirements as needed. In 2024, net cash provided by financing activities consisted of $2.0 million from the exercise of warrants, $38,000 from the issuance of common stock, and $25,000 from proceeds received related to notes payable, partially offset by $42,000 of repayments of notes payable. In 2023, net cash provided by financing activities largely consisted of $5.4 million of net proceeds from the issuance of common stock, $2.8 million from the exercise of warrants, and $114,000 from proceeds from notes payable.
Critical Accounting Policies and Estimates
Our financial statements are prepared in accordance with generally accepted accounting principles in the United States (“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.
We believe that the following critical accounting policies affect our more significant judgments and estimates used in the preparation of our financial statements:
Inventory Valuation. We value inventory at the lower of cost or net realizable value. In addition, we write down any obsolete, unmarketable or otherwise impaired inventory to net realizable value. The determination of obsolete, or excess inventory requires us to estimate the future demand for our products. The estimate of future demand is compared to inventory levels to determine the amount, if any, of obsolete or excess inventory. If actual market conditions are less favorable than those we projected at the time the inventory was written down, additional inventory write-downs may be required. Inventory valuation is re-evaluated on a quarterly basis.
Stock-Based Compensation. Stock-based compensation expenses is measured at the grant date, based on the estimated fair value of the award using the Black-Scholes option pricing model for stock options and market price for restricted stock units. The use of the Black-Scholes option pricing model, requires certain estimates, including expected term of options granted, the method of calculating expected volatilities and the risk-free interest rate used in the option-pricing model. The resulting calculated fair value of stock options is recognized as compensation expenses over the requisite service period, which is generally the vesting period. When there are changes to the assumptions used in the option-pricing model, including fluctuations in the market prices of our common stock, there will be variations in the calculated fair value of our
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future stock option awards, which results in variation in the stock-based compensation expensed recognized. Additionally, any modification of an award that increases its fair value will require us to recognize additional expense.
Income Taxes. We record deferred income taxes for temporary difference between the amounts of assets and liabilities for financial and tax reporting purposes and we record a valuation allowance to reduce our deferred tax assets to the amount that is more likely than not to be realized. We also regularly conduct a comprehensive review of our uncertain tax positions. In this regard, an uncertain tax position represents our expected treatment of a tax position taken in a filed tax return, or planned to be taken in a future tax return, that has not been reflected in measuring income tax expense for financial reporting purposes. Until these positions are sustained by the taxing authorities, we do not recognize the tax benefit resulting from such positions and report the tax effect for uncertain tax positions in our balance sheets.
Off-Balance Sheet Arrangements
None.
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
Not applicable.
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