You should read the following discussion and analysis of our financial condition and results of operations together with and our consolidated financial statements and the related notes appearing elsewhere in this Annual Report on Form 10-K. In addition to historical information, this discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may differ materially from those discussed below. Factors that could cause or contribute to such differences include, but are not limited to, those identified below, and those discussed in the section titled "Risk Factors" included elsewhere in this Annual Report on Form 10-K.
-38- Overview
We are a clinical nutrition company that develops and distributes clinically supported nutrition, medical foods and dietary supplements. The Company offers a portfolio of science-based, clinically supported products designed to support retail consumers, healthcare professionals and providers, and their patients by supporting bone health, eye health, cardiovascular health, and brain health through nutrients such as Calcium, Vitamin D, Vitamin K, Carotenoids, and Omega-3s.
Our profile and focus fundamentally changed with the acquisition of
The acquisition and integration of the Viactiv line of products has changed our
financial position, market profile and brand and operating focus. In order to
leverage the Viactiv platform, the Company has searched for additional
complementary business opportunities. Additionally, the Company is focusing on
new product development that it can launch under the Viactiv brand and in the
year ended
We believe the Activ acquisition has added valuable attributes, that are helping us achieve our goals including (1) Viactiv's brand awareness and acceptance from the consumer; (2) experienced management; (3) established distribution networks and relationships; (4) product development potential; and (5) a long track record of financial performance.
? Brand awareness - Viactiv was initially launched by industry leaders Mead Johnson/Johnson & Johnson approximately twenty years ago, and we believe this history, along with the product's marketing campaigns, taste profile and receipt of consistently positive consumer reviews, have led to strong consumer awareness and acceptance. We are leveraging this strong consumer awareness to expand the Viactiv brand beyond calcium chews. We launched an Omega-3 product earlier this year called Omega Boost Gel Bites, and we are marketing it to a similar target audience as the calcium chews. This along with cross selling across products are important actions we are taking to take advantage of the Viactiv brand awareness to help us grow our business. ? Experienced management - As part of the Activ acquisition, we hired the senior executive responsible for the Viactiv brand atAdare Pharmaceuticals, Inc. ("Adare") as our Chief Commercial Officer. This senior executive was a member of the executive leadership team of Adare, and he has contributed strong sales, marketing and research and development skills and experiences to our leadership team. We have combined his skill set with other professionals on our team that had complementary skills, including manufacturing, logistics, financial management and medical education. Building out our team in this manner has helped us scale our capabilities and better exploit our collective industry experience. ? Established distribution - Viactiv's products are currently marketed through many of the nation's largest retailers, including, among others, Walmart (retail and online), Target and Amazon. We added a direct-to-consumer eCommerce capability on our website viactiv.com earlier this year to expand our sales channels. The Viactiv calcium chews can now be purchased through any of these channels, and we subsequently added our ocular products to this platform. We are also working to leverage our distribution and supply networks to grow our Omega Boost Gel Bites product which is currently sold on our direct-to-consumer site as well as one online retailer. We are evaluating additional channel expansion for Omega Boost Gel Bites in addition to offering bundles with other GHSI products to our customers. ? Track record of financial performance - The Viactiv brand has a strong history of financial success both before and after our acquisition of the brand. Sales in the first nine months of 2022 were impacted by supply chain challenges that limited the inventory we were able to distribute for sale. Our results have also been adversely impacted by general economic conditions that have negatively affected the broader vitamin, mineral and supplement category at retail outlets. Viactiv generated net revenues of approximately$10,640,000 in 2022 which accounts for 96% of our total revenues in 2022. For the year endedDecember 31, 2021 , on a pro forma basis, our total revenues would have been approximately$12,766,000 and the Viactiv products would have accounted for 94% of our pro forma total revenues for the year. Over time, we expect the acquisition of Viactiv to contribute increasing revenue and consistent operating margins and profitability, as well as a multitude of growth opportunities, to our Company. -39-
Availability of Capital
We may continue to seek to raise additional debt and/or equity capital to fund future operations and acquisitions as necessary, but there can be no assurances that we will be able to secure such additional financing in the amounts necessary to fully fund our operating requirements on acceptable terms or at all. If we are unable to access sufficient capital resources on a timely basis, we may be forced to reduce or discontinue our product development programs and curtail or cease operations.
The Company will continue to incur significant expenses related to the commercialization of its products and with respect to its efforts to build its infrastructure, expand its operations, and execute on its business plans. Even if profitability is achieved in the future, the Company may not be able to sustain profitability on a consistent basis. The Company expects to continue to incur substantial losses and negative cash flow from operations for the foreseeable future.
The Company does not have any credit facilities as a source of present or future funds. If the Company raises additional funds through the issuance of equity or convertible debt securities, the percentage ownership of the Company's stockholders could be significantly diluted, and these newly issued securities may have rights, preferences or privileges senior to those of existing stockholders. Debt financing, if obtained, may involve agreements that include covenants limiting or restricting the ability to take specific actions, such as incurring additional debt, would increase expenses and may require that Company assets secure such debt.
Recent Developments Reverse Stock Split
We held a special meeting of stockholders on
The Proposal was approved by the Company's stockholders at the Special Meeting
and on
When the Reverse Stock Split became effective, every 50 shares of the Company's issued and outstanding common stock were automatically combined, converted and changed into 1 share of the Company's common stock, without any change in the number of authorized shares or the par value per share. In addition, a proportionate adjustment was be made to the per share exercise price and the number of shares issuable upon the exercise of all outstanding stock options, restricted stock units and warrants to purchase shares of common stock and the number of shares reserved for issuance pursuant to the Company's equity incentive compensation plans. Any fraction of a share of common stock that created as a result of the Reverse Stock Split was rounded up to the next whole share. As a result, we issued an additional 35,281 common shares for rounding. Accordingly, all common shares, stock options, stock warrants and per share amounts in these consolidated financial statements have been adjusted retroactively to reflect the reverse stock splits as if the splits occurred at the beginning of the earliest period presented in this Annual Report.
On
-40-
On
The Company held a special meeting of stockholders on
Pursuant to the Purchase Agreement, on
The holders of shares of Series C Preferred Stock are entitled to dividends, on
an as-if converted basis, equal to dividends actually paid, if any, on shares of
Common Stock. The Series C Preferred Stock is convertible, at the option of the
holders and, in certain circumstances, by the Company, into shares of Common
Stock at a conversion price of
-41-
The proceeds of the Offering were held in a third-party escrow account, along with the additional amount that would be necessary to fund the 105% redemption price, until the expiration of the redemption period for the Preferred Stock, as applicable, subject to the earlier payment to redeeming holders.
In connection with the Offering, the Company agreed to pay
As a result of the
As of
Supply Chain Constraints; Inflationary Pressures
We experienced supply chain constraints due to the COVID-19 pandemic and its
aftermath. These constraints began in approximately
Launch of Viactiv® Omega Boost Gel Bites
In
We hope that this new product will not only increase our revenues but also be the first of many new product launches over upcoming quarters. The Omega Boost Gel Bites also represent an expansion of the Viactiv brand beyond calcium products. Initial customer reaction has been positive as judged by online reviews. Although sales of our Omega Boost Gel Bites have been modest since its launch, we are optimistic about the potential of the product as we increase consumer awareness, receive additional clinical support for the efficacy of the product, refine our marketing activities and increase distribution.
Adding these products has enabled us to create additional value in multiple ways. We believe the Viactiv brand and established distribution will make our Omega Boost Gel Bites sales and marketing functions more successful. Introducing this new product in 2022 expanded our portfolio beyond calcium chews which is an important aspect of our growth strategy. The Viactiv brand has traditionally focused its marketing of calcium supplements to female purchasers at different life stages. We believe this target audience will also be interested in purchasing our omega-3 supplements that we believe provide a preferred alternative to existing omega-3 soft gels and gummy products.
-42-
The introduction of the Omega Boost Gel Bites product greatly expanded the total addressable market for Viactiv by expanding the brand into the established sizeable omega-3 market. We hope that our omega-3 product will distinguish itself from the competition over time.
We have also expanded our sales channels for Viactiv by launching a direct-to-consumer website. This new channel offers Viactiv customers an additional channel to purchase our products, but it also provides customers with more customized offers and information.
We plan to leverage the established distribution channels and marketing experience that Viactiv enjoys to our other products, which we hope will accelerate those products' revenue growth. Viactiv has traditionally distributed its calcium chews through traditional retailers with physical locations, online retailers and direct to consumer via our website. We launched our Omega Boost Gel Bites on the viactiv.com website, and we continue to add online retailers. We are currently evaluating whether to expand distribution to traditional retailers. Initial customer reaction to the Omega Boost Gel Bites has been positive as judged by online reviews, customer surveys and focus groups. While sales of our Omega Boost Gel Bites have been modest, we are optimistic about the product's potential as we increase consumer awareness, receive additional clinical support for the efficacy of the product, and refine our marketing activities.
Launch of
During
Strategic Objectives, Goals and Strategies
Our ability to maximize stockholder value requires that we build a solid corporate foundation and demonstrate growth and commercial success on top of that foundation. We have taken a number of steps the last two years to strengthen our corporate foundation, including acquiring Viactiv, winding down and reevaluating Vector Vision, hiring key team members, launching a new product, strengthening our eCommerce capabilities and streamlining operations.
Our three primary objectives are:
? Demonstrate Commercial Success: We are focused on growing sales of our existing Viactiv product portfolio, growing sales of new products introduced in 2022 and positioning the other clinical nutrition products to maximize results. We have taken steps to address this objective during 2022 by launching the new Omega Boost Gel Bites, which adds a key product to our portfolio. New products are also important to reduce the risk of customer of supplier concentrations. We continue to work with our manufacturing partners to begin rebuilding inventories which were negatively impacted by the supply chain constraints we have experienced. Lack of inventory was the biggest impediment to our ability to grow sales of our calcium products in the first half of 2022, but we have made progress in rebuilding these stocks and re-stocking retailers during the second half of 2022. We have also communicated a price increase to our retail partners that was implemented during the year. Despite the operational improvements, our sales declined in the twelve months endedDecember 31, 2022 . These sales declines are consistent with declines in the broader vitamin, mineral and supplement category at retail locations and were also the result of the continuing supply constraints we experienced during the six months endedDecember 31, 2022 . -43- ? Strengthen our Commercial Engine: We believe we need to effectively implement several strategies, including expanding our distribution within the sales channels, strengthening our Viactiv brand and related marketing, building our innovation pipeline and strengthening our team. During the year, we continued to discuss new distribution opportunities with new and existing customers as well as enhancing our direct-to-consumer capability on viactiv.com. We also advanced our marketing efforts by conducting consumer surveys and focus groups. We continue to monitor customer trends and identify opportunities for new product development.. As we enter 2023, we plan to focus our efforts on commercializing the Omega Boost Gel Bites that were introduced in 2022, and we will evaluate plans to launch another product in 2023. During the six months endedDecember 31, 2022 , we strengthened our inventory levels in order to increase our marketing trials in an effort to get back to consistent selling levels with Amazon.com. We continue to pursue additional marketing strategies to increase the distribution of all Viactiv products across our existing sales channels. ? Strengthen our Clinical Nutrition Strategy: We are strengthening our Clinical Nutrition Strategy, by, among others, advancing clinical evidence regarding our existing and future products, partnering with specialty manufacturers and suppliers to leverage innovations, and working to increase awareness of our products within the healthcare community. During the twelve months endedDecember 31, 2022 , we announced interim results of an independent clinical study designed to evaluate the effectiveness of new Viactiv Omega Boost Gel Bites at increasing Omega-3 saturation levels on red blood cells. Our interim clinical results showed a 50% improvement in Omega-3 levels in just 4 weeks of customer usage. Finally, we continue to meet with manufacturing partners to research the supply of science based ingredients and new formats that could be incorporated into our future products.
Evaluation of Strategic Alternatives
The Company is also evaluating alternative strategic paths focused on maximizing
stockholder value, and we have hired a financial advisor to support this
process. In
Our management team and Board of Directors believe that the current market valuation of the Company does not accurately reflect the potential value of the Company and the clinical nutrition platform and the brand that we are building. The Company is therefore exploring a diverse range of strategic options to help grow the Company and enhance stockholder value, including, among other things, a sale of the Company or Viactiv brand, merger, acquisition, reverse acquisition, or other strategic transaction. There can be no assurances, however, that this process will result in a transaction, or that if a transaction is completed, it will ultimately enhance stockholder value. There is no set timetable for the strategic review process and the Company does not intend to provide periodic updates until the Board of Directors makes a formal decision and determines that disclosure is appropriate and/or necessary under the circumstances.
Concentration of Risk
As a result of the recent banking failures in the
-44- Revenue
During the year ended
Accounts receivable
As of
Purchases from vendors
During the years ended
Accounts payable
As of
Critical Accounting Policies and Estimates
Our financial statements have been prepared in conformity with accounting
principles generally accepted in
The following critical accounting policies affect the more significant judgments and estimates used in the preparation of our financial statements.
Revenue Recognition
We recognize revenue in accordance with Accounting Standards Codification (ASC) 606, Revenue from Contracts with Customers. Revenue is recognized when control of promised goods or services is transferred to the customer in an amount that reflects the consideration to which we expect to be entitled in exchange for those products or services. We review our sales transactions to identify contractual rights, performance obligations, and transaction prices, including the allocation of prices to separate performance obligations, if applicable.
All products sold by us are distinct individual products and are offered for sale as finished goods only, and there are no performance obligations required post-shipment for customers to derive the expected value from them. Contracts with customers contain no incentives or discounts that could cause revenue to be allocated or adjusted over time.
-45- Inventories
Inventories are stated at the lower of cost or net realizable value, with cost determined on a first-in, first-out ("FIFO") basis. We record adjustments to our inventory for estimated obsolescence or diminution in net realizable value equal to the difference between the cost of the inventory and the estimated net realizable value. The difference is recognized as a loss in the period in which it occurs. Once inventory has been written down, it creates a new cost basis for inventory that is not subsequently written up.
Intangible Assets
The Company follows ASC 360 in accounting for finite-lived intangible assets, which requires impairment losses to be recorded when indicators of impairment are present and the undiscounted cash flows estimated to be generated by the assets are less than the assets' carrying amounts.
Goodwill
The Company tests goodwill for impairment annually on
Convertible Preferred Stock
Preferred shares subject to mandatory redemption are classified as liability instruments and are measured at fair value. The Company classifies conditionally redeemable preferred shares, which includes preferred shares that feature redemption rights that are either within the control of the holder or subject to redemption upon the occurrence of uncertain events not solely within the Company's control, as temporary equity ("mezzanine") until such time as the conditions are removed or lapse.
-46- Business Combinations
We account for our business combinations using the acquisition method of accounting where the purchase consideration is allocated to the tangible and intangible assets acquired, and liabilities assumed, based on their respective fair values as of the acquisition date. The excess of the fair value of the purchase consideration over the estimated fair values of the net assets acquired is recorded as goodwill. When determining the fair values of assets acquired and liabilities assumed, management makes significant estimates and assumptions, especially with respect to intangible assets. Critical estimates in valuing intangible assets include, but are not limited to, expected future cash flows, which includes consideration of future growth and margins, future changes in technology, expected cost and time to develop in-process research and development, brand awareness and discount rates. Fair value estimates are based on the assumptions that management believes a market participant would use in pricing the asset or liability.
Stock-Based Compensation
We periodically issue stock-based compensation to officers, directors, contractors and consultants for services rendered. Such issuances vest and expire according to terms established at the issuance date.
Stock-based payments to officers, directors, consultants, contractors, and employees, which include grants of employee stock options, are recognized in the financial statements based on their fair values. Stock option grants, which are generally time or performance vested, are measured at the grant date fair value and charged to operations on a straight-line basis over the vesting period. The fair value of stock options is determined utilizing the Black-Scholes option-pricing model, which is affected by several variables, including the risk-free interest rate, the expected dividend yield, the expected life of the equity award, the exercise price of the stock option as compared to the fair market value of the common stock on the grant date and the estimated volatility of the common stock over the term of the equity award.
Recent Accounting Pronouncements
A description of recently issued accounting pronouncements that may potentially impact our financial position, results of operations or cash flows is disclosed in Note 2 - Summary of Significant Accounting Policies to our consolidated financial statements appearing elsewhere in this Annual Report on Form 10-K.
Recent Trends - Market Conditions
We have been experiencing supply chain constraints due to the COVID-19 pandemic.
These constraints began in approximately
Plan of Operations General Overview
We are focused on building a leading clinical nutrition company. Our team continues to assess the business, the core fundamentals, and the market opportunity for our products and services. With the acquisition of Viactiv brand and business in 2021, management believes that we will be able to accelerate our growth and development.
Our team is focused on building a strong foundation by developing a business model and infrastructure that is designed for long-term commercial success. This process will take time, but we continue to take important steps required to build a stronger company. Based on the availability of sufficient funding, we intend to increase our commercialization and business development activities, including engaging in new product development and further strategic transaction acquisitions, to capitalize on growth opportunities. We are also exploring, with the assistance of our financial advisor, a diverse range of strategic options to help grow the Company and enhance stockholder value, including, among other things, a sale of the Company or Viactiv brand, merger, acquisition, reverse acquisition, or other strategic transaction.
Over the long-term, we believe one of the critical keys to our success will be to create value in well-differentiated and robust brands through strong clinically proven claims that address consumer needs in growing markets, both domestically and internationally. We are committed to bringing compelling products to market under meaningful and differentiated brands supported by strong science.
-47-
We are currently working on several initiatives that we believe will help achieve these long-term goals as described above under "Strategic Objectives, Goals and Strategies" and below.
Our growth initiatives are focused on increasing revenue and bringing compelling products to market under meaningful and differentiated brands that are supported by strong science. Management intends to focus on those products that possess the greatest chance for commercial success within a reasonable period of time and with a reasonable deployment of capital.
? We intend to improve our sales channels by increasing product commercialization through better access to sales channels and to leverage our collective experience, particularly from the Viactiv product distribution, to increase and improve the distribution of all of our products. We added a direct-to-consumer eCommerce capability on viactiv.com during 2022 to expand our sales channels. Our calcium chews can now be purchased through a number of sales channels, including stores owned by traditional retailers, websites of online retailers and directly from Viactiv at viactiv.com. We launched our Omega Boost Get Bites earlier in 2022 on the Viactiv direct-to-consumer site, and we added distribution of the product by adding it to certain online retailers during the year. ? We intend to enhance our product strategy by continuing to develop new products that increase our product breadth, like the Omega Boost Gel Bites. New products are an important component of our sales growth strategy, but they also diversify our customer base and supply chains. We also continue to critically evaluate our current product portfolio in order to improve or discontinue certain of our existing products. We are focused on products with differentiated formulations, product taste, compelling product formats, and competitive cost structures. ? We intend to improve our brand strategy by improving the management and exploitation of our brand portfolio particularly, by leveraging Viactiv's strong consumer awareness and acceptance. Launching the Omega Boost Gel Bites was an important step to introducing new products to consumers aware of the Viactiv brand. This new product introduction also reinforced key attributes of the Viactiv brand, including consumer experience and product efficacy. ? We intend to strengthen our clinical nutrition strategy by continuing to advance clinical evidence regarding our products, working with manufacturers and suppliers to leverage our partner's innovations and increasing awareness of our products and efforts within the healthcare community. ? We plan to expand our scientific work by improving the science that supports our products and drives our product development process and increasing clinical evidence regarding our products from established health care professionals. For example, during the twelve months endedDecember 31, 2022 , we announced interim results of an independent clinical study designed to evaluate the effectiveness of new Viactiv Omega Boost Gel Bites at increasing Omega-3 saturation levels on red blood cells. Our interim clinical results showed a 50% improvement in Omega-3 levels in just 4 weeks of customer usage. Results of Operations
Through
-48-
At
We previously had two reportable segments, a Clinical Nutrition Segment and a
Medical Devices Segment. In
Comparison of Years Ended
Years Ended December 31, 2022 2021 Change Revenue$ 11,049,772 $ 7,233,118 $ 3,816,654 53 % Cost of goods sold 6,529,385 4,122,684 2,406,701 58 % Gross Profit 4,520,387 3,110,434 1,409,953 45 % Operating Expenses: Research and development 193,800 64,358 129,442 201 % Sales and marketing 2,069,660 2,324,569 (254,909 ) (11 %) General and administrative 9,602,244 11,204,885 (1,602,641 ) (14 %) Impairment of Intangible assets 10,065,833 - 10,065,833 Impairment of Goodwill - 11,893,134 (11,893,134 ) Acquisition transaction costs - 2,103,680 (2,103,680 ) Loss on disposal of equipment 9,448 160,137 (150,689 ) (94 %) Loss on lease termination, net - 106,477 (106,477 ) Total Operating Expenses 21,940,985 27,857,240 (5,916,255 ) (21 %) Loss from Operations (17,420,598 ) (24,746,806 ) (7,326,208 ) (30 %) Other Income (Expense): Change in fair value of warrant derivative liability 2,345,800 - 2,345,800 Interest income 152,570 1,797 150,773 839 % Total other Income (Expense) 2,498,370 1,797 2,496,573 Net loss (14,922,228 ) (24,745,009 ) 9,822,781 (40 %) Preferred stock deemed dividend 941,585 - 941,585 Net Loss available to common stockholders$ (15,863,813 ) $ (24,745,009 ) $ 8,881,196 (36 %) Revenue
For the year ended
Cost of Goods Sold
For the year ended
-49- Gross Profit
For the year ended
Research and Development
For the year ended
Sales and Marketing
For the year ended
General and Administrative
For the year ended
Acquisition Transaction Costs
For the year ended
Impairment of Intangible Assets
On
Impairment ofGoodwill
We evaluate goodwill for impairment annually on
-50-
Loss on Disposal of Fixed Assets
For the year ended
Loss on Lease Termination
For the year ended
Change in Fair Value of Warrant Derivative Liability
For the year ended
Interest Expense
There was no interest expense during the years ended
Net Loss
For the year ended
Preferred Stock Deemed Dividend
As a result of the offering on
Liquidity and Capital Resources
For the year ended
Notwithstanding the net loss for 2022, management believes that our current cash balance is sufficient to fund operations for in excess of one year from the date of the Company's 2022 financial statements are issued.
-51-
Our financing has historically come primarily from the issuance of convertible notes, promissory notes and from the sale of common and preferred stock. We will continue to incur significant expenses for continued commercialization activities related to our clinical nutrition product lines and building our infrastructure. Development and commercialization of clinical nutrition products involves a lengthy and complex process. Additionally, our long-term viability and growth may depend upon the successful development and commercialization of new complementary products or product lines.
We may continue to seek to raise additional debt and/or equity capital to fund future operations and acquisitions as necessary, but there can be no assurances that we will be able to secure such additional financing in the amounts necessary to fully fund our operating requirements on acceptable terms or at all. If we are unable to access sufficient capital resources on a timely basis, we may be forced to reduce or discontinue our product development programs and curtail or cease operations.
Sources and Uses of Cash
The following table sets forth the Company's major sources and uses of cash for each of the following periods:
Years Ended December 31, 2022 2021 Net cash used in operating activities$ (7,446,812 ) $ (10,644,416 )
Net cash provided by (used in) investing activities 4,990,054 (31,011,401 ) Net cash provided by financing activities
14,268,321 37,231,012 Net increase (decrease) in cash$ 11,811,563 $ (4,424,805 ) Operating Activities
Net cash used in operating activities was approximately
Investing Activities
Net cash provided by investing activities was approximately
In 2021, we used cash of approximately
Financing Activities
Net cash provided by financing activities was approximately
JOBS Act
On
-52-
We have chosen to take advantage of the extended transition periods available to emerging growth companies under the JOBS Act for complying with new or revised accounting standards until those standards would otherwise apply to private companies provided under the JOBS Act. As a result, our financial statements may not be comparable to those of companies that comply with public company effective dates for complying with new or revised accounting standards.
Subject to certain conditions set forth in the JOBS Act, as an "emerging growth
company," we intend to rely on certain of these exemptions, including, without
limitation, (i) providing an auditor's attestation report on our system of
internal controls over financial reporting pursuant to Section 404(b) of the
Sarbanes-Oxley Act and (ii) complying with any requirement that may be adopted
by the
PRINCIPAL COMMITMENTS Appointment of CEO
Effective on
The Company and
If
None of the Company's executives were paid bonuses for the year ended
Office lease
In July, 2021, the Company entered into a month-to-month lease for its primary
corporate office space located in
Trends, Events and Uncertainties
Other than as discussed above, we are not currently aware of any trends, events or uncertainties that are likely to have a material effect on our financial condition in the near term, although it is possible that new trends or events may develop in the future that could have a material effect on our financial condition.
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