2. Basis of Presentation and Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2013 |
Accounting Policies [Abstract] | ' |
2. Basis of Presentation and Significant Accounting Policies | ' |
Interim Financial Statements |
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”) and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted. These financial statements should be read in conjunction with the consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2012. |
In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments (consisting of normal recurring adjustments) necessary for a fair presentation of these financial statements. Operating results for three and nine-months period ended September 30, 2013 are not necessarily indicative of the results for future periods or the full year. |
Principles of Consolidation |
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The condensed consolidated financial statements include the accounts of Pernix’s wholly-owned subsidiaries: Pernix Therapeutics, LLC, GTA GP, Inc., GTA LP, Inc., Gaine, Inc., Macoven, Pernix Manufacturing (acquired July 1, 2012), Respicopea, Inc. (acquired May 14, 2012), Cypress (acquired December 31, 2012) and Pernix Sleep, Inc. (acquired March 6, 2013). Respicopea, Pernix Manufacturing, Cypress and Pernix Sleep are included only for the periods subsequent to their acquisitions. Transactions between and among the Company and its consolidated subsidiaries are eliminated. |
Management’s Estimates and Assumptions |
The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the period. Actual results could differ from those estimates. The Company reviews all significant estimates affecting the condensed consolidated financial statements on a recurring basis and records the effect of any necessary adjustments prior to their issuance. Significant estimates of the Company include: revenue recognition, sales allowances such as returns on product sales, government program rebates, managed care rebates, customer coupon redemptions, wholesaler/pharmacy discounts, product service fees, rebates and chargebacks, sales commissions, amortization, depreciation, stock-based compensation, the determination of fair values of assets and liabilities in connection with business combinations, and deferred income taxes. |
Fair Value of Financial Instruments |
A financial instrument is defined as cash equivalent, evidence of an ownership interest in an entity, or a contract that creates a contractual obligation or right to deliver or receive cash or another financial instrument from another party. The Company’s financial instruments consist primarily of cash equivalents (including our Regions Trust Account which invests in short-term securities consisting of sweep accounts, money market accounts and money market mutual funds), an investment in equity securities (TherapeuticsMD) (which was divested on June 14, 2013), contingent consideration and a put right in connection with the acquisition of Cypress. |
Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The fair value hierarchy is based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value as follows: |
Level 1 | Quoted prices in active markets for identical assets or liabilities as of the reporting date. | | | | | | | | | | | | | | | |
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Level 2 | Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities as of the reporting date. | | | | | | | | | | | | | | | |
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Level 3 | Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. | | | | | | | | | | | | | | | |
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Revenue Recognition |
The Company’s consolidated net revenues represent the Company’s net product sales and collaboration revenues. The Company records all of its revenue from product sales and collaboration or co-promotion agreements when realized or realizable and earned. Revenue is realized or realizable and earned when all of the following criteria are met: (1) existence of persuasive evidence of an arrangement; (2) occurrence of delivery or rendering of services; (3) the seller’s price to the buyer is fixed or determinable; and (4) reasonable assurance of collectability. The Company records revenue from product sales when the customer takes ownership and assumes risk of loss. Royalty revenue is recognized upon shipment from the manufacturer to the purchaser. Co-promotion revenue is recognized in the period in which the product subject to the arrangement is sold. At the time of sale, estimates for a variety of sales deductions, such as returns on product sales, government program rebates, price adjustments and prompt pay discounts are recorded. |
The following table sets forth the computation of basic and diluted net income per share: |
| | Three Months Ended | | | Nine months ended | |
September 30, | September 30, |
| | 2013 | | | 2012 | | | 2013 | | | 2012 | |
Numerator: | | | | | | | | | | | | |
Net loss | | $ | (6,048,954 | ) | | $ | (270,342 | ) | | $ | (20,064,702 | ) | | $ | -10,911 | |
Denominator: | | | | | | | | | | | | | | | | |
Weighted-average common shares, basic | | | 37,120,890 | | | | 29,069,119 | | | | 36,204,340 | | | | 27,765,275 | |
Dilutive effect of stock options | | ─ | | | ─ | | | ─ | | | | ─ | |
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Weighted-average common shares, diluted | | | 37,120,890 | | | | 29,069,119 | | | | 36,204,340 | | | | 27,765,275 | |
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Net loss per share, basic and diluted | | $ | (0.16 | ) | | $ | (0.01 | ) | | $ | (0.55 | ) | | $ | ─ | |
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The Company’s customers for its products consist of drug wholesalers, retail drug stores, mass merchandisers and grocery store pharmacies in the United States. The Company primarily sells its products directly to large national drug wholesalers, which in turn resell the products to smaller or regional wholesalers, retail pharmacies, chain drug stores, and other third parties. The following tables list the Company’s customers that individually comprised greater than 10% of total gross product sales for the three and nine months ended September 30, 2013 and 2012, or 10% of total accounts receivable as of September 30, 2013 and December 31, 2012. |
| | Three Months Ended | | | Nine months ended | |
September 30, | September 30, |
| | 2013 | | | 2012 | | | 2013 | | | 2012 | |
McKesson Corporation | | | 30% | | | | 29% | | | | 34% | | | | 29% | |
AmerisourceBergen Drug Corporation | | | 26% | | | | 7% | | | | 17% | | | | 11% | |
Cardinal Health, Inc. | | | 22% | | | | 41% | | | | 27% | | | | 36% | |
Walgreens Corporation | | | 5% | | | | 11% | | | | 6% | | | | 7% | |
Total | | | 83% | | | | 88% | | | | 84% | | | | 83% | |
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| | Accounts Receivable | | | | | | | | | |
| | September 30, | | | December 31, | | | | | | | | | |
| | 2013 | | | 2012 | | | | | | | | | |
AmerisourceBergen Drug Corporation | | | 36% | | | | 6% | | | | | | | | | |
McKesson Corporation | | | 29% | | | | 17% | | | | | | | | | |
Cardinal Health, Inc. | | | 14% | | | | 43% | | | | | | | | | |
Walgreens Corporation | | | 3% | | | | 11% | | | | | | | | | |
Total | | | 82% | | | | 77% | | | | | | | | | |
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Other Revenue Sharing Arrangements |
The Company enters into collaborative arrangements to develop and commercialize drug candidates. Collaborative activities might include research and development, marketing and selling (including promotional activities and physician detailing), manufacturing, and distribution. These collaborations often require royalty or profit share payments, contingent upon the occurrence of certain future events linked to the success of the product. Revenues related to products sold by the Company pursuant to these arrangements are included in product sales, while other sources of revenue such as royalties and profit share receipts are included in collaboration, royalty and other revenue as further discussed below. Operating expenses for costs incurred pursuant to these arrangements are reported in their respective expense line item. |
The Company seeks to enter into co-promotion agreements to enhance the promotional efforts and sales of products. The Company may enter into co-promotion agreements whereby it obtains rights to market other parties’ products in return for certain commissions or percentages of revenue on the sales Pernix generates. Alternatively, Pernix may enter into co-promotion agreements with respect to its products whereby it grants another party certain rights to market or otherwise promote one or more of its products. Typically, the Company will enter into this type of co-promotion arrangement when a particular product is not aligned with its product focus or it lacks sufficient sales force representation in a particular geographic area. Co-promotion revenue is included in net revenues. Expense from co-promotion agreements is included in cost of product sales. |
As previously reported, in December 2010, we entered into a joint venture (JV) with infirst+ (formerly SEEK) for the development of BC 1036. On May 14, 2012, the Company acquired the exclusive rights from SEEK, its former joint venture partner, to commercialize and market products utilizing the joint venture’s intellectual property (IP) in the areas of cough, cold, sinus and allergy in the United States and Canada. Effective August 30, 2013, we re-licensed all of our rights to these assets in the United States and licensed the Dr. Cocoa trademark and logo to infirst+ in exchange for a royalty of 5% of net sales in the United States through 2019 and 2.5% of net sales in the United States and Canada from 2020 through 2029. Through our subsidiary, Pernix Manufacturing, we are currently working with infirst+ on a supply agreement to supply certain of infirst+’s manufactured product in the United States. As a result of this transaction, we no longer have any rights to a royalty for products utilizing the IP outside of the United States and Canada. |
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In September 2013, the Company amended the terms of our co-promotion agreement with ParaPRO. ParaPRO will assume responsibility for distribution of NATROBA and related activities, and the Company and its subsidiaries will no longer purchase quantities of NATROBA at a discount for sale to customers. The Company will continue to provide promotion services for NATROBA in its assigned territories for co-promotion fees based on prescriptions generated by its sales force. With respect to generic products covered by the agreement, the Company will continue to provide distribution and co-promotion services for fees based on units distributed and prescriptions dispensed in defined territories. The Company’s management expects the Company’s gross product sales for NATROBA to decrease based on the removal of the distribution-related revenue from the terms of the co-promotion arrangement. However, the Company’s management expects that the corresponding decreases in cost of goods and gross-to-net deductions and other distribution costs will substantially offset this decrease in gross product sales. |
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Cost of Product Sales |
Cost of product sales is comprised of (1) costs to manufacture or acquire products sold to customers; (2) royalty, co-promotion and other revenue sharing payments under license and other agreements granting the Company rights to sell related products; (3) direct and indirect distribution costs incurred in the sale of products; and (4) the value of any write-offs of obsolete or damaged inventory that cannot be sold. The Company acquired the rights to sell certain of its commercial products through license and assignment agreements with the original developers or other parties with interests in these products. These agreements obligate the Company to make payments under varying payment structures based on our net revenue from related products. |
As part of the acquisitions of Cypress and Somaxon, the Company adjusted the predecessor cost basis increasing inventory to fair value as required by ASC 820. As a result, $8,600,000 and $695,000, respectively, was recorded to adjust inventory to fair value. For the three and nine months ended September 30, 2013, approximately $412,000 and $5,123,000, respectively, of the increase in the basis of the inventory was included in cost of product sales. |
Net Revenues |
Product Sales |
The Company recognizes revenue from its product sales in accordance with its revenue recognition policy discussed above. The Company sells its products primarily to large national wholesalers, which have the right to return the products they purchase, and accordingly the Company estimates the amount of future returns at the time of revenue recognition. The Company recognizes product sales net of estimated allowances for product returns, government program rebates, price adjustments, and prompt pay discounts. |
Product Returns |
Consistent with industry practice, the Company offers contractual return rights that allow its customers to return short-dated or expiring products within an 18-month period, commencing from six months prior to and up to twelve months subsequent to the product expiration date. The Company’s products have a 15 to 36-month expiration period from the date of manufacture. The Company adjusts its estimate of product returns if it becomes aware of other factors that it believes could significantly impact its expected returns. These factors include its estimate of inventory levels of its products in the distribution channel, the shelf life of the product shipped, review of consumer consumption data as reported by external information management companies, actual and historical return rates for expired lots, the forecast of future sales of the product, competitive issues such as new product entrants and other known changes in sales trends. The Company estimates returns at percentages up to 10% of sales of branded and generic products and, from time to time, higher return percentages on new product launches. Returns estimates are based upon historical data and other facts and circumstances that may impact future expected returns to derive an average return percentage for our products. The returns reserve may be further adjusted as sales history and returns experience is accumulated on our portfolio of products or as our portfolio of products changes. The Company reviews and adjusts these reserves quarterly. There is a time lag between the date we determine the estimated allowance and when we receive product returns and issue credits to customers. Changes in facts and circumstances arising during this interval may result in adjustments to our estimated allowance being recorded over several periods, which would impact our operating results in those periods. |
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Government Program Rebates |
The liability for Medicaid, Medicare and other government program rebates is estimated based on historical and current rebate redemption and utilization rates contractually submitted by each state’s program administrator and assumptions regarding future government program utilization for each product sold. |
Price Adjustments |
The Company’s estimates of price adjustments, which include customer rebates, managed care rebates, service fees, chargebacks, shelf stock adjustments, coupon redemptions and other fees and discounts, are based on our estimated mix of sales to various third-party payors who are entitled, either contractually or statutorily, to discounts from the listed prices of our products and contracted service fees with our wholesalers. In the event that the sales mix to third-party payors or the contract fees paid to the wholesalers are different from the Company’s estimates, the Company may be required to pay higher or lower total price adjustments and/or incur chargebacks that differ from its original estimates and such difference may be significant. |
The Company’s estimates of discounts are applied pursuant to the contracts negotiated with certain customers and are primarily based on sales volumes. The Company, from time to time, offers certain promotional product-related incentives to its customers. These programs include sample cards to retail consumers, certain product incentives to pharmacy customers and other sales stocking allowances. For example, the Company has initiated coupon programs for certain of its promoted products whereby the Company offers a point-of-sale subsidy to retail consumers. The Company estimates its liabilities for these coupon programs based on redemption information provided by a third party claims processing organization. The Company accounts for the coupon redemption costs of these special promotional programs as price adjustments, resulting in a reduction in gross revenue. The administrative fees related to these programs are accounted for in selling, general and administrative expenses. |
Any price adjustments that are not contractual or are non-recurring but that are offered at the time of sale or when a specific triggering event occurs, such as sales stocking allowances or price protection adjustments, are recorded as a reduction in revenue when the sales order is recorded or when the triggering event occurs. These allowances may be offered at varying times throughout the year or may be associated with specific events such as a new product launch, the reintroduction of a product or product price changes. |
Prompt Payment Discount |
The Company typically requires its customers to remit payments within the first 30 days for branded products and within 60 to 120 days for generics, depending on the customer and the products purchased. The Company offers wholesale distributors a prompt payment discount if they make payments within these deadlines. This discount is generally 2-3%, but may be higher in some instances due to product launches and/or industry expectations. Because the Company’s wholesale customers typically take the prompt pay discount, we accrue 100% of prompt pay discounts. These discounts are based on the gross amount of each invoice at the time of our original sale to them. Earned discounts are applied at the time of payment. This allowance is recorded as a reduction of accounts receivable. |
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Segment Information |
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The Company currently markets two major product lines: a branded pharmaceuticals product line and a generic pharmaceuticals product line. These product lines qualify for reporting as a single segment in accordance with GAAP because they are similar in the nature of the products and services, production processes, types of customers, distribution methods and regulatory environment. The Company has a manufacturing subsidiary but the majority of its revenue is currently generated through intercompany sales and is eliminated in consolidation. Accordingly, it is deemed immaterial for segment reporting purposes. The Company initiated an OTC division in 2012 but this division has not marketed any products to date and, therefore, has no revenue and is currently deemed immaterial for segment reporting purposes. |
Earnings per Share |
Earnings per common share is presented under two formats: basic earnings per common share and diluted earnings per common share. Basic earnings per common share is computed by dividing net income attributable to common shareholders by the weighted average number of common shares outstanding during the period. Diluted earnings per common share is computed by dividing net income by the weighted average number of common shares outstanding during the period, plus the potentially dilutive impact of restricted stock and common stock equivalents (i.e. stock options). Dilutive common share equivalents consist of the incremental common shares issuable upon exercise of stock options and vesting of restricted stock. |
The following table sets forth the computation of basic and diluted net income per share: |
| | Three Months Ended | | | Nine months ended | |
September 30, | September 30, |
| | 2013 | | | 2012 | | | 2013 | | | 2012 | |
Numerator: | | | | | | | | | | | | |
Net loss | | $ | (6,048,954 | ) | | $ | (270,342 | ) | | $ | (20,064,702 | ) | | $ | -10,911 | |
Denominator: | | | | | | | | | | | | | | | | |
Weighted-average common shares, basic | | | 37,120,890 | | | | 29,069,119 | | | | 36,204,340 | | | | 27,765,275 | |
Dilutive effect of stock options | | ─ | | | ─ | | | ─ | | | | ─ | |
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Weighted-average common shares, diluted | | | 37,120,890 | | | | 29,069,119 | | | | 36,204,340 | | | | 27,765,275 | |
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Net loss per share, basic and diluted | | $ | (0.16 | ) | | $ | (0.01 | ) | | $ | (0.55 | ) | | $ | ─ | |
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At September 30, 2013, the Company had 662,788 shares of unvested restricted stock and 1,647,333 total outstanding options of which 837,994 are vested and exercisable. Options and restricted stock not included above are anti-dilutive. See Note 15, Employee Compensation and Benefits, for information regarding the Company’s outstanding options. |
Investments in Marketable Securities and Other Comprehensive Income |
The Company held investments in marketable equity securities as available-for-sale and the change in the market value gives rise to other comprehensive income. The components of other comprehensive income are recorded in the condensed consolidated statements of comprehensive income, net of the related income tax effect. As of September 30, 2013, the Company has liquidated its investments in marketable equity securities as described below. |
On October 5, 2011, the Company acquired 2.6 million shares of TherapeuticsMD for a purchase price of $1.0 million, or $0.38 per share, representing approximately 3.2% of TherapeuticsMD’s outstanding common stock at that time. The Company’s purchase was contingent upon TherapeuticsMD’s acquisition of VitaMedMD, which occurred on October 4, 2011. In connection with the Company’s purchase of shares of TherapeuticsMD, the Company also entered into a software license agreement with VitaMedMD pursuant to which VitaMedMD granted the Company an exclusive license to use certain of its physician, patient and product data gathering software in the field of pediatric medicine for a period of five years for a monthly fee of $21,700. As of September 30, 2013, the Company has not activated this software license agreement and has not paid monthly fees pursuant thereto. Cooper Collins, the Company’s then Chief Executive Officer, was appointed to the board of Therapeutics MD on February 29, 2012. |
On June 14, 2013, the Company sold all its shares of TherapeuticsMD for approximately $4,605,000 in cash proceeds, recognizing a gain on the investment of approximately $3,605,000. Approximately $2,300,000 of the proceeds were utilized to pay down its term loan (See Note 12, Debt). |
Reclassifications |
Certain reclassifications have been made to prior period amounts in our consolidated statements of comprehensive (loss) income to conform to the current period presentation. These reclassifications related to the classification of the cost of samples as a selling expense instead of being included in cost of product sales and the classification of coupon processing and program administrative fees as selling expense instead of being included in net sales. These reclassifications had no effect on net loss as previously reported. |
Recent Accounting Pronouncements |
In July 2013, the Financial Accounting Standards Board issued a clarification regarding the presentation of an unrecognized tax benefit related to a net operating loss carryforward, a similar tax loss, or a tax credit carryforward. Under this new standard, the liability related to an unrecognized tax benefit, or a portion thereof, should be presented in the financial statements as a reduction to a deferred tax asset if available under the tax law of the applicable jurisdiction to settle any additional income taxes that would result from the disallowance of a tax position. Otherwise, the unrecognized tax benefit should be presented in the financial statements as a separate liability. The assessment is based on the unrecognized tax benefit and deferred tax asset that exist at the reporting date. The provisions of the new standard are effective on a prospective basis beginning in 2014 for annual and interim reporting periods. Early adoption is permitted. While we are still determining the impact of this standard on the presentation of both our deferred tax assets and income taxes payable, implementation of the standard will have no impact on our consolidated statements of operations. |
There have been no other recent accounting pronouncements that have not yet been adopted by us that are expected to have a material impact on our condensed consolidated financial statements from the accounting pronouncements previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2012. |
Liquidity and Capital Resources |
The Company’s operations have been financed primarily through revenue from sales of its marketed products, the sale of equity securities, its credit facilities, the proceeds from its sale of assets to Breckinridge and the proceeds from the exercise of warrants and stock options. The Company has incurred losses from operations and negative operating cash flows since June 2012, and it expects to continue to incur losses for the foreseeable future as it continues its commercial activities, commercializes any other products to which it obtains rights or receives regulatory approvals and pursues the development of or acquisition of rights to other products or product candidates. |
In addition, the Company faces the potential for significant cash outflows in the near term based on the contingent consideration and put rights related to our acquisition of Cypress. The Company has initiated the indemnity claim process with the Cypress selling stockholders to obtain financial relief under the original securities purchase agreement which may offset or reduce the amounts of contingent liabilities the Company faces relating to the Cypress acquisition. The Company believes that its claims are well-supported. In the event that the Company is unsuccessful in obtaining a satisfactory outcome with respect to such claims, including any future related litigation that may be undertaken, the Company may be unable to meet certain contingent obligations relating to this matter and the Company's liquidity may be impaired. |
With respect to the Company’s operating obligations that are not related to the Cypress acquisition, the Company intends to rely upon its cash on hand and accounts receivable generated through sales of its products (including those generated during the cold and flu season, when sales of the Company’s cough and cold products have historically trended upward), as well as potential continued cost reductions in its business. However, based on our recurring losses, negative cash flows from operations, financial obligations and working capital levels, the Company may need to raise additional funds to finance its operations. If the Company is unable to maintain sufficient financial resources, including by raising additional funds when needed, the Company’s business, financial condition and results of operations will be materially and adversely affected. |
The Company intends to obtain any additional funding it may require through public or private equity or debt financings, strategic relationships, including the divestiture of non-core assets, assigning receivables, milestone payments or royalty rights, or other arrangements and the Company cannot assure such funding will be available on reasonable terms, or at all. Additional equity financing will be dilutive to stockholders, and debt financing, if available, may involve restrictive covenants. Any exploration of strategic alternatives may not result in an agreement or transaction and, if completed, any agreement or transaction may not be successful or on attractive terms. The inability to enter into a strategic transaction, or a strategic transaction that is not successful or on attractive terms, could accelerate our need for cash and make securing funding on reasonable terms more difficult. In addition, if the Company raises additional funds through collaborations or other strategic transactions, it may be necessary to relinquish potentially valuable rights to its potential products or proprietary technologies, or grant licenses on terms that are not favorable to the Company. |
The Company has an effective shelf registration statement on Form S-3 filed with the SEC under which it may offer from time to time any combination of debt securities, common and preferred stock and warrants. However, the rules and regulations of the SEC or other regulatory agencies may restrict its ability to conduct certain types of financing activities, or may affect the timing of and the amounts it can raise by undertaking such activities. For example, under current SEC regulations, because the aggregate market value of our common stock held by non-affiliates (“public float”) is less than $75 million, the amount that it can raise through primary public offerings of securities in any twelve-month period using one or more registration statements on Form S-3 is limited to an aggregate of one-third of our public float. |
If our efforts in raising additional funds when needed are unsuccessful, the Company may be required to delay, scale-back or eliminate plans or programs relating to our business, relinquish some or all rights to our products or renegotiate less favorable terms with respect to such rights than it would otherwise choose or cease operating as a going concern. In addition, if the Company does not meet its payment obligations to third parties as they come due, the Company may be subject to litigation claims. Even if the Company were successful in defending against these potential claims, litigation could result in substantial costs and be a distraction to management, and may result in unfavorable results that could further adversely impact our financial condition. |
If the Company is unable to continue as a going concern, the Company may have to liquidate its assets and may receive less than the value at which those assets are carried on its financial statements, and it is likely that investors will lose all or a part of their investments. These financial statements do not include any adjustments that might result from the outcome of this uncertainty. |