UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number:
(Exact name of registrant as specified in its charter)
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(Address of principal executive offices, including zip code)
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Securities registered pursuant to Section 12(b) of the Act:
Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Sections 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer | ☐ | Accelerated filer | ☐ | |
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☒ | Smaller reporting company |
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Emerging growth company |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
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The number of shares outstanding of the issuer’s common stock, par value $0.0001 per share, as of November 22, 2021, was
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ADAMIS PHARMACEUTICALS CORPORATION AND SUBSIDIARIES
CONTENTS OF QUARTERLY REPORT ON FORM 10-Q
2 |
Summary of Material Risks Associated With Our Business
The business of Adamis Pharmaceuticals Corporation (“we,” “us,” “our,” “Adamis,” or the “company”) is subject to numerous risks and uncertainties that you should be aware of before making an investment decision, including those highlighted in the section entitled “Risk Factors.” These risks include, but are not limited to, the following:
● | There is substantial doubt about our ability to continue as a going concern. We have incurred significant losses since our inception, anticipate that we will continue to incur losses in 2021, and may continue to incur losses in the future. We may never achieve or sustain profitability. |
● | Statements in this Report concerning our future plans and operations are dependent on our having adequate funding and the absence of unexpected delays or adverse developments. We may require additional financing in the future and may not be able to secure required funding, which could force us to delay, reduce or eliminate our commercialization efforts or product development programs and could cause us to cease operations. |
● | We may never commercialize additional product candidates that are subject to regulatory approval or earn a profit. |
● | Several of our potential products and technologies are in early stages of development, or have been discontinued or are suspended. |
● | Our development plans concerning our products and product candidates are affected by many factors, the outcome of which are difficult to predict. |
● | We could experience delays in the commencement or completion of clinical testing of our product candidates, which could result in increased costs and delays and adversely affect our business and financial condition. We may be required to suspend, repeat or terminate our clinical trials if trials are not well designed, do not meet regulatory requirements or the results are negative or inconclusive. |
● | We are subject to the risk of lawsuits or other legal proceedings. |
● | We are subject to substantial government regulation, which could materially adversely affect our business. We may encounter difficulties or delays in applying for or obtaining regulatory approval for our products. If we do not receive required regulatory approvals for our products, we may not be able to develop and commercialize our products or technologies. |
● | Even if they are approved and commercialized, our potential products may not be able to compete effectively with other products targeting similar markets. |
● | Our failure to adequately protect or to enforce our intellectual property rights or secure rights to third party patents or other intellectual property rights could materially harm our proprietary position in the marketplace or prevent the commercialization of our products. We may become involved in patent litigation or other intellectual property proceedings, which could result in liability for damages and have a material adverse effect on our business and financial position. |
● | If we determine that our intangible assets or other assets have become impaired, our total assets and financial results could be adversely affected. |
● | We borrowed funds pursuant to the Paycheck Protection Program. Even though our loans have been forgiven pursuant to the program, we remain subject to possible review and audit in connection with such loans. | |
● | Our business is impacted by state and federal statutes and regulations. | |
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Our US Compounding Inc. subsidiary, or USC, which is registered as a human drug compounding outsourcing facility under Section 503B of the U.S. Food, Drug & Cosmetic Act, as amended, or FDCA, is subject to many federal, state and local laws, regulations, and administrative practices, including, among others: federal registration as an outsourcing facility, state and local licensure, and registration requirements concerning the operation of outsourcing facilities and the compounding, labeling, marketing, sale and distribution of products from our registered outsourcing facility. Effective as of July 30, 2021, we entered into an asset purchase agreement pursuant to which we sold and transferred certain assets of USC related to its human compounding pharmaceutical business, and we have approved a restructuring pursuant to which the remaining operations and business of USC will be wound down and wound up and assets relating to USC’s business will be sold or otherwise disposed of. Nevertheless, USC and we could become involved in proceedings with the U.S. Food & Drug Administration, or FDA , or other federal or state regulatory authorities alleging non-compliance with applicable federal or state regulatory legal requirements, which could adversely affect our business, financial condition and results of operations. |
3 |
● | We have received a grand jury subpoena issued in connection with a criminal investigation. As we have previously disclosed, on May 11, 2021, each of the company and our USC subsidiary received a grand jury subpoena from the U.S. Attorney’s Office (“USAO”) for the Southern District of New York issued in connection with a criminal investigation, requesting a broad range of documents and materials relating to, among other matters, certain veterinary products sold by the company’s USC subsidiary, certain practices, agreements and arrangements relating to products sold by USC, including veterinary products, and certain regulatory and other matters relating to the company and USC. The Audit Committee of the board of directors (the “Board”) has engaged outside counsel to conduct an independent internal investigation to review these and other matters. The company has also received a request from the Securities and Exchange Commission (“SEC”) that the company voluntarily provide documents and information relating to certain matters including the subject matter of the subpoena from the USAO. The Company has produced and will continue to produce and provide documents in response to the subpoena and requests. The company intends to cooperate with the USAO and SEC. At this time, the company is unable to determine what, if any, additional actions the USAO, SEC or other federal or state authorities may take, what, if any, remedies or remedial measures the USAO, SEC or other federal or state authorities may seek, or what, if any, impact the foregoing matters may have on the Company’s business, previously reported financial results, financial results included in this Report, or future financial results. We could receive additional requests from the USAO, SEC or other authorities, which may require further investigation. The foregoing matters may divert management’s attention, cause the company to suffer reputational harm, require the company to devote significant financial resources, subject the company and its officers and directors to civil or criminal proceedings, and depending on the resolution of the matters or any proceedings, result in fines, penalties, equitable remedies, and affect the company’s business, previously reported financial results, financial results included in this Report, future financial results. The occurrence of any of these events could have a material adverse effect on the company’s business, financial condition and results of operations. | |
● | Changes in healthcare laws could adversely affect the ability or willingness of customers to purchase our products and, as a result, adversely impact our business and financial results. | |
● | We identified a material weakness in our internal control over financial reporting, concluded that our internal control over financial reporting was not effective and that our disclosure controls and procedures were not effective at the reasonable assurance level, and restated our unaudited condensed consolidated financial statements for the periods ended March 31, 2020, June 30, 2020, and September 30, 2020, which may lead to additional risks and uncertainties, including loss of investor confidence, legal investigations or proceedings, and negative impacts on our business, financial condition and stock price. In addition, we identified a material weakness in our internal control over financial reporting and concluded that our internal control over financial reporting was not effective as of March 31, 2021, June 30, 2021 and September 30, 2021. If we fail to effectively remediate material weaknesses in our internal control over financial reporting, it could continue to adversely affect our ability to report our results of operations and financial condition accurately and in a timely manner. |
● | Our business depends on complex information systems, and any failure to successfully maintain these systems or implement new systems to handle our changing needs could materially harm our operations. Cybersecurity or other system failures could disrupt our business, result in liabilities, and adversely affect our business, financial condition and results of operations. | |
● | Provisions of our charter documents could discourage an acquisition of our company that would benefit our stockholders and may have the effect of entrenching, and making it difficult to remove, management. | |
● | Our failure to meet the continued listing requirements of Nasdaq could result in a delisting of our common stock, which could negatively impact the market price and liquidity of our common shares and our ability to access the capital markets. |
4 |
ADAMIS PHARMACEUTICALS CORPORATION AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
March 31, 2021 | ||||||||
(Unaudited) | December 31, 2020 | |||||||
ASSETS | ||||||||
CURRENT ASSETS | ||||||||
Cash and Cash Equivalents | $ | $ | ||||||
Accounts Receivable, net | ||||||||
Inventories | ||||||||
Prepaid Expenses and Other Current Assets | ||||||||
Total Current Assets | ||||||||
LONG TERM ASSETS | ||||||||
Intangible Assets, net | ||||||||
Goodwill | ||||||||
Fixed Assets, net | ||||||||
Right-of-Use Assets | ||||||||
Other Non-Current Assets | ||||||||
Total Assets | $ | $ | ||||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
CURRENT LIABILITIES | ||||||||
Accounts Payable | $ | $ | ||||||
Deferred Revenue, current portion | ||||||||
Accrued Other Expenses | ||||||||
Accrued Bonuses | ||||||||
Contingent Loss Liability | |
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Lease Liabilities, Current Portion | ||||||||
Bank loans - Building, current portion | |
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Paycheck Protection Plan (PPP) Loan , current portion | ||||||||
Total Current Liabilities | ||||||||
LONG TERM LIABILITIES | ||||||||
Deferred Revenue, net of current portion | ||||||||
Deferred Tax Liability, net | ||||||||
Lease Liabilities, net of current portion | |
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PPP Loan, net of current portion | ||||||||
Warrant Liabilities, at fair value | ||||||||
Total Liabilities | ||||||||
COMMITMENTS AND CONTINGENCIES, see Note 9 | ||||||||
STOCKHOLDERS’ EQUITY | ||||||||
Preferred Stock – Par Value $ ; Shares Authorized; Series A-1 and Series A-2 Convertible, shares Issued and Outstanding at March 31, 2021 (Unaudited) and December 31, 2020, respectively. | ||||||||
Common Stock - Par Value $ ; Shares Authorized; and Issued; and Outstanding at March 31, 2021 (Unaudited) and December 31, 2020, respectively | ||||||||
Additional Paid-in Capital | ||||||||
Accumulated Deficit | ( |
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Treasury Stock - Shares, at cost | ( |
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Total Stockholders’ Equity | ||||||||
Total Liabilities and Stockholders’ Equity | $ | $ |
The accompanying notes are an integral part of these Condensed Consolidated Financial Statements
5 |
ADAMIS PHARMACEUTICALS CORPORATION AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Three Months Ended March 31, | ||||||||
2021 | 2020 | |||||||
(Unaudited) | ||||||||
REVENUE, net | $ | $ | ||||||
COST OF GOODS SOLD | ||||||||
Gross Profit | ||||||||
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES |
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RESEARCH AND DEVELOPMENT |
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IMPAIRMENT EXPENSE - Goodwill | ||||||||
Loss from Operations | ( |
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OTHER INCOME (EXPENSE) | ||||||||
Interest Expense | ( |
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Other Income | |
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Change in Fair Value of Warrants | ( |
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Total Other Income (Expense), net | ( |
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Net (Loss) | $ | ( |
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Basic and Diluted (Loss) Per Share | $ | ( |
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Basic and Diluted Weighted Average Shares Outstanding |
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The accompanying notes are an integral part of these Condensed Consolidated Financial Statements
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ADAMIS PHARMACEUTICALS CORPORATION AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
Three Months Ended March 31, 2021 (Unaudited) | Series A-2 Convertible
Preferred Stock |
Common Stock | Additional
Paid-In |
Treasury Stock | Accumulated | |||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Capital | Shares | Amount | Deficit | Total | ||||||||||||||||||||||||||||
Balance December 31, 2020, as reported | — | $ | $ | $ | $ | ( |
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Adjustment, Conversion of 2019 Warrants Liability upon Adoption of ASU 2020-06 | — | — | — | ( |
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Balance December 31, 2020, as adjusted | — | ( |
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Common Stock Issued, Net of Issuance Costs of $
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Exercise of Warrants | — | — | |
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Issuance of Restricted Stock Units (RSUs) | — | ( |
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Share Based Compensation | — | — | — | |||||||||||||||||||||||||||||||||
Net (Loss) | — | — | ( |
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Balance March 31, 2021 | — | $ | $ | $ | $ | ( |
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Three Months Ended March 31, 2020 (Unaudited) | Series A-2 Convertible
Preferred Stock |
Common Stock | Additional
Paid-In |
Treasury Stock | Accumulated | |||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Capital | Shares | Amount | Deficit | Total | ||||||||||||||||||||||||||||
Balance December 31, 2019 | — | $ | $ | $ | $ | ( |
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Common Stock Issued, Net of Issuance Costs of $
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— | — | ||||||||||||||||||||||||||||||||||
Issuance of Restricted Stock Units (RSUs) | — | ( |
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Issuance of 2020 Warrants | — | — | ( |
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Share Based Compensation | — | — | — | |||||||||||||||||||||||||||||||||
Net (Loss) | — | — | ( |
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Balance March 31, 2020 | — | $ | $ | $ | $ | ( |
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The accompanying notes are an integral part of these Condensed Consolidated Financial Statements
7 |
ADAMIS PHARMACEUTICALS CORPORATION AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
Three Months Ended March 31, | ||||||||
2021 | 2020 | |||||||
(Unaudited) | (Unaudited) | |||||||
CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||
Net (Loss) | $ | ( |
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( |
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Adjustments to Reconcile Net (Loss) to Net | ||||||||
Cash (Used in) Operating Activities: | ||||||||
Stock Based Compensation |
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Change in Fair Value of Warrant Liability | ( |
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Provision for Bad Debts | ||||||||
Provision for Excess and Obsolete Inventory | |
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Non-Cash Operating Lease Expense | ( |
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Depreciation and Amortization Expense |
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Impairment of Goodwill |
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Change in Operating Assets and Liabilities: | ||||||||
Accounts Receivable - Trade | ( |
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Inventories, net | ( |
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Prepaid Expenses and Other Current Assets | ||||||||
Accounts Payable | ( |
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Deferred Revenue | ( |
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Accrued Other Expenses and Bonuses |
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Net Cash (Used in) Operating Activities | ( |
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( |
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CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||
Purchase of Equipment | ( |
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Net Cash (Used in) Investing Activities | ( |
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CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||
Proceeds from Issuance of Common Stock | ||||||||
Costs of Issuance of Common Stock | ( |
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Proceeds from Exercise of Warrants | ||||||||
Proceeds of PPP Loan | |
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Principal Payment of Finance Leases | ( |
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Payment of Bank Loans | ( |
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Net Cash Provided by Financing Activities |
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Increase in Cash and Cash Equivalents |
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Cash and Cash Equivalents: | ||||||||
Beginning Cash and Cash Equivalents | ||||||||
Ending Cash and Cash Equivalents | $ | $ |
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The accompanying notes are an integral part of these Condensed Consolidated Financial Statements
8 |
ADAMIS PHARMACEUTICALS CORPORATION AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
Three Months Ended March 31, | ||||||||
2021 | 2020 | |||||||
(Unaudited) | (Unaudited) | |||||||
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION | ||||||||
Cash Paid for Interest | $ | $ | ||||||
SUPPLEMENTAL DISCLOSURE OF NON-CASH FINANCING AND INVESTING ACTIVITIES | ||||||||
Increase (Decrease) in Accrued Capital Expenditures | $ | $ | ( |
) |
The accompanying notes are in an integral part of these Condensed Consolidated Financial Statements
9 |
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
Note 1: Basis of Presentation
The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X promulgated by the Securities and Exchange Commission (“SEC”). Accordingly, certain information and footnote disclosures normally included in annual financial statements have been condensed or omitted. In the opinion of management, the accompanying unaudited interim condensed consolidated financial statements reflect all adjustments (including normal recurring adjustments and the elimination of intercompany accounts) considered necessary for a fair statement of all periods presented. The results of operations of Adamis Pharmaceuticals Corporation (“the Company”) for any interim periods are not necessarily indicative of the results of operations for any other interim periods or for a full fiscal year. These unaudited interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and footnotes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 (the “2020 Form 10-K”).
On January 30, 2020, the World Health Organization (“WHO”) declared that the novel coronavirus (COVID-19) outbreak was a global health emergency, which prompted national governments to begin putting actions in place to slow the spread of COVID-19. In March 2020, the WHO classified the COVID-19 outbreak as a pandemic. The outbreak of COVID-19 has resulted in travel restrictions, quarantines, “stay-at-home” and “shelter-in-place” orders and extended shutdown of certain businesses around the world. The governmental actions and the widespread disruptions arising from the pandemic have adversely affected certain aspects of our business. The extent and duration of the pandemic is unknown, and the future effects on our business are uncertain and difficult to predict, including in light of recent new variants of the virus. The Company is continuing to monitor the events and circumstances surrounding the COVID-19 pandemic, which may require adjustments to the Company’s estimates and assumptions in the future.
Segment Reporting
Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic No. 280, Segment Reporting (“ASC 280”), establishes standards for the way that public business enterprises report information about operating segments in their annual consolidated financial statements and requires that those enterprises report selected information about operating segments in interim financial reports. ASC 280 also establishes standards for related disclosures about products and services, geographic areas and major customers. The Company’s business segments are based on the organization structure used by the chief operating decision maker for making operating and investment decisions and for assessing performance. Commencing April 1, 2020, our management, including the chief executive officer, who is our chief operating decision maker (“CODM”), began managing our operations as operating in two business segments: Drug Development and Commercialization which includes without limitation out-licensing the Company’s FDA approved products; and Compounded Pharmaceuticals which includes the Company’s registered outsourcing facility, based on changes to the way that management monitors performance, aligns strategies, and allocates resources results. We determined that each of these operating segments represented a reportable segment. These consolidated financial statements and related footnotes, including prior year financial information, are presented as if there were two reporting segments for all periods presented, to the extent described in Note 12. We are a specialty biopharmaceutical company focused on developing products in various therapeutic areas, including allergy, opioid overdose, respiratory and inflammatory disease; and a registered drug compounding outsourcing facility, which compounds sterile prescription medications and certain nonsterile preparations and compounds for human and veterinary use by patients, physician clinics, hospitals, surgery centers, vet clinics and other clients throughout most of the United States.
Liquidity and Capital Resources
The Company’s cash and cash equivalents were $
The Company prepared the condensed consolidated financial statements assuming that the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities during the normal course of business. In preparing these condensed consolidated financial statements, consideration was given to the Company’s future business as described below, which may preclude the Company from realizing the value of certain assets.
The Company has significant operating cash flow deficiencies. Additionally, the Company may need additional funding in the future to help support commercialization of its products and conduct the clinical and regulatory activities relating to the Company’s product candidates, satisfy existing obligations and liabilities, and otherwise support the Company’s intended business activities and working capital needs. The preceding conditions raise substantial doubt about the Company’s ability to continue as a going concern. The condensed consolidated financial statements for the three months ended March 31, 2021, were prepared under the assumption that we would continue our operations as a going concern, which contemplates the realization of assets and the satisfaction of liabilities during the normal course of business. Our unaudited condensed consolidated financial statements do not include any adjustments that may result from the outcome of this uncertainty. Management’s plans include attempting to secure additional required funding through equity or debt financings, sales or out-licensing of intellectual property or other assets, products, product candidates or technologies, seeking partnerships with other pharmaceutical companies or third parties to co-develop and fund research and development efforts, or similar transactions, and through revenues from existing agreements and sales of prescription compounded formulations. There is no assurance that the Company will be successful in obtaining the necessary funding to meet its business objectives. In addition, the COVID-19 pandemic has had an adverse impact on the Company. A severe or prolonged economic downturn or political disruption could result in a variety of risks to our business, including our ability to raise capital when needed on acceptable terms, if at all.
10 |
The Company computes basic loss per share by dividing the loss attributable to holders of common stock for the period by the weighted average number of shares of common stock outstanding during the period. The diluted loss per share calculation is based on the treasury stock method and gives effect to dilutive options, warrants and other potential dilutive common stock. The effect of common stock equivalents was anti-dilutive and was excluded from the calculation of weighted average shares outstanding. Potential dilutive securities, which are not included in diluted weighted average shares outstanding for the three months ended March 31, 2021 and March 31, 2020, consist of outstanding equity classified warrants shares and shares, respectively, outstanding options shares and shares, respectively, and outstanding restricted stock units shares and shares, respectively.
Recently Adopted Accounting Pronouncement
Accounting Standards Update (“ASU”) 2020-06—Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, simplifies accounting for convertible instruments by removing major separation models required under current Generally Accepted Accounting Principles (GAAP). Consequently, more convertible debt instruments will be reported as a single liability instrument and more convertible preferred stock as a single equity instrument with no separate accounting for embedded conversion features. The ASU removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception, which will permit more equity contracts to qualify for it. The ASU also simplifies the diluted earnings per share (EPS) calculation in certain areas. The amendments in this update are effective for public business entities that meet the definition of a Securities and Exchange Commission (SEC) filer, excluding entities eligible to be smaller reporting companies as defined by the SEC, for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. For all other entities, the amendments are effective for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. The Company has adopted early ASU 2020-06 applying the modified retrospective approach. The early adoption is expected to affect warrants and warrants liabilities as noted below.
The Company has issued and outstanding warrants that contain certain clauses that may require cash settlement in certain circumstances. As of December 31, 2020, the Company had Warrant Liabilities of $
11 |
Note 2: Revenues
Revenue Recognition
Revenue is recognized pursuant to ASC Topic 606, “Revenue from Contracts with Customers” (ASC 606). Accordingly, revenue is recognized at an amount that reflects the consideration to which the Company expects to be entitled in exchange for transferring goods or services to a customer. This principle is applied using the following 5-step process:
1. | Identify the contract with the customer | |
2. | Identify the performance obligations in the contract | |
3. | Determine the transaction price | |
4. | Allocate the transaction price to the performance obligations in the contract | |
5. | Recognize revenue when (or as) each performance obligation is satisfied |
Adamis is a specialty biopharmaceutical company focused on developing and commercializing products in various therapeutic areas, including allergy, opioid overdose, respiratory and inflammatory disease. The Company’s subsidiary US Compounding, Inc. or USC, provides compounded sterile prescription medications and certain nonsterile preparations and compounds, for human and veterinary use by patients, physician clinics, hospitals, surgery centers, vet clinics and other clients throughout most of the United States. USC’s product offerings broadly include, among others, corticosteroids, hormone replacement therapies, hospital outsourcing products, and injectables.
Adamis and USC have contracts with customers when (i) the Company enters into an enforceable contract with a customer that defines each party’s rights regarding the goods or services to be transferred and identifies the related payment terms, (ii) the contract has commercial substance, and (iii) the Company determines that collection of substantially all consideration for goods and services that are transferred is probable based on the customer’s intent and ability to pay the promised consideration.
12 |
Compounded Pharmaceuticals Facility Revenue Recognition
With respect to sales of prescription compounded medications by the Company’s USC subsidiary, revenue arrangements consist of a single performance obligation which is satisfied at the point in time when goods are delivered to the customer. The transaction price is determined based on the consideration to which the Company will be entitled in exchange for transferring goods and services to the customer which is the price reflected in the individual customer’s order. Additionally, the transaction price for medication sales is adjusted for estimated product returns that the Company expects to occur under its return policy. The estimate is based upon historical return rates, which has been immaterial.
Drug Development and Commercialization Revenue Recognition
Sandoz
See Note 5 to our consolidated financial statements in the 2020 Form 10-K for information relating to our exclusive distribution and commercialization agreement dated as of July 1, 2018 with Sandoz Inc. (the “Sandoz Agreement”), which was terminated pursuant to a termination agreement entered into on May 11, 2020.
USWM
The Company has determined that there are two performance obligations in its exclusive distribution and commercialization agreement (the “USWM Agreement”) with USWM, LLC (“USWM” or “US WorldMeds”): (i) the manufacture and supply of SYMJEPI and ZIMHI products to USWM; and (ii) the exclusive distribution and commercialization in the United States.
Revenues from the manufacture and supply of SYMJEPI™ and ZIMHI™ are recognized at a point in time upon delivery to USWM. The right of exclusive distribution and commercialization is considered a symbolic license and will be recognized over time over the life of the contract. The Company believes that due to ongoing efforts to comply with regulations that a performance obligation continues to exist over the life of the contract. Under the terms of the USWM Agreement, the Company is entitled to receive various amounts and milestone payments, including: (1) certain non-refundable up-front fees for executing the agreement and regulatory milestone payments, both of which will be recognized over the expected customer life, estimated to be equal to the initial
Practical Expedients
As part of the adoption of the ASC Topic 606, the Company elected to use the following practical expedients: (i) incremental costs of obtaining a contract in the form of sales commissions are expensed when incurred because the amortization period would have been one year or less. These costs are recorded within Selling, General and Administrative expenses; (ii) taxes collected from customers and remitted to government authorities and that are related to the sales of the Company’s products, are excluded from revenues; and (iii) shipping and handling activities are accounted for as fulfillment costs and recorded in cost of sales.
13 |
Disaggregation of Revenue
Our sterile environment operations are governed by specific regulatory and quality requirements. Any deviation from these standards could result in a stoppage of operations, recall of products, and a significant reduction in revenues. The Company outsources the manufacturing of the SYMJEPI product to third party manufacturers who bear the responsibility of maintaining a suitable environment as governed by specific regulatory and quality requirements.
The following table presents the Company’s revenues disaggregated by outsourced manufacturing, sterile and non-sterile regulatory environments for the three months ended March 31, 2021 and 2020.
Three Months Ended | Three Months Ended | |||||||
March 31, 2021 | March 31, 2020 | |||||||
Drug Development & Commercialization: | ||||||||
Outsourced Manufacturing | $ | $ | ||||||
Compounded Pharmaceuticals: | ||||||||
Sterile | ||||||||
Non-Sterile | ||||||||
Total Compounded Pharmaceuticals Revenues | ||||||||
Total | $ | $ |
The Company’s revenues relating to its FDA approved product SYMJEPI are dependent on an exclusive distribution agreement with USWM, which replaced the previous Sandoz Agreement in May 2020, and the Company’s pharmacy formulations rely, in large part, on sales generated from clinics and hospital customers. Adverse economic conditions pose a risk that the Company’s customers may reduce or cancel spending, which would impact the Company’s revenues. The COVID-19 outbreak has adversely affected revenues from sales of USC products, in part due to reductions or cancellations of elective surgeries and reduction in office visits to physicians’ offices, healthcare facilities or clinics by patients, and the resulting decreased demand by USC’s customers for certain of USC’s products, and will likely continue to adversely affect revenues from sales of USC products for a period of time which cannot be predicted.
The following table presents the Company’s revenue disaggregated by end market for the three months ended March 31, 2021 and 2020.
Three Months Ended | Three Months Ended | |||||||
March 31, 2021 | March 31, 2020 | |||||||
Drug Development & Commercialization: | ||||||||
Distribution Channel | $ | $ | ||||||
Compounded Pharmaceuticals: | ||||||||
Clinics/Hospitals | ||||||||
Direct to Patients | ||||||||
Total Compounded Pharmaceuticals Revenues | ||||||||
Total | $ | $ |
Deferred Revenue
Deferred Revenue are contract liabilities that the Company records when cash payments are received or due in advance of the Company’s satisfaction of performance obligations. The Company’s performance obligation is met when control of the promised goods is transferred to the Company’s customers. For the three months ended March 31, 2021 and 2020, $
14 |
Cost to Obtain a Contract
The Company capitalizes incremental costs of obtaining a contract with a customer if the Company expects to recover those costs and that it would not have been incurred if the contract had not been obtained. The deferred costs, reported in the prepaid expenses and other current assets and other non-current assets on the Company’s Consolidated Balance Sheets, will be amortized over the economic benefit period of the contract.
In 2018, the Company capitalized the $
Note 3: | Inventories |
Inventories at March 31, 2021 and December 31, 2020 consisted of the following:
March 31, 2021 | December 31, 2020 | |||||||
Finished Goods | $ |
|
$ |
|
||||
Work-in-Process |
|
|||||||
Devices & Raw Materials |
|
|
||||||
$ |
|
$ |
|
Reserve for obsolescence as of March 31, 2021 and December 31, 2020 was approximately $
Note 4: | Fixed Assets |
Fixed assets at March 31, 2021 and December 31, 2020 are summarized in the table below:
Description |
Useful Life
(Years) |
March 31,
2021 |
December 31,
2020 |
|||||||||
Building |
|
$ |
|
$ |
|
|||||||
Machinery and Equipment |
|
|
|
|||||||||
Furniture and Fixtures |
|
|
|
|||||||||
Automobile |
|
|
|
|||||||||
Leasehold Improvements |
|
|
|
|||||||||
Total Fixed Assets |
|
|
||||||||||
Less: Accumulated Depreciation |
( |
) |
( |
) | ||||||||
Land |
|
|
||||||||||
Construction In Progress - Equipment |
|
|
||||||||||
Fixed Assets, net | $ |
|
$ |
|
For the three months ended March 31, 2021 and 2020, depreciation expense was approximately $
15 |
Note 5: | Goodwill and Intangible Assets |
Intangible assets at March 31, 2021 and December 31, 2020 are summarized in the tables below:
March 31, 2021 | Gross
Carrying Value |
Accumulated
Amortization |
Net Carrying
Amount |
||||||||||
Definite-lived Intangible assets, estimated lives in years: | |||||||||||||
FDA 503B Registration & Compliance - USC, |
$ |
|
$ |
( |
) | $ |
|
||||||
Customer Relationships - USC, |
|
( |
) | ||||||||||
Total Definite-lived Assets |
|
( |
) |
|
|||||||||
Trade Name and Brand - USC, Indefinite |
|
— |
|
||||||||||
SYMJEPI Domain Name |
|
— |
|
||||||||||
Balance, March 31, 2021 | $ |
|
$ |
( |
) | $ |
|
December 31, 2020 | Gross
Carrying Value |
Accumulated
Amortization |
Impairment | Net Carrying
Amount |
|||||||||||
Definite-lived Intangible assets, estimated lives in years: | |||||||||||||||
Patents, Taper DPI Intellectual Property, |
$ |
|
$ |
( |
) | $ | ( |
) | $ | — | |||||
FDA 503B Registration & Compliance - USC, |
|
( |
) | — |
|
||||||||||
Customer Relationships - USC, |
|
( |
) | — |
|
||||||||||
Website Design- USC, |
|
( |
) | — | — | ||||||||||
Total Definite-lived Assets |
|
( |
) | ( |
) |
|
|||||||||
Trade Name and Brand - USC, Indefinite |
|
— | — |
|
|||||||||||
SYMJEPI Domain Name |
|
— | — |
|
|||||||||||
Balance, December 31, 2020 | $ |
|
$ |
( |
) | $ | ( |
) | $ |
|
Amortization expense for the three months ended March 31, 2021 and 2020 was approximately $
Estimated amortization expense of definite-lived intangible assets at March 31, 2021 for each of the five succeeding years and thereafter is as follows:
Year ending December 31, | ||||||
Remainder of 2021 | $ |
|
||||
2022 |
|
|||||
2023 |
|
|||||
2024 |
|
|||||
2025 |
|
|||||
Thereafter |
|
|||||
Total | $ |
|
||||
16 |
We have two operating segments and two reporting units. During the three months ended March 31, 2020, COVID-19 spread across the globe and adversely impacted economic growth, including as a result of government mandated shut-downs, stay-at-home policies and social distancing efforts intended to mitigate the spread of the virus. In light of the current economic downturn, that we believe affected the trading prices of our common stock, we determined that it was more likely than not that the fair value of our reporting unit was less than its carrying value. This triggered the Company to perform an interim impairment assessment to test the carrying value of goodwill, all of which is related to the Compounded Pharmaceuticals reporting unit, as of March 31, 2020. We also performed our annual impairment testing related to our Compounded Pharmaceuticals reporting unit as of December 31, 2020. The results of the annual impairment test indicated that the estimated fair value of the reporting unit was less than its carrying value. This was primarily due to a decline in projected net cash flows as a result of the continued impact of COVID-19 on revenue and related cash flows.
For both the interim and annual impairment assessments, the Company utilized a combination of the market-based approach and income approach to determine the fair value of our Compounded Pharmaceuticals business segment. Our quantitative assessments utilized a market-based approach and assessed guideline publicly traded companies operating in the drug manufacturing and compounding industry in the healthcare sector that are similar from an investment standpoint to the Company. The income approach required management to estimate the future cash flows related to our reporting unit and included an adjustment to the discount rate for a company specific risk premium to account for the increased risk to future cash flows in the current environment. As a result of these analyses, the carrying value of our reporting unit exceeded the fair value by approximately $
The carrying value of the Company’s goodwill as of March 31, 2021 and December 31, 2020 was approximately $ .
Change in the carrying amount of goodwill consist of the following activity:
Amount | ||||||
Balance, December 31, 2019 |
$ | |||||
Less: March 31, 2020 Impairment |
( |
) | ||||
Less: December 31, 2020 Impairment |
( |
) | ||||
Balance, December 31, 2020 |
$ | |||||
Balance, March 31, 2021 |
$ |
17 |
Note 6: Leases
The Company has three operating leases, one for an office space, another for an office space and manufacturing facility, and one for office equipment; and one finance lease for plant equipment. As of March 31, 2021, the leases have remaining terms between less than
The tables below present the operating and financing lease assets and liabilities recognized on the condensed consolidated balance sheets as of March 31, 2021 and December 31, 2020:
Right-of Use Assets | March 31, 2021 | December 31, 2020 | ||||||
Operating Leases | $ | $ | |
|||||
Financing Leases | |
|||||||
$ | $ | |
Lease Liabilities, Current | March 31, 2021 | December 31, 2020 | ||||||
Operating Leases | $ | $ | |
|||||
Financing Leases | |
|||||||
$ | $ | |
||||||
Lease Liabilities, Non-Current | ||||||||
Operating Leases | $ | $ | |
|||||
Total Lease Liabilities |
The amortizable lives of operating and financing leased assets are limited by the expected lease term.
The Company’s leases generally do not provide an implicit rate, and therefore the Company uses its incremental borrowing rate as the discount rate when measuring operating and financing lease liabilities. The incremental borrowing rate represents an estimate of the interest rate the Company would incur at lease commencement to borrow an amount equal to the lease payments on a collateralized basis over the term of a lease within a particular currency environment. The Company used incremental borrowing rates as of January 1, 2019 for leases that commenced prior to that date.
The Company’s weighted average remaining lease term and weighted average discount rate for operating and financing leases as of March 31, 2021 and December 31, 2020 are:
March 31, 2021 | Operating | Financing | ||||||
Weighted Average Remaining Lease Term |
|
|
||||||
Weighted Average Discount Rate | % | % |
December 31, 2020 | Operating | Financing | ||||||
Weighted Average Remaining Lease Term |
|
|
||||||
Weighted Average Discount Rate | % | % |
The table below reconciles the undiscounted future minimum lease payments (displayed by year and in the aggregate) under non-cancelable leases with terms of more than one year to the total lease liabilities recognized on the condensed consolidated balance sheets as of March 31, 2021:
Year Ending December 31, | Operating | Financing | ||||||
Remainder of 2021 | $ | $ | ||||||
2022 | ||||||||
2023 | |
|||||||
2024 | ||||||||
2025 | ||||||||
Undiscounted Future Minimum Lease Payments | ||||||||
Less: Difference between undiscounted lease payments and discounted lease liabilities | ||||||||
Total Lease Liabilities | $ | $ | ||||||
Short-Term Lease Liabilities | $ | $ | ||||||
Long-Term Lease Liabilities | $ | $ |
18 |
Operating lease expense was approximately $
Amortization expenses related to our financing leases for the three months ended March 31, 2021 and 2020 was approximately $
Cash paid for amounts included in the measurement of operating lease liabilities were approximately $
Note 7: Debt
Building Loan
In connection with the closing of the acquisition of USC by the Company in April 2016 and the agreements relating to the transaction, an entity of which certain then-current or former officers, or stockholders, of USC were members, agreed to sell to the Company, the building and property owned by the entity on which USC’s offices are located, in consideration of the Company being added as an additional “borrower” and assuming the obligations under the loan agreement, promissory note and related loan documents that the entity and certain other parties previously entered into with First Federal Bank or its successor Bear State Bank (together with Arvest Bank, as successor in interest to Bear State Bank, referred to as “Lender” or the “Bank”).
On November 10, 2016, a Loan Amendment and Assumption Agreement was entered with into the Bank. Pursuant to the agreement, as subsequently amended, the Company agreed to pay the Bank monthly payments of principal and interest which currently are approximately $
As of March 31, 2021 and December 31, 2020, the outstanding principal balance owed on the applicable note was approximately $
First Draw Paycheck Protection Program Loan
On April 13, 2020, the Company received $
Under the terms of the Note and the PPP Loan, interest accrues on the outstanding principal at the rate of
The CARES Act and the PPP provide a mechanism for forgiveness of up to the full amount borrowed. Under the PPP, the Company may apply for and be granted forgiveness for all or part of the PPP Loan. The amount of loan proceeds eligible for forgiveness is based on a formula that takes into account a number of factors, including the amount of loan proceeds used by the Company during a specified period after the loan origination for certain purposes including payroll costs, interest on certain mortgage obligations, rent payments on certain leases, and certain qualified utility payments, provided that at least
19 |
The Note may be prepaid in part or in full, at any time, without penalty. The Company may prepay
Second Draw PPP Loan
On March 15, 2021, the Company entered into a Note (the “PPP2 Note”) in favor of the Bank, in the principal amount of $
As of March 31, 2021 and December 31, 2020, the outstanding unpaid principal balance of the PPP Loans were $
At March 31, 2021, the principal maturities of the amended long-term debts were as follows:
Years Ending December 31 |
|
|
|
Building Loan |
|
|
First Draw PPP Loan* |
|
|
|
|
Second Draw PPP Loan** |
|
|
|
Total |
|
Remainder of 2021 |
|
|
$ |
|
$ |
|
|
|
$ |
|
|
|
$ |
||||
2022 |
|
|
|
|
|
|
|
|
|
|
|
||||||
2023 | |
|
|||||||||||||||
2024 | |
|
|||||||||||||||
2025 | |
|
|||||||||||||||
Thereafter | |
|
|||||||||||||||
Total | $ | |
$ | |
$ | |
$ | |
|||||||||
Short-Term Loans | $ | $ | $ | $ | |||||||||||||
Long-Term Loans | $ | $ | $ | $ |
* |
|
** |
20 |
Note 8: Fair Value Measurement
The carrying value of the Company’s cash and cash equivalents, prepaid expenses and other current assets, accounts payable and accrued liabilities, approximate fair value due to the short-term nature of these items. Based on the borrowing rates currently available to the Company for debt with similar terms and consideration of default and credit risk, the carrying value of the debt approximates fair value.
Fair value is defined as the exchange price that would be received for an asset or an exit price paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs.
The fair value hierarchy defines a three-level valuation hierarchy for disclosure of fair value measurements as follows:
|
Level 1: |
Unadjusted quoted prices in active markets for identical assets or liabilities; |
|
Level 2: |
Inputs other than quoted prices included within Level 1 that are observable, unadjusted 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 related assets or liabilities; and |
|
Level 3: |
Unobservable inputs that are supported by little or no market activity for the related assets or liabilities. |
The categorization of a financial instrument within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement.
The following table sets forth the Company’s financial instruments that were measured at fair value on a recurring basis by level within the fair value hierarchy:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements at March 31, 2021 |
||||||||||||||
|
|
Total |
|
Level 1 |
|
Level 2 |
|
Level 3 |
|||||||||
Liabilities |
|
|
|
|
|
|
|
|
|||||||||
2020 Warrant Liability |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
The fair value measurement of the warrants issued by the Company in February 2020 (the “2020 Warrants”) are based on significant inputs that are unobservable and thus represents a Level 3 measurement. The Company’s estimated fair value of the Warrant liability is calculated using the Black Scholes Option Pricing Model. Key assumptions include the average volatility of the Company’s stock of approximately
|
|
Fair Value Measurements at December 31, 2020 |
|||||||||||||||
|
|
Total |
|
Level 1 |
|
Level 2 |
|
Level 3 |
|||||||||
Liabilities |
|
|
|
|
|
|
|
|
|||||||||
2019 Warrant Liability |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
2020 Warrant Liability |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Warrant Liability |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
The fair value measurement of the warrants issued by the Company in August 2019 (the “2019 Warrants”) and the 2020 Warrants are based on significant inputs that are unobservable and thus represents a Level 3 measurement. The Company’s estimated fair value of the Warrant liability is calculated using the Black Scholes Option Pricing Model. Key assumptions include the expected volatility of the Company’s stock of approximately
The following table sets forth a summary of the changes in the fair value of the Company’s Level 3 financial instruments, which are treated as liabilities, as follows:
|
|
|
|
|
|
|
|
|
||||||||
|
|
2019 Warrants |
|
2020 Warrants |
||||||||||||
|
|
Number of |
|
Liability |
|
Number of |
|
Liability |
||||||||
Balance at December 31, 2020 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
Adoption of ASC 2020-06, see Note 1 |
|
|
( |
) |
|
|
( |
) |
|
|
— |
|
|
|
— |
|
Change in Fair Value of Warrants at date of exercise |
— |
— |
— |
|
|
|||||||||||
Exercise of Warrants |
— |
— |
) |
( |
) | |||||||||||
Change in Fair Value, March 31, 2021 | — | — | — |
|
||||||||||||
Balance at March 31, 2021 | $ |
|
$ |
|
21 |
The Company has certain assets, such as goodwill, that are measured at fair value on a non-recurring basis and are adjusted to fair value only when the carrying values are more than the fair values. Based on market data of companies operating in the compounding and generic drug manufacturing industry, for the March 31, 2020 and December 31, 2020 goodwill impairment analysis, the Company used a discount rate of
As discussed in Note 5, Intangible Assets And Goodwill, the Company performed an interim impairment assessment to test the carrying value of goodwill, all of which is related to the Compounded Pharmaceuticals reporting unit, as of March 31, 2020. As a result of the analysis, the carrying value of our reporting unit exceeded the fair value by approximately $
Note 9: Commitments and Contingencies
Legal Proceedings
The Company may from time to time become party to actions, claims, suits, investigations or proceedings arising from the ordinary course of our business, including actions with respect to intellectual property claims, breach of contract claims, labor and employment claims, claims relating to our compounded pharmacy business, and other matters. We may also become party to litigation in federal and state courts relating to opioid drugs. Any litigation could divert management time and attention, could involve significant amounts of legal fees and other fees and expenses, or could result in an adverse outcome having a material adverse effect on our financial condition, cash flows or results of operations. Actions, claims, suits, investigations and proceedings are inherently uncertain and their results cannot be predicted with certainty. Except as described below, we are not currently involved in any legal proceedings that we believe are, individually or in the aggregate, material to our business, results of operations or financial condition. However, regardless of the outcome, litigation can have an adverse impact on us because of associated cost and diversion of management time.
Nephron
On September 21, 2018, Nephron Pharmaceuticals Corporation, Nephron S.C., Inc., and Nephron Sterile Compounding Center LLC (collectively, “Nephron”) filed a lawsuit in the United States District Court for the Middle District of Florida, Orlando Division, alleging claims against our wholly owned subsidiary USC —and a USC employee who previously was an employee of Nephron. The original complaint asserted thirteen causes of action against the employee and USC alleging generally misappropriation of Nephron’s trade secrets. The plaintiffs subsequently amended their complaint to include Adamis as a defendant. After several motions to dismiss, only four claims remained from the third amended complaint: (1) misappropriation under the Federal Defend Trade Secrets Act (“DFSA”), (2) breach of contract (against the employee only), (3) misappropriation under the Florida Uniform Trade Secrets Act (“FUTSA”), and (4) tortious interference with an advantageous business relationship. The gravamen of these claims was that the employee improperly misappropriated trade secret information from the employee’s former employer, Nephron, prior to starting employment at USC and that USC improperly recruited the employee for employment at USC. The third amended complaint alleged that Adamis and USC aided in this misappropriation by “using and/or disclosing and/or retaining the same in an effort to unfairly compete against Nephron.” The third amended complaint sought actual, compensatory, consequential, special, and punitive damages, attorneys’ fees and costs, prejudgment interest, preliminary and permanent injunctive relief, and other relief. On September 3, 2019, Adamis and USC answered denying the claims and asserting various defenses and affirmative defenses.
22 |
Fact discovery closed on March 2, 2020. Expert discovery, including regarding the alleged damages that Nephron sought against Adamis and USC, occurred during the second and third quarters of 2020. On May 6, 2020, Adamis and USC moved for summary judgment to dismiss the three claims that remained pending against them. In October 2020, the magistrate judge presiding over the motion delivered a Report and Recommendation recommending that the court enter an order granting the motion in part and denying the motion in part. The magistrate recommended that the court deny the motion for summary judgment by Adamis and USC with respect to the plaintiffs’ claims under the DFSA and FUTSA, concluding that there were triable issues of material fact that precluded the entry of summary judgment, and that the court grant the motion for summary judgment in favor of Adamis and USC with respect to the claim for tortious interference. Adamis and USC filed objections to the Report and Recommendation with the court; however, the court adopted the recommendation of the magistrate and granted in part and denied in part the motion of Adamis and USC for summary judgment. Pursuant to court procedures, a mediation between the parties was held in October 2020, and the case was not resolved. In March 2021, the court granted a motion by Nephron to hold Adamis and USC in civil contempt for violation of a previous consent preliminary injunction related to the hiring by USC of an employee, and ordered that Adamis and USC compensate Nephron for certain fees and expenses in the litigation relating to the matter as well as pay a fine, in an amount to be determined. A hearing on the amount of such sanctions was held on April 6, 2021, but decisions regarding sanctions were deferred until after trial. After the hearing, the court ruled on various pre-trial motions relating to the conduct of the trial. The case was set for trial on April 19, 2021.
As previously disclosed in the 2020 Form 10-K, while we continue to believe that the claims and damages sought by the plaintiff were without merit, in light of several factors including the recent hearing and outcome of decisions concerning pre-trial motions, the legal expenses of ongoing litigation and trial, the uncertainties of litigation and jury trials, and the possibility of punitive damages and other adverse awards or sanctions, on April 9, 2021, Adamis, USC and Nephron agreed to terms of settlement of the Florida litigation as well as a related case filed by Nephron against USC, Adamis and a second USC employee in the United States District Court for the District of New Jersey alleging misappropriation of trade secrets from Nephron. Under the terms of the settlement agreement entered into by Adamis, the Nephron entities and certain other individuals (the “individual parties”), and related documents entered into by the parties thereto, the Company paid Nephron an amount equal to $
The Company records accruals for loss contingencies associated with legal matters when the Company determines it is probable that a loss has been or will be incurred and the amount of the loss can be reasonably estimated. Where a material loss contingency is reasonably possible and the reasonably possible loss or range of possible loss can be reasonably estimated, U.S. GAAP requires us to disclose an estimate of the reasonably possible loss or range of loss or make a statement that such an estimate cannot be made. Because litigation is inherently unpredictable and unfavorable results could occur, assessing contingencies is highly subjective and requires significant judgments about future events, including determining both the probability and estimated amount of a possible loss or range of loss. The amount of any ultimate loss may differ from any accruals or estimates that the Company may make.
As a result of the above matters, the Company has determined that liabilities associated with legal contingencies relating to the Nephron legal proceedings above are probable and can be reasonably estimated, and has accrued $
Other
The Company has a production threshold commitment to a manufacturer of our SYMJEPI Products where the Company would be required to pay for maintenance fees if it does not meet certain periodic purchase order minimums. Any such maintenance fees would be prorated as a percentage of the required minimum production threshold. Maintenance fees for the three months ended March 31, 2021 and 2020 were approximately $
Note 10: Common Stock
In January and February 2021, the Company issued common stock upon exercise of investor warrants. The warrant holders exercised for cash at exercise prices ranging from $
On February 2, 2021, the Company completed the closing of an underwritten public offering of
23 |
At the Company’s 2020 annual meeting of stockholders, the stockholders approved the Company’s 2020 Equity Incentive Plan (the “2020 Plan”). The 2020 Plan provides for the grant of incentive stock options, non-statutory stock options, restricted stock awards, restricted stock unit awards, stock appreciation rights, performance stock awards, and other forms of equity compensation (collectively “stock awards”). In addition, the 2020 Plan provides for the grant of cash awards. The initial aggregate number of shares of common stock that may be issued initially pursuant to stock awards under the 2020 Plan is
On January 1, 2021, pursuant to the 2020 Equity Incentive Plan the number of shares reserved for the issuance of stock awards increased by
shares.
Stock Options
2009 Equity Incentive Plan |
Weighted Average Exercise Price |
Weighted Average Remaining Contract Life | ||||||||||
Total Outstanding Vested and Expected to Vest as of December 31, 2020 |
|
$ |
|
years | ||||||||
Options Canceled/Expired |
( |
) |
|
— | ||||||||
Total Outstanding Vested and Expected to Vest as of March 31, 2021 |
|
$ |
|
years | ||||||||
Vested at March 31, 2021 |
|
$ |
|
years |
Expense related to stock options for the three months ended March 31, 2021 and 2020 was approximately $
and $ , respectively. As of March 31, 2021, the unamortized compensation expense related to stock options was approximately $ . The weighted-average period in years over which the remaining unamortized expense will be recognized is years.
The aggregate intrinsic value (the difference between the Company’s closing stock price on the last trading day of the year and the exercise price, multiplied by the number of in-the-money options) of
and stock options outstanding at March 31, 2021 and December 31, 2020 was $ , respectively. The aggregate intrinsic value of and stock options exercisable at March 31, 2021 and December 31, 2020 was $ , respectively.
Restricted Stock Units
|
Number of Shares/Unit |
|
Weighted |
|||||
Non-vested RSUs as of December 31, 2020 |
|
|
|
$ |
|
|||
RSUs vested during the period |
|
|
) |
|
|
|||
RSUs forfeited during the period |
|
|
) |
|
|
|||
Non-vested RSUs as of March 31, 2021 |
|
|
|
$ |
|
Expense related to RSUs for the three months ended March 31, 2021 and 2020 was approximately $ As of March 31, 2021, unrecognized compensation expense related to these RSUs was approximately $ and $ , respectively. and will be recorded as compensation expense in years.
24 |
The following table summarizes warrants outstanding at March 31, 2021 and December 31, 2020:
March 31, 2021 | Warrant Shares | Exercise Price Per Share |
Date Issued | Expiration Date | |||||||||
Old Adamis Warrants |
|
$ |
|
|
|
||||||||
Preferred Stock Series A-2 Warrants |
|
$ |
|
|
|
||||||||
2016 Warrants |
|
$ |
|
|
|
||||||||
2019 Warrants |
|
** | $ |
|
|