Statements in this Form 10-K that are not strictly historical are forward-looking statements and include statements about products in development, results and analyses of pre-clinical studies, clinical trials and studies, research and development expenses, cash expenditures, and alliances and partnerships, among other matters. You can identify these forward-looking statements because they involve our expectations, intentions, beliefs, plans, projections, anticipations, or other characterizations of future events or circumstances. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those in the forward-looking statements as a result of any number of factors. These factors include, but are not limited to, risks relating to our ability to conduct and obtain successful results from ongoing clinical trials, commercialize our technology, obtain regulatory approval for our product candidates, contract with third parties to adequately test and manufacture our proposed therapeutic products, protect our intellectual property rights and obtain additional financing to continue our development efforts. Some of these factors are more fully discussed in Part I, Item 1A, "Risk Factors" and in our consolidated financial statements and related notes, included elsewhere herein. We do not undertake to update any of these forward-looking statements or to announce the results of any revisions to these forward-looking statements except as required by law. For further information regarding forward-looking statements, please refer to the "Information Regarding Forward-Looking Statements" at the beginning of Part I of this Form 10-K. 44
--------------------------------------------------------------------------------
Table of Contents
Our Management's Discussion and Analysis of Financial Condition and Results of Operations ("MD&A") is provided in addition to the accompanying financial statements and notes to assist readers in understanding our results of operations, financial condition and cash flows.
Overview We are a specialty pharmaceutical company focused on our clinically-validated and patent-protected PLxGuard drug delivery platform to provide more effective and safer products. Our PLxGuard drug delivery platform works by targeting the release of active pharmaceutical ingredients to various portions of the gastrointestinal tract. We believe this has the potential to improve the absorption of many drugs currently on the market or in development, and to reduce the risk of stomach erosions and ulcers associated with certain drugs. VAZALORE, available in two doses, 325 mg and 81 mg, is an FDA-approved liquid-filled aspirin capsule that provides patients with vascular disease and diabetic patients who are candidates for aspirin therapy based on physician recommendation, with fast, reliable and predictable platelet inhibition. It also reduces the risk of stomach erosions and ulcers, as compared to immediate release aspirin, common in an acute setting. Our commercialization strategy will target the over-the-counter ("OTC') market, taking advantage of the existing distribution channels for aspirin. We intend to market VAZALORE to the healthcare professional and the consumer through several sales and marketing channels. Our product pipeline also includes other oral nonsteroidal anti-inflammatory drugs using the PLxGuard drug delivery system that may be developed, including PL1200 Ibuprofen 200 mg and PL1200 Ibuprofen 400 mg, for pain and inflammation in Phase 1 clinical stage. Critical Accounting Policies Our consolidated financial statements have been prepared in accordance with generally accepted accounting principles inthe United States of America ("U.S. GAAP"). The preparation of these financial statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses. Note 3 of the Notes to Consolidated Financial Statements included elsewhere herein describes the significant accounting policies used in the preparation of the financial statements. Certain of these significant accounting policies are considered to be critical accounting policies, as defined below. A critical accounting policy is defined as one that is both material to the presentation of our financial statements and requires management to make difficult, subjective or complex judgments that could have a material effect on our financial condition and results of operations. Specifically, critical accounting estimates have the following attributes: (1) we are required to make assumptions about matters that are highly uncertain at the time of the estimate; and (2) different estimates we could reasonably have used, or changes in the estimate that are reasonably likely to occur, would have a material effect on our financial condition or results of operations. Estimates and assumptions about future events and their effects cannot be determined with certainty. We base our estimates on historical experience and on various other assumptions believed to be applicable and reasonable under the circumstances. These estimates may change as new events occur, as additional information is obtained and as our operating environment changes. These changes have historically been minor and have been included in the financial statements as soon as they became known. Based on a critical assessment of our accounting policies and the underlying judgments and uncertainties affecting the application of those policies, management believes that our financial statements are fairly stated in accordance withU.S. GAAP and present a meaningful presentation of our financial condition and results of operations. We believe the following critical accounting policies reflect our more significant estimates and assumptions used in the preparation of our consolidated financial statements: Use of Estimates The preparation of our consolidated financial statements in conformity withU.S. 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 consolidated financial statements and the reported amount of revenues and expenses during the reporting period. In the accompanying consolidated financial statements, estimates are used for, but not limited to, the impairment assessment of goodwill, the fair value of warrant liability, the fair value of stock-based compensation, allowance for inventory obsolescence, contingent liabilities, fair value and depreciable lives of long-lived assets, and deferred taxes and associated valuation allowance. Actual results could differ from those estimates. 45
--------------------------------------------------------------------------------
Table of Contents Fair Value Measurements Fair value is defined as the price that would be received in the sale of an asset or that would be paid to transfer a liability in an orderly transaction between market participants at the measurement date. The Company has categorized all investments recorded at fair value based upon the level of judgment associated with the inputs used to measure their fair value.
Hierarchical levels, directly related to the amount of subjectivity associated with the inputs to fair valuation of these assets and liabilities, are as follows:
? Level 1: Quoted prices in active markets for identical assets or liabilities that the organization has the ability to access at the reporting date. ? Level 2: Inputs other than quoted prices included in Level 1, which are either observable or that can be derived from or corroborated by observable data as of the reporting date. ? Level 3: Inputs include those that are significant to the fair value of
the asset or liability and are generally less observable from objective
resources and reflect the reporting entity's assumptions about the assumptions market participants would use in pricing the asset or liability. The Company's financial instruments (cash and cash equivalents, receivables, accounts payable and accrued liabilities) are carried in the consolidated balance sheet at cost, which reasonably approximates fair value based on their short-term nature. The Company's warrant liability is recorded at fair value, with changes in fair value being reflected in the statements of operations for the period of change. The fair value of the term loan approximates its face value of$0.6 million based on the Company's current financial condition and on the variable nature of term loan's interest feature as compared to current rates.
Research and Development Expenses
Costs incurred in connection with research and development activities are expensed as incurred. Research and development expenses consist of direct and indirect costs associated with specific projects, manufacturing activities, and include fees paid to various entities that perform research related services for the Company. Stock-Based Compensation The Company recognizes expense in the consolidated statements of operations for the fair value of all stock-based compensation to key employees, nonemployee directors and advisors, generally in the form of stock options and stock awards. The Company uses the Black-Scholes option valuation model to estimate the fair value of stock options on the grant date. Compensation cost is amortized on a straight-line basis over the vesting period for each respective award. The Company accounts for forfeitures as they occur. Adopted Accounting Guidance For a discussion of significant accounting guidance recently adopted or unadopted accounting guidance that has the potential of being significant, see Note 3 of the Notes to the Consolidated Financial Statements included elsewhere herein. Results of Operations Revenue Total revenues were$0.03 million and$0.6 million for the years endedDecember 31, 2020 and 2019, respectively. All the revenue recognized in 2020 and 2019 is attributable to work performed under a federal grant from theNational Institutes of Health grant which came to an end in the second quarter of 2020. 46
--------------------------------------------------------------------------------
Table of Contents Operating Expenses Total operating expenses were$13.5 million during the year endedDecember 31, 2020 , a 9% decrease from operating expenses of$14.8 million during the year endedDecember 31, 2019 . Operating expenses for the years endedDecember 31, 2020 and 2019 were as follows: Years Ended December 31, Increase (Decrease) 2020 2019 $ % Operating Expenses Research and development expenses$ 4,338,974 $ 4,741,130 $ (402,156 ) (8.5 )% General and administrative expenses 9,150,568 10,026,627 (876,059 ) (8.7 )% Total operating expenses$ 13,489,542 $ 14,767,757 $ (1,278,215 ) (8.7 )%
Research and Development Expenses
Research and development expenses totaled$4.3 million for the year endedDecember 31, 2020 , compared to$4.7 million for the year endedDecember 31, 2019 , reflecting continued product development and manufacturing activities for VAZALORE. This decrease was due to 2020 activities which included the bioequivalence study to provide data for the sNDA filing, stability and validation work compared to manufacture, packaging, stability, and analytical costs related to the registration batches in 2019. We expect the research and development costs to be about the same in 2021 as manufacturing activities continue with the development and stability of VAZALORE.
General and Administrative Expenses
General and administrative expenses totaled$9.2 million for the year endedDecember 31, 2020 , compared to$10.0 million for the year endedDecember 31, 2019 . The decrease is due to lower compensation related expenses combined with savings from COVID-19 restrictions on conference and travel costs. We expect our selling, general and administrative expenses to increase as a result of the expected commercial launch of VAZALORE. Other expense Other expense totaled$1.8 million for the year endedDecember 31, 2020 , compared to$6.3 million for the year endedDecember 31, 2019 . The change is primarily attributable to the non-cash change in fair value of warrant liability primarily due to the fluctuation of the price of the Company's common stock ($1.4 million of other expense for the year endedDecember 31, 2020 , as compared to$5.7 million of other expense in the prior year).
Liquidity and Capital Resources
The following table summarizes the primary uses and sources of cash for the periods indicated: Years Ended December 31, 2020 2019 Net cash used in operating activities$ (12,243,592 ) $ (12,659,035 ) Net cash used in investing activities$ (102,000 ) $ (230,294 ) Net cash provided by financing activities$ 20,792,939 $ 12,640,366
Net cash used in operating activities was$12.2 million and$12.7 million for the years endedDecember 31, 2020 and 2019, respectively. The decrease was due to lower compensation and COVID-19 impacted conference and travel costs offset somewhat by the increase in the settlement of 2019 year-end liabilities in 2020. 47
--------------------------------------------------------------------------------
Table of Contents
Net cash used in investing activities totaled
Net Cash Provided by Financing Activities
Net cash provided by financing activities totaled$20.8 million and$12.6 million for the years endedDecember 31, 2020 and 2019, respectively, and reflects$7.7 million net proceeds from the issuance of Series B Preferred Stock and$16.8 million net proceeds from the issuance of common stock in the 2020 period, which was higher than the net proceeds of$13.7 million from the issuance of Series A Preferred Stock and$2.1 million net proceeds from the sale of common stock in the prior year. The current year period also includes higher payments of the Term Loan as the prior year period reflected two less payments due to the start of the payment amortization period.
Future Liquidity and Capital Needs
As ofDecember 31, 2020 , we had working capital of$19.4 million , including cash and cash equivalents of$22.4 million . In addition, duringMarch 2019 , we entered into an equity distribution agreement (the "Equity Distribution Agreement") withJMP Securities, Inc. ("JMP") to issue and sell shares of our common stock, having an aggregate offering price of up to$12.5 million , from time to time during the term of the Equity Distribution Agreement, through an "at-the-market" equity offering program (the "ATM Offering") at our sole discretion, under which JMP acted as our agent. AtDecember 31, 2020 , we had$10.2 million available under this ATM Offering. The JMP Equity Distribution Agreement and related ATM Offering was terminated onMarch 2, 2021 . OnMarch 5, 2021 the Company completed an underwritten public offering (the "Public Offering") in which we issued 7,875,000 shares of our common stock at a price to the public of$8.00 per share. Gross proceeds of the Public Offering were$63 million , before deducting underwriting discounts and commissions and other offering expenses payable by the Company. Net proceeds of the Public Offering were$59 million . The underwriters retained a 30-day option to purchase up to 1,181,250 shares of common stock at the public offering price, less underwriting discounts and commission. We have not generated any revenue from the sale of products and have incurred operating losses in each year since we commenced operations. As ofDecember 31, 2020 , we had an accumulated deficit of$102.1 million . We expect to continue to incur significant operating expenses and operating losses for the foreseeable future as we continue the development and commercialization of VAZALORE. Although these losses and expected losses give rise to substantial doubt, the Company's cash on hand atDecember 31, 2020 combined with the proceeds from the Public Offering support that the Company can fund its obligations for at least one year from the date these financial statements were issued and mitigate the substantial doubt consideration. Our prior losses, combined with expected future losses, have had and will continue to have an adverse effect on our stockholders' equity and working capital. If we are unable to achieve and sustain profitability, the market value of our common stock will likely decline. Because of the numerous risks and uncertainties associated with developing biopharmaceutical products, we are unable to predict the extent of any future losses or when, if ever, we will become profitable. We may need to obtain additional financing in the future, in addition to the proceeds from the Public Offering, to execute our commercialization plan. We may obtain additional financing through public or private equity offerings, debt financings (including related-party financings), a credit facility or strategic collaborations. Additional financing may not be available to us when we need it or it may not be available to us on favorable terms, if at all. Our failure to raise capital as and when needed could have a negative impact on our financial condition and our ability to pursue our business strategies. We currently have no understandings, commitments or agreements relating to any of these types of transactions, other than in connection with the underwriters' over-allotment option as part of the Public Offering. If we are unable to raise additional funds when needed, we may be required to sell or license our technologies or clinical product candidates or programs that we would prefer to develop and commercialize ourselves.
Impact of COVID-19 Pandemic on Financial Statements
OnMarch 11, 2020 , theWorld Health Organization declared the outbreak of COVID-19 as a "pandemic", or a worldwide spread of a new disease. Many countries imposed quarantines and restrictions on travel and mass gatherings to slow the spread of the virus and have closed non-essential businesses. In response to COVID-19, the Company has not experienced a disruption or delay in the development of VAZALORE™. However, the extent to which COVID-19 may impact our business will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the duration of the pandemic, travel restrictions and social distancing inthe United States and other countries, business closures or business disruptions and the effectiveness of actions taken inthe United States and other countries to contain and treat the pandemic. The Company has not experienced any significant negative impact on theDecember 31, 2020 audited consolidated financial statements related to COVID-19. For more discussion on our risks related to COVID-19, please see risk factors included under "Item 1A. Risk Factors" herein. Inflation
The Company believes that the rates of inflation in recent years have not had a significant impact on its operations.
Off-Balance Sheet Arrangements
The Company did not have any off-balance sheet arrangements as of
© Edgar Online, source