$TRVI
Trevi Therapeutics, Inc.

2021 Form 10-K Financial Statement

#000156459022010875 Filed on March 17, 2022

View on sec.gov

Income Statement

Concept 2021 2020 Q4 2020
Revenue $0.00 $0.00 $0.00
YoY Change
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $9.492M $2.630M $10.16M
YoY Change -6.57% 35.57% 38.99%
% of Gross Profit
Research & Development $22.98M $6.560M $22.33M
YoY Change 2.94% 36.1% 15.45%
% of Gross Profit
Depreciation & Amortization $50.00K $20.00K $47.00K
YoY Change 6.38% 100.0% 20.51%
% of Gross Profit
Operating Expenses $32.48M $9.190M $22.33M
YoY Change 45.45% 35.75% -16.2%
Operating Profit -$32.48M
YoY Change
Interest Expense $1.202M -$310.0K $456.0K
YoY Change 163.6% -234.78% -42.42%
% of Operating Profit
Other Income/Expense, Net -$375.0K -$287.0K
YoY Change 30.66% -149.74%
Pretax Income -$33.96M -$9.510M -$32.78M
YoY Change 3.6% 45.41% 25.75%
Income Tax -$21.00K $20.00K -$18.00K
% Of Pretax Income
Net Earnings -$33.94M -$9.520M -$32.76M
YoY Change 3.61% 45.57% 25.75%
Net Earnings / Revenue
Basic Earnings Per Share -$1.49
Diluted Earnings Per Share -$1.486M -$516.5K -$1.814M
COMMON SHARES
Basic Shares Outstanding 22.84M
Diluted Shares Outstanding 22.84M

Balance Sheet

Concept 2021 2020 Q4 2020
SHORT-TERM ASSETS
Cash & Short-Term Investments $36.83M $45.00M $45.00M
YoY Change -18.16% -21.48% -21.48%
Cash & Equivalents $36.83M $45.00M $45.00M
Short-Term Investments
Other Short-Term Assets $886.0K $265.0K $1.010M
YoY Change -12.28% -84.23% -39.88%
Inventory
Prepaid Expenses $1.003M
Receivables
Other Receivables
Total Short-Term Assets $37.96M $46.27M $46.27M
YoY Change -17.97% -22.3% -22.3%
LONG-TERM ASSETS
Property, Plant & Equipment $184.0K $103.0K $330.0K
YoY Change -44.24% -12.71% -23.26%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $334.0K $532.0K $530.0K
YoY Change -36.98% 2560.0% 2550.0%
Total Long-Term Assets $518.0K $862.0K $860.0K
YoY Change -39.77% 91.98% 91.11%
TOTAL ASSETS
Total Short-Term Assets $37.96M $46.27M $46.27M
Total Long-Term Assets $518.0K $862.0K $860.0K
Total Assets $38.48M $47.13M $47.13M
YoY Change -18.36% -21.45% -21.45%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $2.849M $2.016M $2.020M
YoY Change 41.04% 26.08% 26.25%
Accrued Expenses $3.849M $3.426M $3.380M
YoY Change 13.88% -2.14% 2.42%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due $5.947M
YoY Change
Total Short-Term Liabilities $12.72M $5.555M $5.560M
YoY Change 128.85% 6.85% 6.92%
LONG-TERM LIABILITIES
Long-Term Debt $8.652M $14.15M $14.15M
YoY Change -38.86%
Other Long-Term Liabilities $24.00K $140.0K $140.0K
YoY Change -82.86% -46.15% -46.15%
Total Long-Term Liabilities $8.676M $14.29M $14.29M
YoY Change -39.29% 5396.15% 5396.15%
TOTAL LIABILITIES
Total Short-Term Liabilities $12.72M $5.555M $5.560M
Total Long-Term Liabilities $8.676M $14.29M $14.29M
Total Liabilities $21.40M $19.85M $19.85M
YoY Change 7.81% 263.53% 263.55%
SHAREHOLDERS EQUITY
Retained Earnings -$147.0M
YoY Change 28.68%
Common Stock $19.00K
YoY Change 5.56%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $17.08M $27.28M $27.28M
YoY Change
Total Liabilities & Shareholders Equity $38.48M $47.13M $47.13M
YoY Change -18.36% -21.45% -21.45%

Cashflow Statement

Concept 2021 2020 Q4 2020
OPERATING ACTIVITIES
Net Income -$33.94M -$9.520M -$32.76M
YoY Change 3.61% 45.57% 25.75%
Depreciation, Depletion And Amortization $50.00K $20.00K $47.00K
YoY Change 6.38% 100.0% 20.51%
Cash From Operating Activities -$28.95M -$8.920M -$29.00M
YoY Change -0.19% 43.87% 25.58%
INVESTING ACTIVITIES
Capital Expenditures $0.00 $0.00 $32.00K
YoY Change -100.0% 255.56%
Acquisitions
YoY Change
Other Investing Activities
YoY Change
Cash From Investing Activities $0.00 $0.00 -$32.00K
YoY Change -100.0% 255.56%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 20.78M 640.0K 16.72M
YoY Change 24.25% -77.16%
NET CHANGE
Cash From Operating Activities -28.95M -8.920M -29.00M
Cash From Investing Activities 0.000 0.000 -32.00K
Cash From Financing Activities 20.78M 640.0K 16.72M
Net Change In Cash -8.171M -8.280M -12.31M
YoY Change -33.63% 33.55% -124.57%
FREE CASH FLOW
Cash From Operating Activities -$28.95M -$8.920M -$29.00M
Capital Expenditures $0.00 $0.00 $32.00K
Free Cash Flow -$28.95M -$8.920M -$29.03M
YoY Change -0.3% 43.87% 25.67%

Facts In Submission

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<div style="align:left;"> <table border="0" cellpadding="0" cellspacing="0" style="border-collapse:collapse; width:100%;"> <tr> <td style="width:3.62%;white-space:nowrap" valign="top"> <p style="margin-bottom:0pt;margin-top:6pt;font-weight:bold;color:#000000;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;"><span style="font-weight:bold;color:#000000;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">1.</span></p></td> <td valign="top"> <p style="margin-bottom:0pt;margin-top:6pt;font-weight:bold;color:#000000;font-style:normal;text-transform:none;font-variant: normal;font-family:Times New Roman;font-size:10pt;"><span style="font-weight:normal;"/>Nature of the Business </p></td></tr></table></div> <p style="margin-top:6pt;margin-bottom:0pt;text-indent:3.62%;color:#000000;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Trevi Therapeutics, Inc. (“Trevi” or the “Company”) is a clinical-stage biopharmaceutical company focused on the development and commercialization of the investigational therapy Haduvio (nalbuphine ER) to treat serious neurologically mediated conditions. The Company is currently developing Haduvio for the treatment of chronic pruritus associated with prurigo nodularis and chronic cough in patients with idiopathic pulmonary fibrosis (“IPF”). These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems. Due to nalbuphine’s mechanism of action as a modulator of opioid receptors, the Company believes Haduvio has the potential to be effective in treating each of these conditions. </p> <p style="margin-top:6pt;margin-bottom:0pt;text-indent:3.62%;color:#000000;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Haduvio is an oral extended-release formulation of nalbuphine. Nalbuphine is a mixed κ-opioid receptor agonist and μ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States (“U.S.”) and Europe. The κ- and μ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine’s mechanism of action also mitigates the risk of abuse associated with μ-opioid agonists because it antagonizes or blocks, the μ-opioid receptor. Parenteral nalbuphine is not classified as a controlled substance in the U.S. and most of Europe. </p> <p style="margin-top:6pt;margin-bottom:0pt;text-indent:3.62%;font-weight:bold;font-style:italic;color:#000000;font-family:Times New Roman;font-size:10pt;text-transform:none;font-variant: normal;">Liquidity</p> <p style="margin-top:6pt;margin-bottom:0pt;text-indent:3.62%;color:#000000;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">In accordance with Accounting Standards Update (“ASU”) No. 2014-15, <span style="font-style:italic;">Disclosures of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40)</span> (“ASU No. 2014-15”), management must evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued. This evaluation initially does not take into consideration the potential mitigating effect of management’s plans that have not been fully implemented as of the date the financial statements are issued. When substantial doubt exists under this methodology, management evaluates whether the mitigating effect of its plans sufficiently alleviates substantial doubt about the Company’s ability to continue as a going concern. The mitigating effect of management’s plans, however, is only considered if both (1) it is probable that the plans will be effectively implemented within one year after the date that the financial statements are issued and (2) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that the financial statements are issued. Generally, to be considered probable of being effectively implemented, the plans must have been approved before the date that the financial statements are issued. </p> <p style="margin-top:6pt;margin-bottom:0pt;text-indent:3.62%;color:#000000;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The Company’s Consolidated Financial Statements have been prepared on a going concern basis, which contemplates the continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business. Since inception, the Company has financed its operations primarily through private placements of convertible preferred stock and convertible notes prior to its initial public offering (“IPO”), borrowings under its prior term loan facility, proceeds from its IPO and concurrent private placement completed in May 2019, sales of its common stock pursuant to the at-the-market Sales Agreement (the “ATM Sales Agreement”) (Note 7) with SVB Leerink LLC that the Company entered into in June 2020, the term loan facility with Silicon Valley Bank (“SVB”) that the Company entered into in August 2020 (Note 6) and the<span style="color:#000000;"> </span>private placements completed in October 2021 (Note 7). </p> <p style="margin-top:6pt;margin-bottom:0pt;text-indent:3.62%;color:#000000;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The Company has incurred recurring losses since inception, including net losses of $33.9 million and $32.8 million for the years ended December 31, 2021 and 2020, respectively. As of December 31, 2021, the Company had cash and cash equivalents of $36.8 million compared to $45.0 million of cash and cash equivalents as of December 31, 2020. The Company has incurred losses and negative cash flows from operations and had an accumulated deficit of $180.9 million as of December 31, 2021. The Company expects to continue to incur losses for the foreseeable future. As of March 17, 2022, the date of issuance of these Consolidated Financial Statements, the Company believes that its cash and cash equivalents as of December 31, 2021, will not be sufficient to fund its operating expenses and capital expenditure requirements for 12 months from the date of issuance of these Consolidated Financial Statements, even without giving effect to the potential collateralization of the outstanding SVB term loan (Note 6) and, therefore, substantial doubt exists about the Company’s ability to continue as a going concern. The Company plans to seek to address this condition by raising additional capital to finance its operations. The future viability of the Company is dependent on its ability to raise additional capital to finance its operations. Although the Company has been successful in raising capital in the past, there is no assurance that it will be successful in obtaining such additional financing. Therefore, it is not considered probable, as defined in ASU No. 2014-15, </p> <p style="margin-top:6pt;margin-bottom:0pt;color:#000000;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><span style="color:#000000;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">that the Company’s plans to raise additional capital will alleviate the substantial doubt regarding its ability to continue as a going concern.</span></p> <p style="margin-top:6pt;margin-bottom:0pt;text-indent:3.62%;color:#000000;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">To execute its business plans, the Company will need substantial funding to support its continuing operations and pursue its growth strategy. Until such time that the Company can generate significant revenue from product sales, if ever, the Company expects to finance its operations through the sale of common stock in public offerings and/or private placements, debt financings or other capital sources, including collaborations with other companies or other strategic transactions. The Company may not be able to obtain financing when needed on acceptable terms or at all. The terms of any financing may adversely affect the holdings or the rights of the Company’s stockholders. If the Company is unable to obtain funding, the Company could be forced to delay, reduce or abandon its product development programs or commercialization efforts, which could adversely affect its business prospects.</p>
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<p style="margin-top:6pt;margin-bottom:0pt;margin-left:3.62%;text-indent:0%;font-weight:bold;font-style:italic;color:#000000;font-family:Times New Roman;font-size:10pt;text-transform:none;font-variant: normal;">Use of Estimates </p> <p style="margin-top:6pt;margin-bottom:0pt;text-indent:3.62%;color:#000000;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The preparation of financial statements in conformity with accounting principles generally accepted in the U.S. (“GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of the expenses during the reporting periods. Significant estimates and assumptions reflected in these Consolidated Financial Statements include but are not limited to the recognition of research and development (“R&amp;D”) expenses, the valuation of stock-based awards and the valuation allowance of deferred tax assets resulting from net operating losses. In addition, management’s assessment of the Company’s ability to continue as a going concern involves the estimation of the amount and timing of future cash inflows and outflows. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates. The inputs into the Company’s estimates also considered the economic implications of the COVID-19 pandemic on the Company’s estimates.</p>
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