$LQDA
Liquidia Corp

2023 Q1 Form 10-K Financial Statement

#000155837023004191 Filed on March 20, 2023

View on sec.gov

Income Statement

Concept 2023 Q1 2022 Q4 2022
Revenue $4.493M $15.94M $15.94M
YoY Change 28.67% 395.64% 23.98%
Cost Of Revenue $654.0K $2.859M $2.859M
YoY Change -5.76% 293.84% -5.42%
Gross Profit $3.839M $13.08M $13.08M
YoY Change 37.21% 425.33% 33.02%
Gross Profit Margin 85.44% 82.06% 82.06%
Selling, General & Admin $7.793M $32.41M $32.41M
YoY Change -37.68% 284.42% 82.66%
% of Gross Profit 203.0% 247.87% 247.87%
Research & Development $5.278M $19.44M $19.44M
YoY Change 11.63% 261.2% -5.27%
% of Gross Profit 137.48% 148.63% 148.63%
Depreciation & Amortization $569.0K $566.0K $3.647M
YoY Change -39.92% -35.06% -35.01%
% of Gross Profit 14.82% 4.33% 27.89%
Operating Expenses $5.278M $51.85M $51.85M
YoY Change 11.63% 274.3% 152.7%
Operating Profit -$9.232M -$38.77M -$38.77M
YoY Change -36.21% 241.21% 14.71%
Interest Expense $1.124M -$1.248M -$1.248M
YoY Change 135.15% 521.89% -253.12%
% of Operating Profit
Other Income/Expense, Net -$2.513M -$2.245M
YoY Change 70.84% 187.23%
Pretax Income -$11.75M -$41.02M -$41.02M
YoY Change -26.33% 254.71% 18.61%
Income Tax $0.00
% Of Pretax Income
Net Earnings -$11.70M -$41.02M -$41.02M
YoY Change -26.61% 254.71% 18.61%
Net Earnings / Revenue -260.41% -257.39% -257.39%
Basic Earnings Per Share -$0.18 -$0.67
Diluted Earnings Per Share -$0.18 -$0.67 -$0.67
COMMON SHARES
Basic Shares Outstanding 64.69M 64.49M 60.96M
Diluted Shares Outstanding 64.66M 60.96M

Balance Sheet

Concept 2023 Q1 2022 Q4 2022
SHORT-TERM ASSETS
Cash & Short-Term Investments $94.41M $93.28M $93.28M
YoY Change 63.36% 62.25% 62.25%
Cash & Equivalents $94.41M $93.28M $93.28M
Short-Term Investments
Other Short-Term Assets $1.147M $1.511M $1.511M
YoY Change 31.24% 90.69% 90.69%
Inventory
Prepaid Expenses
Receivables $4.131M $5.017M $5.017M
Other Receivables $0.00 $0.00 $0.00
Total Short-Term Assets $99.69M $99.81M $99.81M
YoY Change 60.91% 62.89% 62.89%
LONG-TERM ASSETS
Property, Plant & Equipment $4.346M $4.151M $6.252M
YoY Change -5.81% -17.26% -15.85%
Goodwill $3.903M $3.903M
YoY Change 0.0% 0.0%
Intangibles $3.643M $3.726M
YoY Change -13.78% -15.13%
Long-Term Investments
YoY Change
Other Assets $15.33M $15.51M $15.51M
YoY Change -7.01% -7.32% -7.32%
Total Long-Term Assets $29.23M $29.39M $29.39M
YoY Change -7.41% -9.45% -9.45%
TOTAL ASSETS
Total Short-Term Assets $99.69M $99.81M $99.81M
Total Long-Term Assets $29.23M $29.39M $29.39M
Total Assets $128.9M $129.2M $129.2M
YoY Change 37.85% 37.84% 37.84%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $841.0K $2.197M $2.197M
YoY Change -49.52% 105.33% 105.33%
Accrued Expenses $3.877M $6.422M $6.422M
YoY Change -35.12% 8.01% 8.01%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due $2.102M $181.0K $181.0K
YoY Change 529.34% -41.79% -41.79%
Total Short-Term Liabilities $6.820M $8.800M $8.800M
YoY Change -14.49% 20.1% 20.11%
LONG-TERM LIABILITIES
Long-Term Debt $30.76M $19.88M $20.05M
YoY Change 57.95% 90.96% 86.31%
Other Long-Term Liabilities $9.697M $9.926M $9.926M
YoY Change -7.09% -4.33% -4.33%
Total Long-Term Liabilities $40.46M $19.88M $29.98M
YoY Change 107.74% 90.96% 41.82%
TOTAL LIABILITIES
Total Short-Term Liabilities $6.820M $8.800M $8.800M
Total Long-Term Liabilities $40.46M $19.88M $29.98M
Total Liabilities $47.28M $38.78M $38.78M
YoY Change 23.97% 36.23% 36.23%
SHAREHOLDERS EQUITY
Retained Earnings -$362.3M -$350.6M
YoY Change 11.31% 13.25%
Common Stock $65.00K $64.00K
YoY Change 22.64% 23.08%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $81.64M $90.42M $90.42M
YoY Change
Total Liabilities & Shareholders Equity $128.9M $129.2M $129.2M
YoY Change 37.85% 37.84% 37.84%

Cashflow Statement

Concept 2023 Q1 2022 Q4 2022
OPERATING ACTIVITIES
Net Income -$11.70M -$41.02M -$41.02M
YoY Change -26.61% 254.71% 18.61%
Depreciation, Depletion And Amortization $569.0K $566.0K $3.647M
YoY Change -39.92% -35.06% -35.01%
Cash From Operating Activities -$8.457M -$4.603M -$28.59M
YoY Change -13.55% -39.11% -16.01%
INVESTING ACTIVITIES
Capital Expenditures $366.0K $491.0K $592.0K
YoY Change -2557.46% 452.14%
Acquisitions
YoY Change
Other Investing Activities $2.000K $0.00 $5.000K
YoY Change
Cash From Investing Activities -$364.0K -$491.0K -$587.0K
YoY Change 2357.46% 447.47%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net $20.00M $10.50M
YoY Change 90.48% 1.42%
Cash From Financing Activities 9.950M 57.00K 64.96M
YoY Change -1.31% -94.41% 146.82%
NET CHANGE
Cash From Operating Activities -8.457M -4.603M -28.59M
Cash From Investing Activities -364.0K -491.0K -587.0K
Cash From Financing Activities 9.950M 57.00K 64.96M
Net Change In Cash 1.129M -5.037M 35.79M
YoY Change 276.33% -23.21% -557.51%
FREE CASH FLOW
Cash From Operating Activities -$8.457M -$4.603M -$28.59M
Capital Expenditures $366.0K $491.0K $592.0K
Free Cash Flow -$8.823M -$5.094M -$29.18M
YoY Change -9.8% -32.43% -14.54%

Facts In Submission

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<p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-weight:bold;margin:0pt 0pt 12pt 0pt;">1. Business</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-weight:bold;margin:0pt 0pt 12pt 0pt;">Description of the Business</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;">Liquidia Corporation (“Liquidia” or the “Company”) is a biopharmaceutical company focused on the development, manufacture, and commercialization of products that address unmet patient needs, with current focus directed towards the treatment of pulmonary hypertension (“PH”). Liquidia Corporation operates through its wholly owned operating subsidiaries, Liquidia Technologies, Inc. (“Liquidia Technologies”) and Liquidia PAH, LLC (“Liquidia PAH”), formerly known as RareGen, LLC (“RareGen”).</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;">The Company generates revenue primarily pursuant to a promotion agreement between Liquidia PAH and Sandoz Inc. (“Sandoz”), dated as of August 1, 2018, as amended (the “Promotion Agreement”), sharing profit derived from the sale of Sandoz’s substitutable generic treprostinil injection (“Treprostinil Injection”) in the United States. Liquidia PAH has the exclusive rights to conduct commercial activities to encourage the appropriate use of Treprostinil Injection. The Company employs a targeted sales force calling on physicians and hospital pharmacies in the treatment of pulmonary arterial hypertension (“PAH”), as well as key stakeholders involved in the distribution and reimbursement of Treprostinil Injection. Strategically, the Company believes that its commercial presence in the field will enable an efficient base to expand from for the launch of YUTREPIA upon final approval, leveraging existing relationships and further validating its reputation as a company committed to supporting PAH patients.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;">The Company conducts research, development and manufacturing of novel products by applying its subject matter expertise in cardiopulmonary diseases and our proprietary PRINT® technology, a particle engineering platform that enables precise production of uniform drug particles designed to improve the safety, efficacy, and performance of a wide range of therapies. Through development of the Company’s own products and research with third parties, the Company has experience applying PRINT across multiple routes of administration and drug payloads including inhaled therapies, vaccines, biologics, nucleic acids and ophthalmic implants, among others.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;">The Company’s lead product candidate, for which it holds worldwide commercial rights, is YUTREPIA for the treatment of PAH. YUTREPIA is an inhaled dry powder formulation of treprostinil designed with PRINT to improve the therapeutic profile of treprostinil by enhancing deep lung delivery while using a convenient, low resistance dry-powder inhaler (“DPI”) and by achieving higher dose levels than the labelled dose of current inhaled therapies. The Company’s New Drug Application (“NDA”) for YUTREPIA was tentatively approved by the U.S. Food and Drug Administration (“FDA”) for the treatment of PAH in November 2021. The FDA also confirmed that the clinical data in the NDA would support the Company’s pursuit of a supplemental NDA to treat patients with pulmonary hypertension and interstitial lung disease (PH-ILD) upon the expiration of regulatory exclusivity for the nebulized form of treprostinil in March 2024.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-weight:bold;margin:0pt 0pt 12pt 0pt;">Recent Developments</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">On January 9, 2023, the Company entered into a Revenue Interest Financing Agreement (the “RIFA”) with HealthCare Royalty Partners IV, L.P. (“HCR”) and HealthCare Royalty Management, LLC. Pursuant to the RIFA and subject to customary closing conditions, HCR has agreed to pay the Company an aggregate investment amount of up to $100.0 million (the “Investment Amount”). Under the terms of the RIFA, $32.5 million of the Investment Amount was funded on January 27, 2023 (the “Initial Investment Amount”), $22.4 million of which was used to satisfy in full and retire the Company’s indebtedness under the Amended and Restated Loan and Security Agreement with Silicon Valley Bank, with the excess proceeds less transaction costs of approximately $0.7 million funded to the Company. Under the RIFA, an additional $35.0 million of the Investment Amount will be funded fifteen business days after the earlier of regulatory approval of YUTREPIA or a favorable determination relating to the asserted patents in the ongoing patent litigation with </p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;">United Therapeutics Corporation and $25.0 million of the Investment Amount will be funded fifteen business days after the mutual agreement of HCR and the Company to fund such amount.  See Note 16 for further information.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-weight:bold;margin:0pt 0pt 12pt 0pt;">Risks and Uncertainties</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;padding-bottom:12pt;margin:0pt;">The Company is subject to risks and uncertainties common to companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, dependence on third parties and key personnel, protection of proprietary technology, compliance with government regulations, and the ability to secure additional capital to fund operations.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;background:#ffffff;margin:0pt;">The current global macro-economic environment is volatile, which may result in supply chain constraints and elevated rates of inflation. In addition, the Company operates in a dynamic and highly competitive industry and believes that changes in any of the following areas could have a material adverse effect on the Company’s future financial position, results of operations, or cash flows: the ability to obtain future financing; advances and trends in new technologies and industry standards; results of clinical trials; regulatory approval and market acceptance of the Company’s products; development of sales channels; certain strategic relationships; litigation or claims against the Company related to intellectual property, product, regulatory, or other matters; and the Company’s ability to attract and retain employees necessary to support its growth.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;text-indent:36pt;background:#ffffff;margin:0pt;"><span style="font-size:13.5pt;visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;background:#ffffff;margin:0pt;">Product candidates developed by the Company require approval from the FDA and/or other international regulatory agencies prior to commercial sales. There can be no assurance that the Company's product candidates will receive the necessary approvals. If the Company is denied approval, approval is delayed, or the Company is unable to maintain approval, it could have a material adverse impact on the Company.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;background:#ffffff;margin:0pt;"><span style="font-size:13.5pt;visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;background:#ffffff;margin:0pt;">The Company relies on single source manufacturers and suppliers for the supply of its product candidates. This adds to the manufacturing risks faced by the Company, which could be left without backup facilities in the event of any failure by a supplier. Any disruption from these manufacturers or suppliers could have a negative impact on the Company’s business, financial position and results of operations.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;background:#ffffff;margin:0pt;"><span style="font-size:13.5pt;visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-weight:bold;margin:0pt 0pt 12pt 0pt;">Liquidity</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;">The Company expects to incur significant expenses and operating losses for the foreseeable future as it seeks regulatory approval and prepares for commercialization of any approved product candidates. These efforts require significant amounts of capital, adequate personnel and infrastructure, and extensive compliance-reporting capabilities. Even if the Company's development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales. The Company may require additional capital in advance of a potential commercial launch of YUTREPIA. If the Company is unable to access the contingent Investment Amounts from the RIFA or generate substantial YUTREPIA product revenue by the second quarter of 2024, the Company will require additional capital. The Company may also require additional capital to pursue in-licenses or acquisitions of other product candidates. If the Company concludes it requires but is unable to obtain funding, the Company could be required to delay, reduce, or eliminate research and development programs, product portfolio expansion, or future commercialization efforts, which could adversely affect its business prospects.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">In accordance with Accounting Standards Update (“ASU”) 2014-15,<i style="font-style:italic;"> Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40)</i>, the Company has evaluated whether there are conditions and 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 consolidated financial statements are issued. The Company has financed its growth and operations through a combination of funds generated from revenues, the issuance of convertible preferred stock and common stock, bank borrowings, bank borrowings with warrants and the issuance of convertible notes and warrants, and revenue interest financing. Since inception, the Company has incurred recurring losses, including net loss of $41.0 million for the year ended December 31, 2022 and the Company had an accumulated deficit of $350.6 million as of December 31, 2022. Although the Company expects to continue to generate operating losses for the foreseeable future, management believes that based on its current operating plan, excluding any potential contingent Investment </p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;">Amounts from the RIFA and future YUTREPIA product revenue, its cash and cash equivalents will be sufficient to fund operations and capital expenditure requirements and allow it to remain in compliance with its minimum cash covenants pursuant to the RIFA for at least twelve months from the issuance date of these consolidated financial statements. If the Company is unable to access additional Investment Amounts from the RIFA, there could be substantial doubt about the Company’s ability to continue as a going concern as of the date of the issuance of the Company’s second quarter 2023 financial statements. The Company has based these estimates on assumptions that may differ from actual results, and it could use its available resources sooner than expected.</p>
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<p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-style:italic;font-weight:bold;margin:0pt 0pt 12pt 0pt;">Use of Estimates</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;">The preparation of financial statements in accordance with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and the disclosure of contingent assets and liabilities, at the date of the financial statements, as well as the reported amounts of revenues and expenses during the period. These estimates are based on historical experience and various other assumptions believed reasonable under the circumstances. The Company evaluates its estimates on an ongoing basis, including those related to the valuation of stock-based awards, certain accruals, and intangible and contract acquisition cost amortization, and makes changes to the estimates and related disclosures as experience develops or new information becomes known. Actual results will most likely differ from those estimates.</p>
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