2023 Q2 Form 10-Q Financial Statement

#000155837023008392 Filed on May 08, 2023

View on sec.gov

Income Statement

Concept 2023 Q2 2023 Q1
Revenue $4.786M $4.493M
YoY Change 22.15% 28.67%
Cost Of Revenue $671.0K $654.0K
YoY Change -8.21% -5.76%
Gross Profit $4.115M $3.839M
YoY Change 29.12% 37.21%
Gross Profit Margin 85.98% 85.44%
Selling, General & Admin $9.245M $7.793M
YoY Change 33.95% -37.68%
% of Gross Profit 224.67% 203.0%
Research & Development $17.70M $5.278M
YoY Change 239.05% 11.63%
% of Gross Profit 430.01% 137.48%
Depreciation & Amortization $589.0K $569.0K
YoY Change -41.45% -39.92%
% of Gross Profit 14.31% 14.82%
Operating Expenses $17.70M $5.278M
YoY Change 239.05% 11.63%
Operating Profit -$22.83M -$9.232M
YoY Change 154.46% -36.21%
Interest Expense $1.426M $1.124M
YoY Change 163.1% 135.15%
% of Operating Profit
Other Income/Expense, Net -$692.0K -$2.513M
YoY Change 45.07% 70.84%
Pretax Income -$23.52M -$11.75M
YoY Change 148.94% -26.33%
Income Tax
% Of Pretax Income
Net Earnings -$23.52M -$11.70M
YoY Change 148.94% -26.61%
Net Earnings / Revenue -491.37% -260.41%
Basic Earnings Per Share -$0.36 -$0.18
Diluted Earnings Per Share -$0.36 -$0.18
COMMON SHARES
Basic Shares Outstanding 64.72M 64.69M
Diluted Shares Outstanding 64.79M 64.66M

Balance Sheet

Concept 2023 Q2 2023 Q1
SHORT-TERM ASSETS
Cash & Short-Term Investments $88.20M $94.41M
YoY Change -15.07% 63.36%
Cash & Equivalents $88.20M $94.41M
Short-Term Investments
Other Short-Term Assets $601.0K $1.147M
YoY Change -33.74% 31.24%
Inventory
Prepaid Expenses
Receivables $4.095M $4.131M
Other Receivables $0.00 $0.00
Total Short-Term Assets $92.89M $99.69M
YoY Change -14.39% 60.91%
LONG-TERM ASSETS
Property, Plant & Equipment $4.171M $4.346M
YoY Change -1.14% -5.81%
Goodwill $3.903M $3.903M
YoY Change 0.0% 0.0%
Intangibles $3.554M $3.643M
YoY Change -12.05% -13.78%
Long-Term Investments
YoY Change
Other Assets $15.16M $15.33M
YoY Change -6.13% -7.01%
Total Long-Term Assets $28.71M $29.23M
YoY Change -6.14% -7.41%
TOTAL ASSETS
Total Short-Term Assets $92.89M $99.69M
Total Long-Term Assets $28.71M $29.23M
Total Assets $121.6M $128.9M
YoY Change -12.57% 37.85%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $1.918M $841.0K
YoY Change 35.84% -49.52%
Accrued Expenses $15.73M $3.877M
YoY Change 205.83% -35.12%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00
YoY Change
Long-Term Debt Due $1.845M $2.102M
YoY Change 556.58% 529.34%
Total Short-Term Liabilities $19.50M $6.820M
YoY Change 185.14% -14.49%
LONG-TERM LIABILITIES
Long-Term Debt $31.92M $30.76M
YoY Change 62.79% 57.95%
Other Long-Term Liabilities $9.528M $9.697M
YoY Change -7.58% -7.09%
Total Long-Term Liabilities $41.45M $40.46M
YoY Change 111.39% 107.74%
TOTAL LIABILITIES
Total Short-Term Liabilities $19.50M $6.820M
Total Long-Term Liabilities $41.45M $40.46M
Total Liabilities $60.94M $47.28M
YoY Change 64.81% 23.97%
SHAREHOLDERS EQUITY
Retained Earnings -$385.9M -$362.3M
YoY Change 15.19% 11.31%
Common Stock $65.00K $65.00K
YoY Change 1.56% 22.64%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $60.66M $81.64M
YoY Change
Total Liabilities & Shareholders Equity $121.6M $128.9M
YoY Change -12.57% 37.85%

Cashflow Statement

Concept 2023 Q2 2023 Q1
OPERATING ACTIVITIES
Net Income -$23.52M -$11.70M
YoY Change 148.94% -26.61%
Depreciation, Depletion And Amortization $589.0K $569.0K
YoY Change -41.45% -39.92%
Cash From Operating Activities -$5.564M -$8.457M
YoY Change -33.99% -13.55%
INVESTING ACTIVITIES
Capital Expenditures $243.0K $366.0K
YoY Change -3571.43%
Acquisitions
YoY Change
Other Investing Activities $0.00 $2.000K
YoY Change -100.0%
Cash From Investing Activities -$243.0K -$364.0K
YoY Change 12050.0%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net $20.00M
YoY Change 90.48%
Cash From Financing Activities -409.0K 9.950M
YoY Change -100.75% -1.31%
NET CHANGE
Cash From Operating Activities -5.564M -8.457M
Cash From Investing Activities -243.0K -364.0K
Cash From Financing Activities -409.0K 9.950M
Net Change In Cash -6.216M 1.129M
YoY Change -113.5% 276.33%
FREE CASH FLOW
Cash From Operating Activities -$5.564M -$8.457M
Capital Expenditures $243.0K $366.0K
Free Cash Flow -$5.807M -$8.823M
YoY Change -31.05% -9.8%

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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;">We are 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’). We operate through our 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;">We currently generate revenue 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. We employ a targeted sales force calling on physicians and hospital pharmacies involved in the treatment of pulmonary arterial hypertension (“PAH”) in the United States, as well as key stakeholders involved in the distribution and reimbursement of Treprostinil Injection. Strategically, we believe that our 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 our 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;">We conduct research, development and manufacturing of novel products by applying our subject matter expertise in cardiopulmonary diseases and our proprietary PRINT® technology, a particle engineering platform, to enable precise production of uniform drug particles designed to improve the safety, efficacy and performance of a wide range of therapies. Through development of our own products and research with third parties, we have 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;">Our lead product candidate 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 labeled doses of current inhaled therapies. The United States Food and Drug Administration (“FDA”) tentatively approved our New Drug Application (“NDA”) for YUTREPIA for the treatment of PAH in November 2021. The FDA also confirmed that the clinical data in the NDA would support our pursuit of a supplemental NDA to treat patients with pulmonary hypertension and interstitial lung disease (PH-ILD) upon the expiration of regulatory exclusivity in March 2024.</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;">We are 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, we operate in a dynamic and highly competitive industry and believes that changes in any of the following areas could have a material adverse effect on our 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 our products; development of sales channels; certain strategic relationships; litigation or claims against our related to intellectual property, product, regulatory, or other matters; and our ability to attract and retain employees necessary to support our growth.</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;">Product candidates we develop require approval from the FDA and/or other international regulatory agencies prior to commercial sales. There can be no assurance that our product candidates will receive the necessary approvals. If we are denied approval, approval is delayed, or we are unable to maintain approval, it could have a material adverse impact our 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;text-align:justify;background:#ffffff;margin:0pt;">We rely on single source manufacturers and suppliers for the supply of our product candidates, which adds to the manufacturing risks we face. In the event of any failure by a supplier, we could be left without backup facilities. Any disruption from these manufacturers or suppliers could have a negative impact on our 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="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;">We expect to incur significant expenses and operating losses for the foreseeable future as we seek regulatory approval and prepare 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 our development efforts are successful, it is uncertain when, if ever, we will realize significant revenue from product sales. We may require additional capital in advance of a potential commercial launch of YUTREPIA. If we are unable to access the contingent Investment Amounts from the RIFA (see Note 11) or generate meaningful YUTREPIA product revenue by the second quarter of 2024, we will require additional capital. We may also require additional capital to pursue in-licenses or acquisitions of other product candidates. If we conclude we require but are unable to obtain funding, we could be required to delay, reduce, or eliminate research and development programs, product portfolio expansion, or future commercialization efforts, which could adversely affect our business prospects.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 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>, we have evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within one year after the date that the condensed consolidated financial statements are issued. We have financed our 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, the issuance of convertible notes and warrants, and revenue interest financing. Since inception, we have incurred recurring losses, including a net loss of $11.7 million for the three months ended March 31, 2023 and we had an accumulated deficit of $362.3 million as of March 31, 2023. Although we expect to continue to generate operating losses for the foreseeable future, we believe that based on our current operating plan, excluding any potential contingent Investment Amounts from the RIFA and future YUTREPIA product revenue, that our cash and cash equivalents will be sufficient to fund operations and capital expenditure requirements and allow us to remain in compliance with the minimum cash covenants pursuant to the RIFA for at least twelve months from the issuance date of these consolidated condensed financial statements. If we are unable to access additional Investment Amounts from the RIFA, there could be substantial doubt about our ability to continue as a going concern as of the date of the issuance of our second quarter 2023 financial statements. We have 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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