2023 Q3 Form 10-Q Financial Statement

#000155837023014376 Filed on August 10, 2023

View on sec.gov

Income Statement

Concept 2023 Q3 2023 Q2
Revenue $3.678M $4.786M
YoY Change 16.21% 22.15%
Cost Of Revenue $570.0K $671.0K
YoY Change -22.97% -8.21%
Gross Profit $3.108M $4.115M
YoY Change 28.16% 29.12%
Gross Profit Margin 84.5% 85.98%
Selling, General & Admin $10.56M $9.245M
YoY Change 57.31% 33.95%
% of Gross Profit 339.77% 224.67%
Research & Development $7.440M $17.70M
YoY Change 64.89% 239.05%
% of Gross Profit 239.38% 430.01%
Depreciation & Amortization $510.0K $589.0K
YoY Change -54.79% -41.45%
% of Gross Profit 16.41% 14.31%
Operating Expenses $7.440M $17.70M
YoY Change 64.89% 239.05%
Operating Profit -$14.89M -$22.83M
YoY Change 68.62% 154.46%
Interest Expense $1.761M $1.426M
YoY Change 184.03% 163.1%
% of Operating Profit
Other Income/Expense, Net -$899.0K -$692.0K
YoY Change 244.44% 45.07%
Pretax Income -$15.79M -$23.52M
YoY Change 73.67% 148.94%
Income Tax
% Of Pretax Income
Net Earnings -$15.79M -$23.52M
YoY Change 73.67% 148.94%
Net Earnings / Revenue -429.31% -491.37%
Basic Earnings Per Share -$0.24 -$0.36
Diluted Earnings Per Share -$0.24 -$0.36
COMMON SHARES
Basic Shares Outstanding 64.74M 64.72M
Diluted Shares Outstanding 64.86M 64.79M

Balance Sheet

Concept 2023 Q3 2023 Q2
SHORT-TERM ASSETS
Cash & Short-Term Investments $76.20M $88.20M
YoY Change -22.5% -15.07%
Cash & Equivalents $76.23M $88.20M
Short-Term Investments
Other Short-Term Assets $3.400M $601.0K
YoY Change 112.23% -33.74%
Inventory
Prepaid Expenses
Receivables $3.338M $4.095M
Other Receivables $0.00 $0.00
Total Short-Term Assets $82.98M $92.89M
YoY Change -19.48% -14.39%
LONG-TERM ASSETS
Property, Plant & Equipment $4.400M $4.171M
YoY Change 11.59% -1.14%
Goodwill $3.903M $3.903M
YoY Change 0.0% 0.0%
Intangibles $3.491M $3.554M
YoY Change -8.42% -12.05%
Long-Term Investments
YoY Change
Other Assets $15.10M $15.16M
YoY Change -3.61% -6.13%
Total Long-Term Assets $28.66M $28.71M
YoY Change -2.88% -6.14%
TOTAL ASSETS
Total Short-Term Assets $82.98M $92.89M
Total Long-Term Assets $28.66M $28.71M
Total Assets $111.6M $121.6M
YoY Change -15.79% -12.57%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $1.812M $1.918M
YoY Change 58.95% 35.84%
Accrued Expenses $7.600M $15.73M
YoY Change 24.82% 205.83%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00
YoY Change
Long-Term Debt Due $2.700M $1.845M
YoY Change 1068.83% 556.58%
Total Short-Term Liabilities $12.16M $19.50M
YoY Change 62.95% 185.14%
LONG-TERM LIABILITIES
Long-Term Debt $42.20M $31.92M
YoY Change 113.77% 62.79%
Other Long-Term Liabilities $9.300M $9.528M
YoY Change -8.25% -7.58%
Total Long-Term Liabilities $51.50M $41.45M
YoY Change 160.88% 111.39%
TOTAL LIABILITIES
Total Short-Term Liabilities $12.16M $19.50M
Total Long-Term Liabilities $51.50M $41.45M
Total Liabilities $63.64M $60.94M
YoY Change 69.54% 64.81%
SHAREHOLDERS EQUITY
Retained Earnings -$401.6M -$385.9M
YoY Change 16.71% 15.19%
Common Stock $65.00K $65.00K
YoY Change 1.56% 1.56%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $48.01M $60.66M
YoY Change
Total Liabilities & Shareholders Equity $111.6M $121.6M
YoY Change -15.79% -12.57%

Cashflow Statement

Concept 2023 Q3 2023 Q2
OPERATING ACTIVITIES
Net Income -$15.79M -$23.52M
YoY Change 73.67% 148.94%
Depreciation, Depletion And Amortization $510.0K $589.0K
YoY Change -54.79% -41.45%
Cash From Operating Activities -$11.56M -$5.564M
YoY Change 100.21% -33.99%
INVESTING ACTIVITIES
Capital Expenditures $10.47M $243.0K
YoY Change -11238.3% -3571.43%
Acquisitions
YoY Change
Other Investing Activities $0.00 $0.00
YoY Change -100.0%
Cash From Investing Activities -$10.47M -$243.0K
YoY Change 11038.3% 12050.0%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 10.07M -409.0K
YoY Change 2793.68% -100.75%
NET CHANGE
Cash From Operating Activities -11.56M -5.564M
Cash From Investing Activities -10.47M -243.0K
Cash From Financing Activities 10.07M -409.0K
Net Change In Cash -11.96M -6.216M
YoY Change 116.67% -113.5%
FREE CASH FLOW
Cash From Operating Activities -$11.56M -$5.564M
Capital Expenditures $10.47M $243.0K
Free Cash Flow -$22.03M -$5.807M
YoY Change 287.85% -31.05%

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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 an amendment to our NDA to treat patients with pulmonary hypertension and interstitial lung disease (PH-ILD) upon the expiration of regulatory exclusivity in March 2024. We filed an amendment to our NDA to include PH-ILD as a labelled indication on July 24, 2023.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;"><span style="white-space:pre-wrap;">We are also developing L606, an investigational, liposomal formulation of treprostinil administered twice-daily with a short-duration next-generation nebulizer, which we licensed from Pharmosa. L606 is currently being evaluated in an open-label study in the United States for treatment of PAH with a planned pivotal study for the treatment of PH-ILD.</span></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 </p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;background:#ffffff;margin:0pt;">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 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="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;">Recent Events</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-style:italic;font-weight:bold;margin:0pt 0pt 12pt 0pt;"><span style="background:#ffffff;">License Agreement with Pharmosa Biopharm</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;">In June 2023, we entered into a License Agreement with Pharmosa Biopharm Inc (“Pharmosa”) pursuant to which we were granted an exclusive license in North America to develop and commercialize L606, an inhaled, sustained-release formulation of treprostinil currently being evaluated in a clinical trial for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), and a non-exclusive license for the manufacture, development and use (but not commercialization) of such licensed product in most countries outside North America (the “Pharmosa License Agreement”).</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;">Under the terms of the Pharmosa License Agreement, we will be responsible for development, regulatory and commercial activities of L606 in North America. Pharmosa will manufacture clinical and commercial supplies of the liposomal formulation through its global supply chain and support us in establishing a redundant global supply chain. In consideration for these exclusive rights, we paid Pharmosa an upfront license fee of $10 million and will pay Pharmosa potential development milestone payments tied to PAH and PH-ILD indications of up to $30 million, potential sales milestones of up to $185 million and two tiers of low, double-digit royalties on net sales of L606. Pharmosa will also receive a $10 million milestone payment for each additional indication approved after PAH and PH-ILD and each additional product approved under the license. We also retain the first right to negotiate for development and commercialization of L606 in Europe and other territories should Pharmosa seek a partner, subject to satisfaction of certain conditions as set forth in the Pharmosa License Agreement.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;">Concurrently with the execution of the Pharmosa License Agreement, we also entered into an Asset Transfer Agreement with Pharmosa pursuant to which Pharmosa will transfer its physical materials so that we can perform the necessary actions contemplated under the Pharmosa License Agreement.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-style:italic;font-weight:bold;padding-bottom:12pt;margin:0pt;"><span style="background:#ffffff;">Second and Third Amendments to Revenue Interest Financing Agreement</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;background:#ffffff;margin:0pt;">In June 2023 and July 2023, we entered into a Second Amendment and Third Amendment, respectively, to the Revenue Interest Financing Agreement (“RIFA”) with HealthCare Royalty Partners IV, L.P. (“HCR”), pursuant to which HCR moved $2.5 million from the fourth tranche to the second tranche such that HCR would fund a total of $10.0 million of the Investment Amount (as defined in the RIFA) under the second tranche. The $10.0 million was funded on July 27, 2023 and was used for the upfront license fee due to Pharmosa in connection with the transactions contemplated by the Pharmosa License Agreement. In addition, pursuant to the amendments, the third tranche of $35.0 million and fourth tranche of $22.5 million will now be funded only upon the mutual agreement of both HCR and us.</p>
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FinanceLeaseLiabilityPaymentsDueYearTwo
64000
CY2023Q2 lqda Lease Liability Payments Due Year Two
LeaseLiabilityPaymentsDueYearTwo
1420000
CY2023Q2 us-gaap Lessee Operating Lease Liability Payments Due Year Three
LesseeOperatingLeaseLiabilityPaymentsDueYearThree
1158000
CY2023Q2 us-gaap Finance Lease Liability Payments Due Year Three
FinanceLeaseLiabilityPaymentsDueYearThree
0
CY2023Q2 lqda Lease Liability Payments Due Year Three
LeaseLiabilityPaymentsDueYearThree
1158000
CY2023Q2 us-gaap Lessee Operating Lease Liability Payments Due
LesseeOperatingLeaseLiabilityPaymentsDue
4477000
CY2023Q2 us-gaap Finance Lease Liability Payments Due
FinanceLeaseLiabilityPaymentsDue
236000
CY2023Q2 lqda Lease Liability Payments Due Total
LeaseLiabilityPaymentsDueTotal
4713000
CY2023Q2 us-gaap Lessee Operating Lease Liability Undiscounted Excess Amount
LesseeOperatingLeaseLiabilityUndiscountedExcessAmount
679000
CY2023Q2 us-gaap Finance Lease Liability Undiscounted Excess Amount
FinanceLeaseLiabilityUndiscountedExcessAmount
14000
CY2023Q2 lqda Lease Liability Undiscounted Excess Amount
LeaseLiabilityUndiscountedExcessAmount
693000
CY2023Q2 us-gaap Operating Lease Liability
OperatingLeaseLiability
3798000
CY2023Q2 us-gaap Finance Lease Liability
FinanceLeaseLiability
222000
CY2023Q2 lqda Lease Liability
LeaseLiability
4020000
CY2022Q4 lqda Revenue Interest Financing Agreement
RevenueInterestFinancingAgreement
32500000
lqda Revenue Interest Financing Agreement Issuance Costs
RevenueInterestFinancingAgreementIssuanceCosts
836000
lqda Revenue Interest Financing Agreement Non Cash Interest Expense
RevenueInterestFinancingAgreementNonCashInterestExpense
2328000
lqda Revenue Interest Financing Agreement Amortization Of Debt Discount
RevenueInterestFinancingAgreementAmortizationOfDebtDiscount
48000
lqda Payments On Revenue Interest Financing Liability
PaymentsOnRevenueInterestFinancingLiability
500000
CY2023Q2 lqda Revenue Interest Financing Agreement
RevenueInterestFinancingAgreement
33540000
CY2023Q2 lqda Revenue Interest Financing Payable Current
RevenueInterestFinancingPayableCurrent
1741000
CY2023Q2 lqda Revenue Interest Financing Payable Noncurrent
RevenueInterestFinancingPayableNoncurrent
31799000
us-gaap Gains Losses On Extinguishment Of Debt
GainsLossesOnExtinguishmentOfDebt
-2300000
lqda Maximum Net Sales Threshold As Basis For Payment Of Future Contingent Royalties
MaximumNetSalesThresholdAsBasisForPaymentOfFutureContingentRoyalties
1500000
lqda Net Sales Earned Relating To Payment Of Future Contingent Royalties
NetSalesEarnedRelatingToPaymentOfFutureContingentRoyalties
0
CY2023Q2 lqda Non Cancelable Future Commitment For Product Manufacturing Costs
NonCancelableFutureCommitmentForProductManufacturingCosts
4300000

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