LIQUIDIA CORPORATION
| PART I | | 4 |
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| Item 1. | Business | 4 |
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| Item 1A. | Risk Factors | 35 |
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| Item 1B. | Unresolved Staff Comments | 82 |
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| Item 1C. | Cybersecurity | 82 |
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| Item 2. | Properties | 83 |
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| Item 3. | Legal Proceedings | 84 |
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| Item 4. | Mine Safety Disclosures | 84 |
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| PART II | | 84 |
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| Item 5. | Market For Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 84 |
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| Item 6. | [Reserved] | 85 |
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| Item 7. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 85 |
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| Item 7A. | Quantitative and Qualitative Disclosures About Market Risk | 95 |
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| Item 8. | Financial Statements and Supplementary Data | 96 |
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| Item 9. | Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | 96 |
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| Item 9A. | Controls and Procedures | 96 |
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| Item 9B. | Other Information | 97 |
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| Item 9C. | Disclosure Regarding Foreign Jurisdictions that Prevent Inspections | 97 |
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| PART III | | 98 |
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| Item 10. | Directors, Executive Officers and Corporate Governance | 98 |
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| Item 11. | Executive Compensation | 98 |
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| Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 99 |
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| Item 13. | Certain Relationships and Related Transactions, and Director Independence | 100 |
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| Item 14. | Principal Accounting Fees and Services | 100 |
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| PART IV | | 101 |
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| Item 15. | Exhibits and Financial Statement Schedules | 101 |
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This Annual Report on Form 10-K includes our trademarks, trade names and service marks, such as Liquidia, the Liquidia logo, YUTREPIA and PRINT, which are protected under applicable intellectual property laws and are the property of Liquidia Technologies, Inc. This Annual Report on Form 10-K also contains trademarks, trade names and service marks of other companies, which are the property of their respective owners. Solely for convenience, trademarks, trade names and service marks referred to in this Annual Report on Form 10-K may appear without the ®, ™ or SM symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the right of the applicable licensor to these trademarks, trade names and service marks. We do not intend our use or display of other parties’ trademarks, trade names or service marks to imply, and such use or display should not be construed to imply, a relationship with, or endorsement or sponsorship of us by, these other parties.
Cautionary Note Regarding Forward-Looking Statements
This Annual Report on Form 10-K contains forward-looking statements. All statements other than statements of historical facts contained in this Annual Report on Form 10-K may be forward-looking statements. We intend such forward-looking statements to be subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).The forward-looking statements are contained principally in the sections entitled “Risk Factors,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” but are also contained elsewhere in this Annual Report on Form 10-K. In some cases, you can identify forward-looking statements by terms such as “anticipates,” “believes,” contemplates,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “might,” “plans,” “potential,” “predicts,” “projects,” “should,” “targets,” “will,” “would” or the negative of these terms or other similar expressions. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements include, but are not limited to, statements about:
| ● | the timing of and our ability to obtain and maintain regulatory approvals for our product candidates, including the potential for, and timing regarding, final approval by the FDA (as defined below) of and our ability to commercially launch YUTREPIA and L606, including the potential impact of regulatory review, approval, and exclusivity developments which may occur for competitors, and the scope of any such approvals and the indications for which we receive approval; |
| ● | the timeline or outcome related to our patent litigation with United Therapeutics that was filed in the U.S. District Court for the District of Delaware, our litigation with United Therapeutics that was filed in the Superior Court for Durham County, North Carolina, the lawsuit we filed against the FDA in the U.S. District Court for the District of Columbia, including the cross claims filed by United Therapeutics in that action, or any future litigation with United Therapeutics or any other third-party, including any related rehearings or appeals; |
| ● | the timing and our ability to enroll our planned clinical trials for our product candidates, including planned clinical trials for YUTREPIA and L606; |
| ● | the timing and availability of data from our clinical trials and our ability to meet endpoints in such clinical trials; |
| ● | our plans to develop and commercialize our product candidates; |
| ● | the timing and related contents of our planned regulatory filings and/or applications; |
| ● | the clinical utility of our product candidates and their potential advantages compared to other treatments; |
| ● | our commercialization, marketing and distribution capabilities and strategy; |
| ● | our ability to establish and maintain arrangements for the manufacture of our product candidates and the ability and sufficiency of our current manufacturing facilities to produce development and commercial quantities of our product candidates; |
| ● | our ability to establish and maintain collaborations, including any third-party license agreements; |
| ● | our expectations regarding the size of the patient populations, market opportunities, market acceptance, third-party payor coverage and opportunity for those products that we commercialize, including our own products and products we commercialize in collaboration with third parties, including Sandoz’s fully substitutable generic treprostinil injection; |
| ● | the availability and market acceptance of medical devices and components of medical devices used to administer our drug products and drug products that we commercialize with third parties, including ICU Medical’s CADD-MS® 3 ambulatory infusion pump (“CADD-MS 3 infusion pump”), the RG 3ml Medication Cartridge that we developed in collaboration with Chengdu Shifeng Medical Technologies LTD. used for the subcutaneous administration of Sandoz’s generic treprostinil injection, ICU Medical’s CADD Legacy and CADD-Solis infusion pumps used for the intravenous administration of Sandoz’s generic treprostinil injection, an infusion pump that we are developing with Sandoz for the subcutaneous administration of Sandoz’s generic treprostinil injection, Plastiape’s RS00 Model 8 dry powder inhaler, which we plan to use for the administration of YUTREPIA, and any devices used for the administration of L606; |
| ● | our and our business partners’ ability to develop and to obtain and maintain regulatory clearances and approvals, and the timing of any such clearances and approvals, for medical devices used to administer our products and products we commercialize, including a nebulizer for the administration of L606 and the infusion pump that we are developing with Sandoz; |
| ● | the effects on our company or our subsidiaries of future changes in law, including regulatory developments or legislative actions, including changes in healthcare, environmental and other laws and regulations to which we are subject, tariffs that may apply to products that we purchase or sell, or judicial decisions overturning or establishing new legal precedents; |
| ● | adverse outcomes of pending or threatened litigation or governmental investigations, including our ongoing litigation involving United Therapeutics and the FDA and any future litigation with United Therapeutics, the FDA or any other third party; |
| ● | the failure to renew, or the revocation of, any license or other required permits; |
| ● | our ability to retain, attract and hire key personnel; |
| ● | our intellectual property position and the duration of our patent rights; |
| ● | prevailing economic, market and business conditions; |
| ● | changes in the industry in which we operate; |
| ● | the volatility and unpredictability of the stock market and credit market conditions; |
| ● | conditions beyond our control, such as natural and man-made disasters, global health emergencies, such as pandemics and epidemics, or geopolitical conflict, such as acts of war, terrorism and civil disorder; |
| ● | our ability to continue operations as a going concern without obtaining additional funding; |
| ● | our ability to satisfy the covenants contained in the HCR Agreement (as defined below); |
| ● | the cost and availability of capital and any restrictions imposed by lenders or creditors; |
| ● | unexpected charges or unexpected liabilities arising from a change in accounting policies, including any such changes by third parties with whom we collaborate and from whom we receive a portion of their net profits, or the effects of acquisition accounting varying from our expectations; |
| ● | the risk that the credit ratings of the Company or our subsidiaries may be different from market expectations, which may increase borrowing costs and/or make it more difficult for us to pay or refinance our debts and require us to borrow or divert cash flow from operations in order to service debt payments; |
| ● | conduct of and changing circumstances related to third-party relationships on which we rely, including the level of credit worthiness of counterparties; |
| ● | fluctuations in interest rates; |
| ● | fluctuations in the trading price of our common stock; |
| ● | variations between the stated assumptions on which forward-looking statements are based and our actual experience; |
| ● | our estimates regarding future expenses, capital requirements and needs for additional financing; and |
| ● | our expectation that the use of proceeds from prior public and private equity offerings and the period over which such proceeds, together with our available cash, will be sufficient to meet our operating needs. |
You should refer to the “Risk Factors” section of this Annual Report on Form 10-K for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. The forward-looking statements in this Annual Report on Form 10-K are only predictions, and we may not actually achieve the plans, intentions or expectations included in our forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. Because forward-looking statements are
inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements.
These forward-looking statements speak only as of the date of this Annual Report on Form 10-K. While we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should therefore not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this Annual Report on Form 10-K.
Unless the context otherwise requires, references in this Annual Report on Form 10-K to“we,” “us”,“our”,“Liquidia”* and the*“Company”* refer to Liquidia Corporation, a Delaware corporation, and unless specified otherwise, include our wholly owned subsidiaries, Liquidia Technologies, Inc., a Delaware corporation (“Liquidia Technologies”) and Liquidia PAH, LLC (formerly known as RareGen, LLC (“RareGen”)), a Delaware limited liability company (“Liquidia PAH”).*
