LQDA on Nasdaq

Liquidia Corporation

In its 2026 annual report the company says: “We are a biopharmaceutical company driven by science and compassion to revolutionize care for patients with challenging respiratory and vascular diseases such as pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. We operate through our wholly owned operating subsidiaries, Liquidia Technologies, Inc. and Liquidia PAH, LLC, formerly known as RareGen.”4 It is headquartered in Morrisville, North Carolina.1 Its shares trade on Nasdaq under the symbol LQDA.1

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Last updated Oct 21, 2026.

Overview

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  • TickerLQDA on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersMorrisville, North Carolina1
  • Websitewww.liquidia.com
  • Incorporated inDE3
  • Business address419 Davis Drive, Suite 100, Morrisville, Nc 275603
  • Filer categoryNon-accelerated filer3

We are a biopharmaceutical company driven by science and compassion to revolutionize care for patients with challenging respiratory and vascular diseases such as pulmonary arterial hypertension (“PAH”) and pulmonary hypertension associated with interstitial lung disease (“PH-ILD”). We operate through our wholly owned operating subsidiaries, Liquidia Technologies, Inc. and Liquidia PAH, LLC, formerly known as RareGen.4 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

-32.5%Operating margin5
-43.5%Net margin5
1031.2%Revenue growth, 20255
-154.0%Return on equity5
-$40.0MFree cash flow5

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Products and services

Product brought in 94% of the revenue Liquidia Corporation broke down this way in fiscal 2025.

  1. Product$148.3M594%
  2. Service$10.0M56%down 28% from 2024
Products and services by year
Products and services202320242025
Product$148.3M
Service$17.5M$14.0M$10.0M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development20¢$39.3M
  • Selling, general and admin80¢$157.2M

Out of $158.3M in revenue.5 The company lost money this year.

Financial statements

Revenue67895$158.3M in 2025+1861% since 2019
0$50.0M$100.0M$150.0M$200.0M2019: $8.1M$8.1M20192020: $739.6K$739.6K2020−91%2021: $12.9M$12.9M2021+1638%2022: $15.9M$15.9M2022+24%2023: $17.5M$17.5M2023+10%2024: $14.0M$14.0M2024−20%2025: $158.3M$158.3M2025+1031%
Operating income67895-$51.4M in 2025+10% since 2019
-$150.0M-$100.0M-$50.0M02019: -$46.8M-$46.8M20192020: -$59.1M-$59.1M2020+26%2021: -$33.8M-$33.8M2021−43%2022: -$38.8M-$38.8M2022+15%2023: -$73.4M-$73.4M2023+89%2024: -$121.3M-$121.3M2024+65%2025: -$51.4M-$51.4M2025−58%
Net income67895-$68.9M in 2025+45% since 2019
-$150.0M-$100.0M-$50.0M02019: -$47.6M-$47.6M20192020: -$59.8M-$59.8M2020+26%2021: -$34.6M-$34.6M2021−42%2022: -$41.0M-$41.0M2022+19%2023: -$78.5M-$78.5M2023+91%2024: -$128.3M-$128.3M2024+63%2025: -$68.9M-$68.9M2025−46%

Every line of the income statement as filed: the last 3 fiscal years, latest first.5

Period ending2025-12-312024-12-312023-12-31
Revenues:$158.3M$14.0M$17.5M
Research and development$39.3M$47.8M$43.2M
Selling, general and administrative$157.2M$81.6M$44.7M
Total costs and expenses$209.7M$135.3M$90.9M
Income (loss) from operations-$51.4M-$121.3M-$73.4M
Interest income$6.6M$7.7M$3.5M
Interest expense-$24.2M-$14.7M-$6.3M
Loss on extinguishment of debt-$2.3M
Total other expense, net-$17.5M-$7.0M-$5.1M
Net loss and comprehensive loss-$68.9M-$128.3M-$78.5M
Net loss per common share, basic (in dollars per share)-$0.80-$1.63-$1.21
Net loss per common share, diluted (in dollars per share)-$0.80-$1.63-$1.21
Weighted average common shares outstanding, basic (in shares)86.1M shares78.7M shares65.0M shares
Weighted average common shares outstanding, diluted (in shares)86.1M shares78.7M shares65.0M shares

Compare Liquidia Corporation with another company

Corporate structure

Liquidia Corporation sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Liquidia Corporation

  • Liquidia Corporation Morrisville, North Carolina

Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Liquidia Corporation reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$25.8M5 Dec 31, 2025$24.1M5 Dec 31, 2024+7.1%
Accumulated depreciation$14.0M5 Dec 31, 2025$15.8M5 Dec 31, 2024−11.6%
Property and equipment, net$11.8M5 Dec 31, 2025$8.3M5 Dec 31, 2024+42.7%
Operating-lease assets (leased space)$3.9M5 Dec 31, 2025$4.2M5 Dec 31, 2024−5.7%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$190.7M5 Dec 31, 2025$176.5M5 Dec 31, 2024+8.0%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$3.9M5 Dec 31, 2025$3.9M5 Dec 31, 20240%
Intangible assets, net (excluding goodwill)$3.0M5 Dec 31, 2025$3.2M5 Dec 31, 2024−6.5%
Accumulated amortization$2.7M5 Dec 31, 2025$2.5M5 Dec 31, 2024+8.3%

Inventory

ItemLatestA year beforeChange
Inventory, total$23.8M5 Dec 31, 2025$241.0K5 Dec 31, 2024+9776.3%
Raw materials$3.7M12 Dec 31, 2024
Work in process$7.1M12 Dec 31, 2024

Properties, in its own words

Our corporate headquarters is located in Morrisville, North Carolina, and consists of approximately 45,000 square feet of space under a lease that expires on December 31, 2031 and includes an option for us to renew the lease for an additional five years through December 31, 2036. The primary use of this location is general office, laboratory, research and development and light manufacturing. In June 2025, we entered into a lease for a second manufacturing and office space in Morrisville, North Carolina that consists of approximately 70,131 square feet of space. The lease expires on November 1, 2036, with the option to extend for two additional periods of five years each with appropriate notice. This lease is not expected to commence until October 2026. We will seek additional space as needed to accommodate our growth.

Item 2 of the 10-K filed Mar 5, 2026.4

Leadership

Who has led Liquidia Corporation, and when. Pick a name to see everywhere that person has worked.

Board members and other officers (19)

Timeline

  1. Oct 14, 20268-K Entered a material agreement; Ended a material agreement; Regulation FD disclosure34
  2. Sep 30, 20268-K Other events35
  3. Sep 3, 20268-K Other events36
  4. Aug 12, 20268-K Results of operations; Other events37
  5. Jun 17, 20268-K Shareholder vote38
  6. Jun 8, 20268-K Other events39
  7. May 11, 20268-K Results of operations; Other events40
  8. Mar 5, 20268-K Results of operations41
  9. Jan 9, 20268-K Regulation FD disclosure42
  10. Nov 3, 20258-K Results of operations43
  11. Oct 30, 20258-K Entered a material agreement44
  12. Aug 12, 20258-K Results of operations45
  13. Jan 4, 2022New chief executive Roger Jeffs becomes CEO13
  14. Dec 15, 2020New chief executive Damian Degoa becomes CEO15
  15. Nov 20, 2020New chief executive Neal Franklin Fowler becomes CEO14

Calendar

Coming up

  1. Nov 2, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.04) a share, on Nov 3, 2025.46

When it reported results

  1. Aug 12, 2026Reported quarterly or annual results37
  2. May 11, 2026Reported quarterly or annual results40
  3. Mar 5, 2026Reported quarterly or annual results41
  4. Nov 3, 2025Reported quarterly or annual results43
  5. Aug 12, 2025Reported quarterly or annual results45
  6. May 8, 2025Reported quarterly or annual results47
  7. Mar 19, 2025Reported quarterly or annual results48
  8. Nov 13, 2024Reported quarterly or annual results49

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

581 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 96 major events, 350 insider forms, 24 large holders, 91 other. The latest 20:

  1. Oct 14, 20268-K EDGAR
  2. Oct 13, 20264 OWNERSHIP DOCUMENT EDGAR
  3. Oct 13, 20264 OWNERSHIP DOCUMENT EDGAR
  4. Oct 13, 20264 OWNERSHIP DOCUMENT EDGAR
  5. Oct 13, 20264 OWNERSHIP DOCUMENT EDGAR
  6. Oct 13, 20264 OWNERSHIP DOCUMENT EDGAR
  7. Oct 13, 20264 OWNERSHIP DOCUMENT EDGAR
  8. Oct 13, 20264 OWNERSHIP DOCUMENT EDGAR
  9. Oct 13, 20264 OWNERSHIP DOCUMENT EDGAR
  10. Oct 13, 20264 OWNERSHIP DOCUMENT EDGAR
  11. Oct 7, 20264 OWNERSHIP DOCUMENT EDGAR
  12. Sep 30, 20268-K EDGAR
  13. Sep 15, 20264 OWNERSHIP DOCUMENT EDGAR
  14. Sep 14, 2026144 EDGAR
  15. Sep 11, 2026144 EDGAR
  16. Sep 3, 20264 OWNERSHIP DOCUMENT EDGAR
  17. Sep 3, 20268-K EDGAR
  18. Aug 25, 20264 OWNERSHIP DOCUMENT EDGAR
  19. Aug 21, 2026144 EDGAR
  20. Aug 21, 20264 OWNERSHIP DOCUMENT EDGAR

The 581 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

264 open-market trades by officers, directors and large owners since October 2021: 24 buys and 240 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 14, 2026SINGH RAMANDirectorSale8,468$66.16$560.2KForm 4
Sep 11, 2026SINGH RAMANDirectorSale9,024$68.62$619.2KForm 4
Sep 1, 2026Krepp SarahChief Human Resource OfficerSale274$67.76$18.6KForm 4
Aug 21, 2026Adair JasonChief Business OfficerSale73,631$69.09$5.1MForm 4
Aug 20, 2026Rielly-Gauvin KatherineDirectorSale18,393$72.23$1.3MForm 4
Aug 19, 2026Rielly-Gauvin KatherineDirectorSale36,789$74.99$2.8MForm 4
Aug 19, 2026Saggar RajeevChief Medical OfficerSale50,000$74.06$3.7MForm 4
Aug 17, 2026Saggar RajeevChief Medical OfficerSale29,534$76.84$2.3MForm 4
Jul 27, 2026Boyle DanaChief Accounting OfficerSale1,600$87.53$140.0KForm 4
Jul 27, 2026Adair JasonChief Business OfficerSale688$87.53$60.2KForm 4
Jul 23, 2026Bloch Stephen MDirectorSale100,000$89.49$8.9MForm 4
Jul 22, 2026Bloch Stephen MDirectorSale100,000$88.38$8.8MForm 4
Jul 21, 2026Bloch Stephen MDirectorSale75,000$79.98$6.0MForm 4
Jul 20, 2026Bloch Stephen MDirectorSale3,596$79.55$286.1KForm 4
Jul 13, 2026Krepp SarahChief Human Resource OfficerSale7,864$71.51$562.4KForm 4
Jul 13, 2026Khindri SanjeevChief Development OfficerSale1,185$71.51$84.7KForm 4
Jul 13, 2026Kaseta MichaelCFO and COOSale20,430$71.51$1.5MForm 4
Jul 13, 2026JEFFS ROGERChief Executive OfficerSale35,249$71.51$2.5MForm 4
Jul 13, 2026Adair JasonChief Business OfficerSale7,863$71.51$562.3KForm 4
Jul 13, 2026Schundler RussellGeneral CounselSale14,738$71.51$1.1MForm 4

All 264 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Roger A. JeffsPh.D.$824.0K$7.7M58
2025Michael Kaseta50$592.2K$4.2M58
2025Russell Schundler51$540.8K$3.7M58
2025Rajeev SaggarM.D.52$539.3K$2.9M58
2025Scott Moomaw56$449.9K$2.7M58
2024Chief Executive Officer$800.0K$6.8M58
2024Chief Financial Officer andChief Operating Officer $573.0K$3.8M58
2024General Counsel andSecretary$525.0K$2.9M58
2024Chief Medical Officer$523.6K$2.1M58
2024Chief Commercial Officer$436.8K$1.9M58
2023Chief Executive Officer$689.0K$4.9M58
2023Chief Financial Officer andChief Operating Officer $501.1K$2.4M58
2023General Counsel andSecretary$477.0K$2.1M58
2023Chief Medical Officer$503.5K$1.8M58
2023Chief Commercial Officer$420.0K$1.7M58

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
BlackRock, Inc.10,788,586$860.2M0.0%+5,299,442
Farallon Capital Management, L.l.c.8,365,038$666.9M3.9%−291,000
Caligan Partners LP8,118,892$647.3M31.2%No change
Findell Capital Management LLC3,502,112$279.2M46.0%No change
Vanguard Capital Management LLC3,139,183$250.3M0.0%+212,238
State Street Corp3,030,395$241.6M0.0%+1,148,796
Opaleye Management Inc.2,447,500$195.1M17.7%−97,500
Geode Capital Management, LLC2,121,290$169.2M0.0%+192,321
Bank Of America Corp /de/1,991,566$158.8M0.0%−296,226
Vanguard Portfolio Management LLC1,532,151$122.2M0.0%+899,526
Caprock Group, LLC1,409,759$112.4M2.2%+42,524
Mpm Bioimpact LLC1,386,174$110.5M6.7%−18,984
D. E. Shaw & Co., Inc.1,267,706$101.1M0.1%+394,641
Fuller & Thaler Asset Management, Inc.1,209,604$96.4M0.3%New
Goldman Sachs Group Inc958,892$76.5M0.0%+146,902
Federated Hermes, Inc.816,187$65.1M0.1%+377,420
Northern Trust Corp709,063$56.5M0.0%+129,188
Charles Schwab Investment Management Inc674,033$53.7M0.0%+116,833
Morgan Stanley658,441$52.5M0.0%+313,770
Boothbay Fund Management, LLC622,716$49.6M0.9%−2,332
UBS Group AG606,558$48.4M0.0%+399,321
Fmr LLC595,629$47.5M0.0%+13,429
American Century Companies Inc542,131$43.2M0.0%New
Vanguard Fiduciary Trust Co503,774$40.2M0.0%+31,501
Susquehanna International Group, Llp471,067$37.6M0.0%−530,014

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How Liquidia Corporation is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARLiquidia Corp2
  • CIK0001819576
  • Employer ID (EIN)85-17109624
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company4
  • Incorporated inDelaware4
  • Fiscal year endsDecember 312
  • Industry code (SIC)2834 Pharmaceutical Preparations2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business address419 Davis Drive, Suite 100, Morrisville, NC 275602
  • Phone919.328.44002
  • Shares outstanding89,508,891 as of Jul 29, 202611
  • Public float$847.0M as of Jun 30, 20254
  • AuditorPricewaterhouseCoopers LLP, Raleigh, North Carolina PCAOB ID 238; it also attests to the company’s internal control over financial reporting4
  • On EDGAR sinceAug 5, 20202
  • Filings700 in all: 4 (387), 8-K (115), 144 (45), 10-Q (17), S-8 (14), 3 (11), SC 13G/A (11), 4/A (8)2
    All 37 form types

    CORRESP (7), SC 13G (7), 10-K (6), 425 (6), DEF 14A (6), DEFA14A (6), EFFECT (6), SCHEDULE 13G/A (6), UPLOAD (6), S-3 (5), SC 13D/A (5), ARS (4), 424B2 (2), 424B3 (2), PRE 14A (2), S-3/A (2), S-4/A (2), 424B4 (1), 424B5 (1), 5 (1), 5/A (1), 8-K12B (1), 8-K12B/A (1), D (1), FWP (1), S-3ASR (1), S-4 (1), SC 13D (1), SCHEDULE 13G (1)

  • Latest filingsAnnual report (10-K) Mar 5, 2026
    Quarterly report (10-Q) Aug 12, 2026
    Proxy statement (DEF 14A) Apr 24, 2026
    Latest 8-K (8-K) Oct 14, 2026

Securities registered for trading

ClassSymbolExchange
Common stock, $0.001 par value per shareLQDAThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Mar 5, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Liquidia Corporation names in Item 1A of its 10-K filed Mar 5, 2026: 70 risks under these headings, as written.4

  • whether to invest in our common stock. The occurrence of any of the events or developments described below could harm our business, financial condition, results of operations and growth prospects. In such an event, the market price of our common stock could decline and you may lose all or part of your investment. Additional risks and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations. We may update these risk factors in our periodic and other filings with the SEC.
  • Risks Related to our Financial Position and Need for Additional Capital
  • We expect to incur significant expenses for the foreseeable future as we commercialize YUTREPIA and advance YUTREPIA and our other product candidates through clinical trials, seek regulatory approvals and pursue commercialization of new indications for YUTREPIA and any approved product candidates. The future viability of our company will depend on our ability to fund future operations and capital requirements with revenue from YUTREPIA and, if necessary, additional capital from external financing.
  • We have a history of losses and our ability to sustain profitability in the future remains uncertain.
  • Our financing facility with HCR contains operating and financial covenants that restrict our business and financing activities, and is subject to acceleration in specified circumstances, which may result in HCR taking possession and disposing of any collateral.
  • Our management has broad discretion in using our available capital and may not use it effectively.
  • We depend on skilled labor, and our business and prospects may be adversely affected if we lose the services of our skilled personnel, including those in senior management, or are unable to attract new skilled personnel.
  • Our ability to use our net operating loss carry forwards and research and development tax credits may be limited.
  • Changes to existing tax laws, or challenges to our tax positions could adversely affect our business and financial condition.
  • We are a biopharmaceutical company with only one approved product that was only recently approved by the FDA, which may make it difficult for you to evaluate our business, financial condition and prospects.
  • Sales of YUTREPIA and Treprostinil Injection are dependent on market acceptance by patients, health care providers and by third-party payors, while interactions with these persons and entities are subject to compliance requirements.
  • Our business may also be impacted by the need to maintain compliant operations (including oversight and monitoring of personnel and our activities) in relation to interactions with the persons and parties noted above, relative to FDA and healthcare law requirements, and with consideration of government and industry compliance best practices.
The other 59 risks
  • Medical devices, which we do not control, are necessary for the administration of YUTREPIA, L606 and Treprostinil Injection.
  • Liquidia PAH does not hold the FDA regulatory approval for Treprostinil Injection and is dependent on Sandoz to manufacture and supply Treprostinil Injection in compliance with FDA requirements, and is more broadly dependent on their FDA and healthcare compliance relative to Treprostinil Injection.
  • Sandoz’s ability to consistently manufacture and supply Treprostinil Injection in a timely manner may also be interrupted by production shortages or other supply interruptions. Our share of net profits under the Promotion Agreement is reduced by certain manufacturing costs and other write-offs related to Sandoz’s inability to sell Treprostinil Injection, including in the event that Treprostinil Injection expires prior to sale. Currently, Treprostinil Injection expires 24 months after the date of manufacture.
  • We maintain our cash at financial institutions, often in balances that exceed federally insured limits.
  • Risks Related to the Commercialization of our Products, Product Candidates and Generic Treprostinil Injection
  • We face significant competition from large pharmaceutical companies, among others, in developing and commercializing our products and product candidates, and our operating results will suffer if we are unable to compete effectively, including if one or more such products have a superior product profile to YUTREPIA and/or L606.
  • If the FDA or comparable regulatory authorities in other countries approve generic versions of our product candidates, or do not grant our product candidates a sufficient period of market exclusivity before approving their generic versions, our ability to generate revenue may be adversely affected.
  • Our products may not achieve market acceptance or adequate third-party payor coverage.
  • We may not be able to scale or maintain our commercial operation, including scaling and maintaining marketing and sales capabilities or entering into agreements with third parties to market and sell our drug products.
  • Forecasting and accounting for YUTREPIA product sales requires us to make numerous assumptions and, if our estimates are inaccurate, our business may be harmed and our share price may be adversely affected.
  • We may be exposed to claims and may not be able to obtain or maintain adequate product liability insurance.
  • Our business and operations may be adversely affected by the effects of public health emergencies, including pandemics and epidemics.
  • We are currently operating in a period of global economic uncertainty and capital markets disruption, which has been significantly impacted by geopolitical instability. Changes and instability in global economic conditions and geopolitical matters could have a material adverse effect on our business, financial condition and results of operations.
  • The political and economic environment in the United States could materially impact our business operations and financial performance, and uncertainty surrounding the potential legal, regulatory and policy changes by the United States may directly affect us and the global economy.
  • Risks Related to the Development and Regulatory Approval of our Products and Product Candidates
  • We are primarily dependent on the success of YUTREPIA, for which we recently received FDA approval, and L606, and these products and product candidates may fail to receive or to maintain marketing approval (in a timely manner or at all) for some or all of the indications for which we have received or are seeking approval or may not be commercialized successfully.
  • Our preclinical studies and clinical trials, including our planned clinical trials in new indications for YUTREPIA and pivotal clinical trial of L606, may not be successful and delays in such preclinical studies or clinical trials may cause our costs to increase and significantly impair our ability to commercialize our product candidates. Results of previous clinical trials or interim results of ongoing clinical trials may not be predictive of future results.
  • Clinical trials and data analysis can be expensive, time-consuming and difficult to design and implement. If we are unsuccessful in obtaining regulatory approval for any of our products or product candidates for the indications studied, or any required clinical studies of our products do not provide positive results, we may be required to delay or abandon development of such products or indications, which would have a material adverse impact on our business.
  • Interim, “top-line,” or preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • The marketing approval processes of the FDA and comparable regulatory authorities in other countries are unpredictable and our products and product candidates may be subject to multiple rounds of review or may not receive marketing approval.
  • We may encounter difficulties in enrolling patients in our clinical trials.
  • Products and product candidates that the FDA deems to be combination products, such as YUTREPIA and L606, or that otherwise rely on innovative drug delivery systems, may face additional challenges, risks and delays in the product development and regulatory approval process.
  • We are currently pursuing the FDA 505(b)(2) pathway for our current product candidates. If we are unable to rely on the 505(b)(2) regulatory pathway, or otherwise choose not to rely on the 505(b)(2) regulatory pathway, to apply for marketing approval of our product candidates in the United States, seeking approval of these product candidates through the 505(b)(1) NDA pathway would require full reports of investigations of safety and effectiveness, and the process of obtaining marketing approval for our product candidates would likely be significantly longer and more costly.
  • We may be unable to continually develop a pipeline of product candidates, which could affect our business and prospects.
  • Disruptions at the FDA, the SEC and other government agencies caused by funding shortages, government shutdowns, layoffs or global health emergencies or their inability to hire, retain or deploy key leadership and other personnel, could prevent new or modified products from being developed, approved or commercialized in a timely manner or at all or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our operations.
  • We have conducted, and may in the future conduct, clinical trials for our product candidates outside the United States and the FDA may not accept data from such trials.
  • Even with regulatory approval for YUTREPIA, our products and business remain subject to ongoing regulatory obligations and review.
  • Even with approval of YUTREPIA in the United States and even if we obtain marketing approval for our other product candidates in the United States, we or our collaborators may not obtain marketing approval for YUTREPIA or our other product candidates elsewhere.
  • Risks Related to Government Regulation
  • The pharmaceutical industry is subject to a range of laws and regulations in areas including healthcare program requirements and fraud, waste, and abuse; healthcare and related marketing compliance and transparency; and privacy and data security. Our failure to comply with these laws and regulations as they are, or in the future become, applicable to us may have an adverse effect on our business.
  • Recently enacted and future legislation and other developments may increase the difficulty and cost for us to obtain marketing approval of and commercialize our products and product candidates and affect the prices we may obtain.
  • We and the third parties with whom we work are subject to stringent and evolving U.S. and foreign laws, regulations and rules, contractual obligations, industry standards, policies and other obligations related to data privacy and security. Any actual or perceived failure to comply with such obligations could lead to government enforcement actions (which could include civil or criminal penalties), private litigation (including class claims), negative publicity or other adverse consequences that could negatively affect our operating results and business.
  • We, directly or through our third-party service providers, may adopt, use or incorporate artificial intelligence (“AI”) technology and capabilities into the information technology systems or software that we use in our business and operations. Defects in such AI technology or related security breaches, loss of data and other disruptions as well as changes in implementation standards and enforcement practices under a rapidly evolving regulatory framework for AI technology may adversely affect our business and operations and potentially expose us to increasing liability.
  • Environmental, social and governance matters may impact our business and reputation.
  • Climate change or legal, regulatory or market measures to address climate change may negatively affect our business, results of operations, cash flows and prospects.
  • Risks Related to Our Dependence on Third Parties
  • We rely on third parties to conduct our preclinical studies and clinical trials.
  • We depend on third parties for clinical and commercial supplies, including single suppliers for the active ingredient, the device, encapsulation and packaging of YUTREPIA and single suppliers for the drug product and device for L606. In the event of any disruption in these supplies, our ability to develop and commercialize, and the timeline for commercialization of, YUTREPIA and/or L606 may be adversely affected.
  • If we are unable to establish or maintain licensing and collaboration arrangements with other pharmaceutical companies on acceptable terms, or at all, we may not be able to develop and commercialize additional product candidates using our PRINT technology.
  • Our collaboration and licensing arrangements may not be successful.
  • Risks Related to our Intellectual Property
  • We may be subject to claims from third parties that our products infringe their intellectual property rights.
  • Our commercial success depends largely on our ability to protect our intellectual property.
  • Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
  • If we are unable to protect our trade secrets, the value of our PRINT technology and product candidates may be negatively impacted, which would have a material and adverse effect on our competitive position and prospects.
  • We rely on licenses to intellectual property that are owned by third parties.
  • We may become involved in litigation to protect our intellectual property, to enforce our intellectual property rights or to defend against claims of intellectual property infringement by third parties, which could be expensive, time-consuming and may not be successful.
  • We may not be able to enforce our intellectual property rights throughout the world.
  • We need to protect our trademark, trade name and service mark rights to prevent competitors from taking advantage of our name recognition.
  • Risks Related to the Manufacturing of our Products and Product Candidates
  • We may experience unexpected challenges as we ramp up our manufacturing capacity to meet demand or during commercial manufacturing, which may result in our inability to supply sufficient quantities of product to meet demand.
  • L606 is based on proprietary, novel technology, which has not been used to manufacture any products that have been previously approved by the FDA, making it difficult to predict the time and cost of development and of subsequently obtaining final regulatory approval.
  • Our facilities are subject to extensive and ongoing regulatory requirements and failure to comply with these regulations may result in significant liability.
  • Our operations are concentrated in Morrisville, North Carolina and interruptions affecting us or our suppliers due to natural or man-made disasters or other unforeseen events could materially and adversely affect our operations and result in losses that may not be covered by insurance.
  • We are subject to information technology systems failures, security breaches, loss or leakage of data, technological malfunctions or other disruptions, which could result in, among other things, material disruption of our operations, financial losses, the inability to process transactions, the unauthorized release of confidential information and reputational risk, restrictions on accessing critical information and potential exposure to liability, all of which would negatively impact our business, financial condition or results of operations.
  • Risks Related to our Common Stock
  • Future sales of our common stock or securities convertible into our common stock in the public market could cause our stock price to fall.
  • We expect that the market price of our common stock may be volatile, and you may lose all or part of your investment.
  • Our principal stockholders and management own a significant percentage of our stock and will be able to exercise significant influence over matters subject to stockholder approval.
  • As a public company, we are obligated to develop and maintain proper and effective internal controls over financial reporting and any failure to do so may adversely affect investor confidence in us and, as a result, the trading price of our shares.
  • Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of us difficult, limit attempts by our stockholders to replace or remove our current management and adversely affect our stock price.
  • Our certificate of incorporation designates the Court of Chancery of the State of Delaware as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or other employees.
  • Because we do not anticipate paying any cash dividends on our common stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain.
  • An impairment of our long-lived contract acquisition costs and intangible assets, including goodwill, could have a material non-cash adverse impact on our results of operations.

Legal proceedings

For information on our legal proceedings, see Note 13 Legal Proceedings included in our consolidated financial statements beginning on page F-33 of this Annual Report on Form 10-K.

The opening of Item 3, Legal Proceedings.4

Sources

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