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New words:
Adair, aerial, altogether, ampule, analog, argument, arriving, ASCENT, attack, AUCinf, begun, bidding, biodiversity, Bioeconomy, Biomanufacturing, Biosecure, blister, bombardment, border, break, broaden, burdensome, cabinet, capacity, carbon, certiorari, chamber, chargeback, Chinese, civilian, Cmax, Columbia, Congressional, convening, Conversely, correlated, correlating, Corsair, Counsel, CSA, curative, cv, cyber, cybersecurity, destruction, drought, dwindled, electricity, energy, enjoin, enjoined, enjoining, eradication, Erroneously, evacuation, exacerbated, exit, extortion, fault, foil, forecasted, forfeited, forfeiture, fourteen, franchise, gas, Gaza, greenhouse, half, heat, Hezbollah, hoped, identification, imatinib, Imputation, incident, infiltrated, insider, instructed, Israel, Israeli, issuable, Jason, Kingdom, Lebanon, Legend, lightweight, malfunction, mesh, mission, modulation, moisture, Moomaw, Multicenter, network, nondeductible, orderly, outpatient, oversee, overseen, Palestinian, patch, patching, pattern, peak, persistence, persuasive, plasma, pose, pouch, precedential, prelaunch, presidential, PSU, ramp, raw, rebate, recalculate, reconciliation, recover, recovered, Recovery, redundant, reject, rejected, Rejection, remit, remitted, Rescue, resilience, restraining, RGA, rocket, Russell, safeguarding, Schundler, Scott, sea, sealed, secondary, sequester, sequestration, seralutinib, server, shorten, silent, simultaneously, sleeping, slowly, smart, southern, SpA, speed, spent, spoilage, startup, storing, strict, stringent, Strip, subdural, survival, susceptible, sweeping, Taiwan, takeover, Taxpayer, temporarily, Territory, terrorist, theft, thirteenth, thirty, threat, tied, touch, tract, transdermal, translate, Union, unsettled, upfront, upgrade, vibrating, virtually, vulnerability, walk, weather, week, West, widening, withholding, writ
Removed:
activated, anniversary, annum, CCPA, circle, Clarifying, collaborative, compound, contractor, depreciable, discussing, disputing, economically, employing, evolving, executed, expensing, expiring, explore, filer, floating, FTC, FTCA, glaxosmithkline, golden, headquartered, ICFR, ICO, inscribed, inspired, intent, Interaction, irrevocably, Jumpstart, Lippe, metabolized, micrometer, modified, molecular, naturally, nonbinding, nonconvertible, notwithstanding, occurring, parachute, phased, plc, pollen, predominately, prepared, PRV, recession, remanded, returned, Robert, Shah, Topic, Tushar, unvested, widespread, Xcelience
Financial report summary
?Competition
Pfizer • Heron Therapeutics • Gilead Sciences • Mannkind • United Therapeutics • Insmed • Morphic HoldingRisks
- Risks Related to our Financial Position and Need for Additional Capital
- We expect to incur significant expenses and operating losses for the foreseeable future as we advance our product candidates through clinical trials, seek regulatory approval and pursue commercialization of any approved product candidates. The future viability of our company may depend on our ability to raise additional capital to finance our future operations.
- We have a history of losses and our future profitability remains uncertain.
- We may need further financing for our existing business and future growth, which may not be available on acceptable terms, if at all. Failure to obtain funding on acceptable terms and on a timely basis may require us to curtail, delay or discontinue our product development efforts or other operations. The failure to obtain further financing may also prevent us from capitalizing on other potential product candidates or indications which may be more profitable than YUTREPIA and/or L606 or for which there may be a greater likelihood of success.
- Our financing facility with HCR requires mutual agreement of both HCR and us in order to draw down on our financing facility, 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 the net proceeds from our financing facility with HCR and prior equity offerings and may not use them effectively.
- Our ability to use our net operating loss carry forwards and certain other tax attributes may be limited.
- We are a late-stage clinical biopharmaceutical company with no approved products and no historical revenue from the sale of our own products, which may make it difficult for you to evaluate our business, financial condition and prospects.
- 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 Sandoz’s FDA and healthcare compliance relative to Treprostinil Injection.
- Sales of Treprostinil Injection are dependent on market acceptance of generic treprostinil for parenteral administration by patients, health care providers and by third-party payors, while interactions with these persons and entities are subject to compliance requirements. The commercial success of Treprostinil Injection may also be impacted by increasing generic competition which may result in declining prices for Treprostinil Injection.
- Medical devices, which we do not control, are necessary for the administration of Treprostinil Injection.
- We maintain our cash at financial institutions, often in balances that exceed federally insured limits.
- Risks Related to the Commercialization of our Product Candidates and Generic Treprostinil Injection
- United Therapeutics has initiated lawsuits against us in which it claims that YUTREPIA is infringing its patents and that we have misappropriated its trade secrets and has initiated a lawsuit against the FDA challenging the FDA’s acceptance of our amended NDA for YUTREPIA for review, which may result in our company being further delayed in its efforts to commercialize YUTREPIA.
- We face significant competition from large pharmaceutical companies, among others, in developing our products and in gaining regulatory approval to bring them to market in time to achieve commercial success, and our operating results will suffer if we are unable to compete effectively.
- Our products may not achieve market acceptance.
- We may not be able to build a commercial operation, including establishing and maintaining marketing and sales capabilities or entering into agreements with third parties to market and sell our drug products.
- We may be exposed to claims and may not be able to obtain or maintain adequate product liability insurance.
- Risks Related to the Development and Regulatory Approval of our Product Candidates
- We are primarily dependent on the success of our product candidate, YUTREPIA, for which we received tentative approval from the FDA, and this product candidate may fail to receive final marketing approval (in a timely manner or at all) or may not be commercialized successfully.
- Our preclinical studies and clinical trials 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 our products, 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, which would have a material adverse impact on our business.
- The marketing approval processes of the FDA and comparable regulatory authorities in other countries are unpredictable and our 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.
- 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 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 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.
- 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.
- Risks Related to Our Dependence on Third Parties
- 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 active ingredient, bulk product manufacturing and packaging of L606.
- 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.
- 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 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 Product Candidates
- Our product candidates are based on our 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 operations are concentrated in Morrisville, North Carolina and interruptions affecting us or our suppliers due to natural disasters or other unforeseen events could materially and adversely affect our operations.
- Risks Related to our Employees
- 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.
- 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.
- General Risks Related to the Commercialization of our Product Candidates
- Our business and operations may be adversely affected by the effects of health epidemics, including the COVID-19 pandemic.
- 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.
- We are subject to risks related to information technology systems, including cyber-security risks; successful cyber-attacks or technological malfunctions can result in, among other things, financial losses, the inability to process transactions, the unauthorized release of confidential information and reputational risk, all of which would negatively impact our business, financial condition or results of operations.
- General Risks Related to the Development and Regulatory Approval of our Product Candidates
- Even if we obtain marketing approval for our product candidates in the United States, we or our collaborators may not obtain marketing approval for the same product candidates elsewhere.
- General Risks Related to Healthcare 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 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.
- General Risks Related to Our Dependence on Third Parties
- We rely on third parties to conduct our preclinical studies and clinical trials.
- General Risks Related to Legal Compliance Matters
- Even if we obtain regulatory approval for a product candidate, our products and business will remain subject to ongoing regulatory obligations and review.
- 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.
- General Risks Related to our Intellectual Property
- We may become involved in litigation to protect our intellectual property or enforce our intellectual property rights, which could be expensive, time-consuming and may not be successful.
- Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
- General Risks Related to the Manufacturing of our Product Candidates
- Our facilities are subject to extensive and ongoing regulatory requirements and failure to comply with these regulations may result in significant liability.
Management Discussion
- Revenue was $17.5 million for the year ended December 31, 2023, compared with $15.9 million for the year ended December 31, 2022. Revenue related primarily to the Promotion Agreement. The increase of $1.6 million was primarily due to favorable gross-to-net chargeback, rebate, and managed care adjustments offset by the impact of lower sales quantities as compared to the prior year.
- Cost of revenue was $2.9 million for the year ended December 31, 2023, compared with $2.9 million for the year ended December 31, 2022. Cost of revenue related to the Promotion Agreement as noted above. During the fourth quarter of 2024, our sales force expanded in size, however, this increase was offset by a decrease in amortization.
- Research and development expenses were $43.2 million for the year ended December 31, 2023 compared with $19.4 million for the year ended December 31, 2022. The increase of $23.8 million or 122% was driven largely by the $10.0 million upfront license fee payment to Pharmosa for the exclusive license in North America to develop and commercialize L606. We incurred an additional $2.6 million in expenses related to our L606 program during the year ended December 31, 2023. Expenses related to our YUTREPIA program increased by $6.3 million from $6.7 million during the year ended December 31, 2022 to $13.0 million during the year ended December 31, 2023 primarily due to increased manufacturing activities related to pre-launch commercial supply and the startup of our ASCENT study during 2023. Personnel and consulting expenses, including stock compensation expense, increased $5.1 million primarily due to increased headcount to support the potential commercialization of YUTREPIA.