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YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. and, where applicable, their suppliers are subject to inspections by the FDA at any time, and the discovery of violative conditions, including failure to conform to cGMP, could result in enforcement...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. approval that could restrict the distribution or use of the drug. Discovery of previously unknown problems with a drug or the failure to comply with applicable FDA requirements can have negative con...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. corporate integrity agreements, debarment, or exclusion from federal healthcare programs; mandated modification of promotional materials and labeling and the issuance of corrective information; th...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. safety issue. Also, new government requirements, including those resulting from new legislation, may be established, or the FDA’s policies may change, which could delay or prevent regulatory approva...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. fewer than 200,000 individuals in the United States, or if it affects more than 200,000 individuals in the United States, there is no reasonable expectation that the cost of developing and marketing...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. of the request. In the United States, orphan drug designation entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages, and user...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. v. Becerra , 14 F.4th 1299 (11th Cir. 2021), the court disagreed with the FDA’s longstanding position that the ODE only applies to the approved use or indication within an eligible disease. This de...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. to obtain approval of a drug for new uses or indications within the same orphan designated disease or condition that have not yet been approved. It is unclear how future litigation, legislation, age...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. persons in the European Union when the application is made, or (2) a life-threatening, seriously debilitating, or serious and chronic condition in the European Union and that without incentives it i...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. when, without incentives, it is unlikely that sales of the drug in the European Union would be sufficient to justify the necessary investment in developing the drug or biological product. In the Eu...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. same therapeutic indication. This period may be reduced to six years if, after five years, the orphan drug designation criteria are no longer met, including where it is shown that the product is suf...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. approval date. The patent term restoration period is generally one-half the time between the effective date of an IND and the submission date of an NDA plus the time between the submission date of a...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. any other new drug containing the same active moiety, which is the molecule or ion responsible for the action of the drug substance. During the exclusivity period, the FDA may not accept for review ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. an existing NDA, if new clinical investigations, other than bioavailability studies, that were conducted or sponsored by the applicant are deemed by the FDA to be essential to the approval of the ap...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. clinical studies and adequate and well-controlled clinical trials necessary to demonstrate safety and effectiveness. ODE, as described above, may offer a seven-year period of marketing exclusivity, ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. including, in the United States, the Centers for Medicare & Medicaid Services (“CMS”), other divisions of the U.S. Department of Health and Human Services (“HHS”), the Drug Enforcement Administratio...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. 2010 (the “ACA”). If drugs are made available to authorized users of the Federal Supply Schedule of the General Services Administration, additional laws and requirements apply. The handling of any co...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. may subject us to liability pursuant to certain U.S. environmental laws and regulations, under which current or previous owners or operators of real property and entities that disposed or arranged f...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. injunctions, voluntary recall or seizure of drugs, total or partial suspension of production, denial or withdrawal of product approvals, or refusal to allow a firm to enter into supply contracts, in...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. ; or (iv) additional record-keeping requirements. If any such changes were to be imposed, they could adversely affect the operation of our business. Coverage and Reimbursement Sales of our drugs wi...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. reimbursement for drugs or biological products exists, and one payor’s determination to provide coverage and adequate reimbursement for a product does not assure that other payors will make a simila...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. may be a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our products to each payor separately, with no assurance that coverage and a...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit our net revenue and results. Decreases in third-par...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. the minimum basic Medicaid rebate percentage on most branded prescription drugs of average manufacturer price (“AMP”) and adding a new rebate calculation for “line extensions” (i.e., new formulation...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. conciliation Act of 1990. Under the American Rescue Plan Act of 2021, effective January 1, 2024, the statutory cap on Medicaid Drug Rebate Program rebates that manufactures pay to state Medicaid prog...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. . Part D prescription drug plan sponsors are not required to pay for all covered Part D drugs, and each drug plan can develop its own drug formulary that identifies which drugs it will cover and at w...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. and reviewed by a pharmacy and therapeutic committee. Government payment for some of the costs of prescription drugs may increase demand for drugs for which we may obtain marketing approval. However...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. 340B drug pricing program. The required 340B discount on a given product is calculated based on the AMP and Medicaid rebate amounts reported by the manufacturer. As of 2010, the ACA expanded the typ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. entities or would require participating manufacturers to agree to provide 340B discounted pricing on drugs used in an inpatient setting. The American Recovery and Reinvestment Act of 2009 provides ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. to treat are the subject of a trial. It is also possible that comparative effectiveness research demonstrating benefits in a competitor’s drug could adversely affect the sales of our drug candidate....
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. went into effect in April 2013 and will remain in effect through 2031, with the exception of a temporary suspension implemented under various COVID-19 relief legislation from May 1, 2020 through Mar...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. reform measures, as discussed further below, may be adopted in the future, any of which may result in additional reductions in Medicare and other healthcare funding and otherwise affect the prices w...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. which we receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future. In addition, in some foreign countries, the proposed pricing for a d...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. reimbursement and pricing arrangements for any of our drugs. Historically, drugs launched in the European Union do not follow price structures of the U.S. and generally tend to be significantly lowe...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. of certain branded prescription drugs, and a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 70% (increased pursuant to the Bipartisan Budget Act of 201...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. material impact on our business. The ACA requires pharmaceutical manufacturers of branded prescription drugs to pay a branded prescription drug fee to the federal government. Each such manufacturer...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. . In addition, in order to be eligible to have its products paid for with federal funds under the Medicaid programs and purchased by certain federal grantees and agencies, a manufacturer also must pa...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. of the ACA. In June 2021, the Supreme Court held that Texas and other challengers had no legal standing to challenge the ACA, upholding the ACA. In January 2021, President Biden also issued an execu...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. prices for their marketed products, which has resulted in several Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transpare...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. of that drug or biological product if it is equal to or greater than $35 for a monthly supply or usual course of treatment. Prescription drugs and biological products that are in violation of these ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. rebates for all Medicare Part B and Part D drugs, with limited exceptions, if their drug prices increase faster than inflation, and redesigning Medicare Part D to reduce out-of-pocket prescription d...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize any of the product candidates for which we receive approval. At the state level...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , on May 30, 2018, the Right to Try Act, was signed into law. The law, among other things, provides a federal framework for certain patients to access certain investigational new drug products that h...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. arrangements, directly or indirectly, with third-party payors, healthcare providers, and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. federal Anti-Kickback Statute, which broadly prohibits, among other things, any person from knowingly and willfully offering, soliciting, receiving or providing remuneration, directly or indirectly,...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. interpreted to apply to arrangements between manufacturers, on the one hand, and prescribers, purchasers, and other healthcare-related professionals on the other. They can apply to manufacturers who...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. fines or settlement; the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), as amended, which among other things, also created criminal liability for knowingly and willfully fal...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. or transferring remuneration to a federal healthcare beneficiary that a person knows or should know is likely to influence the beneficiary’s decision to order or receive items or services reimbursab...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. include doctors, dentists, optometrists, podiatrists and chiropractors), certain non-physician healthcare professionals (such as physician assistants and nurse practitioners, among others), and teac...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; consumer protection and unfair competition laws, which broadly regulate marke...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. of investigations, prosecutions, convictions, and settlements in the healthcare industry. It is possible that governmental authorities will conclude that our business practices 31 Table of Content...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. a corporate integrity agreement or similar settlement to resolve allegations of non-compliance with these laws and the curtailment or restructuring of our operations. If any of the physicians or oth...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. security of health information in some circumstances. For example, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and their implementing regulations als...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , and places increased privacy and security obligations on entities handling personal data of consumers or households. The CCPA will require covered companies to provide certain disclosures to consum...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. privacy laws, as well as uncertain changes in future regulation and legislation, could impact our business strategies, increase our potential liability, increase our compliance costs, and adversely ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. requirements of the Data Protection Directive, the GDPR, and the related national data protection laws of the European Union member states may result in fines and other administrative penalties. The...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. marketed if a marketing authorization from the competent regulatory agencies has been obtained. Similar to the United States, the various phases of preclinical and clinical research in Europe are su...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. (“NCA”) and one or more Ethics Committees (“ECs”). Under the current regime, all suspected unexpected serious adverse reactions 32 Table of Contents to the investigated drug that occur during the...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. quarter of 2022. The Clinical Trials Regulation seeks to simplify and streamline the approval of clinical trials in the European Union. For example, the sponsor can submit a single application for a...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. an “opt-out” from an approval. In such a case, the clinical trial cannot be conducted in that member state. The Clinical Trials Regulation also aims to streamline and simplify the rules on safety re...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency and which is valid throughout the entire territory of the EEA. The Centralized Procedure is mandatory for...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. and only cover their respective territory, are available for drugs not falling within the mandatory scope of the Centralized Procedure. Where a drug has already been authorized for marketing in a me...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. draft summary of the drug characteristics (“SPC”), and a draft of the labeling and package leaflet, which are sent to the other member states, or the Member States Concerned, for their approval. If ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. safety, and efficacy. European Chemical Entity Exclusivity In Europe, new chemical entities, sometimes referred to as new active substances, qualify for eight years of data exclusivity upon marke...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , are held to bring a significant clinical benefit in comparison with existing therapies. 33 Table of Contents Brexit and the Regulatory Framework in the United Kingdom On June 23, 2016, the elec...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. EU, EU law remains applicable in Northern Ireland. There are a number of new marketing authorization routes available in the United Kingdom, Great Britain (England, Scotland and Wales) or Northern I...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. manufacturers, and approval of product candidates in the United Kingdom. Other Foreign Countries For other countries outside of the United States and the European Union, the requirements governing...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , operating restrictions, and criminal prosecution. Employees and Human Capital We have operated by leveraging skilled experts, consultants, contract research organizations, and contractors to mana...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , identifying, recruiting, retaining, incentivizing and integrating our existing and additional employees, advisors and consultants, while being committed to a diverse and dynamic workplace. The prin...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. 2017. In August 2021, we effected a reverse merger pursuant to which a wholly owned subsidiary of ours, merged with and into Aadi Subsidiary, Inc. (formerly Aadi Bioscience, Inc.) (“Private Aadi”), ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. 90272. We maintain a website at www.aadibio.com, to which we regularly post copies of our press releases as well as additional information about us. Our filings with the Securities and Exchange Commi...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , including all forward-looking statements or information, are made as of the date of the document in which the statement is included, and we do not assume or undertake any obligation to update any o...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. of some of the forward-looking statements that are qualified by these risk factors. If any of the following risks actually occur, our business, financial condition, results of operations and future ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. net losses since our inception, and we expect to continue to incur significant net losses for the foreseeable future. Our ability to generate revenue and achieve profitability depends significantly...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. finance our operations. If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our research and drug developmen...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. approved, could be delayed or prevented. We are dependent on a single-source supplier for the drug product FYARRO, and the loss of such supplier could harm our business. If we cannot replicate the...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. prove to be more profitable or to have a greater likelihood of success. We face significant competition, and if our competitors develop and market technologies or products more rapidly than we do o...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. unable to commercialize FYARRO or any future product candidates and our business will be substantially harmed. FYARRO is, and any other product candidate we may develop in the future for which we o...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. commercialize our product or any future product candidates or otherwise implement our business plan. If we are unable to establish or appropriately scale up our sales or marketing capabilities or e...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. expect to continue to do so for additional clinical trials. This reliance on third parties, some of which are sole source suppliers, increases the risk that we will not have sufficient quality and q...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. approved for commercial sale, which may make it difficult for you to evaluate our current business and likelihood of success and viability. We are a commercial-stage biopharmaceutical company with ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. to overcome many of the risks and uncertainties frequently encountered by companies in new and rapidly evolving fields, particularly in the biopharmaceutical area. Consequently, any predictions abou...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. FYARRO in May 2021. The U.S. Food and Drug Administration (the “FDA”) accepted our NDA in July 2021 and approved FYARRO for the treatment of advanced malignant PEComa in November 2021. Based on the...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. first quarter of 2022. In addition, in October 2022 we entered into a collaboration and supply agreement with Mirati Therapeutics, Inc. (“Mirati”) to evaluate the combination of Mirati’s adagrasib (...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. the sales and marketing activities necessary for successful product commercialization. As a result, it may be more difficult for you to accurately predict our likelihood of success and viability tha...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , federal grants and proceeds from licenses. Our net losses were $60.5 million and $110.1 million for the years ended December 31, 2022 and 2021, respectively. We had an accumulated deficit of $203.2...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. as research and development expenses related to our ongoing operations. As a result, we expect to continue to incur significant operating expenses for the foreseeable future due to the cost of comme...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. commercializing FYARRO in additional indications and any future product candidates, we expect to continue to incur significant expenses and increasing operating losses over the next several years an...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. achieve and maintain profitability and the performance of our stock. Our ability to generate revenue and achieve profitability depends significantly on our ability to achieve several objectives rel...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. foreign jurisdictions or any future product candidates. We do not anticipate generating revenue from product sales significant enough to achieve profitability for the foreseeable future. Our ability...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. ; maintaining commercially viable supply and manufacturing relationships with third parties that can provide adequate, in both amount and quality, products and services to support clinical developme...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. research organizations (“CROs”) and clinical sites for the clinical development of FYARRO in other indications and any other future product candidates that we may develop; timely receipt of regulat...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. for product candidates; satisfying any required post-regulatory approval commitments to applicable regulatory authorities; identifying, assessing and developing new product candidates; obtaining,...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. generate revenue that is significant or large enough to achieve profitability. If we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis....
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. time-consuming, expensive and uncertain process that takes years to complete. Our operations have consumed substantial amounts of cash since inception, and we expect our expenses to increase in conn...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. . In addition, even if we obtain regulatory approval for any of other product candidates, including additional indications for FYARRO , we expect to incur significant commercialization expenses rel...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. not for any other indication, or any other product candidate, in the United States. In addition, we will incur additional costs associated with operating as a public company. Accordingly, we will ne...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. capital resources sooner than we currently expect. Changing circumstances, some of which may be beyond our control, could cause us to consume capital significantly faster than we currently anticipat...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. significant amount of capital. Our existing cash, cash equivalents and short-term investments will not be sufficient to fund all of the activities that are necessary to complete the development of ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. be available to us in sufficient amounts or on acceptable terms, or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership i...