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Abbreviated, absence, ADRD, African, agency, American, analyze, ancillary, ANDA, Anne, apply, appointment, arm, ASU, attend, avoid, began, Black, body, bona, buyback, calendar, called, CARDIOLITE, certification, Chair, chemotherapy, claim, CLARiTI, Clarity, Clyde, component, composition, conducted, Counsel, Court, crossed, Daniel, database, death, Delaware, dementia, derecognition, disaggregated, disaggregation, District, Dotatate, Eighty, Eli, entity, etiologic, EU, evacuation, experienced, exploit, exposure, FASB, feedback, fide, flexibility, flexible, gastrin, GmbH, guidance, hazard, healthy, Heino, HR, immature, IND, influence, infringement, interchange, investee, investor, Kingdom, leadership, light, Lilly, Lu, lutetium, managerial, Mary, mCRPC, median, met, neuroendocrine, NEUROLITE, Niedzwiecki, nonvoting, online, OS, outlicensed, ownership, patent, pediatric, peptide, Perspective, Pharmaka, placement, presence, pretax, privilege, profile, pronouncement, qualified, readily, reconciliation, recruit, refrigerated, refused, repeating, resided, resolution, resolved, role, ROTOP, rulemaking, SA, Secretary, somatostatin, specific, sponsored, SSTR, stage, statistically, stay, stayed, strategy, sublease, sued, Terminology, Topic, ultimately, unrealized, unsold, usage, volatility, voting, waste, wholly, Xenon
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AAA, allocation, ASC, Assuming, BMS, cancel, carried, commencing, constituted, defective, deferred, delayed, designated, determining, drawn, element, Endocyte, Environmental, evidence, execution, exploring, extinguishment, fix, floating, forecasted, foreign, gene, government, hand, hedge, hedged, immaterial, inclusion, indemnification, indemnify, integrated, involved, judgment, LIBOR, licensee, licensing, life, lump, notification, notional, objective, offered, offsetting, passage, payoff, policy, printing, Procedure, proposed, Protection, Puerto, realizability, realizable, realize, receivable, reclassified, recoverable, refinanced, regularly, reimburse, repaid, replaced, represented, requiring, Rico, simultaneously, SonoThera, Squibb, swap, taxing, termination, type, untimely, utilize, valuation, weighed, withhold
Financial report summary
?Competition
Nektar Therapeutics • Biodelivery Sciences International • QSAM Biosciences • Actinium Pharmaceuticals • FluoroPharma Medical • Redhill Biopharma • Mallinckrodt • Shine • Fusion Pharmaceuticals • POINT Biopharma GlobalRisks
- Our ability to continue to grow PYLARIFY as a commercial product is dependent on (A) the ability of PMFs to manufacture PYLARIFY to meet product demand, (B) our ability to promote PYLARIFY to customers, (C) our ability to obtain and maintain adequate coding, coverage and payment for PYLARIFY, (D) our ability to maintain PYLARIFY as the leading PSMA PET imaging agent, including after the potential expiration of TPT Status at the end of 2024 and (E) our ability to clinically and commercially differentiate PYLARIFY from other products.
- The near-term growth of our business is also dependent on our ability to continue to grow the appropriate use of DEFINITY in suboptimal echocardiograms in the face of competition from other existing echocardiography agents and potential generic competitors as a result of patent and regulatory exclusivity expirations.
- Our dependence upon third parties for the manufacture and supply of a substantial portion of our products and certain key components and raw materials and upon our in-house manufacturing for DEFINITY could prevent us from delivering our products to our customers in the required quantities, within the required timeframes, or at all, which could result in order cancellations and decreased revenues.
- The global supply of Mo-99 is fragile and not stable. Our dependence on a limited number of third party suppliers for Mo-99 could prevent us from delivering some of our products to our customers in the required quantities, within the required timeframe, or at all, which could result in order cancellations and decreased revenues.
- We can give no assurance that Curium will be successful with its commercialization of piflufolastat F 18 in Europe.
- We may not be able to successfully launch PYLARIFY AI as a commercial product.
- Our just-in-time manufacturing of radiopharmaceutical products relies on the reliability of our equipment and processes, the timely receipt of radioactive raw materials and the timely shipment of finished goods, and any disruption of our supply or distribution networks could have a negative effect on our business.
- In the U.S., we are heavily dependent on a few large customers to generate a majority of our revenues for our single-photon emission computerized tomography (SPECT) nuclear medical imaging products in our Precision Diagnostic product category. For PYLARIFY, we depend in part on some of our PMF partners to generate sales and collect revenue. Outside of the U.S., we rely primarily on distributors to generate a substantial portion of our revenue.
- We face significant competition in our business and may not be able to compete effectively.
- Ultrasound enhancing agents may cause side effects which could limit our ability to sell DEFINITY.
- Many of our customers are highly dependent on payments from third-party payors, including government sponsored programs, particularly Medicare, in the U.S. and other countries in which we operate, and reductions in third party coverage and reimbursement rates for our products (or services provided with our products) could adversely affect our business and results of operations.
- Reforms to the U.S. healthcare system may adversely affect our business.
- Our business and industry are subject to complex and costly regulations. If government regulations are interpreted or enforced in a manner adverse to us or our business, we may be subject to enforcement actions, penalties, exclusion and other material limitations on our operations.
- Our marketing and sales practices may contain risks that could result in significant liability, require us to change our business practices, and restrict our operations in the future.
- We may not be able to hire or retain the number of qualified personnel, particularly scientific, medical and sales personnel, required for our business, which would harm the development and sales of our products and limit our ability to grow.
- If we lose the services of our key personnel, our business could be adversely affected.
- Our business depends on our ability to successfully introduce new products and adapt to a changing technology and medical practice landscape.
- Our future growth may depend on our ability to identify and acquire or in-license additional products, businesses or technologies, and if we do not successfully do so, or otherwise fail to integrate any new products, lines of business or technologies into our operations, we may have limited growth opportunities and it could result in significant impairment charges or other adverse financial consequences.
- Challenges with product quality or product performance, including defects, caused by us or our manufacturers or suppliers could result in a decrease in customers and revenues, unexpected expenses and loss of market share.
- In the ordinary course of business, we may be subject to product liability claims and lawsuits, including potential class actions, alleging that our products have resulted or could result in an unsafe condition or injury.
- We use hazardous materials in our business and must comply with environmental laws and regulations, which can be expensive.
- If we are unable to protect our intellectual property, our competitors could develop and market products with features similar to our products, and demand for our products may decline.
- Our patents are subject to generic challenge, and the validity, enforceability and commercial value of these patents are highly uncertain.
- We may be subject to claims that we have infringed, misappropriated or otherwise violated the patent or other intellectual property rights of a third party. The outcome of any of these claims is uncertain and any unfavorable result could adversely affect our business, financial condition and results of operations.
- We may be adversely affected by prevailing economic conditions and financial, business and other factors beyond our control.
- Our business is subject to international economic, political and other risks that could negatively affect our results of operations or financial position.
- We face currency and other risks associated with international sales.
- Many of our customer relationships outside of the U.S. are, either directly or indirectly, with governmental entities, and we could be adversely affected by violations of the FCPA and similar worldwide anti-bribery laws outside the U.S.
- Our business depends on the continued effectiveness and availability of our information technology infrastructure, and failures of this infrastructure could harm our operations.
- A disruption in our computer networks, including those related to cybersecurity, could adversely affect our operations or financial position.
- We may be limited in our ability to utilize, or may not be able to utilize, net operating loss carryforwards to reduce our future tax liability.
- We are involved in various legal proceedings that are uncertain, costly and time-consuming and could have a material adverse impact on our business, financial condition and results of operations.
- We may not, or may take longer to, realize the expected benefits and opportunities related to, the POINT License Agreements.
- We may not, or may take longer to, realize the expected benefits and opportunities related to, the Cerveau Acquisition.
- The process of developing new drugs and obtaining regulatory approval is complex, time-consuming and costly, and the outcome is not certain.
- We can give no assurance that GE Healthcare will be successful with the further clinical development of flurpiridaz.
- Even if clinical development candidates receive regulatory approval, we can give no assurance that they can be successfully commercialized.
- We have been and expect to continue to be dependent on partners for the development of certain product candidates, which expose us to the risk of reliance on these partners.
- We depend on licenses from third parties for our rights to develop and commercialize certain product candidates. If we fail to achieve milestone requirements or to satisfy other conditions, we may lose those rights under those license agreements, and our business, results of operations and financial condition could be adversely affected.
- The conditional conversion feature of the 2.625% Convertible Senior Notes due 2027, if triggered, may adversely affect our financial condition and operating results.
- The issuance or sale of shares of our common stock, or rights to acquire shares of our common stock, could depress the trading price of our common stock.
- Repurchases by us of our common stock may affect the value of our common stock.
- We have indebtedness which may limit our financial and operating activities and may adversely affect our ability to incur additional debt to fund future needs.
- We may not be able to generate sufficient cash flow to meet our debt service obligations.
- Despite our indebtedness, we may incur more debt, which could exacerbate the risks described above.
- Our 2022 Revolving Facility contains restrictions that will limit our flexibility in operating our business.
- U.S. credit markets may impact our ability to obtain financing or increase the cost of future financing, including interest rate fluctuations based on macroeconomic conditions that are beyond our control.
- Our stock price could fluctuate significantly, which could cause the value of your investment to decline, and you may not be able to resell your shares at or above your purchase price.
- If securities or industry analysts do not publish research or reports about our business, if they adversely change their recommendations regarding our stock, or if our results of operations do not meet their expectations, our stock price and trading volume could decline.
- We do not anticipate paying any cash dividends for the foreseeable future, and accordingly, stockholders must rely on stock appreciation for any return on their investment.
- Anti-takeover provisions in our charter documents and Delaware law and certain provisions in the Notes and Indenture may make an acquisition of us more difficult.