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H.S. senior Avg
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New words:
ahead, Aine, Ann, AppTec, ASU, Austin, biased, BIOSECURE, BMGF, bold, breaker, Bureau, calling, Chair, citing, Commerce, Communist, COVID, creation, dAIsY, deploy, deploying, deployment, elebsiran, entity, escape, estate, ethical, exit, flawed, fueled, Gina, Hanly, herewith, immunogenicity, inactive, inconsequential, instruction, introduced, Janet, latency, leasehold, Lee, line, Lloyd, MBA, medRxiv, military, modulate, month, nominal, open, opportunity, optimization, Pang, Phillip, poster, prospective, proven, Raimondo, regimen, retrospective, RNA, ROU, Sato, saving, St, stepping, Sung, tobevibart, transform, undermined, Vicki, vision, Yellen
Removed:
ACA, accessible, actively, acute, Addressing, adequacy, administer, Affordable, age, aging, Aid, aimed, allegation, altered, American, argued, art, Assembly, AstraZeneca, ballot, bear, bebtelovimab, Brexit, bribery, Britain, burden, buy, carryforward, catastrophic, CCPA, Celltrion, centralized, circulating, CJEU, clinically, CMS, cocktail, collect, collected, combat, combating, Comirnaty, commitment, competent, compliant, comprising, connected, constrain, consume, contingency, continually, cooperation, CPRA, CTA, CTR, damaged, dated, death, deauthorization, deauthorized, deductibility, deep, deliver, destabilized, Directive, dismissed, drew, driven, earn, easier, economically, Economy, Education, Eli, Enanta, England, entirety, erasure, Eurasian, evidenced, evolved, EVUSHELD, examiner, exceeding, excise, expanding, exploring, Favored, Fc, field, fine, fined, framework, Francisco, geography, Gilead, globally, granting, Great, handle, handled, harmonized, heighten, HITECH, HMR, hospitalization, hospitalized, identifier, immaterial, implementing, importation, incorporate, indefinitely, indirect, initiative, institution, intravenously, invalidating, inventor, Invivyd, Ireland, ISO, Janssen, Japan, jointly, justify, kg, left, legitimize, Likewise, Lilly, listing, loosely, lowest, mandate, master, matured, Merck, methodology, MHRA, mild, minimum, moderate, Moderna, molnupiravir, Nation, NOL, noncash, noncurrent, Northern, Novavax, NSO, older, oral, outbreak, parallel, parte, participant, PAXLOVID, pediatric, Pfizer, phishing, plc, portal, predictable, predicted, prepare, present, proceed, producing, progression, Promoting, promulgated, proportionate, rare, reached, reauthorization, receptive, reducing, referendum, Regeneron, regime, regulating, remdesivir, reopening, resurgence, returning, reviewing, revising, rolling, rollout, Russian, sample, Samsung, San, Sanofi, scaling, Scotland, seed, Shield, Shionogi, showed, shown, SI, significance, situation, spending, Spikevax, statistical, statistically, Steering, stopping, submitted, subsidy, substance, suggested, supervising, Supreme, syndrome, therewith, threshold, tie, tier, timelier, topline, Trump, Trust, unaware, uncollectible, unconstitutional, underrepresented, uninterrupted, uphold, vitro, voluntary, weighing, wide, withdrawn, withheld, workplace, XBB, Xencor, Xtend
Financial report summary
?Competition
Pfizer • Regeneron Pharmaceuticals • Novavax • Inovio Pharmaceuticals • Sanofi • Dicerna Pharmaceuticals • Arbutus Biopharma • Immunome • Atreca Inc - Ordinary Shares • AbbvieRisks
- We have incurred net losses and anticipate that we will continue to incur net losses in the foreseeable future.
- We do not expect meaningful future revenue from the sale of sotrovimab for the treatment of COVID-19, even if it were reauthorized by the FDA. If the FDA were to revise or revoke our EUA, our business could be adversely impacted.
- Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability.
- We may require substantial additional funding to finance our operations. If we are unable to raise capital when needed, we could be forced to delay, reduce or terminate certain of our development programs or other operations.
- Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our product candidates.
- Adverse developments affecting the financial services industry, including events or concerns involving liquidity, defaults or nonperformance by financial institutions, could adversely affect our business, financial condition or results of operations.
- Our future success is substantially dependent on the successful clinical development, regulatory approval and commercialization of our product candidates in a timely manner. If we are not able to obtain required regulatory approvals, we will not be able to commercialize our product candidates and our ability to generate product revenue will be adversely affected.
- The development of additional product candidates is risky and uncertain, and we can provide no assurances that we will be able to replicate our approach for other diseases.
- We are developing, and in the future may develop, other product candidates in combination with other therapies, which exposes us to additional risks.
- Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials and we cannot assure you that any ongoing, planned or future clinical trials will lead to results sufficient for the necessary regulatory approvals and market authorizations. We have and may continue to commit substantial financial resources with respect to clinical trials that may not be successful, and may not be able to recoup those investments.
- Interim, “top-line” and 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.
- Clinical product development involves a lengthy and expensive process. We may incur additional costs and encounter substantial delays or difficulties in our clinical trials.
- Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be delayed, made more difficult or rendered impossible by multiple factors outside our control.
- Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit their commercial potential or result in significant negative consequences following any potential marketing approval.
- We are a party to strategic collaboration and license agreements pursuant to which we are obligated to make substantial payments upon achievement of milestone events and, in certain cases, have relinquished important rights over the development and commercialization of certain current and future product candidates. We also intend to explore additional strategic collaborations, which may never materialize or may require that we spend significant additional capital or that we relinquish rights to and control over the development and commercialization of our product candidates.
- If the market opportunities for our product candidates are smaller than we believe they are or any approval we obtain is based on a narrower definition of the patient population, our business may suffer.
- We face substantial competition, which may result in others developing or commercializing products before or more successfully than we do.
- Even if any of our product candidates receive marketing approval, they may fail to achieve adoption by physicians, patients, third-party payors or others in the medical community necessary for commercial success.
- Even if we obtain regulatory approvals for our product candidates, they will remain subject to ongoing regulatory oversight and potential enforcement actions.
- Even if we obtain and maintain approval for our product candidates from the FDA, we may never obtain approval outside of the United States, which would limit our market opportunities.
- Negative developments and negative public opinion of new technologies on which we rely may damage public perception of our product candidates or adversely affect our ability to conduct our business or obtain regulatory approvals for our product candidates.
- Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any product candidate that we may develop. In addition, our insurance policies may be inadequate and potentially expose us to unrecoverable risks.
- Any biologic product candidates for which we intend to seek approval may face competition sooner than anticipated.
- Our relationships with customers, physicians, and third-party payors are subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, and other healthcare laws and regulations. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.
- If we obtain regulatory approval in the United States, coverage and adequate reimbursement may not be available for any product candidates that we commercialize, which could make it difficult for us to sell profitably.
- Healthcare legislative reform measures may have a negative impact on our business, financial condition, results of operations and prospects.
- We are subject to anti-corruption, anti-bribery, anti-money laundering, and similar laws, and non-compliance with such laws can subject us to criminal and/or civil liability and harm our business.
- We rely on third parties to produce clinical and commercial supplies of our product candidates.
- Changes in U.S. and international trade policies, particularly with respect to China, may adversely impact our business and operating results.
- Our business involves the use of hazardous materials and we and our third-party manufacturers and suppliers must comply with environmental, health and safety laws and regulations, which can be expensive and restrict how we do, or interrupt our, business.
- We rely on third parties to conduct, supervise and monitor our preclinical studies and clinical trials, and if those third parties perform in an unsatisfactory manner, it may harm our business.
- If we breach our license agreements or any of the other agreements under which we acquired, or will acquire, the intellectual property rights to our product candidates, we could lose the ability to continue the development and commercialization of the related product candidates.
- If we are unable to obtain and maintain patent protection for our product candidates and technology, or if the scope of the patent protection obtained is not sufficiently broad or robust, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to successfully commercialize our product candidates and technology may be adversely affected.
- Obtaining and maintaining our patent rights depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for noncompliance with these requirements.
- Patent terms may be inadequate to protect our competitive position on our product candidates or any products approved in the future for an adequate amount of time and additional competitors could enter the market with generic or biosimilar versions of such products.
- Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could have a negative impact on the success of our business.
- We may be subject to claims asserting that our employees, consultants or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property.
- We may be involved in lawsuits to protect or enforce our patents, the patents of our licensors or our other intellectual property rights, which could be expensive, time-consuming and unsuccessful.
- We may not be able to protect our intellectual property rights throughout the world, which could negatively impact our business.
- If the U.S. government, the World Trade Organization, or WTO, or other governmental body imposes an intellectual property rights waiver, our ability to successfully commercialize our COVID-19 product candidates and protect our related technology could be adversely affected.
- If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
- Any trademarks we may obtain may be infringed or successfully challenged, resulting in harm to our business.
- The exercise by the Bill & Melinda Gates Foundation of its licenses to certain of our intellectual property and its development and commercialization of products that we are also developing and commercializing could have an adverse impact on our market position.
- We are highly dependent on our key personnel, and if we are not able to retain these members of our management team or recruit and retain additional management, clinical and scientific personnel, our business will be harmed.
- We have in the past and may in the future acquire or invest in other companies or technologies, which could divert our management’s attention, result in dilution to our stockholders and otherwise disrupt our operations and adversely affect our operating results.
- We have experienced significant growth in our organization in recent years and expect to continue to expand, and we may experience difficulties in managing this growth, which could disrupt our operations.
- Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.
- Our business could be materially adversely affected by the effects of public health outbreaks, pandemics or epidemics, including the COVID-19 pandemic and future pandemics.
- If our information systems, or those maintained on our behalf, fail or suffer security breaches, such events could result in, without limitation, the following: a significant disruption of our product development programs; an inability to operate our business effectively; unauthorized access to or disclosure of the personal information we process; and other adverse effects on our business, financial condition, results of operations and prospects.
- We are subject to stringent privacy laws, information security laws, regulations, policies and contractual obligations related to data privacy and security and changes in such laws, regulations, policies, contractual obligations and failure to comply with such requirements could subject us to significant fines and penalties, which may have a material adverse effect on our business, financial condition or results of operations.
- Our employees, principal investigators, consultants and commercial partners may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading.
- Our financial condition and results of operations may fluctuate from quarter to quarter and year to year, which makes them difficult to predict.
- The market price of our common stock has been, and in the future, may be, volatile and fluctuate substantially, which could result in substantial losses for purchasers of our common stock.
- Concentration of ownership of our common stock among our existing executive officers, directors and principal stockholders may prevent new investors from influencing significant corporate decisions.
- If research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business or our market, our stock price and trading volume could decline.
- Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain.
- We have incurred and we will continue to incur significant increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives.
- If we fail to develop or maintain proper and effective internal control over financial reporting, our ability to produce accurate and timely financial statements could be impaired, investors may lose confidence in us and the trading price of our common stock may decline.
- Our reported financial results may be adversely affected by changes in accounting principles generally accepted in the United States.
- Provisions in our corporate charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
- Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
Management Discussion
- The decrease in collaboration revenue for the three months ended March 31, 2024 compared to the same period in 2023 was primarily due to lower revenues from the release of profit-sharing amount previously constrained and from the sales of sotrovimab under the 2020 GSK Agreement. The negative collaboration revenue for the three months ended March 31, 2024 consisted of $0.3 million profit-sharing loss from the sale of sotrovimab and $0.7 million profit-sharing amount constrained.
- The increase in contract revenue for the three months ended March 31, 2024 compared to the same period in 2023 was primarily due to $51.7 million of deferred revenue recognized during the three months ended March 31, 2024 as GSK’s rights to select up to two additional non-influenza target pathogens under the 2021 GSK Agreement expired on March 25, 2024.
- The decrease in grant revenue for the three months ended March 31, 2024 compared to the same period in 2023 was primarily due to lower revenue recognized in accordance with our agreement with BARDA.