Content analysis
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H.S. senior Avg
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New words:
AASLD, AEs, aforementioned, content, CRO, discontinue, fraction, MA, multicenter, newest, preapproval, refining, trend, upcoming
Removed:
certification, cheaper, document, excellence, extraordinary, finalized, heightened, molecularly, NDC, profitable, reaching, reimportation, relief, roughly, rulemaking, scale, sourced, Trump, unmet
Financial report summary
?Competition
Canada • Ionis Pharmaceuticals • Vertex Pharmaceuticals • Arrowhead Pharmaceuticals • Sanofi • Alnylam Pharmaceuticals • Achaogen • Precision Biosciences • Arbutus Biopharma • Silence TherapeuticsRisks
- Business interruptions resulting from the ongoing coronavirus disease (COVID-19) outbreak or similar public health crises could cause a disruption of the development of our product candidates and adversely impact our business.
- We have a history of operating losses; we expect to continue to incur significant losses for the foreseeable future and may never achieve or maintain profitability, which could result in a decline in the market value of our common stock.
- Our quarterly operating results may fluctuate significantly or may fall below the expectations of investors or securities analysts, each of which may cause our stock price to fluctuate or decline.
- Our approach to the discovery and development of innovative therapeutic treatments based on novel technologies is unproven and may not result in marketable products.
- The market may not be receptive to our product candidates based on a novel therapeutic modality, and we may not generate any future revenue from the sale or licensing of product candidates.
- Our product candidates are in varied stages of development and may fail or suffer delays that materially and adversely affect their commercial viability and/or our strategy with respect to seeking regulatory approval.
- Breakthrough Therapy Designation by the FDA may not actually lead to a faster development or regulatory review or approval process.
- If third parties on which we depend to conduct our preclinical studies, or any future clinical trials, do not perform as contractually required, fail to satisfy regulatory or legal requirements, or miss expected deadlines, our development program could be delayed with materially adverse effects on our business, financial condition, results of operations, and prospects.
- Because we rely on third-party manufacturing and supply partners, our supply of research and development, preclinical studies, and clinical trial materials may become limited or interrupted or may not be of satisfactory quantity or quality.
- We may not successfully engage in strategic transactions, including any additional collaborations we seek, which could adversely affect our ability to develop and commercialize product candidates, impact our cash position, increase our expense, and present significant distractions to our management.
- We face competition from entities that have developed or may develop product candidates for our target disease indications, including companies developing novel treatments and technology platforms based on modalities and technology similar to ours. If these companies develop technologies or product candidates more rapidly than we do or their technologies, including delivery technologies, are more effective, our ability to develop and successfully commercialize product candidates may be adversely affected.
- Any inability to attract and retain qualified key management and personnel would impair our ability to implement our business plan.
- Interim and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available or as additional analyses are conducted and as the data are subject to audit and verification procedures that could result in material changes in the final data.
- As more of our product candidates advance into clinical trials, including pivotal trials, and commercialization, if approved, we may experience difficulties in managing our growth and expanding our operations.
- We or our collaborative partners may conduct clinical trials for product candidates outside of the U.S., and the FDA and comparable foreign regulatory authorities may not accept data from such trials.
- If any of our product candidates are approved for marketing and commercialization and we are unable to develop sales, marketing, and distribution capabilities on our own or enter into agreements with third parties to perform these functions on acceptable terms, if at all, we will be unable to successfully commercialize any such future products.
- If we or our third-party service providers fail to comply with U.S. and foreign regulatory requirements, regulatory authorities could limit or withdraw any marketing or commercialization approvals we may receive and subject us to other penalties that could materially harm our business.
- We face risks arising from the results of the public referendum held in the United Kingdom and its subsequent withdrawal from the European Union.
- Price controls imposed in foreign markets and downward pricing pressure in the U.S. may adversely affect our future profitability.
- Our business entails a significant risk of product liability and our ability to obtain sufficient insurance coverage could harm our business, financial condition, results of operations, or prospects.
- Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have a material adverse effect on our business.
- Our internal computer systems, or those of third parties with which we do business, including our CROs or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our product development programs or the theft of Company or patient confidential information.
- If we do not comply with laws regulating the protection of the environment and health and human safety, our business could be adversely affected.
- Our information technology systems could face serious disruptions that could adversely affect our business.
- Our current operations are largely concentrated in our locations in Lexington, Massachusetts and any events affecting these locations may have material adverse consequences.
- Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
- The investment of our cash, cash equivalents, and held-to-maturity investments is subject to risks which may cause losses and affect the liquidity of these investments.
- Changes in accounting rules and regulations, or interpretations thereof, could result in unfavorable accounting charges or require us to change our compensation policies.
- If we are not able to obtain and enforce patent protection for our technologies or product candidates, development and commercialization of our product candidates may be adversely affected.
- Intellectual property rights of third parties could adversely affect our ability to commercialize our product candidates, and we might be required to litigate or obtain licenses from third parties to develop or market our product candidates. Such litigation could be costly and licenses may be unavailable on commercially reasonable terms.
- We may be unable to protect our intellectual property rights throughout the world.
- We, our licensors, or existing or future collaborators or licensees may become subject to third-party claims or litigation alleging infringement of patents or other proprietary rights or seeking to invalidate patents or other proprietary rights, and we may need to resort to litigation to protect or enforce our patents or other proprietary rights, all of which could be costly, time consuming, delay, or prevent the development and commercialization of our product candidates, or put our patents and other proprietary rights at risk.
- If we or our collaborative partners fail to comply with our obligations under any license, collaboration, or other agreements, we may be required to pay damages and could lose intellectual property rights that are necessary for developing and protecting our product candidates and delivery technologies, or we could lose certain rights to grant sublicenses.
- If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
- We may be, in the future, subject to claims that we or our employees or consultants have wrongfully used or disclosed alleged trade secrets of our employees’ or consultants’ former employers or their clients. These claims may be costly to defend and if we do not successfully do so, we may be required to pay monetary damages, may be prohibited from using some of our research and development work, and may lose valuable intellectual property rights or personnel.
- If our trademarks and trade names are not adequately protected, we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
- We may be unable to obtain U.S. or foreign regulatory approval and, as a result, may be unable to commercialize our product candidates.
- If we or current or future collaborators, manufacturers, or service providers fail to comply with healthcare laws and regulations, we or they could be subject to enforcement actions and substantial penalties, which could affect our ability to develop, market, and sell our products, and may harm our reputation.
- If we or current or future collaborators, manufacturers, or service providers fail to comply with applicable federal, state, or foreign laws or regulations, we could be subject to enforcement actions, which could affect our ability to develop, market, and sell our products successfully and could harm our reputation and lead to reduced acceptance of our products by the market. These enforcement actions include, among others:
- Any drugs we develop may become subject to unfavorable pricing regulations, third-party coverage, and reimbursement practices or healthcare reform initiatives, thereby harming our business.
- Our ability to obtain reimbursement or funding from the federal government may be impacted by possible reductions in federal spending.
- Inadequate funding for the FDA, the SEC, and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner, or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
- Our stock price is volatile and purchasers of our common stock could incur substantial losses.
- The employment agreements with our executive officers may require us to pay severance and other benefits to officers who are terminated in connection with a change of control of the Company, which could harm our financial condition.
- Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant influence over matters subject to stockholder approval.
- Anti-takeover provisions in our 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.
- We incur significant costs as a result of operating as a public company, and our management is required to devote substantial time to new compliance initiatives and corporate governance practices.
- 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 may incur significant costs from class action litigation due to our historical or expected stock volatility.
- Our bylaws contain exclusive forum provisions, which may limit a stockholder’s ability to bring a claim in a judicial forum it finds favorable and may discourage lawsuits with respect to such claims.
- Sales of shares issued in private placements may cause the market price of our shares to decline.
- The future issuance of equity or of debt securities that are convertible into equity will dilute our share capital.
- If securities or industry analysts do not publish research or reports about our business, or if they issue an adverse opinion regarding our stock, our stock price and trading volume could decline.
- Our stockholders may experience significant dilution as a result of future equity offerings and exercise of outstanding options.
- Future sales of our common stock in the public market could cause our stock price to fall.
Management Discussion
- Dicerna receives cash in the form of upfront, milestone, and reimbursement payments from its collaboration partners. However, except for BI, upfront payments received are typically recognized as revenue over time, as revenue from Dicerna’s collaboration partners is recognized on a cost-to-cost measure of progress. As a result, the amount of revenue Dicerna recognizes each period is directly correlated with the amount of services performed during the period.
- Revenue increased $14.1 million for the three months ended September 30, 2021 compared to the same period in 2020, primarily reflecting increased services provided and changes in estimated services to be performed under the collaboration agreement with Novo.
- The increase in revenue for the nine months ended September 30, 2021 is primarily attributable to an increase in services provided and changes in estimated services to be performed under the collaboration agreement with Novo.