Content analysis
?Positive | ||
Negative | ||
Uncertain | ||
Constraining | ||
Legalese | ||
Litigous | ||
Readability |
H.S. sophomore Avg
|
New words:
Adolescent, Adult, alleviate, analyzed, AYA, borrow, borrowing, Capriata, categorized, closer, condensed, CT, cybersecurity, Darien, debtor, deficiency, disaggregated, disaggregation, EC, enclosed, Euro, Floor, Frederick, front, Golden, implicit, intelligence, landscape, leasehold, mentioned, NCCN, Norgine, overstated, revisited, Road, Roberto, SOC, specialist, subtracted, threat, Tucker, unaudited, unrestricted
Removed:
Artali, attest, brain, breakthrough, Chapman, chose, collusion, COSO, daily, detection, diligence, disabling, division, exert, fast, filer, frequent, Mario, Middle, Millennium, neck, occurred, origination, ovarian, override, Overview, partnering, plaintiff, preliminary, project, prospectively, rapidly, remotely, resubmission, rolling, spread, surge, testicular, tradename, undergoing, USD, violated, vulnerability
Financial report summary
?Competition
Eisai • Pfizer • AMGEN • Astrazeneca • Roche • Novartis • Decibel Therapeutics • Merck KGaARisks
- Item 1A. Risk Factors
- Risks Related to Our Business
- We have a history of significant losses and have had limited revenues to date through the sale of our product. If we do not generate significant revenues, we will not achieve profitability.
- Our business is subject to substantial competition.
- If we do not maintain current or enter into new collaborations with other companies, we might not successfully develop our product or generate sufficient revenues to expand our business.
- Regulatory approval of our product is time-consuming, expensive and uncertain, and could result in unexpectedly high expenses and delay our ability to sell our product in the U.S. and abroad.
- If our licenses to proprietary technology owned by others are terminated or expire, we may suffer increased development costs and delays, and we may not be able to successfully commercialize our product.
- If we are unable to adequately protect or maintain our patents and licenses related to our product, or if we infringe upon the intellectual property rights of others, we may not be able to successfully maintain commercial status of our product.
- If our third-party manufacturers breach or terminate their agreements with us, or if we are unable to secure arrangements with third party manufacturers on acceptable terms as needed in the future, we may suffer significant production delays and additional costs.
- We conduct our business internationally and are subject to laws and regulations of several countries which may affect our ability to access regulatory agencies and may affect the enforceability and value of our licenses.
- Our cash invested in money market funds might be subject to loss.
- We have only recently transitioned from a development stage biopharmaceutical company to a commercial stage biopharmaceutical company, which may make it difficult for you to evaluate the success of our business to date and to assess our future viability.
- There are limitations on the liability of our directors, and we may have to indemnify our officers and directors in certain instances.
- Our business and operations could be adversely affected by the effects of health epidemics, like the recent COVID-19 pandemic.
- Natural disasters, epidemic or pandemic disease outbreaks, trade wars, political unrest or other events could disrupt our business or operations or those of our development partners, manufacturers, regulators or other third parties with whom we conduct business now or in the future.
- Risks Related to the Clinical Development and Marketing Approval of Our Product outside the United States
- The marketing approval processes of foreign authorities are lengthy, time-consuming and inherently unpredictable, and if we are ultimately unable to obtain marketing approval for our product abroad, our business will be substantially harmed.
- Now that we have achieved marketing approval for our product in the United States, it will be subject to ongoing obligations and continued regulatory review, which may result in significant additional expense. Our product could be subject to labeling and other restrictions, and we may be subject to penalties and legal sanctions if we fail to comply with regulatory requirements or experience unanticipated problems with our approved product.
- Our current and future relationships with healthcare professionals, investigators, consultants, collaborators, actual customers, potential customers and third-party payors in the United States and elsewhere may be subject, directly or indirectly, to applicable anti-kickback, fraud and abuse, false claims, physician payment transparency, health information privacy and security and other healthcare laws and regulations, which could expose us to sanctions.
- The impact of recent healthcare reform legislation and other changes in the healthcare industry and healthcare spending on us is currently unknown and may adversely affect our business model.
- If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on our business, financial condition or results of operations.
- Our employees, sales agents and consultants may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
- Risks Related to Commercialization of Our Product
- After regulatory approvals in the United States, European Union and other territories, the commercial success of our product will depend on market awareness and acceptance of our product.
- If the market opportunities for our product are smaller than we believe they are, then our revenues may be adversely affected, and our business may suffer.
- Coverage and reimbursement may be limited or unavailable in certain market segments for our product, which could make it difficult for us to sell our product profitably.
- Price controls may be imposed in foreign markets, which may adversely affect our future profitability.
- Rapid technological change could make our product obsolete.
- Changes to the Orphan Drug Act or successful legal challenges to the FDA’s interpretation of the Orphan Drug Act may affect our ability to obtain or subsequently maintain orphan drug exclusivity or affect the scope of orphan drug exclusivity for our product.
- Our operations and relationships with healthcare providers, healthcare organizations, customers and third-party payors are subject to applicable anti-bribery, anti-kickback, fraud and abuse, transparency and other healthcare laws and regulations, which could expose us to, among other things, enforcement actions, criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings.
- Risks Related to Third Parties
- Risks Related to Our Intellectual Property
- Risks Related to Our Industry
- We use hazardous materials and chemicals in our research and development, and our failure to comply with laws related to hazardous materials could materially harm us.
- Efforts to reduce product pricing and health care reimbursement and changes to government policies could negatively affect the profitability of our product.
- Risks Related to Owning Our Common Shares
- We may be unable to maintain the listing of our common shares on the Nasdaq Capital Market or the TSX and that would make it more difficult for shareholders to dispose of our common shares.
- The market price of our common shares is highly volatile and could cause the value of your investment to significantly decline.
- Our existing principal shareholders hold a substantial number of our common shares and may be able to exercise influence in matters requiring approval of our shareholders.
- There are a large number of our common shares underlying outstanding options, and reserved for issuance under our stock option plan, that may be sold in the market, which could depress the market price of our shares and result in substantial dilution to the holders of our common shares.
- We may need to raise additional funds in the future to continue our operations. Any equity offering could result in significant dilution to the ownership interests of shareholders and may result in dilution of the value of such interests and any debt offering will increase financial risk.
- Our management has significant flexibility in using the current available cash.
- We have not paid any dividends since incorporation and do not anticipate declaring any dividends in the foreseeable future. As a result, you may not be able to recoup your investment through the payment of dividends on your common shares and the lack of a dividend payable on our common shares might depress the value of your investment.
- We may be a passive foreign investment company, or “PFIC,” which could result in adverse United States federal income tax consequences to U.S. investors.
- Failure to maintain effective internal controls in accordance with Section 404 of the Sarbanes-Oxley Act of 2002 could have an adverse effect on our business.