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Financial report summary
?Competition
Astrazeneca • Roche • Seagen • Novartis • Macrogenics • Molecular Templates • Endocyte • Xencor • Puma Biotechnology • Pieris PharmaceuticalsRisks
- Risks Related to Our Business and the Development and Commercialization of Our Product Candidates
- We have a limited number of product candidates, all which are still in clinical development. If we do not obtain regulatory approval of one or more of our product candidates, or experience significant delays in doing so, our business will be materially adversely affected.
- Clinical trials are expensive, time consuming, difficult to design and implement, and involve uncertain outcomes. Furthermore, the results of previous preclinical studies and clinical trials may not be predictive of future results, and the results of our current and planned clinical trials may not satisfy the requirements of the FDA or comparable regulatory authorities outside the United States.
- If clinical trials for our product candidates are prolonged, delayed or stopped, we may be unable to obtain regulatory approval and commercialize our product candidates on a timely basis, or at all, which would require us to incur additional costs and delay our receipt of any product revenue.
- If we, or any of our partners, are unable to enroll patients in clinical trials, we will be unable to complete these trials on a timely basis or at all.
- The design or our execution of clinical trials may not support regulatory approval.
- Interim, preliminary or topline 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.
- Our business has been and may continue to be adversely affected by the COVID-19 pandemic.
- The Fast Track and Breakthrough Therapy designations we have received for zanidatamab may not result in faster development, regulatory review or approval process.
- Development of product candidates in combination with other therapies could expose us to additional risks.
- Disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified product candidates from being developed, or approved or commercialized in a timely manner or at all, which could negatively impact our business.
- Successful development of our current and future product candidates is uncertain and we may discontinue or reprioritize the development of any of our product candidates at any time, at our discretion.
- Our product candidates may have undesirable side effects that may delay or prevent marketing approval or, if approval is received, require them to be taken off the market, require them to include safety warnings or otherwise limit their sales; no regulatory agency has made any determination that any of our product candidates are safe or effective for use by the general public for any indication.
- We face significant competition, and if our competitors develop and market products that are more effective, safer or less expensive than our product candidates, our commercial opportunities will be negatively impacted.
- If any of our product candidates receive regulatory approval, the approved products may not achieve broad market acceptance among physicians, patients, the medical community and third-party payors, in which case revenue generated from their sales would be limited.
- We may be unable to obtain orphan drug exclusivity in specific indications for zanidatamab or in future product candidates that we may develop. If our competitors are able to obtain orphan product exclusivity for their products in specific indications, we may not be able to have competing products approved in those indications by the applicable regulatory authority for a significant period of time.
- Even if we obtain FDA approval of any of our product candidates, we may never obtain approval or commercialize such products outside of the United States, which would limit our ability to realize their full market potential.
- Reimbursement decisions by third-party payors may have an adverse effect on pricing and market acceptance. If there is not sufficient reimbursement for our products, it is less likely that our products will be widely used.
- If the market opportunities for any product that we or our strategic partners develop are smaller than we believe they are, our revenue may be adversely affected and our business may suffer.
- We may not be successful in our efforts to use our therapeutic platforms to build a pipeline of product candidates.
- Even if we receive regulatory approval to commercialize any of the product candidates that we develop, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense.
- If any product liability lawsuits are successfully brought against us or any of our strategic partners, we may incur substantial liabilities and may be required to limit commercialization of our product candidates.
- If we or any of our third-party manufacturers encounter manufacturing difficulties, our ability to provide supply of our product candidates for clinical trials or our products for patients, if approved, could be delayed or prevented.
- Material modifications in methods of product candidate manufacturing or formulation may result in additional costs or delay.
- Strategic transactions could disrupt our business, cause dilution to our shareholders and otherwise harm our business.
- Many governments impose strict price controls, which may adversely affect our future profitability.
- Security breaches and incidents, loss of data and other disruptions could compromise sensitive information related to our business or protected health information or prevent us from accessing critical information and expose us to liability, which could adversely affect our business and our reputation.
- We are subject to stringent and changing obligations related to privacy and security. Our actual or perceived failure to comply with such obligations could lead to regulatory investigations or actions, litigation, fines and penalties, disruptions of our business operations, reputational harm and other adverse business consequences.
- Current and future legislation may increase the difficulty and cost for us to commercialize any products that we or our strategic partners develop and affect the prices we may obtain.
- Unstable or unfavorable global market and economic conditions may have adverse consequences on our business, financial condition and stock price.
- Our business may become subject to economic, political, regulatory and other risks associated with international operations.
- Our business and current and future relationships with customers and third-party payors in the United States and elsewhere will be subject, directly or indirectly, to applicable federal and state anti-kickback, fraud and abuse, false claims, transparency, health information privacy and security, and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens, and diminished profits and future earnings.
- We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws and regulations. Compliance with these legal standards could impair our ability to compete in domestic and international markets. We can face criminal liability and other serious consequences for violations that can harm our business.
- We have received an unsolicited, non-binding proposal from an existing investor to purchase our Company.
- The shareholders’ rights plan adopted by our board of directors may discourage a third party from acquiring us in a manner that could result in a premium price to our shareholders.
- Risks Relating to the Post-Redomicile Parent Company
- The rights of stockholders under Delaware law may differ from the rights of shareholders under the BCBCA.
- Delaware law and provisions in the New Zymeworks amended and restated certificate of incorporation and New Zymeworks amended and restated bylaws might delay, discourage or prevent a change in control of New Zymeworks or changes in its management, thereby depressing the market price of the Delaware Common Stock.
- The New Zymeworks amended and restated bylaws will designate a state or federal court located within the State of Delaware as the exclusive forum for substantially all disputes between New Zymeworks and its stockholders, and also provide that the federal district courts will be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act, each of which could limit New Zymeworks’ stockholders’ ability to choose the judicial forum for disputes with New Zymeworks or its directors, officers, stockholders or employees.
- There has been no prior public trading for the shares of Delaware Common Stock on a national securities exchange and the market price of the shares of Delaware Common Stock may be subject to volatility.
- New Zymeworks may need to enter into certain new arrangements which may not be on terms as favorable as arrangements entered into by us.
- New Zymeworks’ ability to pay dividends in the future is not guaranteed.
- The issuance of additional shares of Delaware Common Stock in connection with future equity financings, acquisitions or growth opportunities, any New Zymeworks equity incentive plan or otherwise may dilute all other shareholdings.
- We may fail to realize certain benefits of the Redomicile Transactions, including as a result of the shares of Delaware Common Stock not being included in a U.S. stock market index.
- The Redomicile Transactions may result in sales of shares of Delaware Common Stock by certain retail and institutional shareholders or investment funds that are not permitted to hold shares of Delaware Common Stock under their internal guidelines.
- Our business may be impacted by the uncertainty associated with the Redomicile Transactions.
- The Redomicile Transactions are conditional, and the conditions may not be satisfied.
- Distributions to non-U.S. holders of Delaware Common Stock may be subject to U.S. withholding
- New Zymeworks’ effective tax rate may change in the future, including as a result of the Redomicile Transactions.
- We will allocate time and resources to effecting the Redomicile Transactions and incur non-recurring costs related to the Redomicile Transactions.
- We may choose to defer or abandon the Redomicile Transactions.
- Negative publicity resulting from the Redomicile Transactions could adversely affect our business and the market price of our common shares and the shares of Delaware Common Stock.
- Completion of the Redomicile Transactions may trigger certain provisions in agreements to which we are a party.
- Payments in connection with the exercise of dissent rights by our shareholders may impact New Zymeworks’ financial resources.
- Enforcement of rights against New Zymeworks in Canada may be limited.
- Risks Relating to the Exchangeable Shares
- The Exchangeable Shares will not be listed on any stock exchange.
- Shareholders who elect to receive Exchangeable Shares will experience a delay in receiving Delaware Common Stock from the date they request an exchange, which may affect the value of the shares the holder receives in such exchange.
- There may be a taxable event for an Eligible Holder as a result of a transaction beyond such Eligible Holder’s control.
- Receipt of Delaware Common Stock by Eligible Holders who do not elect to receive Exchangeable Shares with respect to any portion of their common shares will be a taxable event for Canadian income tax purposes, and could also be taxable to shareholders who are not U.S. holders.
- The tax treatment of Exchangeable Shares for non-Canadian tax purposes is uncertain.
- Risks Related to Our Financial Position and Need for Additional Capital
- We have incurred significant losses since inception and anticipate that we will continue to incur losses for the foreseeable future. We have no products approved for commercial sale, and to date we have not generated any revenue or profit from product sales. We may never achieve or sustain profitability.
- Biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of uncertainty. We have never generated any revenue from product sales and may never be profitable.
- We will require substantial additional funding, which may not be available to us on acceptable terms, or at all, and, if not available, may require us to delay, scale back, or cease our product development programs or operations.
- Raising additional capital may cause dilution to our shareholders, restrict our operations or require us to relinquish substantial rights.
- Risks Related to Our Dependence on Third Parties
- Our existing strategic partnerships are important to our business, and future strategic partnerships will likely also be important to us. If we are unable to maintain our strategic partnerships, or if these strategic partnerships are not successful, our business could be adversely affected.
- We face significant competition in seeking new strategic partners.
- We rely on third-party manufacturers to produce our product candidates and on other third parties to provide supplies and store, monitor and transport bulk drug substance and drug product. We and our third-party partners may encounter difficulties with respect to these activities that could delay or impair our ability to initiate or complete our clinical trials or commercialize approved products.
- We rely on third parties to monitor, support, conduct and oversee clinical trials of the product candidates that we are developing and, in some cases, to maintain regulatory files for those product candidates. We may not be able to obtain regulatory approval for our product candidates or commercialize any products that may result from our development efforts if we are not able to maintain or secure agreements with such third parties on acceptable terms, if these third parties do not perform their services as required, or if these third parties fail to timely transfer any regulatory information held by them to us.
- We rely on third parties for various operational and administrative aspects of our business, including for certain cloud-based software platforms, which impact our financial, operational and research activities. If any of these third parties fail to provide timely, accurate and ongoing service or if the cloud-based platforms suffer outages that we are unable to mitigate, our business may be adversely affected.
- Risks Related to Our Intellectual Property
- Our commercial success depends significantly on our ability to operate without infringing the patents and other proprietary rights of third parties.
- If we are unable to obtain, maintain and enforce patent and trade secret protection for our product candidates and related technology, our business could be materially harmed.
- Our patents covering one or more of our products or product candidates could be found invalid or unenforceable if challenged.
- Our intellectual property rights will not necessarily provide us with competitive advantages.
- We may become involved in lawsuits to protect or enforce our patents and trade secrets, which could be expensive, time consuming and unsuccessful.
- Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
- If we do not obtain protection under the Hatch-Waxman Amendments and similar legislation in other countries for extending the term of patents covering each of our product candidates, our business may be materially harmed.
- If we are unable to protect the confidentiality of our proprietary information, the value of our technology and products could be adversely affected.
- Obtaining and maintaining our patent protection depends on compliance with various procedural, documentary, fee payment and other requirements imposed by regulations and governmental patent agencies, and our patent protection could be reduced or eliminated for noncompliance with these requirements.
- We may be subject to claims challenging the inventorship of our patents and other intellectual property.
- Patent protection and patent prosecution for some of our product candidates may be dependent on, and the ability to assert patents and defend them against claims of invalidity may be maintained by, third parties.
- Changes in patent laws or patent jurisprudence could diminish the value of patents in general, thereby impairing our ability to protect our products.
- We may not be able to protect our intellectual property rights throughout the world.
- We use open source software in connection with our internal research and development programs, which could negatively affect our ability to develop products and subject us to litigation or other actions.
- We will need to obtain FDA approval for any proposed product candidate names, and any failure or delay associated with such approval may adversely affect our business.
- Risks Related to Additional Legal and Compliance Matters
- Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, insider trading, and noncompliance with our policies and procedures.
- If we or our contractors or agents market products in a manner that violates healthcare fraud and abuse laws, or if we violate government price reporting laws and transparency laws, we may be subject to civil or criminal penalties.
- If we do not comply with laws regulating the protection of the environment and health and human safety, our business could be adversely affected.
- Risks Related to Employee Matters and Managing Growth
- We may fail to achieve the expected cost savings and related benefits from our reduction in workforce initiated in January 2022 and the announcement of our key strategic priorities for 2022 and 2023.
- Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.
- As we advance our development and commercialization plans and strategies, we may need to grow or modify our organization, and we may experience difficulty in managing such change, which could disrupt our operations.
- Risks Related to Our Common Shares
- Our share price is likely to be volatile and the market price of our common shares may drop below the price paid by shareholders.
- An active trading market for our common shares may not be sustained.
- Substantial future sales of our common shares, or the perception that these sales could occur, may cause the price of our common shares to drop significantly, even if our business is performing well.
- Our management team has broad discretion to use the net proceeds from public and private and debt financings and its investment of these proceeds may not yield a favorable return. They may invest the proceeds in ways with which our shareholders disagree.
- We do not anticipate paying cash dividends for the foreseeable future, and accordingly, shareholders must rely on share appreciation for any return on their investment.
- We are governed by the corporate laws of Canada, which in some cases have a different effect on shareholders than the corporate laws of the United States.
- U.S. civil liabilities may not be enforceable against us, our directors, our officers or certain experts named in our Annual Report on Form 10-K.
- U.S. holders of our common shares may suffer adverse U.S. federal income tax consequences if we are characterized as a passive foreign investment company.
- Our principal shareholders, in aggregate, could exert substantial control over us which could delay or prevent a change in corporate control or result in the entrenchment of management or the board of directors.
- Provisions in our corporate charter documents and Canadian law could make an acquisition of us, which may be beneficial to our shareholders, more difficult and may prevent attempts by our shareholders to replace or remove our current management and/or limit the market price of our common shares.
- If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud. As a result, shareholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of our common shares.
- We are at risk of securities class action litigation.
- If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our share price and trading volume could decline.