Macrogenics (MGNX) risk factors, FY2025 10-K

Other

1. 01Summary of Risk Factors Affecting Our Business

Risks Related to Our Financial Position and Need for Additional Capital

1. 02We 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
2. 03We have incurred significant losses since inception and anticipate continuing to incur losses for the foreseeable future. We may never achieve or sustain profitability
3. 04Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish substantial rights
4. 05Our ability to use our net operating loss carryforwards and other tax attributes may be limited

Risks Related to Our Business and the Development and Commercialization of Our Product Candidates

1. 06If clinical trials for our product candidates are prolonged, delayed or stopped, for any reason, we may be unable to obtain regulatory approval and commercialize our product candidates on a timely basis, which would require us to incur additional costs and delay our receipt of any product revenue
2. 07Certain of our antibody-drug conjugate, or ADC, product candidates incorporate technology developed by our collaboration partners. To date, no ADC product candidates incorporating any such technology have been approved by the FDA
3. 08Our product candidates, if approved, may fail to achieve or maintain market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success
4. 09Our product candidates may have undesirable side effects, including fatalities. These side effects may delay or prevent further clinical development or 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 sales57% rewritten
5. 104 myocarditis (N=1), and Grade 4 neutropenia and concurrent septic shock (N=1) which led to a Grade 5 event. Under the partial clinical hold, no new patients will be enrolled in the LINNET study until the partial hold is lifted by the FDANew
6. 11Our manufacturing facility is subject to significant government regulations and approvals, which are often costly and could result in adverse consequences to our business if we fail to comply with the regulations or maintain the approvals
7. 12Our manufacturing facility is not currently being primarily utilized for the production of our own product candidates, and we may not be able to efficiently and effectively offset the costs of maintaining the facility through contract manufacturing services for third parties in the futureNew
8. 13We face significant competition and if our competitors continue to develop and market products that are more effective, safer or less expensive than our product candidates or if they are ahead of us in development, our current or future commercial opportunities may be negatively impacted27% rewritten
9. 14Actual or anticipated changes to the laws and regulations governing the health care system may have a negative impact on cost and access to health insurance coverage and reimbursement of healthcare items and services81% rewritten
10. 15Reimbursement 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
11. 16If any product liability lawsuits are successfully brought against us or any of our collaborators, we may incur substantial liabilities and may be required to limit commercialization of our products or product candidates
12. 17We and/or our collaboration partners may never obtain approval or commercialize our products outside of the United States, which would limit our ability to realize their full market potential
13. 18Changes in U.S. tax law may have a material adverse effect on our business, financial condition and results of operations, and changes in international trade relations may have a material adverse effect on the commercialization of some or all of our product candidates
14. 19Public health crises such as pandemics or similar outbreaks may have a significant negative impact on our clinical trials, nonclinical studies, development, manufacturing and commercialization of our product candidates and other aspects of our business, staff, and operations66% rewritten

Risks Related to Our Dependence on Third Parties

1. 20Our existing therapeutic collaborations are important to our business, and future collaborations may also be important to us. If we are unable to maintain any of these collaborations, or if these collaborations are not successful, our business could be adversely affected
2. 21Failure to successfully develop and commercialize companion diagnostics with third party contractors for use with our product candidates could harm our ability to commercialize our product candidates81% rewritten
3. 22candidates. We do not have experience or capabilities in developing or commercializing diagnostics and are relying, and in the future plan to continue to rely, in large part on third parties to perform these functionsNew
4. 23Independent clinical investigators and CROs that we engage to conduct our clinical trials may not devote sufficient time or attention to our clinical trials or be able to repeat their past success
5. 24Commercialization collaborations will be important to our business. If we are unable to maintain commercialization collaborations, or if commercialization collaborations are not successful, our business could be adversely affected
6. 25All of the risks relating to commercialization, and health care legal compliance described in this Annual Report on Form 10-K also apply to the commercialization activities of our collaborators54% rewritten

Risks Related to Our Intellectual Property

1. 26Our success depends significantly on our ability to operate without infringing the valid patents and other proprietary rights of third parties
2. 27Our success will depend in part on our ability to operate without infringing the proprietary rights of third parties. Third parties may have or obtain patents or proprietary rights that could limit our ability to make, use, sell, offer for sale or import our future approved products or impair our competitive position
3. 28If we are unable to obtain and enforce patent protection for our products and our product candidates and related technology, our business could be materially harmed
4. 29We may become involved in lawsuits to protect or enforce our patents, which could be expensive, time consuming and unsuccessful
5. 30If we fail to comply with our obligations under our intellectual property licenses with third parties, we could lose license rights that are important to our business
6. 31If we are unable to protect the confidentiality of our proprietary information, the value of our technology and products could be adversely affected
7. 32Obtaining and maintaining our patent protection depends on compliance with various procedural, documentary, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
8. 33If we do not obtain protection under the Hatch-Waxman Amendments and similar foreign legislation for extending the term of patents covering each of our product candidates, our business may be materially harmed

Risks Related to Legal Compliance Matters

1. 34If we do not comply with laws regulating the protection of the environment and health and human safety, our business could be adversely affected
2. 35We and our collaborators are subject to various healthcare laws, and our failure, or the failure of our collaborators, to comply with those laws could result in significant penalties and adversely affect our business, operations and financial condition44% rewritten
3. 36delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters. Similar to the federal anti-kickback statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violationNew
4. 37In addition, our operations and those of our collaborators may be subject to analogous foreign health care laws in the jurisdictions in which we operate72% rewritten
5. 38security have become significant issues in the United States, Europe, and in many other jurisdictions where we or our partners may in the future conduct our operationsNew
6. 39Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading

Risks Related to Employee Matters and Human Capital Management

1. 40Our future success depends on our ability to attract or retain key executives and to attract, retain and motivate qualified personnel38% rewritten
2. 41We may undertake internal restructuring activities, including associated workforce reductions, that could result in disruptions to our business or otherwise materially harm our results of operations or financial condition20% rewritten
3. 42We may need to grow or contract our organization, and we may experience difficulties in managing this growth or contraction, which could disrupt our operations53% rewritten

Risks Related to Our Common Stock

1. 43We have been and may in the future be subject to securities litigation, which is expensive and could divert management attention and adversely impact our business72% rewritten
2. 44costs and diversion of management’s attention and resources, which could adversely impact our business. Any adverse determination in litigation could also subject us to significant liabilitiesNew
3. 45Provisions of our charter, bylaws, third-party agreements and Delaware law may make an acquisition of us or a change in our management more difficult