Halozyme Therapeutics (HALO) risk factors, FY2025 10-K

Risks Related To Our Business

1. 01If our partnered or proprietary product candidates do not receive and maintain regulatory approvals, or if approvals are not obtained in a timely manner, such failure or delay would substantially impact our ability to generate revenues
2. 02We and our partners may not be successful in obtaining approvals for any additional potential products in a timely manner, or at all
3. 03Use of our partnered or proprietary products and product candidates could be associated with adverse events or product recalls
4. 04If we or any party to a key collaboration agreement fail to perform material obligations under such agreement, or if a key collaboration agreement is terminated for any reason, our business could suffer
5. 05Hylenex and our partners’ ENHANZE products and product candidates rely on the rHuPH20 enzyme, and any adverse development regarding rHuPH20 could substantially impact multiple areas of our business, including current and potential ENHANZE collaborations, as well as any proprietary programs
6. 06development or commercialization activities of our ENHANZE partners, or deter our entry into additional ENHANZE collaborations with third parties
7. 07If we or our partners fail to comply with regulatory requirements applicable to promotion, sale and manufacturing of approved products, regulatory agencies may take action against us or them, which could harm our business
8. 08Failure of our auto-injector and specialty products business to perform could adversely impact future business and operations79% rewritten
9. 09organizations upon whom we rely for the production and supply of our proprietary products, including Hylenex and the bulk rHuPH20 we supply to our partners, and causing other disruptions to our operationsNew
10. 10We may need to raise additional capital in the future and there can be no assurance that we will be able to obtain such funds
11. 11We currently have significant debt and may incur additional debt. Failure by us to fulfill our obligations under the applicable debt agreements may cause repayment obligations to accelerate
12. 12The conditional conversion feature of the Convertible Notes, if triggered, may adversely affect our financial condition and operating results
13. 13Conversion of our Convertible Notes may dilute the ownership interest of existing stockholders or may otherwise depress the price of our common stock
14. 14If proprietary or partnered product candidates are approved for commercialization but do not gain market acceptance resulting in commercial performance below that which was expected or projected, our business may suffer
15. 15Our ability to license our ENHANZE and device technologies to our partners depends on the validity of our patents and other proprietary rights
16. 16Developing, manufacturing and marketing pharmaceutical products for human use involves significant product liability risks for which we may have insufficient insurance coverage
17. 17If our partners do not achieve projected development, clinical, or regulatory goals in the timeframes publicly announced or otherwise expected, the commercialization of our partners products may be delayed and, as a result, our business, financial condition, and results of operations may be adversely affected
18. 18Future strategic corporate transactions could disrupt our business and impact our financial condition
19. 19Our effective tax rate may fluctuate, and we may incur obligations in tax jurisdictions in excess of accrued amounts

Risks Related To Ownership of Our Common Stock

1. 20The market price of our common stock is subject to significant volatility
2. 21Future transactions where we raise capital may negatively affect our stock price
3. 22Anti-takeover provisions in our charter documents, the convertible note indentures and Delaware law may make an acquisition of us more difficult

Risks Related to Our Industry

1. 23Our and our partnered products must receive regulatory approval before they can be sold, and compliance with the extensive government regulations is expensive and time consuming and may result in the delay or cancellation of our or our partnered product sales, introductions or modifications
2. 24Because some of our and our partners’ products and product candidates are considered to be drug/device combination products, the regulatory approval and post-approval requirements that we and they are required to comply with can be more complex38% rewritten
3. 25will be subject to additional FDA and constituent part reporting requirements. Compliance with these requirements will require additional effort and monetary expenditureNew
4. 26We may be required to initiate or defend against legal proceedings related to intellectual property rights, which may result in substantial expense, delay and/or cessation of certain development and commercialization of our products
5. 27We may incur significant liability if it is determined that we are promoting or have in the past promoted the “off-label” use of drugs or medical devices, or otherwise promoted or marketed approved products in a manner inconsistent with the FDA’s requirements67% rewritten
6. 28giving rise to such liability could also form the basis for private civil litigation by third-party payers or other persons allegedly harmed by such conductNew
7. 29If third-party reimbursement and customer contracts are not available, our proprietary and partnered products may not be accepted in the market resulting in commercial performance below that which was expected or projected
8. 30In the U.S., our business may be impacted by changes in federal reimbursement policy resulting from executive actions, federal regulations, or federal demonstration projects42% rewritten
9. 31We face competition and rapid technological change that could result in the development of products by others that are competitive with our proprietary and partnered products, including those under development57% rewritten

General Risks

1. 32If we are unable to attract, hire and retain key personnel our business could be negatively affected
2. 33Our operations might be interrupted by the occurrence of a natural disaster or other catastrophic event
3. 34Cyberattacks, security breaches or system breakdowns may disrupt our operations and harm our operating results and reputation
4. 35Violence, physical attacks or threats of violence directed toward company facilities or key company personnel may disrupt company operations and undermine investor confidence