Risk Factors Update Summary
- Plans to utilize external ABPS and PCI facilities for DAXXIFY® production, facing risks of facility damage or disruption.
- Introduced new pricing for DAXXIFY ®, generating $95.0 million in revenue since September 2022.
- Discussed risks related to manufacturing, including the need for reliable forecasting and sourcing of DAXXIFY ®.
- Changes in legislative and regulatory healthcare reforms could significantly affect reimbursement and business operations.
- Increased pricing pressures due to managed healthcare trends and legislative changes may impact product profitability.
- Added advance notice procedures for stockholders in bylaws to nominate directors at meetings.
- Lack of earthquake insurance and limited disaster recovery plans could lead to substantial expenses.
- Announced approval of DAXXIFY ® for cervical dystonia, the first therapeutics indication.
- Emphasized the need to obtain adequate and timely supply of DAXXIFY ® and RHA ® Collection of dermal fillers.
- Announced a plan to exit the Fintech Platform business to reallocate capital.
- Increased scrutiny on compliance with anti-bribery laws and regulations, impacting business operations and reputation.
- Delays in clinical trials and uncertainty in achieving regulatory objectives may impact financial results.
- Limited experience in commercializing therapeutics products, particularly DAXXIFY ® for cervical dystonia.
- Highlighted the importance of establishing and maintaining relationships with injectors and HCPs.
- Specified requirements for stockholder nominations under Rule 14a-19(b) under the Exchange Act.
- Failure to comply with data privacy laws may result in significant liability and harm business reputation.
- Provisions may discourage potential acquirers from soliciting proxies or attempting control of the company.
Full Text Changes in Most Recent 10-K
Intended use: review the highlighted statements. These are additions to the risk factors disclosure in the most recent 10-K filing compared to the previous 10-K filing. Deleted and moved text is less important and is shown for context.
To view the full company filings, click on the following link to be taken to the SEC EDGAR database landing page for the company: https://www.sec.gov/edgar/browse/?CIK=1479290&owner=exclude
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