Risk Factors Update Summary
- Recently obtained FDA approval for XDEMVY for Demodex blepharitis treatment in July 2023.
- Significant compliance costs may be incurred for implementing lawful transfer mechanisms and conducting data transfer impact assessments.
- Capital requirements are unpredictable and may change, requiring substantial additional funding. This could force delays or reductions in product development.
- Failure to obtain necessary capital could result in delays, reductions, or eliminations of product development.
- Expenses are expected to substantially increase, necessitating a larger amount of capital for commercialization efforts.
- Potential changes in regulatory environment and enforcement rules could impact commercialization efforts.
- An adequacy decision by the European Commission concluded that the U.S. ensures an adequate level of protection.
- Net losses increased from $62.1 million in 2022 to $135.9 million in 2023.
- Expect to incur substantial resources in commercialization efforts for XDEMVY and other product candidates.
- Anticipate increasing operating losses until revenue from XDEMVY exceeds expenses.
- Draw of $5.0 million made on March 15, 2023, and September 15, 2023, respectively.
- The European Commission approved the EU Standard Contractual Clauses in 2021.
- Sales of common stock in IPO and Follow-On Public Offerings raised $74.5 million and $99.3 million, respectively.
- Accumulated deficit increased from $108.8 million in 2022 to $244.7 million in 2023.
- Credit Facility aggregate principal amount reduced from $135.0 million to $125.0 million.
- The European Data Protection Board issued guidance on international data transfers.
- Initiated sales and marketing activities for XDEMVY in August 2023.
- Positive topline results announced for TP-03 for potential treatment of MGD in December 2023.
- The UK Information Commissioner's Office issued guidance on risk assessments for international transfers.
- The European Data Protection Board guidance involves conducting transfer impact assessments and analyzing data access laws.
- International transfer mechanisms, including the International Data Transfer Agreement, have been approved.
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=1819790&owner=exclude
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