Company: NCNA
Filing Date: 2025-03-20
Form Type: 20-F
Source: 0000950170-25-042709
Chunk: 50

Company: NuCana plc
Filing Date: 2025-03-20
Form: 20-F
Item: Item 3
Chunk 50
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. Obtaining foreign marketing approvals and compliance with foreign regulatory requirements could result in significant delays, difficulties and costs for us and could delay or prevent the introduction of our products in certain countries. If we fail to comply with the regulatory requirements in international markets or receive applicable marketing approvals, our target market will be reduced and our ability to realize the full market potential of our product candidates will be harmed.
 •We may not be able to file for marketing approvals and may not receive necessary approvals to commercialize our products in any market. If we obtain approval of our product candidates and ultimately commercialize our product candidates in foreign markets, we would be subject to additional risks and uncertainties, including:
 •our customers’ ability to obtain reimbursement for our product candidates in foreign markets;
 •our inability to directly control commercial activities because we are relying on third parties;
 •the burden of complying with complex and changing foreign regulatory, tax, accounting and legal requirements;
 •different medical practices and customs in foreign countries affecting acceptance in the marketplace;
 •import or export licensing requirements;
 •longer accounts receivable collection times;
 •longer lead times for shipping;
 •language barriers for technical training;
 •reduced or no protection on pharmaceutical products or their use in some foreign countries;
 •the unwillingness of courts in some foreign jurisdictions to enforce patents even when valid and infringed in that country;
 •the possibility of pre-grant or post-grant review proceedings in certain foreign countries that allow a petitioner to hold up patent rights for an extended period or permanently by challenging the patent filing at the patent office of that country;
 •the possibility of a compulsory license issued by a foreign country that allows a third-party entity or a government to manufacture, use or sell our products with a government-set low royalty to us;
 •the existence of additional potentially relevant third-party intellectual property rights;
 •foreign currency exchange rate fluctuations;
 •an increase in restrictions on trade or other protectionist measures; and
 •the interpretation of contractual provisions governed by foreign laws in the event of a contract dispute.
 Foreign sales of our product candidates could also be adversely affected by the imposition of governmental controls, political and economic instability, trade restrictions and changes in tariffs.
 Governments outside the United States tend to impose strict price controls, which may adversely affect our revenues, if any.
 In some countries, particularly the countries of the European Union, the pricing of prescription pharmaceuticals is subject to governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a product. To obtain reimbursement or pricing