Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 43

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 43
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and to control the prices of medicinal products for human use. European Union member states may approve a specific price for a
product or may instead adopt a system of direct or indirect controls on the profitability of the company placing the product on
the market. Other member states allow companies to fix their own prices for products but monitor and control prescription volumes
and issue guidance to physicians to limit prescriptions. Recently, many countries in the European Union have increased the amount
of discounts required on pharmaceuticals and these efforts could continue as countries attempt to manage healthcare expenditures,
especially in light of the severe fiscal and debt crises experienced by many countries in the European Union. The downward pressure
on healthcare costs in general, particularly prescription products, has become intense. As a result, increasingly high barriers
are being erected to the entry of new products. Political, economic and regulatory developments may further complicate pricing
negotiations, and pricing negotiations may continue after reimbursement has been obtained. Reference pricing used by various European
Union member states, and parallel trade, in other words, arbitrage between low- priced and high-priced member states, can further
reduce prices. There can be no assurance that any country that has price controls or reimbursement limitations for pharmaceutical
products will allow favorable reimbursement and pricing arrangements for any products, if approved in those countries.

Government
Regulation of Data Collection Outside of the United States

In
the event we conduct clinical trials in the European Union, we will be subject to additional privacy restrictions. The collection
and use of personal health data in the EEA is governed by the General Data Protection Regulation (the “GDPR”), which
became effective on May 25, 2018. The GDPR applies to the processing of personal data by any company established in the EEA and
to companies established outside the EEA to the extent they process personal data in connection with the offering of goods or
services to data subjects in the EEA or the monitoring of the behavior of data subjects in the EEA. The GDPR enhances data protection
obligations for data controllers of personal data, including stringent requirements relating to the consent of data subjects,
expanded disclosures about how personal data is used, enhanced requirements for securing personal data, requirements to conduct
privacy impact assessments for “high risk” processing, limitations on retention of personal data, mandatory data breach
notification and “privacy by design” requirements, and creates direct obligations on service providers acting as processors.
The GDPR also imposes strict rules on the transfer of personal data outside of the EEA to