Company: RDPTF
Filing Date: 2025-09-18
Form Type: 20-F
Source: 0001213900-25-088699
Chunk: 79

Company: Radiopharm Theranostics Ltd
Filing Date: 2025-09-18
Form: 20-F
Item: Item 3
Chunk 79
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 A separate application will, however, still be required.

Australia

In Australia, the relevant
regulatory body responsible for the pharmaceutical industry is the Therapeutics Goods Administration, or TGA. As with the EMA and FDA
there is a harmonization and collaboration between regulatory authorities. The TGA requires notification of all clinical trials via an
electronic submission of a Clinical Trial Notification (CTN) prior to commencing the clinical trial.

Third-Party Payer Coverage and Reimbursement

Although our drug candidates
have not been commercialized for any indication, if they are approved for marketing, commercial success of our drug candidates will depend,
in part, upon the availability of coverage and reimbursement from third party payers at the federal, state and private levels.

In the United States and internationally,
sales of any product that we market in the future, and our ability to generate revenues on such sales, are dependent, in significant part,
on the availability of adequate coverage and reimbursement from third party payors, such as state and federal governments, managed care
providers and private insurance plans.

Private insurers, such as
health maintenance organizations and managed care providers, have implemented cost-cutting and reimbursement initiatives and likely will
continue to do so in the future. These include establishing formularies that govern the drugs and biologics that will be offered and the
out-of-pocket obligations of member patients for such products. We may need to conduct pharmacoeconomic studies to demonstrate the cost-effectiveness
of our drug candidates for formulary coverage and reimbursement. Even with such studies, our drug candidates may be considered less safe,
less effective or less cost-effective than existing products, and third-party payors may not provide coverage and reimbursement for our
drug candidates, in whole or in part. In addition, particularly in the United States and increasingly in other countries, we are required
to provide discounts and pay rebates to state and federal governments and agencies in connection with purchases of our drug candidates
that are reimbursed by such entities. It is possible that future legislation in the United States and other jurisdictions could be enacted
to potentially impact reimbursement rates for the drug candidates we are developing and may develop in the future and could further impact
the levels of discounts and rebates paid to federal and state government entities. Any legislation that impacts these areas could impact,
in a significant way, our ability to generate revenues from sales of drug candidates that, if successfully developed, we bring to market.
Political, economic and regulatory influences are subjecting the healthcare industry in the