Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 115

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 115
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from a government or other third-party payor is a time-consuming and costly process that could require Tvardi to provide to each payor
supporting scientific, clinical and cost-effectiveness data for the use of Tvardi products on a payor-by-payor basis, with no assurance
that coverage and adequate reimbursement will be obtained. Even if Tvardi obtains coverage for a given product, the resulting reimbursement
payment rates might not be adequate for it to achieve or sustain profitability or may require co-payments that patients find unacceptably
high. Additionally, third-party payors may not cover, or provide adequate reimbursement for, long-term follow-up evaluations required
following the use of product candidates, once approved. It is difficult to predict at this time what third-party payors will decide with
respect to the coverage and reimbursement for Tvardi’s product candidates, if approved.

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Table of Contents

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A primary trend in the United States and European
healthcare industries is toward cost containment, as legislative bodies, government authorities, third-party payors, and others have attempted
to control costs by limiting coverage, pricing and the amount of reimbursement available for certain treatments. Such third-party payors,
including Medicare, may question the coverage of, and challenge or seek to lower the prices charged for medical products, and many third-party
payors limit coverage and reimbursement for newly approved health care products. Moreover, reimbursement, if available, may vary according
to the use of the product and the clinical setting in which it is used, may be based on reimbursement levels already set for lower cost
products and may be incorporated into existing payments for other services. Net prices for products may be reduced by mandatory discounts
or rebates required by government healthcare programs or private payors or by future laws, regulations or guidance seeking to limit prescription
drug prices. Further, coverage policies and third-party reimbursement rates may change at any time. Even if favorable coverage and reimbursement
status is attained for one or more products for which Tvardi receives regulatory approval, less favorable coverage policies and reimbursement
rates may be implemented in the future. If Tvardi is unable to promptly obtain coverage and adequate reimbursement rates from both government-funded
and private payors for any approved products that Tvardi develops, or if net prices are reduced by mandatory discounts or rebates, there
could be a material adverse effect on Tvardi’s operating results, its ability to raise capital needed to commercialize products
and overall