Company: VMCWF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001827
Chunk: 226

Company: Valuence Merger Corp. I
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 226
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 stages of development are key
concerns when considering pharmaceutical companies as most studies show that a drug development program’s probability of success
from Phase I trials to U.S. FDA approval was only 9.6% as of the time of our IPO, based on a study from BIO. Any potential regulatory
or policy changes can impact such success rates to even lower probabilities. Failure to obtain governmental approval of a key drug or
device or other regulatory action could have a material adverse effect on the business of a target company. Such changes may impact the
demand for or costs of certain products and services as changes may delay the introduction of these products and services to the marketplace,
resulting in increased development costs, delayed cost recovery and loss of competitive advantage to the extent that rival companies
have developed competing products or procedures, adversely affecting the company’s revenues and profitability. These types of risks
are unique to each company but typically found across most life science focused companies. Other risks can involve other areas of regulatory
compliance such as monitoring drug safety even after approval. Finally, expansion of facilities by healthcare related providers is subject
to “determinations of need” by the appropriate government authorities. This process not only increases the time and cost
involved in these expansions, but also makes expansion plans uncertain, limiting the revenue and profitability growth potential of healthcare
related facilities operators There also exists potential regulatory risk due to changes to laws, regulations or interpretations that
can cause compliance costs or cause disruptions to companies’ productivity as a business. Overall, these firms are exposed to greater
financial risk than other industries and can also be sensitive to policy changes that could potentially affect industry-wide profitability.
These risks are considered systematic as policy changes can impact industry-wide R&D spending or go-to-market strategies as well
as impact cash flow and product sales. For instance, as of the time of our IPO, governmental budgets across developing countries came
under pressure to reduce spending and control healthcare costs, which could both adversely affect regulatory processes and public funding
available for healthcare products, services and facilities. These healthcare reforms may institute regulatory mandates and other measures
designed to constrain medical costs, including coverage and reimbursement for healthcare services, drugs, or devices. Potential regulatory
changes include drug price caps or access and healthcare cost transparency, all of which can potentially become a risk to profitability
for these companies. The ultimate effects of healthcare reform or any future legislation, regulation, or healthcare initiatives, if any,
on the healthcare sector, whether implemented at the federal or state level or