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Item 1A. Risk Factors
For a discussion of potential risks and uncertainties related to us, see the information included in Part I, Item 1A, "Risk
Factors" of our 2024 10-K. There have been no material changes to the risk factors previously disclosed in our 2024 10-K,
except as noted below:
General economic factors, natural disasters or other unexpected events may adversely affect our business,
financial performance and results of operations.
Although we only operate in the United States, our business, financial performance and results of operations depend in
part on worldwide macroeconomic economic conditions and their impact on consumer spending. Recessionary economic
cycles, changing interest rates, volatile fuel and energy costs, inflation, levels of unemployment, conditions in the residential
real estate and mortgage markets, access to credit, consumer debt levels, tariffs, government spending freezes, unsettled
financial markets and other economic factors that may affect costs of manufacturing prescription medications, consumer
spending or buying habits could materially and adversely affect our customers, our consumers, and demand for our
offerings. Volatility in the financial markets and deterioration in economic conditions, increasing inflation or increasing
unemployment levels has also had and may continue to have a negative impact on consumer spending patterns. Changes
and uncertainty can, among other things, reduce or shift spending away from medical treatments, procedures and doctors
office visits.
In addition, negative national or global economic conditions have adversely affected the PBMs, partner pharmacies and
pharma manufacturers we contract with and their associated industry participants, financial performance, liquidity and
access to capital, and may continue to impact them. This may affect their ability to renew contracts with us on the same or
better terms, which could impact the competitiveness of the discounted prices we are able to offer our consumers. Trade
barriers, duties, tariffs, and retaliatory measures by the U.S. and other governments may impact the pharma manufacturers
we contract with by increasing their costs of business, which could cause them to decrease their marketing spend on our
offerings. All of these factors may be exacerbated by global financial conditions and other geopolitical factors, which could
harm our business, financial condition and results of operations.
Economic factors such as increased insurance and healthcare costs, commodity prices, tariffs, shipping costs, inflation,
higher costs of labor, and changes in or interpretations of other laws, regulations and taxes may also increase our costs and
make our offerings less competitive, increase general and administrative expenses, and otherwise adversely affect our
financial condition and results of operations.
Additionally, global public health crises, natural disasters, such as earthquakes and wildfires, and other adverse weather
and climate conditions, political crises, such as terrorist attacks, war and other political instability or other unexpected
events, could disrupt our operations, internet or mobile networks or the operations of PBMs and their pharmacy networks.
For example, our corporate headquarters and other facilities are located in California, which in the past has experienced
both severe earthquakes and wildfires. Certain of these events may become more frequent or intense as a result of climate
change or other environmental or social pressures. For more information, see our risk factor titled We are subject to a
series of risks related to climate change previously disclosed in our 2024 10-K. If any of these events occurs, , our business
could be adversely affected.
The impact of healthcare reform legislation and other proposed or future changes impacting the healthcare
industry and healthcare spending on us is currently unknown, but may adversely affect our business , financial
could ndition and results of operations.
Our revenue is dependent on the healthcare industry and could be adffected by changes in healthcare spending and
policy. The healthcare industry is subject to changing political, regulatory and other influences. The Affordable Care Act (the
ACA), enacted in March 2010, made major changes in how healthcare is deliversely affected.ed and reimbursed, and increased access
to health insurance benefits to the uninsured and underinsured population of the United States. The ACA, among other
things, increased the number of individuals with Medicaid and private insurance coverage, implemented reimbursement
policies that tie payment to quality, facilitated the creation of accountable care organizations that may use capitation and
other alternative payment methodologies, strengthened enforcement of fraud and abuse laws and encouraged the use of
information technology.
New and changing laws, regulations, executive orders and other governmental actions, particularly from the new
presidential administration, may also create uncertainty about how laws and regulations will be interpreted and applied.
Such changes can adversely affect our business by increasing our costs, reducing spending by our customers, limiting the
Companys ability to pursue or offer new offerings, and requiring changes to our business. Regulatory changes and other
actions that materially adversely affect our business may be announced with little or no advance notice and we may not be
able to effectively mitigate all adverse impacts from such measures. Differing interpretations of such legal obligations can
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expose us to significant fines, government investigations, litigation and reputational harm. If we are found to have violated
laws, regulations, or executive orders, it could materially adversely affect our business, reputation, results of operations and
financial condition.
In addition, recently there has been heightened governmental scrutiny of the manner in which pharma manufacturers
set prices for their marketed products, which has resulted in several U.S. congressional inquiries and proposed and enacted
federal and state legislation designed to, among other things, bring more transparency to medication pricing, reduce the cost
of prescription medications under government payor programs, and review the relationship between pricing and
manufacturer patient programs. For example, in August 2022, former President Biden signed the Inflation Reduction Act of
2022 (the IRA) into law. This statute marks the most significant action by Congress with respect to the pharmaceutical
industry since adoption of the ACA in 2010. Among other things, the IRA requires manufacturers of certain drugs to engage
in price negotiations with Medicare, with prices that can be negotiated subject to a cap; imposes rebates under Medicare
Part B and Medicare Part D to penalize price increases that outpace inflation (first due in 2023); redesigns the Medicare Part
D benefit (beginning in 2024); and replaces the Part D coverage gap discount program with a new manufacturer discounting
program (beginning in 2025). The Centers for Medicare Medicaid Services has published the negotiated prices for the
initial ten drugs, which will first be effective in 2026, and has published the list of the subsequent 15 drugs that will be subject
to negotiation. The IRA permits the Secretary of the Department of Health and Human Services ("HHS") to implement many
of these provisions through guidance, as opposed to regulation, for the initial years. HHS has and will continue to issue and
update guidance as these programs are implemented, although the drug price negotiation program is currently subject to
legal challenges. In addition, the IRA delayed the final rule removing safe harbor protection for price reductions given by
pharmaceutical manufacturers to plan sponsors under Part D, either directly or through PBMs, unless the price reduction is
required by law, until 2032. In July 2025, the government enacted the One Big Beautiful Bill Act (the OBBBA), which
included reforms to programs such as Medicaid and restrictions for certain groups to access the Affordable Care Act
Marketplace. These changes may result in an increase in the number of individuals who are unable to access health
insurance benefits and medical care, and their ability to receive prescriptions and certain prescribed medications. The
impact of the IRA and OBBBA on our business and the pharmaceutical industry cannot yet be fully determined but is likely to
be significant.
More recently, the current presidential administration has proposed the imposition of a 100% tariff on branded or
patented pharmaceutical product produced outside of the United States. Such tariff may increase costs to our customers
and decrease demand for pharmaceutical products and consequently our offerings, which could have a material adverse
effect on our business, financial condition and results of operations. Certain major drug producers and manufacturers are in
negotiations with the administration to receive relief from such tariff. As a result of these negotiations, certain manufacturers
have announced their participation in a new government sponsored direct-to-consumer platform called TrumpRx.gov,
designed to offer consumers discounts on their products and some specialty brands. Details regarding this government
sponsored platform, as well as any potential positive or negative impact on our business, offerings or results of operations,
are unclear at this time but may be significant.
Our ability to realize the benefits of opportunities that we elect to pursue, such as initiatives related to TrumpRx.gov,
may be limited, and we may be unable to fully achieve related business goals. At the same time, ongoing changes and shifts
in healthcare policy, or changes in applicable legal standards, may reduce or even eliminate opportunities we may wish to
pursue. As a result, any returns on our investment in developing these opportunities are uncertain and the failure to achieve
related business goals may adversely affect our financial condition and results of operations.
Congress has and is likely to continue to scrutinize key participants in the healthcare industry, including PBMs. A
number of bills have been introduced in Congress that would further regulate PBMs and impose additional requirements.
The Federal Trade Commission (the "FTC") has issued statements about PBMs and conducted a study of PBMs that
resulted in two published reports, which could motivate further actions by Congress with respect to PBM regulation. Any
findings in the report may motivate further actions by Congress with respect to PBM regulation. In September 2024, the FTC
filed an administrative complaint against the three largest PBMs and their affiliated group purchasing organizations alleging
that the PBMs engaged in anti-competitive and unfair practices that increased costs for insulin medication. It is unclear what
the results of this matter will be, and what impact this will have on the PBM industry and our business, financial condition
and results of operations. See our risk factor titled We are, and may become in the future, subject to various legal
proceedings and claims that arise in or outside the ordinary course of business, which may require significant management
time and attention, result in significant legal expenses and may result in unfavorable outcomes, which may have a material
adverse effect on our business, operating results and financial condition, and negatively affect the price of our Class A
common stock previously disclosed in our 2024 10-K.
Individual states in the United States have also increasingly passed legislation and implemented regulations designed
to control medication pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product
access, disclosure, transparency and reporting requirements to regulatory agencies regarding marketing costs and
discounts provided to patients, such as those provided through our prescription transactions offering and subscription
offerings, for prescription medications dispensed by pharmacies, and, in some cases, designed to encourage importation
from other countries and bulk purchasing. Some states have enacted legislation creating so-called prescription drug
affordability boards, which ultimately may attempt to impose price limits on certain drugs in these states. In addition, the
Supreme Court held in December 2020 in Rutledge v. Pharmaceutical Care Management that ERISA, a federal statute, did
not preempt an Arkansas state law that regulates PBM reimbursements to network pharmacies and other standards for
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PBMs reimbursements to network pharmacies. As a result of this holding, some states have passed, and other states may
pass similar legislation or may otherwise attempt to regulate PBMs, which could have impacts on the healthcare industry.
Further, we may see heightened regulatory scrutiny from state regulators related to our integrated savings programs,
particularly with respect to insurance laws. These regulatory requirements and related scrutiny may impose timing and
expense constraints on us or our industry partners that could adversely affect our partnerships or our operations.
We expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could
impact the amounts that federal and state governments and other third-party payors will pay for healthcare products and
services or require us to restructure our existing arrangements with PBMs and pharma manufacturers, any of which could
adversely affect our business, financial condition and results of operations.