We also expect that the Affordable Care Act, as well as other healthcare reform measures
that have and may be adopted in the future, may result in more rigorous coverage criteria and additional downward pressure on the price that we receive for DEXYCU and YUTIQ in the U.S., and could seriously harm our future revenues. Any reduction in
reimbursement from Medicare, Medicaid, or other government programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to
generate revenues, attain profitability or successfully commercialize DEXYCU and YUTIQ in the U.S.
Patient assistance programs for pharmaceutical
products have come under increasing scrutiny by governments, legislative bodies and enforcement agencies. These activities may result in actions that have the effect of reducing prices or demand for our products, harming our business or reputation,
or subjecting us to fines or penalties.
Recently, there has been enhanced scrutiny of company-sponsored patient assistance
programs, including insurance premium and copay assistance programs and manufacturers donations to third-party charities that provide such assistance. If we, our vendors or donation recipients, are deemed to have failed to comply with relevant
laws, regulations or government guidance in any of these areas, we could be subject to criminal and civil sanctions, including significant fines, civil monetary penalties and exclusion from participation in government healthcare programs, including
Medicare and Medicaid, and burdensome remediation measures. Actions could also be brought against executives overseeing our business or other employees.
It is possible that any actions taken by the Department of Justice (DOJ) as a result of this industry-wide inquiry could reduce demand for our
products and/or reduce coverage of our products, including by federal health care programs such as Medicare and Medicaid and state health care programs. If any or all of these events occur, our business, prospects and stock price could be materially
and adversely affected.
If competitive products are more effective, have fewer side effects, are more effectively marketed and/or cost less than
our products or product candidates, or receive regulatory approval or reach the market earlier, our product candidates may not be approved, and our products or product candidates may not achieve the sales we anticipate and could be rendered
noncompetitive or obsolete.
We believe that pharmaceutical, drug delivery and biotechnology companies, research organizations,
governmental entities, universities, hospitals, other nonprofit organizations and individual scientists are seeking to develop drugs, therapies, products, approaches or methods to treat our targeted diseases or their underlying causes. For our
targeted diseases, competitors have alternate therapies that are already commercialized or are in various stages of development, ranging from discovery to advanced clinical trials. Any of these drugs, therapies, products, approaches or methods may
receive government approval or gain market acceptance more rapidly than our products and product candidates, may offer therapeutic or cost advantages, or may more effectively treat our targeted diseases or their underlying causes, which could result
in our product candidates not being approved, reduce demand for our products and product candidates or render them noncompetitive or obsolete.
Many of our competitors and potential competitors have substantially greater financial, technological, research and development, marketing and
personnel resources than we do. Our competitors may succeed in developing alternate technologies and products that, in comparison to the products or product candidates we have and are seeking to develop:
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are more effective and easier to use;
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have fewer side effects;
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offer other benefits; or
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may otherwise render our products less competitive or obsolete.
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Many of these competitors have greater experience in developing products, conducting clinical trials, obtaining regulatory approvals or
clearances and manufacturing and marketing products than we do.
Guidelines, recommendations and studies published by various organizations could
reduce the use of our products and potential use of product candidates.
Government agencies, professional societies, practice
management groups, private health and science foundations and organizations focused on various diseases may publish guidelines, recommendations or studies that affect our or our competitors products and product candidates. Any such guidelines,
recommendations or studies that reflect negatively on our products or product candidates, either directly or relative to our competitive products, could result in current or potential decreased use, sales of, and revenues from one or more of our
products and product candidates. Furthermore, our success depends in part on our and our partners ability to educate healthcare providers and patients about our products and product candidates, and these education efforts could be rendered
ineffective by, among other things, third-parties guidelines, recommendations or studies.
The increasing use of social media platforms
presents new risks and challenges.
Social media is increasingly being used to communicate about our products and the diseases our
therapies are designed to treat. Social media practices in the biopharmaceutical industry continue to evolve and regulations relating to such use are not always clear. This evolution creates uncertainty and risk of noncompliance with regulations
applicable to our business. For example, patients may use social media channels to comment on the effectiveness of a product or to report an alleged adverse event. When such disclosures occur, there is a risk that we fail to monitor and comply with
applicable adverse event reporting obligations or we may not be able to defend the company or the publics legitimate interests in the face of the political and market pressures generated by social media due to restrictions on what we may say
about our products. There is also a risk of inappropriate disclosure of sensitive information or negative or inaccurate posts or comments about us on any social networking website. If any of these events were to occur or we otherwise fail to comply
with applicable regulations, we could incur liability, face overly restrictive regulatory actions or incur other harm to our business.
The
micro-insert for ILUVIEN and YUTIQ delivers FA, a corticosteroid that is associated with certain adverse side effects in the eye, which may affect the success of this micro-insert for treatment of DME and NIPU.
The micro-insert for both ILUVIEN and YUTIQ delivers the
non-proprietary
corticosteroid FA, which is
associated with cataract formation and elevated IOP and may increase the risk of glaucoma and related surgery to manage those side effects. These side effects shown in the Phase 3 trials for ILUVIEN resulted in limitations to the approved
indications of ILUVIEN, and sales of ILUVIEN may be adversely affected by the potential side effects
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