||expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program;|
||new requirements under the federal Open Payments program and its implementing regulations;|
||a new requirement to annually report drug and biologic samples that manufacturers and distributors provide to physicians;|
||a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research; and|
||a special Medicare Part B payment rate for biosimilars that favors them over the reference biological product.|
legislative changes have been proposed and adopted since the ACA was enacted. These changes include aggregate reductions to Medicare
payments to providers of up to 2% per fiscal year, which went into effect in April 2013. In January 2013 the American Taxpayer
Relief Act of 2012 was signed into law, which, among other things, reduced Medicare payments to several types of providers and
increased the statute of limitations period for the government to recover overpayments to providers from three to five years. The
full impact on our business of the ACA and other new laws is uncertain but may result in additional reductions in Medicare and
other healthcare funding. In addition, with the new Administration and Congress, it is unclear whether there will be additional
administrative or legislative changes, including modification, repeal, or replacement of all, or certain provisions of, the ACA.
Nor is it clear whether other legislative changes will be adopted, if any, or how such changes would affect the demand for vonapanitase,
Governments outside the United States tend to impose strict
price controls, which may adversely affect our revenues, if any.
In international markets, reimbursement and
health care payment systems vary significantly by country, and many countries have instituted price ceilings on specific products
and therapies. In some countries, particularly the countries of the European Union, the pricing of prescription pharmaceuticals
is subject to governmental control. In these countries, pricing negotiations with governmental authorities can take considerable
time after the receipt of marketing approval for a product. To obtain coverage and reimbursement or pricing approval in some countries,
we may be required to conduct a clinical trial that compares the cost-effectiveness of our product candidate to other available
therapies. There can be no assurance that our products will be considered cost-effective by third-party payors, that an adequate
level of reimbursement will be available or that the third-party payors’ reimbursement policies will not adversely affect
our ability to sell our products profitably. If reimbursement of our products is unavailable or limited in scope or amount, or
if pricing is set at unsatisfactory levels, our business could be harmed, possibly materially.
Risks Related to Our Common Stock
We are an “emerging growth company” and as a result
of the reduced disclosure and governance requirements applicable to emerging growth companies, our Common Stock may be less attractive
We are an “emerging growth company,”
or EGC, as defined in the JOBS Act, and we intend to take advantage of certain exemptions from various reporting requirements that
are applicable to other public companies that are not EGCs, including: not being required to comply with the auditor attestation
requirements of Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic
reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation
and stockholder approval of any golden parachute payments not previously approved.
We may take advantage of these reporting exemptions
until we are no longer an EGC. We will remain an EGC until the earlier of (1) the last day of the fiscal year (a) following the
fifth anniversary of the completion of our IPO, (b) in which we have total annual gross revenue of at least $1 billion, or (c)
in which we are deemed to be a large accelerated filer, which means the market value of our Common Stock that is held by non-affiliates
exceeds $700 million as of the prior June 30th, and (2) the date on which we have issued more than $1 billion in non-convertible
debt during the prior three-year period.