What changed in this filing

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Item 1A. Risk Factors

2023-11-13 compared with 2023-08-09 · 42 added, 0 removed, 9 unchanged (82% of the section changed)

5 unchanged sentences

Additional risks and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations.

sales depend on coverage and reimbursement from government and commercial third-party payers, and pricing and reimbursement pressures

have affected, and are likely to continue to affect, our profitability.

of our branded products depend on the availability and extent of coverage and reimbursement from third-party payers, including government

healthcare programs and private insurance plans.

Governments and private payors continue to pursue initiatives to manage drug utilization

and contain costs.

Further, pressures on healthcare budgets from the pandemic, the economic downturn and inflation continue and are likely

to increase across the markets we serve.

Payors are increasingly focused on costs, which have resulted, and are expected to continue

to result, in lower reimbursement rates for our branded products or narrower populations for which payors will reimburse.

Continued intense

public scrutiny of the price of drugs and other healthcare costs, together with payor dynamics, have limited, and are likely to continue

to limit, our ability to set or adjust the price of our products based on their value, which can have a material adverse effect on our

In the United States, particularly over the past few years, several legislative and regulatory proposals have been introduced

and/or signed into law that attempt to lower drug prices.

These include legislation promulgated by the IRA that enables the U.S.

to set prices for certain drugs in Medicare, redesigns Medicare Part D benefits to shift a greater portion of the costs to manufacturers,

and enables the U.S.

government to impose penalties if drug prices are increased at a rate faster than inflation in addition to rebates

imposed on manufacturers associated with drug waste (which could potentially impact sales of TRIESENCE).

Additional proposals focused

on drug pricing continue to be debated, and additional executive orders focused on drug pricing and competition are likely to be adopted

and implemented in some form.

Government actions or ballot initiatives at the state level also represent a highly active area of policymaking

and experimentation, including pursuing proposals that limit drug reimbursement under state-run Medicaid programs based on reference

prices or permitting importation of drugs from Canada.

Such state policies may also eventually be adopted at the federal level.

despite IHEEZO being issued a J-Code for physician-office billing, CMS has an existing policy on anesthesia billing which has historically

not allowed for the separate billing of anesthesia services in the physician’s office, which could be viewed in conflict with IHEEZO’s

reimbursement status for in-office applications.

Because our application for a J-Code for IHEEZO specifically disclosed the likely significant

utilization of IHEEZO in the physician’s office setting of care, along with additional communications to this effect, we intend

to request that CMS clarify that J-Code 2403, IHEEZO’s permanent J-Code is appropriate to be billed for the anesthesia itself (i.e.,

IHEEZO in our case) in the physician’s office setting.

If CMS disagrees with our position, it is possible the separate reimbursement

of IHEEZO would be limited to the surgical setting only (e.g., ASCs).

cannot predict which or how many policy, regulatory, administrative, or legislative changes may ultimately be or effectively estimate

the consequences to our business if, enacted and implemented.

However, to the extent that payer actions further decrease or modify the

coverage or reimbursement available for our products require that we pay increased rebates or shift other costs to us, limit or affect

our decisions regarding the pricing of or otherwise reduce the use of our products, such actions could have a material adverse effect

on our business and results of operations.

Unregistered Sales of Equity Securities and Use of Proceeds

2 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1A. Risk Factors