Operational UncertaintyNear-term uncertainty exists due to a manufacturing pause on the key revenue-driving asset EGRIFTA SV and uncertainty regarding the expansion of the company's pipeline/portfolio.
Regulatory ChallengesThere will be a delay in the adoption of the new EGRIFTA WR formulation by payors, meaning the full impact is unlikely to be realized soon.
Revenue ChallengesThe shortage resulted in an expected $10M — $12M one-time reduction in revenue, and weaker sales are anticipated in the short term.