Fortress Biotech, Inc. Q4 FY2024 earnings call

• 2024 was pivotal: Delivered on guidance, launched Emrosi, submitted Emrosi NDA, received FDA approval in Nov 2024. Balance sheet strong with $20.3M cash. - Emrosi clinical data presented at key medical congresses. Cutia's Amzeeq approval in China triggered $1M milestone. - 2025 started strong: Successful exhibit at 2025 AAD Conference, national sales meeting upcoming, prepped for Emrosi launch with launch quantities in place. - Emrosi seen as transformational, potential peak sales $200M US and $100M international, leveraging current dermatology commercial model.

In 2024, total net product revenue was $55.1 million, down from $59.7 million in 2023. Total revenues were $56.1 million, including a $1 million milestone from Cutia for Amzeeq's China market authorization. Cost of goods sold decreased by $2 million to $20.9 million. R&D expenses increased to $9.9 million due to NDA filing fees and milestones for Emrosi. SG&A expenses decreased by $3.7 million to $40.2 million. Net loss was $14.7 million. Non-GAAP adjusted EBITDA was $800,000. Revenue contribution: Product sales were the main component, with the Cutia milestone adding $1 million to total revenues.

• 2025 guidance to be provided later in the year after assessing Emrosi launch, prescription demand, and payer negotiations. - Q1 not expected to have meaningful Emrosi revenues, with Q2 expected to start seeing meaningful revenues from Emrosi.

Q: On payer coverage, what to expect by end of 2025?

A: Goal is to obtain covered lives, peak commercial coverage expected 12-18 months. Market access team working on commercial and Medicare coverage, peak coverage 12-18 months post launch.

Q: Should we expect reported revenues in Q1?

A: Q1 not expected to have much, Q2 expected to start seeing meaningful revenues from Emrosi.

Q: Thoughts on pricing across legacy portfolio in 2025?

A: Legacy brands like Exelderm and Targadox: Exelderm margins improved as royalties ended; Targadox has script volume erosion due to generics. Core products' net pricing expected to remain steady.

Q: Milestones for Emrosi launch to track?

A: Mainly reimbursement and getting in formularies. Supply and distribution in good shape; progress expected on formulary coverage over 12-18 months.

Q: Step edits and payer responses for Emrosi?

A: Payer step edits primarily through generic oral agents like minocycline or doxycycline. Payer response positive with some unrestricted access.