Executive Summary

Q4 2024 EPS materially beat Wall Street: actual EPS of approximately -$0.30 vs consensus -$0.75; revenue modestly missed: ~$$15.12M vs ~$16.30M consensus. Bold beat on EPS and modest revenue miss suggest cost discipline and mix effects in the quarter [Values retrieved from S&P Global].
Quarter marked by strategic catalysts: FDA approvals for Emrosi (rosacea) and UNLOXCYT (cSCC), and Sun Pharma’s agreement to acquire Checkpoint (Fortress expects ~$28M at close plus a 2.5% royalty on UNLOXCYT) .
Balance sheet stable: cash and cash equivalents ended Q4 at $57.3M (vs $58.9M in Q3), with dermatology net product revenues of $55.1M for 2024 and consolidated net loss to common stockholders of $(55.9)M for the year .
Guidance/milestones updated: CUTX-101 (Menkes disease) NDA under priority review; PDUFA date revised to September 30, 2025 (from June 30, 2025 earlier), highlighting a longer review cycle but maintaining high-impact potential .

What Went Well and What Went Wrong

What Went Well

Two FDA approvals in Q4: Emrosi for inflammatory lesions of rosacea (launch underway with initial prescriptions filled) and UNLOXCYT for metastatic/locally advanced cSCC; management called Q4 “transformational” .
Monetization progress: Sun Pharma-Checkpoint transaction expected to deliver ~$28M at closing plus 2.5% UNLOXCYT net sales royalty and up to $4.8M if CVR milestones achieved, validating Fortress’s asset-creation and monetization model .
Cost rationalization across 2024: R&D and SG&A declined year-over-year, supporting improved annual loss metrics; consolidated R&D including licenses fell to $56.9M (from $106.1M) and SG&A to $87.7M (from $91.0M) .

Management quote: “The fourth quarter of 2024 was transformational for Fortress… We expect continued revenue growth, portfolio milestone achievements and additional future monetization opportunities…” — Lindsay A. Rosenwald, M.D., Chairman, President & CEO .

What Went Wrong

Full-year 2024 consolidated net revenue of $57.7M declined vs 2023 ($84.5M), reflecting lower dermatology revenue ($55.1M vs $59.7M) and fewer one-time items (2023 had larger other/collaboration revenues) .
Preference dividend paused in July 2024 (Series A cumulative redeemable perpetual preferred stock) to preserve flexibility; although cash-saving (~$0.7M/month), it may concern income-focused holders .
Estimate-related miss on revenue in Q4 vs consensus, which could raise questions about early Emrosi contribution and timing of broader portfolio revenue ramps [Values retrieved from S&P Global].

Financial Results

Quarterly Trend (USD; oldest → newest)

Metric	Q4 2023	Q2 2024	Q3 2024	Q4 2024
Revenue ($USD Millions)	$19.95*	$14.90*	$14.63*	$14.12*
Net Income ($USD Millions)	$(9.28)*	$(10.95)*	$(12.87)*	$(6.77)*
Diluted EPS ($USD)	$(1.05)*	$(0.73)*	$(0.76)*	$(0.37)*
Gross Margin (%)	58.1%*	-23.5%*	-0.7%*	19.5%*
EBITDA Margin (%)	9.6%*	-160.8%*	-144.5%*	-118.9%*
EBIT Margin (%)	6.5%*	-168.8%*	-151.0%*	-126.3%*
Total Operating Expenses ($USD Millions)	$36.42*	$40.04*	$36.72*	$34.22*
Cash & Equivalents ($USD Millions)	$80.93*	$76.20*	$58.85*	$57.26*

Note: Asterisk (*) denotes values retrieved from S&P Global.

Supporting reported annual figures:

FY 2024 consolidated net revenue: $57.7M; R&D including licenses: $56.9M; SG&A: $87.7M; consolidated net loss to common stockholders: $(55.9)M; cash & equivalents at 12/31/24: $57.3M .

Q4 2024 vs Estimates (USD)

Metric	Q4 2024 Consensus	Q4 2024 Actual	Surprise
EPS ($)	$(0.75)*	$(0.30)*	+$0.45 (Beat)*
Revenue ($USD Millions)	$16.30*	$15.12*	-$1.18 (Miss)*

Note: Values retrieved from S&P Global.

Segment and KPIs (where disclosed)

Journey Medical net product revenues: FY 2024 $55.1M (vs $59.7M FY 2023) .
Q3 2024 Journey net product revenues: $14.6M (equal to consolidated net revenue that quarter) .
Cash & equivalents at quarter-end: Q3 $58.9M; Q4 $57.3M .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
CUTX-101 NDA PDUFA date	FDA action	June 30, 2025	September 30, 2025	Extended timeline
Series A Preferred Dividend	Ongoing	Paying monthly (pre-July 2024)	Paused until further notice; accrues; ~$0.7M/month deferred	Paused
Debt Structure	Oaktree term loan	Prior $50M loan outstanding	New $35M tranche; eligible +$15M; ~$15M debt reduction (excl. interest/fees)	Refinanced; reduced outstanding debt

No formal numerical revenue or EPS guidance was provided in the Q4 materials .

Earnings Call Themes & Trends

Note: A Q4 2024 earnings call transcript was not available in our document set; themes reflect comparative press release narratives.

Topic	Previous Mentions (Q2 & Q3 2024)	Current Period (Q4 2024)	Trend
Regulatory milestones	DFD-29 NDA accepted (PDUFA 11/4/24); cosibelimab BLA resubmission (PDUFA 12/28/24)	Emrosi approved (rosacea); UNLOXCYT approved (cSCC); CUTX-101 NDA accepted for priority review	Strengthening regulatory momentum
Monetization/BD	Cosibelimab collaborations; Urica/Crystalys equity and royalty structure	Sun Pharma to acquire Checkpoint; Fortress expects ~$28M + 2.5% royalty + up to $4.8M CVR	Accelerated monetization
Dermatology commercial	Q2–Q3 dermatology revenues ~$14.9M and $14.6M; Emrosi pre-launch positioning	Emrosi launch underway; initial distribution/prescriptions	Early launch ramp
Capital allocation	Dividend pause; Oaktree refinancing	Continues; cash ended Q4 at $57.3M	Preserving flexibility
AI/technology	Not highlighted	Strategic AI collaboration with Partex to accelerate asset sourcing	New initiative

Management Commentary

“This transaction is also a successful milestone for Fortress as we expect to receive approximately $28 million at closing in addition to a 2.5% royalty on net sales of UNLOXCYT, and up to an additional $4.8 million if the contingent value right (CVR) is achieved.” — Lindsay A. Rosenwald, M.D. .
“We expect continued revenue growth, portfolio milestone achievements and additional future monetization opportunities given our significant pipeline of late clinical-stage candidates and recently approved products.” — Lindsay A. Rosenwald, M.D. .
“The fourth quarter of 2024 was transformational for Fortress, marked by two FDA approvals — Emrosi and UNLOXCYT — as well as the FDA’s recent acceptance of the New Drug Application for CUTX-101.” — Lindsay A. Rosenwald, M.D. .

Q&A Highlights

A Q4 2024 earnings call transcript was not identified in our document catalog; Q&A themes and clarifications are therefore unavailable from primary sources [ListDocuments returned no Q4 2024 transcript within Feb–Apr 2025].

Estimates Context

Q4 2024 EPS beat: actual approximately -$0.30 vs consensus -$0.75, suggesting lower-than-expected operating drag and/or mix benefits [Values retrieved from S&P Global].
Q4 2024 revenue miss: ~$15.12M vs ~$16.30M, indicating modest shortfall relative to expectations; early Emrosi launch conversion likely to be a focus in future quarters [Values retrieved from S&P Global].
Estimate implications: EPS revisions likely upward in near term given beat; revenue trajectory will hinge on Emrosi adoption and timing of other portfolio contributions [Values retrieved from S&P Global].

Key Takeaways for Investors

Fortress executed on high-impact catalysts: dual FDA approvals (Emrosi, UNLOXCYT) and CUTX-101 priority review acceptance; these diversify and derisk near-term pipeline value .
Monetization path is clearer: Sun Pharma-Checkpoint deal provides expected ~$28M near-term liquidity, royalty participation, and potential CVR upside—supports balance sheet and future optionality .
Cost discipline evident at the annual level (R&D and SG&A down YoY), aiding EPS upside vs consensus in Q4 .
Dividend pause and Oaktree refinancing indicate continued focus on liquidity and capital efficiency ahead of further milestones .
CUTX-101 PDUFA timeline extended to September 30, 2025; remains a significant optionality event with PRV potential retained by Cyprium .
Near-term trading catalyst: Emrosi launch ramp and Sun Pharma deal closing (expected Q2 2025) are likely stock drivers as investors calibrate revenue inflection and monetization proceeds .
Medium-term thesis: Fortress’s model of asset acquisition, development, and monetization plus royalties/dividends can compound value; execution on commercial uptake (Emrosi/Journey) and regulatory events (CUTX-101) will be critical .

Additional source notes:

Q3 2024 operating/financial details (for trend): consolidated net revenue $14.6M; cash $58.9M; net loss to common stockholders $(15.0)M; reflects dermatology-only revenue base that quarter .
FY 2024 totals: consolidated net revenue $57.7M; dermatology product revenue $55.1M; consolidated net loss to common stockholders $(55.9)M ($2.69/share); cash $57.3M at 12/31/24 .

Values retrieved from S&P Global where noted.

Fortress Biotech, Inc. (FBIO)·Q4 2024 Earnings Summary