Fortress Biotech, Inc. (FBIO) Q4 2024 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
The earnings call highlights several negative aspects: increased net loss, declining revenues, and reduced EBITDA. Regulatory and market competition risks are significant, with only 20% payer coverage for Emrosi. The Q&A reveals management's reluctance to provide clear guidance, which could worry investors. Despite some cost optimizations, the financial outlook remains weak, and the lack of guidance suggests uncertainty. These factors outweigh any positive aspects like potential sales growth, leading to a negative sentiment.
Key Financial Performance
Total Net Product Revenue $55.1 million (decrease of $4.6 million or 7.7% year-over-year) due to higher rebate costs and lower unit volumes from legacy products.
Total Revenues $56.1 million (decrease of $22.9 million or 29% year-over-year) includes a $1 million milestone payment; prior year included a $19 million upfront licensing payment.
Cost of Goods Sold $20.9 million (decrease of $2 million or 9% year-over-year) due to decreased product royalties and discontinuation of Ximino.
Research and Development Expenses $9.9 million (increase of $2.3 million or 30% year-over-year) driven by non-recurring payments related to Emrosi NDA filing and milestone payments.
SG&A Expenses $40.2 million (decrease of $3.7 million or 8% year-over-year) due to the realization of expense optimization efforts completed in 2023.
Net Loss to Common Shareholders $14.7 million (increase of $10.8 million year-over-year) compared to a net loss of $3.9 million in 2023, which included significant licensing revenue.
Non-GAAP Adjusted EBITDA $800,000 (decrease of $14.8 million year-over-year) compared to $15.6 million in 2023, which included substantial licensing revenue.
Cash and Cash Equivalents $20.3 million (decrease of $7.1 million year-over-year) compared to $27.4 million at December 31, 2023.
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Operating Highlights
New Product Launch: Emrosi, a best-in-class oral treatment for Rosacea, is set for commercial debut following FDA approval.
Market Opportunity: Emrosi enters a $1 billion plus treatment category with superior Phase 3 clinical results.
Sales Projections: Emrosi is projected to achieve peak annual sales of $200 million in the U.S. and $100 million internationally.
Market Access: Coverage for Emrosi has increased to approximately 20% of commercial lives and 4% of Medicare lives.
Payer Coverage: Expectations for substantial increase in payer coverage throughout 2025.
Operational Efficiency: Achieved positive non-GAAP adjusted EBITDA for six consecutive quarters.
Cost Management: SG&A expenses decreased by 8% due to expense optimization efforts.
Strategic Shift: Focus on leveraging existing dermatology commercial model for Emrosi without expanding the sales force.
Business Development: Potential for licensing commercial rights outside the U.S. to enhance shareholder value.
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Risk or Challenges
Regulatory Risks: The company has incurred significant costs related to FDA filing fees and milestone payments, totaling $22 million, which could impact financial stability if future regulatory approvals are delayed or denied.
Market Competition: Emrosi is entering a competitive market valued at over $1 billion, which poses risks related to market share and pricing pressures from existing treatments.
Financial Performance: The company reported a net loss of $14.7 million in 2024, a significant increase from the previous year's loss of $3.9 million, indicating potential financial instability.
Supply Chain Challenges: The company is in the process of shipping Emrosi inventory into the distribution channel, which may face delays or issues that could affect the product launch.
Payer Coverage: Currently, only 20% of commercial lives have coverage for Emrosi, which may limit initial sales and revenue generation, with expectations for gradual improvement.
Economic Factors: The overall economic environment and healthcare spending trends could impact the adoption of Emrosi and the company's financial performance.
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Guidance & Outlook
Emrosi Launch: Emrosi, a best-in-class oral treatment for Rosacea, is set for commercial debut in early April 2025, with significant interest from dermatologists observed at the AAD Conference.
Market Opportunity: Emrosi is entering a $1 billion plus treatment category, with expectations of peak annual sales of $200 million in the U.S. and $100 million internationally.
Payer Coverage: Coverage for Emrosi has increased to approximately 20% of commercial lives and 4% of Medicare lives, with expectations for substantial growth throughout 2025.
Clinical Publications: Two additional peer-reviewed publications on Emrosi are anticipated in 2025, which will further enhance awareness and credibility.
Sales Force Utilization: Emrosi fits directly into the current dermatology commercial model, eliminating the need for additional sales force.
2025 Financial Guidance: 2025 financial guidance will be provided later in the year after assessing initial Emrosi prescription demand and payer negotiations.
Revenue Expectations: Expectations for Emrosi to generate significant operating leverage and contribute to sustainable positive EBITDA and profitability.
Cash Position: As of December 31, 2024, Journey Medical had $20.3 million in cash, down from $27.4 million in 2023.
Net Loss: Net loss for 2024 was $14.7 million, compared to $3.9 million in 2023.
Adjusted EBITDA: Non-GAAP adjusted EBITDA for 2024 was positive $800,000, down from $15.6 million in 2023.
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Shareholder Return Plan
Total Net Product Revenue 2024: $55.1 million
Total Revenues 2024: $56.1 million (including a $1 million milestone payment)
Net Loss to Common Shareholders 2024: $14.7 million, or $0.72 per share
Non-GAAP Adjusted EBITDA 2024: $800,000, or $0.04 per share
Cash and Cash Equivalents as of December 31, 2024: $20.3 million
Estimated Peak Annual Sales for Emrosi in the U.S.: $200 million
Estimated Peak Annual Sales for Emrosi Internationally: $100 million
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Key Q&A
Q:What do you think we should be expecting as you exit 2025 regarding payer coverage?
A:Our goal is to obtain as many covered lives as possible. The expectation to peak commercial coverage should take anywhere from 12 to 18 months.
Q:How important did KOLs view the erythema data, and what are you doing to disseminate that data?
A:The head-to-head performance is capturing interest more than the erythema data. We have published data in JAMA Dermatology, which will help disseminate the information.
Q:Do you have any thoughts on 2025 guidance?
A:Give us a few more months. We're focusing on the 2024 launch of Emrosi before providing guidance.
Q:Has the reimbursement environment been in line with expectations?
A:It's too early to tell, but we are seeing some coverage happening, around the 20% mark for adoption on formularies.
Q:Is there a step down in fourth quarter '24 that we should think about continuing into 2025?
A:The base business has been steady, but we have some legacy brands that continue to erode.
Q:How do you think about pricing across the portfolio in 2025?
A:Pricing for legacy brands is expected to hold steady, with some erosion in volume due to competition.
Q:What are the main bottlenecks for the Emrosi launch?
A:Supply and getting formulary coverage are the main areas to focus on.
Q:What is the peak coverage percentage expected for Emrosi?
A:We are not ready to give a specific number for peak coverage at this time.
Q:Has there been any pricing move by Galderma for their brand name Oracea since your launch?
A:We have not seen any market movement in terms of pricing since our launch.
Q:Review of Unclear Management Responses
A:Management avoided giving a specific peak coverage percentage for Emrosi and did not provide clarity on 2025 guidance.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
AAD
Chief
Co Founder
Conference
Corporate
Cutia
Dermatology
Director
Dr
FDA
Form
Founder President
Medical
Phase result
SGA
afternoon
approval
attendee
cash
coverage
decrease
dermatology
drug
exhibit
head
information
launch
life
loss
market
milestone payment
patient
payer
product
publication
release
rosacea
royalty
sale
share
statement
today
FBIO Transcript
Fortress Biotech, Inc. (FBIO) Q3 2025 Earnings Call Transcript
Positive11-12
The earnings call reveals positive indicators: improved EBITDA, increased cash reserves, and strong EMROSI growth. The Q&A highlights optimistic future prospects with expanding prescriber base and increasing reimbursements. Despite some uncertainties, such as lack of specific guidance and retention rates, the overall sentiment is positive, driven by EMROSI's successful launch and expected revenue growth. The lack of market cap information limits precise prediction, but given the strong product performance and financial health, a positive stock price movement of 2% to 8% is anticipated.
Fortress Biotech, Inc. (FBIO) Q4 2024 Earnings Call Transcript
Unknown3-26
The earnings call highlights several negative aspects: increased net loss, declining revenues, and reduced EBITDA. Regulatory and market competition risks are significant, with only 20% payer coverage for Emrosi. The Q&A reveals management's reluctance to provide clear guidance, which could worry investors. Despite some cost optimizations, the financial outlook remains weak, and the lack of guidance suggests uncertainty. These factors outweigh any positive aspects like potential sales growth, leading to a negative sentiment.
Fortress Biotech, Inc. (FBIO) Q4 2024 Earnings Call Transcript
Unknown3-26
The earnings call reveals significant challenges: a substantial net loss, decreased revenues, and limited payer coverage for Emrosi. Regulatory risks and supply chain issues further exacerbate concerns. Management's vague responses in the Q&A section and absence of guidance contribute to uncertainty. While there is potential in Emrosi's market, the current financial instability and competitive pressures overshadow optimism, leading to a likely negative stock price movement.
FBIO Report
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