2025-05-15-Jefferies-爱若优科技（ALUR）_重申2025财年指引；美国推出计划按轨进行_新分析助力FDA审批流程_13页_546kb

ALUR Summary: FY25 Guidance, US Launch, and Clinical Progress

Core Content

Allurion Technologies (ALUR) has reiterated its FY25 sales guidance of $30MM, which is slightly above the consensus of $28.6MM. The company continues to expect EBITDA profitability in 2026 and is on track to submit its final PMA model in June 2025, with a potential US launch in 2026.

The 1Q25 sales were $5.6MM, compared to $9.4MM in 1Q24, reflecting a temporary sales suspension in France and a reduction in the sales force. The gross margin (GM) for 1Q25 was ~75%, up from ~73% in 1Q24 and significantly higher than 4Q24's ~45%. The operating loss for 1Q25 was $5.9MM, down from $11.4MM in 1Q24, due to restructuring cost reductions.

ALUR has a cash balance of $20.4MM, which provides sufficient runway for its growth goals and aims to achieve profitability by the end of 2025. The company is also restructuring its workforce by 50% to realign costs with strategic priorities, and it does not expect a material impact from tariffs.

Key Points

Main Viewpoints

• Sales Guidance: ALUR maintained its FY25 sales guidance of $30MM, indicating continued focus on cost optimization and strategic realignment.
• Profitability Outlook: The company expects EBITDA profitability in 2026, driven by cost reductions, margin expansion, and US market entry.
• FDA Interaction: The FDA has allowed ALUR to use alternative statistical methods for analyzing control group data, which could strengthen its case for approval and reduce regulatory risk.
• Clinical Results: Despite missing the 3% superiority margin in the AUDACITY trial, ALUR's data still shows strong weight loss outcomes and a favorable safety profile. The company believes the results are likely to lead to approval.
• Market Potential: ALUR's platform combines a swallowable gastric balloon with a digital therapeutic and remote patient monitoring, offering a unique and potentially high-margin solution.

Key Information

• AUDACITY Trial: The trial achieved the co-primary endpoint of responder rate but missed the 3% superiority margin at 48 weeks. However, the 4.22% mean difference in weight loss at 40 weeks is above the 3% threshold.
• Weight Loss Data: Over 50% of patients using the ALUR Balloon lost >5% of their body weight at 48 weeks, with a mean difference of 3.77%. In the US study, the adverse event rate was 3.1%, significantly lower than other similar products.
• Digital Integration: The ALUR Virtual Care Suite (VCS) enhances patient outcomes, with studies showing significant improvements in lean body mass and fat reduction when combined with the balloon.
• Company Valuation: The price target (PT) is $18, based on ~3x 2026E sales, and is supported by a DCF analysis. The PT reflects a 516% increase from the prior day's closing price.
• Risks: The biggest risk is the lack of US approval. Other risks include macroeconomic headwinds, competition, regulatory delays, and execution challenges.

Financial Highlights

FY25 Guidance (Non-GAAP, $MM)

• Total Sales: $30MM (unchanged from previous guidance)
• Operating Loss: $5.9MM (vs. $11.4MM in 1Q24)
• EBITDA: Expected to decrease by ~50% year-over-year
• Cash Runway: Sufficient to support growth and profitability goals

Historical Performance

• 1Q25 GM: ~75%
• 1Q25 Operating Margin: -105.6%
• 1Q25 Adjusted EPS: $1.46

Investment Thesis

• ALUR's platform includes the world's first swallowable, procedure-less gastric balloon, combined with a proprietary behavior change program and AI-powered digital therapeutic.
• The company is expected to benefit from US and China market entry, with strong DD growth anticipated post-launch.
• ALUR has a strong safety profile, with lower adverse event rates than previous gastric balloon products.
• The company's digital capabilities and partnerships are expected to drive growth and enhance patient outcomes.

Catalysts for Growth

• US FDA Approval: The submission of the final PMA model in June 2025 and potential US launch in 2026.
• Clinical Data: Continued positive results from the AUDACITY trial and additional studies published in peer-reviewed journals.
• Digital Expansion: Launch of the Coach Iris platform and scaling of digital capabilities.
• Strategic Partnerships: Growth in existing partnerships, including with MDT.

Risks

• Regulatory Risk: Approval in the US remains the biggest risk for the company.
• Macro Risk: Economic and inflationary pressures could impact growth and profitability.
• Execution Risk: The success of the company's restructuring and commercialization efforts will be crucial.
• Competition: Intense competition from other weight loss technologies, including GLP-1 drugs.

Analysts

• Matthew Taylor, CFA
• Young Li
• Michael Sarcone, CFA
• Michael Toomey, CFA
• Matthew Aspro

Valuation Table

Metric	2025 (MM)	2026 (MM)	2027 (MM)
Revenue	$30	$32.4	$37.5
EPS	$1.46	$0.17	$-1.46
EV/Rev	0.1x	0.1x	0.1x
P/Rev	0.4x	0.6x	0.6x

Sustainability and ESG

• Product Design: ALUR focuses on advancing therapeutic solutions and ensuring regulatory compliance.
• Product Safety: The company must maintain high standards to support product approval and adoption.
• ESG Targets: The company is asked to consider implementing measurable ESG targets in the future.

Conclusion

ALUR is on track for a US launch in 2026 and expects EBITDA profitability in that year. The company's strong safety profile, combined with its digital therapeutic platform, positions it well for long-term growth. However, the success of its US approval and commercialization efforts remains critical to its future performance.