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01/11 12:03
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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
The earnings call reveals mixed signals. Financial performance shows increased expenses and net loss, though non-GAAP income remains positive. Product development and market expansion are promising, with strong market share gains and regulatory progress. However, the decreased revenue growth guidance and increased COGS raise concerns. The Q&A highlights confidence in IP and manufacturing progress but lacks specifics on timelines and COGS impact. Overall, the sentiment is neutral, with potential for both positive and negative market reactions.
Galafold Revenue $128.9 million this quarter, up 12% at constant exchange rates and up 16% in reported terms. The growth is driven by the number of new patient starts globally and achieving more than 69% of the global market share for treated Fabry patients with amenable mutations.
Pombiliti and Opfolda Revenue $25.8 million this quarter, up 58% at constant exchange rates. The growth is attributed to strong sales growth, record levels of patient demand, and expansion into new markets including 5 new countries in Q2.
Total Revenue $154.7 million, a 22% increase over the same period in 2024 (18% at constant exchange rates). The growth is driven by strong performance in both Galafold and Pombiliti and Opfolda.
Cost of Goods Sold (COGS) 10% of net sales for Q2, compared to 9% in the same period last year. The slight increase is due to changes in product mix.
GAAP Operating Expenses $148.9 million for Q2 2025, up 48% from $100.4 million in Q2 2024. The increase includes a $30 million upfront payment for the U.S. licensing rights to DMX-200.
Non-GAAP Operating Expenses $127.8 million for Q2 2025, up 56% from $82.1 million in Q2 2024. The increase reflects higher R&D and SG&A expenses.
GAAP Net Loss $24.4 million or $0.08 per share for Q2 2025, compared to $15.7 million or $0.05 per share in Q2 2024. The loss includes the $30 million upfront payment for DMX-200.
Non-GAAP Net Income $1.9 million or $0.01 per share for Q2 2025, compared to $18.5 million or $0.06 per share in Q2 2024. The decrease is due to increased operating expenses.
Cash, Cash Equivalents, and Marketable Securities $231 million as of June 30, 2025, compared to $250 million as of December 31, 2024. The decrease is attributed to operational expenses and the upfront payment for DMX-200.
Galafold: Revenue reached $128.9 million this quarter, up 12% at constant exchange rates and 16% in reported terms. Achieved 69% global market share for treated Fabry patients with amenable mutations. Record high growth in naive new patient starts.
Pombiliti and Opfolda: Second quarter revenue reached $25.8 million, up 58% at constant exchange rates. Launched in 5 new markets in Q2, with strong sales growth and record levels of patient demand. Expected to contribute significantly to multiyear growth.
DMX-200: A first-in-class compound in late-stage Phase III development for a rare kidney disease. The pivotal ACTION3 study is on track for full enrollment by year-end. Positioned as a meaningful advancement for FSGS patients.
Geographic Expansion: Pombiliti and Opfolda launched in 5 new markets in Q2, including Italy, Switzerland, Portugal, Czech Republic, and Sweden. Regulatory approval received in Japan for patients aged 15 and older.
Fabry Disease Market: Over 12,000 people receive treatment worldwide, with 6,000 diagnosed patients remaining untreated. Literature suggests a larger underdiagnosed population, indicating substantial market opportunity for Galafold.
Revenue Growth: Achieved total revenue of $154.7 million in Q2 2025, a 22% increase over the same period in 2024. Galafold and Pombiliti/Opfolda are key drivers of growth.
Financial Discipline: On track to achieve GAAP profitability in the second half of 2025. Maintained strong cash position with $231 million as of June 30, 2025.
Strategic Partnership: Advanced partnership with Dimerix for DMX-200, a potential blockbuster treatment for FSGS. $30 million upfront payment made for U.S. licensing rights.
Long-term Growth: Reiterated confidence in achieving $1 billion combined sales for Pombiliti and Opfolda by 2028. Galafold projected to surpass $1 billion in revenue with strong IP protection and market expansion.
Regulatory Approvals and Market Access: Challenges in securing broad patient access throughout the EU for Pombiliti and Opfolda, despite recent regulatory approval in Japan.
Geographic Expansion: The need to launch Pombiliti and Opfolda in up to 10 new countries this year, which may pose logistical and operational challenges.
Financial Discipline: Increased operating expenses, including a $30 million upfront payment for DMX-200, impacting net income and cash reserves.
Product Differentiation: Efforts to differentiate Pombiliti and Opfolda through evidence generation and real-world data, which may take time to influence wider adoption.
Pipeline Development: Dependence on the successful enrollment and outcomes of the Phase III ACTION trial for DMX-200, which is critical for addressing unmet needs in FSGS.
Market Penetration: Challenges in achieving high market shares globally for Galafold, despite strong performance in mature markets.
Economic and Currency Risks: Revenue growth is reported at constant exchange rates, indicating potential exposure to currency fluctuations.
Revenue Growth: The company expects total revenue growth of 15% to 22% for 2025, with Galafold revenue growth projected at 10% to 15% and Pombiliti and Opfolda revenue growth anticipated at 50% to 65%, all at constant exchange rates.
Product Sales Projections: Galafold is expected to surpass $1 billion in revenue, driven by new patient starts, market penetration, and high compliance rates. Pombiliti and Opfolda are projected to reach combined sales of $1 billion by the end of 2028, with peak sales potential exceeding $1 billion for each product.
Market Expansion: Pombiliti and Opfolda are set to launch in up to 10 new countries in 2025, with significant growth expected in markets like the Netherlands and Japan. Galafold is also expanding into new markets and extending its label.
Pipeline Development: The ACTION3 pivotal study for DMX-200, a treatment for FSGS, is on track for full enrollment by the end of 2025. The company plans to request an additional FDA meeting to discuss interim efficacy assessments and next steps for DMX-200.
Profitability: The company reiterates its expectation to achieve GAAP profitability in the second half of 2025.
Long-Term Growth Drivers: Key drivers include increasing patient access, expanding into new markets, enhancing diagnostic rates, and sustaining high compliance and adherence rates for its products.
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The earnings call highlights strong financial performance, with significant revenue growth and a shift to GAAP profitability. Despite increased COGS, net income improved, and cash reserves grew. The Q&A section revealed positive reception of product labels and strategic market expansion plans. However, vague responses on revenue acceleration and supply stability pose some concerns. Overall, the positive financial results, optimistic guidance, and strategic initiatives outweigh these concerns, suggesting a positive stock price movement.
The earnings call reveals mixed signals. Financial performance shows increased expenses and net loss, though non-GAAP income remains positive. Product development and market expansion are promising, with strong market share gains and regulatory progress. However, the decreased revenue growth guidance and increased COGS raise concerns. The Q&A highlights confidence in IP and manufacturing progress but lacks specifics on timelines and COGS impact. Overall, the sentiment is neutral, with potential for both positive and negative market reactions.
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