Amicus Therapeutics, Inc. (FOLD): BCG Matrix [Dec-2025 Updated]

You're looking for a clear, no-nonsense breakdown of Amicus Therapeutics, Inc.'s business portfolio as of late 2025, and the BCG Matrix is the perfect tool to map their current position and future capital allocation needs. Right now, the story is clear: the high-growth Pombiliti + Opfolda combo is the 'Star' pulling the wagon, projecting revenue growth between 50% to 65%, fueled by the steady cash from the 'Cash Cow' Galafold, which delivered $138.3 million in Q3 sales alone. Meanwhile, the entire future hinges on the 'Question Mark' pipeline asset, DMX-200, with its pivotal Phase 3 trial wrapping up this year. Let's map out exactly where Amicus Therapeutics, Inc. needs to place its next big bet.

Background of Amicus Therapeutics, Inc. (FOLD)

You're looking at Amicus Therapeutics, Inc. (FOLD) as of late 2025, and the story here is one of a company hitting key financial milestones. Amicus Therapeutics, Inc. is a global biotechnology firm dedicated to developing and commercializing innovative medicines specifically for rare diseases. Honestly, they've been executing well against their stated goals for the year.

The most recent data, covering the third quarter of 2025, shows the company achieved a significant turning point: GAAP profitability. For Q3 2025, Amicus Therapeutics reported total revenue of $169.1 million, which was a 17% increase year-over-year when measured at constant exchange rates (CER). This strong performance resulted in a GAAP net income of $17 million for the quarter.

The revenue engine is clearly driven by their two commercial products. First, you have Galafold (migalastat), their oral precision medicine for Fabry disease. In Q3 2025, Galafold brought in $138.3 million in net product sales, marking a 15% year-over-year increase. Management noted that Galafold continues to be the standard of care for amenable patients, capturing about 69% of that specific market.

Second, Pombiliti (cipaglucosidase alfa-atga) + Opfolda (miglustat), their therapy for Pompe disease, is showing explosive growth. Q3 2025 sales for this combination were $30.7 million, representing a massive 45% jump compared to the same period last year. The company reiterated its 2025 guidance, projecting Pombiliti + Opfolda revenue growth in the 50% to 65% range at CER, which is definitely something to watch.

Looking at the balance sheet, Amicus Therapeutics maintained a solid footing with a cash position, including cash equivalents and marketable securities, reaching $264 million at the end of Q3 2025. Beyond the current commercial success, the company is advancing its pipeline; for instance, the Phase 3 study of DMX-200 for Focal Segmental Glomerulosclerosis (FSGS) is on track to complete enrollment by the end of 2025.

To put it simply, Amicus Therapeutics is transitioning from a growth-focused entity to one that is demonstrating profitability on its existing rare disease portfolio, while still projecting strong double-digit growth for the full year 2025. They've also reiterated a long-term goal of surpassing $1 billion in total annual sales by 2028.

Amicus Therapeutics, Inc. (FOLD) - BCG Matrix: Stars

You're looking at the engine driving Amicus Therapeutics, Inc.'s near-term expansion, and that's definitely Pombiliti + Opfolda, the two-component therapy for Pompe disease. This product line is clearly positioned as the growth driver for the business right now, consuming cash for its global rollout but aiming for market leadership. We see this high-growth, high-share positioning in the numbers management provided for the fiscal year 2025.

The projected revenue growth rate for Pombiliti + Opfolda in 2025 is set to be a very strong 50% to 65% when measured at constant exchange rates (CER). This aggressive growth trajectory is what defines a Star in the Boston Consulting Group (BCG) matrix-it's capturing a growing market, but it requires substantial investment to fund those global launches and build out its relative market share quickly. Honestly, this investment phase is why Stars often break even or consume cash, even with high sales.

We saw concrete evidence of this accelerating adoption in the third quarter of 2025. Pombiliti + Opfolda net product sales hit $30.7 million for the quarter ending September 30, 2025. That figure represented a reported year-over-year increase of 45%, showing the momentum in new launch markets and growing payer acceptance. This therapy is a major contributor to the company's long-term ambition to exceed $1 billion in total combined sales by 2028.

To give you a clearer picture of the relative performance, here's how the growth profiles stack up between the two core commercial assets as of the Q3 2025 guidance:

The strategy here is clear: invest heavily now to secure market share so that as the high-growth Pompe market matures, Pombiliti + Opfolda can transition into a Cash Cow. The company is actively building that market share through geographic expansion. As of the Q3 2025 update, the therapy had secured pricing and reimbursement agreements in 15 countries, including four new markets added since the second quarter.

Here are some key operational metrics supporting the Star classification:

• Projected 2025 revenue growth at CER: 50% to 65%.
• Q3 2025 net product sales: $30.7 million.
• Year-to-date growth (CER) through Q3 2025: 59%.
• Reimbursement secured in 15 countries as of Q3 2025.
• Goal to exceed $1 billion in combined sales by 2028.

Amicus Therapeutics, Inc. (FOLD) - BCG Matrix: Cash Cows

You're looking at the engine room of Amicus Therapeutics, Inc. (FOLD)'s current financial stability. The product fitting the Cash Cow profile here is Galafold (migalastat) for Fabry disease. This is the established, high-margin revenue base that requires minimal new market development investment to maintain its position.

Galafold's performance in the third quarter of 2025 shows this stability clearly. Net product sales for the quarter ended September 30, 2025, hit $138.3 million. This single product accounted for the majority of the company's total Q3 2025 net product sales of $169.1 million. The growth rate, while not explosive like a Star, is solid and predictable, which is exactly what you want from a Cash Cow.

The market position is dominant, which translates directly into high profitability and cash generation. Galafold is the only approved oral treatment for Fabry disease, securing a high relative market share of around 69% of treated amenable patients globally as of the third quarter of 2025. This dominance means the company can focus on efficiency rather than aggressive market capture.

Here's the quick math on Galafold's recent performance and outlook, which solidifies its Cash Cow status:

The low-growth, high-share profile means investments here are geared toward maintenance and efficiency improvements, not massive promotional spending. This product is generating the cash flow that allows Amicus Therapeutics to fund the development and expansion of its 'Stars' and 'Question Marks' within the portfolio, while also contributing to the company achieving GAAP profitability in the second half of 2025.

You can see the stability reflected in the full-year guidance reiterated for 2025, which projects Galafold revenue growth in the 10% to 15% range at constant exchange rates. This steady, double-digit growth from a market leader is the definition of a product that consumes little but feeds much of the corporate infrastructure and pipeline funding.

The key characteristics supporting this categorization are:

• Established, high-margin revenue base.
• Secures 69% share of the treated amenable patient market.
• Projected FY 2025 revenue growth of 10% to 15% at CER.
• Generated $138.3 million in Q3 2025 net product sales.
• Contributes to Amicus Therapeutics achieving GAAP profitability in H2 2025.

Amicus Therapeutics, Inc. (FOLD) - BCG Matrix: Dogs

You're looking at the small, early-stage pipeline assets and unpublicized research efforts within Amicus Therapeutics, Inc. (FOLD) that fit the Dogs quadrant profile-low market share and low growth potential, which means they are not currently driving significant revenue or are too nascent to have established a market presence.

Dogs are units or products with a low market share and low growth rates. These are the areas where expensive turn-around plans usually do not help, and the strategic move is typically avoidance or minimization.

For Amicus Therapeutics, Inc. (FOLD), the Dogs category is not represented by a major commercial product, as the company is highly focused on its core, high-growth rare disease therapies like Galafold and Pombiliti + Opfolda. Instead, this quadrant is populated by:

• Early-stage, non-core research and development (R&D) programs that are not yet public or strategic.
• General R&D expenses that consume cash without a clear, near-term path to commercialization.

These smaller, non-core programs have low market share and low growth potential, but their cash burn is minimal compared to the overall Non-GAAP Operating Expenses of $380 million to $400 million for 2025.

To put the R&D spend into perspective against the total expected operational burn, consider the following breakdown based on reported figures and guidance:

The R&D component that falls into the Dog category is the portion of the total R&D budget that is not clearly tied to the near-term, high-potential assets like DMX-200 (which is positioned as a Question Mark). The R&D share-based compensation for the three months ended September 30, 2025, was $8,765 thousand. This figure, while small relative to the total Non-GAAP Operating Expenses guidance range of $350 million to $370 million for the full year, represents the cash consumption of these less-defined projects.

The characteristics defining these Dog-like R&D efforts include:

• Programs with low probability of achieving blockbuster status.
• Projects operating in therapeutic areas outside the core focus of Fabry and Pompe diseases.
• Minimal or no external visibility on milestones or market potential.
• Cash burn that is not strategically justified by near-term commercial returns.

These units are prime candidates for divestiture or complete cessation of funding to reallocate capital toward the Stars and high-potential Question Marks. Honestly, you want to keep the cash tied up in these areas minimal.

Amicus Therapeutics, Inc. (FOLD) - BCG Matrix: Question Marks

As a Question Mark, DMX-200 for Focal Segmental Glomerulosclerosis (FSGS) represents a high-growth market opportunity where Amicus Therapeutics, Inc. (FOLD) currently holds zero market share. This asset consumes cash now but has the potential to become a Star if market adoption is achieved quickly. The entire premise rests on the success of the ongoing pivotal trial.

The primary pipeline asset categorized here is DMX-200, a small molecule inhibitor of the chemokine receptor 2 (CCR2), licensed for U.S. rights to treat FSGS. This market is characterized by a significant unmet need, as there are currently no FDA-approved therapies for FSGS in the United States. The FDA alignment in March 2025 on proteinuria as the primary endpoint for marketing approval significantly de-risks the regulatory pathway, but the commercial risk remains high until data is positive and submitted.

The capital commitment for this potential is clear. Amicus Therapeutics, Inc. paid Dimerix an $30 million upfront licensing fee for the U.S. rights. This single outlay was a major factor in the Q2 2025 GAAP operating expenses reaching $148.9 million. As of June 30, 2025, the company's cash, cash equivalents, and marketable securities stood at $231.0 million, reflecting the cash burn from operations and this strategic investment.

The market dynamics suggest high growth potential, which is why this asset is not yet classified as a Dog. The overall FSGS Treatment Market is estimated to be valued at $14.95 billion in 2025 across the top 7 markets, with a projected Compound Annual Growth Rate (CAGR) of 6.75% through 2030, reaching $20.73 billion. More specifically, the primary FSGS segment, which is the target for DMX-200, held a 61.08% revenue share in 2024 and is projected to grow at a 9.01% CAGR through 2030.

The near-term catalyst is the completion of the pivotal Phase 3 ACTION3 study. Enrollment is on track for completion by the end of 2025. As of June 2025, the trial had already dosed approximately ~70% of its total adult patient cohort target of ~286 patients. Success here means Amicus Therapeutics, Inc. could realize significant future value, with potential success-based milestone payments reaching up to $560 million, plus tiered royalties on U.S. net sales ranging from the low-teens to low-twenties percentages.

Here is a summary of the key financial and development metrics associated with this Question Mark:

The strategy for handling this Question Mark is clear: heavy investment to gain market share, which is already underway via the licensing deal and funding the path to approval. Failure to secure positive data means the development costs associated with this asset could result in a write-off against future earnings.

Key elements driving the high-growth/low-share profile include:

• DMX-200 is in Phase 3 development.
• Market has zero approved therapies.
• Full enrollment expected by year-end 2025.
• Potential for Orphan Drug Exclusivity upon approval.
• Amicus Therapeutics, Inc. is funding U.S. regulatory submissions and commercialization.