- BioMarin will buy Amicus for $4.8B in cash ($14.50/share), expected to close in Q2 2026, adding Galafold (Fabry), Pombiliti + Opfolda (Pompe), and U.S. rights to Phase 3 DMX-200 (FSGS).
- The deal brings about $599M in trailing annual revenue and extends Galafold’s U.S. exclusivity to January 2037 via patent settlement.
- BioMarin will fund the purchase with ~$3.7B of non-convertible debt plus cash, targeting gross leverage below 2.5x within two years and non-GAAP EPS accretion within 12 months post-close.
- Shares jumped (Amicus ~30%, BioMarin ~18%–20%) as investors and analysts view it as a pivot toward steadier, protected rare-disease cash flows versus higher-volatility gene therapy bets.
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Strategic Rationale
The acquisition is a clear strategic shift by BioMarin from high-risk R&D/gene therapy toward predictable, commercially approved rare disease therapies. Galafold and the combination of Pombiliti + Opfolda bring immediate revenues ($599 million over past four quarters) and offer enhanced global reach via BioMarin’s infrastructure. The settlement of patent disputes involving Galafold ensures exclusivity until 2037, reducing risks of impending generic competition and stabilizing future cash flows.
Financial & Balance Sheet Implications
Financing will be via $3.7 billion in debt plus cash, pushing BioMarin’s gross leverage closer to ~3–3.5× immediately post-deal. However, BioMarin aims to reduce this to <2.5× within two years through cash flow from acquired assets and operational synergies. Inclusive of accretion to non-GAAP diluted EPS within 12 months post-close, and more pronounced accretion in 2027, the deal presents financial upside, provided execution proceeds per plan.
Competitive Positioning & Markets
BioMarin’s move tightens competition in Fabry and Pompe disease markets. Amicus’ Galafold gains strengthened competitive standing vs. older enzyme replacement therapies, especially those held by Sanofi and Takeda, particularly since Galafold is the only approved oral treatment for Fabry disease in the U.S. Amicus’ reach, while smaller, adds leverage for BioMarin’s global launch capability. For Pompe disease, Pombiliti + Opfolda bring a two-component regimen that could challenge incumbents with improved dosing or outcomes, especially given better commercialization capacity under BioMarin.
Risks & Open Questions
- Integration challenges: merging Amicus’ operations, maintaining patient retention, and realizing expected synergies pose risks, especially across 40 additional markets.
- Pipeline dependency: DMX-200’s Phase 3 trial for FSGS is critical—if results are positive, upside; but failure could tilt valuation narrative toward purchase of commercial cash flows only.
- Debt leverage: elevated post-deal leverage (~3×+) requires discipline to deleverage quickly; economic downturn or reimbursement pressures could strain cash flow projections.
- Regulatory & policy shifts: potential pricing and reimbursement challenges under U.S. drug policy (e.g. Inflation Reduction Act), and global regulatory risk remain, especially with rare disease drug cost scrutiny.
- Time to close: deal subject to regulatory clearance, Amicus shareholder vote, and antitrust conditions—delays or pushback could change return profile.
Strategic Implications
BioMarin’s acquisition may trigger consolidation among mid-cap rare disease biotechs. Assets with commercial stage and regulatory protection are increasingly prized. The deal sets a precedent: investors penalizing exposure to early-stage, high failure-risk gene therapies may push other biotechs to seek similar bolt-on acquisitions to stabilize growth. Meanwhile, companies with payable pipelines but lacking scale may become targets.
Supporting Notes
- Acquisition price: $4.8 billion in all-cash at $14.50 per share; 33% premium over Amicus’ last trading price.
- Revenue base of acquired products: combined net product revenues of ~$599 million for Galafold and Pombiliti + Opfolda over the past four quarters.
- Patent settlement: Galafold’s U.S. exclusivity through January 30, 2037, following litigation with generic applicants Aurobindo and Lupin.
- Financing: ~$3.7 billion non-convertible debt financing, with cash on hand supplementing; target gross leverage <2.5× within two years post‐closing.
- EPS impact: expected to be accretive to non-GAAP diluted EPS within one year after close; substantially accretive beginning in 2027.
- Market reaction: Amicus shares rose ~30%; BioMarin shares up ~17%–20% after announcement.
- Product portfolio gains: adds commercial therapies for Fabry (Galafold) and Pompe (Pombiliti + Opfolda), plus pipeline asset DMX-200 (Phase 3 FSGS).