Amicus Therapeutics reports revenue increase, strong growth projections, and new acquisitions
From GlobeNewswire: 2025-05-01 07:00:00
Amicus Therapeutics reported a 15% increase in total revenue to $125.2 million for Q1 2025. They expanded their portfolio by acquiring the DMX-200 Phase 3 program for a rare kidney disease in the U.S. The company maintained guidance for Galafold and updated guidance for Pombiliti + Opfolda, expecting strong growth and profitability in H2 2025.
Galafold net product sales for Q1 2025 were $104.2 million, a 5% increase year-over-year. Pombiliti + Opfolda net product sales were $21.0 million, up 90% from the previous year. Total GAAP operating expenses decreased by 2.5%. Amicus expects to achieve GAAP profitability in H2 2025 and projects a revenue growth of 15-22% at CER.
Pombiliti + Opfolda was selected as the preferred treatment for late-onset Pompe disease in the Netherlands. Regulatory approvals were granted in Canada and Australia for adult LOPD patients. Amicus signed a commercial manufacturing agreement with Sharp Sterile for Pombiliti. They also secured an exclusive U.S. licensing agreement for the Phase 3 program DMX-200 for FSGS, aiming to surpass $1 billion in total sales by 2028. Amicus Therapeutics projects strong total revenue growth with Galafold and Pombiliti + Opfolda. The updated 2025 financial guidance includes a gross margin in the mid-80% range and non-GAAP operating expenses between $380M to $400M. The company will discuss these results in a conference call and webcast on May 1, 2025.
Galafold is an oral treatment for Fabry disease, stabilizing dysfunctional enzymes in adults with amenable GLA variants. Amicus estimates that 35-50% of Fabry disease patients may benefit from Galafold. The drug is approved in over 40 countries, including the U.S. and EU, with common adverse reactions like headache and nausea.
Pombiliti + Opfolda is a two-component therapy for late-onset Pompe disease in adults not responding to current treatment. Safety information includes risks of hypersensitivity reactions, infusion-associated reactions, and acute cardiorespiratory failure in susceptible patients. The therapy is contraindicated in pregnancy due to potential embryo-fetal harm. Amicus Therapeutics advises females of reproductive potential to use effective contraception during treatment and for at least 60 days after the last dose of POMBILITI. Common adverse reactions include headache, diarrhea, fatigue, nausea, abdominal pain, and pyrexia. For full prescribing information, visit the provided links for POMBILITI and OPFOLDA. Amicus Therapeutics is a biotechnology company dedicated to developing medicines for rare diseases. Non-GAAP financial measures are provided in addition to U.S. GAAP financial information for operational performance evaluation. Forward-looking statements regarding regulatory approval, commercialization, and financial projections are subject to risks and uncertainties outlined in the company’s reports. 1. The stock market saw a significant increase today, with the S&P 500 reaching a record high of 4,300 points. This surge was driven by strong performances from tech and healthcare companies, as investors remain optimistic about economic recovery.
2. In other news, the latest unemployment report showed a decrease in jobless claims, with only 350,000 new claims filed last week. This is the lowest number since the start of the pandemic, indicating a positive trend in the labor market.
3. The housing market continues to boom, with home prices rising by 13.3% compared to last year. Low mortgage rates and high demand have fueled this growth, with experts predicting the trend to continue in the coming months.
4. On the international front, tensions are rising between the US and China over cybersecurity issues. The US government has accused China of cyberattacks on American companies, leading to increased scrutiny and potential sanctions on Chinese technology firms. The situation remains fluid as both countries navigate this delicate issue. 1. The stock market saw a significant increase today, with the S&P 500 reaching an all-time high of 4,352.34. This surge was driven by positive earnings reports from major tech companies like Google and Amazon, as well as optimism about the economic recovery.
2. In other news, the unemployment rate dropped to 5.9% in June, down from 6.1% in May. This marks the lowest unemployment rate since the start of the pandemic, indicating a strong job market recovery as businesses continue to reopen and hire new workers.
3. The housing market also showed signs of strength, with home prices rising by 15% in the past year. Low mortgage rates and high demand have fueled this increase, making it a seller’s market in many areas as buyers compete for limited inventory.
4. On the international front, tensions continue to escalate between Russia and Ukraine, with reports of increased military activity along the border. The United States and European Union have expressed concerns about the situation, calling for a peaceful resolution to the conflict.
5. Lastly, in health news, COVID-19 cases are on the rise in several states, driven by the highly contagious Delta variant. Public health officials are urging people to get vaccinated and follow safety guidelines to prevent further spread of the virus and protect vulnerable populations.
Read more at GlobeNewswire:: Amicus Therapeutics Announces First Quarter 2025 Financial