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Amicus Therapeutics (FOLD) reported preliminary 2024 total revenue of $528.5M, showing significant growth of 32% year-over-year. The company’s performance was driven by two key products: Galafold, with net sales of $458.2M (18% growth), serving ~2,730 Fabry disease patients, and Pombiliti + Opfolda, with net sales of $70.3M, treating ~220 patients in its first full launch year.
For 2025, Amicus projects total revenue growth of 17-24% at constant exchange rates, with Galafold expected to grow 10-15% and Pombiliti + Opfolda 65-85%. The company secured multiple pricing and reimbursement agreements in late 2024/early 2025, including Italy, Sweden, Switzerland, and Czech Republic. A settlement with Teva ensures no generic migalastat in the U.S. until 2037. Amicus anticipates reaching positive GAAP Net Income in H2 2025 and surpassing $1 billion in total sales by 2028.
Amicus Therapeutics (FOLD) ha riportato un fatturato preliminare totale per il 2024 di $528,5 milioni, registrando una crescita significativa del 32% rispetto all’anno precedente. Le performance dell’azienda sono state guidate da due prodotti chiave: Galafold, con vendite nette di $458,2 milioni (crescita del 18%), che serve circa 2.730 pazienti affetti da malattia di Fabry, e Pombiliti + Opfolda, con vendite nette di $70,3 milioni, trattando circa 220 pazienti nel suo primo anno di lancio completo.
Per il 2025, Amicus prevede una crescita del fatturato totale dal 17 al 24% a tassi di cambio costanti, con Galafold previsto in crescita del 10-15% e Pombiliti + Opfolda del 65-85%. L’azienda ha ottenuto numerosi accordi di prezzo e rimborso a fine 2024 / inizio 2025, inclusi Italia, Svezia, Svizzera e Repubblica Ceca. Un accordo con Teva garantisce che non ci sarà alcun migalastat generico negli Stati Uniti fino al 2037. Amicus prevede di raggiungere un utile netto GAAP positivo nel secondo semestre del 2025 e di superare 1 miliardo di dollari di vendite totali entro il 2028.
Amicus Therapeutics (FOLD) reportó unos ingresos totales preliminares para 2024 de $528.5 millones, mostrando un crecimiento significativo del 32% interanual. El rendimiento de la compañía fue impulsado por dos productos clave: Galafold, con ventas netas de $458.2 millones (un crecimiento del 18%), atendiendo a aproximadamente 2,730 pacientes con enfermedad de Fabry, y Pombiliti + Opfolda, con ventas netas de $70.3 millones, tratando a alrededor de 220 pacientes en su primer año de lanzamiento completo.
Para 2025, Amicus proyecta un crecimiento de ingresos totales del 17 al 24% a tasas de cambio constantes, con Galafold se espera crezca entre el 10-15% y Pombiliti + Opfolda entre el 65-85%. La compañía aseguró múltiples acuerdos de precios y reembolsos a fines de 2024/principios de 2025, incluyendo Italia, Suecia, Suiza y República Checa. Un acuerdo con Teva asegura que no habrá migalastat genérico en EE. UU. hasta 2037. Amicus anticipa alcanzar un ingreso neto GAAP positivo en la segunda mitad de 2025 y superar los $1,000 millones en ventas totales para 2028.
아미쿠스 테라퓨틱스 (FOLD)는 2024년 Preliminary 총 수익이 5억 2천 8백 5십만 달러에 달해 전년 대비 32%의 큰 성장을 보여주었다고 발표했다. 회사의 성과는 두 가지 주요 제품에 의해 주도되었다: 갈라폴드, 순매출 4억 5천 8백 2십만 달러(18% 성장), 약 2,730명의 파브리병 환자를 치료하고 있으며, 폼빌리티 + 옵폴다, 순매출 7천 3백만 달러, 첫 번째 완전 출시 연도에 약 220명의 환자를 치료하고 있다.
2025년을 위해 아미쿠스는 환율이 일정할 경우 총 수익이 17-24% 성장할 것으로 예상하며, 갈라폴드는 10-15% 성장할 것으로, 폼빌리티 + 옵폴다는 65-85% 성장할 것으로 예상하고 있다. 이 회사는 2024년 말/2025년 초에 이탈리아, 스웨덴, 스위스 및 체코 공화국을 포함한 여러 가격 및 환급 협정을 확보했다. 테바와의 합의에 따라 미국 내에서 2037년까지 제네릭 미갈라스타트가 출시되지 않도록 보장되고 있다. 아미쿠스는 2025년 하반기에 긍정적인 GAAP 순이익에 도달하고 2028년까지 총 판매액이 10억 달러를 초과할 것으로 예상하고 있다.
Amicus Therapeutics (FOLD) a déclaré un revenu total préliminaire pour 2024 de 528,5 millions de dollars, affichant une croissance significative de 32 % d’une année sur l’autre. La performance de l’entreprise a été soutenue par deux produits clés : Galafold, avec des ventes nettes de 458,2 millions de dollars (augmentation de 18 %), servant environ 2 730 patients atteints de la maladie de Fabry, et Pombiliti + Opfolda, avec des ventes nettes de 70,3 millions de dollars, traitant environ 220 patients lors de sa première année de lancement complet.
Pour 2025, Amicus projette une croissance des revenus totaux comprise entre 17 et 24 % à taux de change constants, avec Galafold prévu d’augmenter de 10 à 15 % et Pombiliti + Opfolda de 65 à 85 %. L’entreprise a sécurisé plusieurs accords de prix et de remboursement fin 2024/début 2025, y compris en Italie, en Suède, en Suisse et en République tchèque. Un accord avec Teva assure qu’aucun migalastat générique ne sera disponible aux États-Unis jusqu’en 2037. Amicus s’attend à atteindre un bénéfice net GAAP positif au second semestre de 2025 et à dépasser 1 milliard de dollars de ventes totales d’ici 2028.
Amicus Therapeutics (FOLD) meldete für 2024 einen vorläufigen Gesamtumsatz von 528,5 Millionen USD, was einem erheblichen Wachstum von 32 % im Vergleich zum Vorjahr entspricht. Die Leistung des Unternehmens wurde von zwei Schlüsselprodukten unterstützt: Galafold mit einem Nettoumsatz von 458,2 Millionen USD (18 % Wachstum), das etwa 2.730 Patienten mit Fabry-Krankheit versorgt, und Pombiliti + Opfolda mit einem Nettoumsatz von 70,3 Millionen USD, das etwa 220 Patienten im ersten vollständigen Verkaufsjahr behandelt.
Für 2025 prognostiziert Amicus ein Umsatzwachstum von 17-24 % zu konstanten Wechselkursen, wobei von Galafold ein Wachstum von 10-15 % und von Pombiliti + Opfolda ein Wachstum von 65-85 % erwartet wird. Das Unternehmen hat Ende 2024/Anfang 2025 mehrere Preis- und Erstattungsvereinbarungen, einschließlich Italien, Schweden, Schweiz und Tschechische Republik, gesichert. Eine Einigung mit Teva stellt sicher, dass bis 2037 kein generisches Migalastat in den USA erhältlich sein wird. Amicus erwartet, in der zweiten Hälfte von 2025 einen positiven GAAP-Nettogewinn zu erreichen und bis 2028 einen Gesamtumsatz von über 1 Milliarde USD zu übertreffen.
Positive
- Strong revenue growth of 32% YoY to $528.5M in 2024
- Galafold net sales reached $458.2M with 18% growth
- Pombiliti + Opfolda achieved $70.3M in first full year
- Patent settlement protects Galafold from generic competition until 2037
- New reimbursement agreements secured in multiple countries
- Projected positive GAAP Net Income by H2 2025
- Target of $1B total sales by 2028
Insights
The preliminary 2024 results and 2025 outlook represent a compelling financial narrative. Total revenue of $528.5M with 32% YoY growth significantly outperforms the rare disease sector’s average growth rate. The dual revenue streams show strong momentum – Galafold reaching $458.2M (18% growth) and Pombiliti + Opfolda contributing $70.3M in its first full year.
The 2025 guidance of 17-24% revenue growth at CER demonstrates confidence in commercial execution. Most notably, the projected H2 2025 GAAP profitability milestone marks a important inflection point for Amicus’s financial maturity. The $1B revenue target by 2028 appears achievable given the current growth trajectory and market penetration rates.
The Teva settlement securing Galafold exclusivity until 2037 significantly de-risks the revenue stream and enhances long-term value proposition. The expanding global reimbursement agreements in key markets provide additional growth catalysts for 2025.
The patient metrics reveal strong market penetration and adoption trends. With 2,730 Fabry disease patients on Galafold and 220 patients on Pombiliti + Opfolda, Amicus has established a solid foundation in both franchises. The 35-50% addressable market for Galafold in Fabry disease suggests significant remaining growth potential.
Recent reimbursement agreements in Italy, Sweden, Switzerland and Czech Republic, coupled with pending regulatory decisions in Australia, Canada and Japan, indicate strategic geographic expansion. The company’s unique position with two commercial rare disease therapies provides operational leverage and commercial synergies. The robust IP protection through 2037 ensures sustainable market leadership in Fabry disease treatment.
2024 Total Revenue of $528M, Representing Significant Growth of 32% Year-Over-Year1
Strong and Growing Demand for Galafold® and Pombiliti® + Opfolda®
Total Revenue Growth of 17-24% at CER Expected in 2025
>3,000 People Treated with an Amicus Therapy Today2
PRINCETON, N.J., Jan. 12, 2025 (GLOBE NEWSWIRE) — Amicus Therapeutics (Nasdaq: FOLD), a patient-dedicated global biotechnology company focused on developing and commercializing novel medicines for rare diseases, today provided its preliminary and unaudited 2024 revenue, corporate updates, and full-year 2025 outlook.
Bradley Campbell, President and Chief Executive Officer of Amicus Therapeutics, Inc., said, “For Amicus, 2024 was a remarkable year in which we set out high expectations and met or exceeded each of them. Amicus delivered significant revenue growth of 32% in addition to Full Year non-GAAP profitability. We grew our core Galafold business and delivered a strong first full year of launch for Pombiliti + Opfolda while securing regulatory and reimbursement milestones that provide the foundation for sustained double-digit growth in 2025 and beyond. The combination of two approved medicines in growing markets, our strong intellectual property position, accelerating profitability, and our unique and leverageable global rare disease organization will enable us to deliver sustainable revenue growth and expand our portfolio over time. We have the capabilities and infrastructure to achieve our vision to become one of the leading rare disease companies bringing transformative therapies to patients and creating significant value for shareholders.”
Corporate Highlights:
- Total revenue in 2024 reached $528.5 million (preliminary and unaudited), representing a year-over-year increase of 32%, reflecting strong operational growth of 32% at constant exchange rates (CER)3. Fourth quarter total revenue was $149.9 million. For the full year 2025, the Company anticipates total revenue growth of 17-24% on a constant currency basis3.
- Galafold (migalastat) net product sales in 2024 were $458.2 million (preliminary and unaudited), representing a year-over-year increase of 18%, or 18% at CER3. Fourth quarter Galafold net product sales were $127.7 million. Given significant growth in patient demand and continued market leadership, there were ~2,730 patients living with Fabry disease on Galafold as of the end of 2024. For the full year 2025, the Company anticipates Galafold revenue growth of 10-15% on a constant currency basis3.
- Pombiliti (cipaglucosidase alfa-atga) + Opfolda (miglustat) net product sales in 2024 were $70.3 million (preliminary and unaudited). Fourth quarter Pombiliti + Opfolda net product sales were $22.2 million. Following a successful first full year of commercial launch, there were ~220 patients treated or scheduled with commercial product as of the end of 2024. For the full year 2025, the Company anticipates Pombiliti + Opfolda revenue growth of 65-85% on a constant currency basis3.
- Multiple Pombiliti + Opfolda pricing and reimbursement agreements recently achieved. Agreements completed in late 2024 and early 2025 include Italy, Sweden, Switzerland, and Czech Republic. First commercial patients from these countries are anticipated to begin treatment over the first half of 2025. The Company also anticipates new regulatory decisions in Australia, Canada, and Japan in 2025 as well as additional reimbursement agreements throughout the year.
- As previously announced, Amicus reached a settlement with Teva on the Galafold U.S. patent litigation. Based on the settlement terms, Teva will not be able to commercialize generic migalastat in the U.S. until Jan 2037.
- Amicus is focused on delivering significant long-term revenue growth and anticipates surpassing $1 billion in total sales in 2028. The Company anticipates continuing to grow its current commercial business with Galafold and Pombiliti + Opfolda resulting in strong revenue growth. Based on current operating plans, Amicus anticipates achieving positive GAAP Net Income during H2 2025.
Amicus is focused on the following key strategic priorities in 2025:
- Delivering total revenue growth of 17-24% at CER3
- Galafold revenue growth of 10-15% at CER3
- Pombiliti + Opfolda revenue growth of 65-85% at CER3
- Advancing ongoing studies to broaden labels and scientific leadership in Fabry and Pompe diseases
- Delivering positive GAAP Net Income during H2 2025
Mr. Campbell will discuss the Amicus corporate objectives and key milestones in a presentation at the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025, at 3:00 p.m. PT. A live webcast of the presentation can be accessed through the Investors section of the Amicus Therapeutics corporate website at http://ir.amicusrx.com/events.cfm, and will be archived for 90 days.
1 Preliminary and unaudited
2 Including clinical trial and expand access participants
3 At constant exchange rates (CER). In order to illustrate underlying performance, Amicus discusses its results in terms of CER growth. This represents growth calculated as if the exchange rates had remained unchanged from those used in the comparative period.
About Galafold
Galafold® (migalastat) 123 mg capsules is an oral pharmacological chaperone of alpha-Galactosidase A (alpha-Gal A) for the treatment of Fabry disease in adults who have amenable galactosidase alpha gene (GLA) variants. In these patients, Galafold works by stabilizing the body’s own dysfunctional enzyme so that it can clear the accumulation of disease substrate. Globally, Amicus Therapeutics estimates that approximately 35 to 50 percent of people living with Fabry disease may have amenable GLA variants, though amenability rates within this range vary by geography. Galafold is approved in more than 40 countries around the world, including the U.S., EU, U.K., and Japan.
U.S. INDICATIONS AND USAGE
Galafold is indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data.
This indication is approved under accelerated approval based on reduction in kidney interstitial capillary cell globotriaosylceramide (KIC GL-3) substrate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
U.S. IMPORTANT SAFETY INFORMATION
ADVERSE REACTIONS
The most common adverse reactions reported with Galafold (≥10%) were headache, nasopharyngitis, urinary tract infection, nausea and pyrexia.
USE IN SPECIFIC POPULATIONS
There is insufficient clinical data on Galafold use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. Advise women of the potential risk to a fetus.
It is not known if Galafold is present in human milk. Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Galafold and any potential adverse effects on the breastfed child from Galafold or from the underlying maternal condition.
Galafold is not recommended for use in patients with severe renal impairment or end-stage renal disease requiring dialysis.
The safety and effectiveness of Galafold have not been established in pediatric patients.
To report Suspected Adverse Reactions, contact Amicus Therapeutics at 1-877-4AMICUS or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For additional information about Galafold, including the full U.S. Prescribing Information, please visit https://www.amicusrx.com/pi/Galafold.pdf.
About Pombiliti + Opfolda
Pombiliti + Opfolda, is a two-component therapy that consists of cipaglucosidase alfa-atga, a bis-M6P-enriched rhGAA that facilitates high-affinity uptake through the M6P receptor while retaining its capacity for processing into the most active form of the enzyme, and the oral enzyme stabilizer, miglustat, that’s designed to reduce loss of enzyme activity in the blood.
U.S. INDICATIONS AND USAGE
POMBILITI in combination with OPFOLDA is indicated for the treatment of adult patients with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency) weighing ≥40 kg and who are not improving on their current enzyme replacement therapy (ERT).
SAFETY INFORMATION
HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS: Appropriate medical support measures, including cardiopulmonary resuscitation equipment, should be readily available. If a severe hypersensitivity reaction occurs, POMBILITI should be discontinued immediately and appropriate medical treatment should be initiated. INFUSION-ASSOCIATED REACTIONS (IARs): If severe IARs occur, immediately discontinue POMBILITI and initiate appropriate medical treatment. RISK OF ACUTE CARDIORESPIRATORY FAILURE IN SUSCEPTIBLE PATIENTS: Patients susceptible to fluid volume overload, or those with acute underlying respiratory illness or compromised cardiac or respiratory function, may be at risk of serious exacerbation of their cardiac or respiratory status during POMBILITI infusion. See PI for complete Boxed Warning. CONTRAINDICATION: POMBILITI in combination with Opfolda is contraindicated in pregnancy. EMBRYO-FETAL TOXICITY: May cause embryo-fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for at least 60 days after the last dose. Adverse Reactions: Most common adverse reactions ≥ 5% are headache, diarrhea, fatigue, nausea, abdominal pain, and pyrexia. Please see full PRESCRIBING INFORMATION, including BOXED WARNING, for POMBILITI (cipaglucosidase alfa-atga) LINK and full PRESCRIBING INFORMATION for OPFOLDA (miglustat) LINK.
About Amicus Therapeutics
Amicus Therapeutics (Nasdaq: FOLD) is a global, patient-dedicated biotechnology company focused on discovering, developing and delivering novel high-quality medicines for people living with rare diseases. With extraordinary patient focus, Amicus Therapeutics is committed to advancing and expanding a pipeline of cutting-edge, first- or best-in-class medicines for rare diseases. For more information, please visit the Company’s website at www.amicusrx.com, and follow on X and LinkedIn.
Non-GAAP Financial Measures
In addition to financial information prepared in accordance with U.S. GAAP, this press release also contains adjusted financial measures that we believe provide investors and management with supplemental information relating to operating performance and trends that facilitate comparisons between periods and with respect to projected information. These adjusted financial measures are non-GAAP measures and should be considered in addition to, but not as a substitute for, the information prepared in accordance with U.S. GAAP. We use these non-GAAP measures as key performance measures for the purpose of evaluating operational performance and cash requirements internally. We typically exclude certain GAAP items that management does not believe affect our basic operations and that do not meet the GAAP definition of unusual or non-recurring items. Other companies may define these measures in different ways. When we provide our expectation for non-GAAP operating expenses and profitability on a forward-looking basis, a reconciliation of the differences between the non-GAAP expectation and the corresponding GAAP measure generally is not available without unreasonable effort due to potentially high variability, complexity and low visibility as to the items that would be excluded from the GAAP measure in the relevant future period, such as unusual gains or losses. The variability of the excluded items may have a significant, and potentially unpredictable, impact on our future GAAP results.
Forward Looking Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 relating to the prospects and timing of the potential regulatory and pricing and reimbursement approvals of our products, commercialization plans, manufacturing and supply plans, financing plans, and the projected revenues, profitability and cash position for the Company. The inclusion of forward-looking statements should not be regarded as a representation by us that any of our plans will be achieved. Any or all of the forward-looking statements in this press release may turn out to be wrong and can be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. For example, statements regarding the goals, progress, timing, and outcomes of discussions with regulatory authorities and pricing and reimbursement authorities, are based on current information. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in our business, including, without limitation: the potential that regulatory authorities may not grant or may delay approval for our product candidates; the potential that required regulatory inspections may be delayed or not be successful and delay or prevent product approval; the potential that we may not be successful in negotiations with pricing and reimbursement authorities; the potential that we may not be successful in commercializing Galafold and/or Pombiliti and Opfolda in Europe, the UK, the US and other geographies; the potential that we will not be able to effectively compete in our approved markets: the potential that generic or new competitor products enter the market; the potential that we may not be able to manufacture or supply sufficient clinical or commercial products; and the potential that we will need additional funding to support the manufacturing and commercialization of our products. With respect to statements regarding corporate financial guidance and financial goals and the expected attainment of such goals and projections of the Company’s revenue, non-GAAP and GAAP profitability and cash position, actual results may differ based on market factors and the Company’s ability to execute its operational and budget plans. In addition, all forward-looking statements are subject to other risks detailed in our Annual Report on Form 10-K for the year ended December 31, 2023, and on Form 10-Q for the quarter ended September 30, 2024. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and we undertake no obligation to revise or update this news release to reflect events or circumstances after the date hereof.
CONTACT:
Investors:
Amicus Therapeutics
Andrew Faughnan
Vice President, Investor Relations
afaughnan@amicusrx.com
(609) 662-3809
Media:
Amicus Therapeutics
Diana Moore
Head of Global Corporate Communications
dmoore@amicusrx.com
(609) 662-5079
FOLD-G
FAQ
What was Amicus Therapeutics (FOLD) total revenue for 2024?
Amicus Therapeutics reported preliminary total revenue of $528.5 million for 2024, representing a 32% increase year-over-year.
How many patients were using Galafold for Fabry disease by end of 2024?
Approximately 2,730 patients with Fabry disease were using Galafold by the end of 2024.
What is FOLD’s revenue growth projection for 2025?
Amicus Therapeutics projects total revenue growth of 17-24% at constant exchange rates for 2025.
When will Amicus (FOLD) face generic competition for Galafold in the US?
Following a settlement with Teva, Amicus won’t face generic competition for Galafold in the US until January 2037.
What are the sales projections for Pombiliti + Opfolda in 2025?
Amicus expects Pombiliti + Opfolda revenue growth of 65-85% at constant exchange rates in 2025.
When does Amicus Therapeutics expect to achieve positive GAAP Net Income?
Amicus anticipates achieving positive GAAP Net Income during the second half of 2025.
