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Amicus Therapeutics Announces Second Quarter 2025 Financial Results and Corporate Updates

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Amicus Therapeutics (Nasdaq: FOLD) reported strong Q2 2025 financial results with total revenue of $154.7M, up 18% at constant exchange rates. The company's performance was driven by two commercial therapies: Galafold revenue reached $128.9M (up 12%) and Pombiliti + Opfolda achieved $25.8M (up 58%).

Key highlights include Japanese regulatory approval for Pombiliti + Opfolda in adult LOPD patients, progress in the ACTION3 Study of DMX-200 for FSGS, and anticipated GAAP profitability in H2 2025. The company maintains its 2025 guidance with projected revenue growth of 15-22% and expects to exceed $1 billion in total revenue by 2028.

Q2 GAAP net loss was $24.4M ($0.08 per share), while non-GAAP net income was $1.9M ($0.01 per share). Cash position stood at $231.0M as of June 30, 2025.

Amicus Therapeutics (Nasdaq: FOLD) ha riportato solidi risultati finanziari per il secondo trimestre 2025 con un fatturato totale di 154,7 milioni di dollari, in crescita del 18% a tassi di cambio costanti. La performance dell'azienda è stata trainata da due terapie commerciali: il ricavo di Galafold ha raggiunto 128,9 milioni di dollari (in aumento del 12%) e Pombiliti + Opfolda ha totalizzato 25,8 milioni di dollari (in crescita del 58%).

Tra i principali eventi si segnalano l'approvazione regolatoria in Giappone per Pombiliti + Opfolda nei pazienti adulti con LOPD, i progressi nello studio ACTION3 di DMX-200 per FSGS e la previsione di redditività GAAP nella seconda metà del 2025. L'azienda conferma le previsioni per il 2025 con una crescita del fatturato stimata tra il 15% e il 22% e si aspetta di superare 1 miliardo di dollari di fatturato totale entro il 2028.

La perdita netta GAAP del secondo trimestre è stata di 24,4 milioni di dollari (0,08 dollari per azione), mentre l'utile netto non GAAP è stato di 1,9 milioni di dollari (0,01 dollari per azione). La posizione di cassa al 30 giugno 2025 era di 231,0 milioni di dollari.

Amicus Therapeutics (Nasdaq: FOLD) reportó sólidos resultados financieros en el segundo trimestre de 2025 con ingresos totales de $154.7M, un aumento del 18% a tipos de cambio constantes. El desempeño de la empresa estuvo impulsado por dos terapias comerciales: los ingresos de Galafold alcanzaron $128.9M (un aumento del 12%) y Pombiliti + Opfolda lograron $25.8M (un incremento del 58%).

Los aspectos destacados incluyen la aprobación regulatoria en Japón para Pombiliti + Opfolda en pacientes adultos con LOPD, avances en el estudio ACTION3 de DMX-200 para FSGS y la rentabilidad GAAP anticipada para la segunda mitad de 2025. La compañía mantiene su guía para 2025 con un crecimiento proyectado de ingresos del 15-22% y espera superar los $1 mil millones en ingresos totales para 2028.

La pérdida neta GAAP en el segundo trimestre fue de $24.4M ($0.08 por acción), mientras que el ingreso neto no GAAP fue de $1.9M ($0.01 por acción). La posición de efectivo al 30 de junio de 2025 fue de $231.0M.

아미커스 테라퓨틱스 (Nasdaq: FOLD)는 2025년 2분기에 총 매출 1억 5470만 달러를 기록하며 환율 변동을 고려한 기준으로 18% 성장한 강력한 실적을 발표했습니다. 회사의 성과는 두 가지 상업용 치료제에 의해 견인되었으며, Galafold 매출은 1억 2890만 달러(12% 증가), Pombiliti + Opfolda는 2580만 달러(58% 증가)를 기록했습니다.

주요 하이라이트로는 일본에서 성인 LOPD 환자를 위한 Pombiliti + Opfolda의 규제 승인, FSGS 치료제 DMX-200의 ACTION3 연구 진전, 2025년 하반기 GAAP 수익성 예상이 포함됩니다. 회사는 2025년 매출 성장률 15-22% 전망을 유지하며, 2028년까지 총 매출 10억 달러 이상 달성을 기대하고 있습니다.

2분기 GAAP 순손실은 2440만 달러(주당 0.08달러)였으며, 비GAAP 순이익은 190만 달러(주당 0.01달러)였습니다. 2025년 6월 30일 기준 현금 보유액은 2억 3100만 달러였습니다.

Amicus Therapeutics (Nasdaq : FOLD) a annoncé de solides résultats financiers pour le deuxième trimestre 2025 avec un chiffre d'affaires total de 154,7 millions de dollars, en hausse de 18 % à taux de change constants. La performance de l'entreprise a été portée par deux thérapies commerciales : le chiffre d'affaires de Galafold a atteint 128,9 millions de dollars (en hausse de 12 %) et Pombiliti + Opfolda a réalisé 25,8 millions de dollars (en progression de 58 %).

Les points clés incluent l'approbation réglementaire japonaise pour Pombiliti + Opfolda chez les patients adultes atteints de LOPD, les progrès de l'étude ACTION3 sur le DMX-200 pour la FSGS, et la rentabilité GAAP attendue au second semestre 2025. L'entreprise maintient ses prévisions pour 2025 avec une croissance du chiffre d'affaires projetée entre 15 et 22 % et prévoit de dépasser 1 milliard de dollars de chiffre d'affaires total d'ici 2028.

La perte nette GAAP du deuxième trimestre s'est élevée à 24,4 millions de dollars (0,08 dollar par action), tandis que le bénéfice net non GAAP était de 1,9 million de dollars (0,01 dollar par action). La trésorerie au 30 juin 2025 s'élevait à 231,0 millions de dollars.

Amicus Therapeutics (Nasdaq: FOLD) meldete starke Finanzergebnisse für das zweite Quartal 2025 mit einem Gesamtumsatz von 154,7 Mio. USD, was einem Anstieg von 18 % bei konstanten Wechselkursen entspricht. Die Leistung des Unternehmens wurde von zwei kommerziellen Therapien getragen: Der Umsatz von Galafold erreichte 128,9 Mio. USD (plus 12 %) und Pombiliti + Opfolda erzielten 25,8 Mio. USD (plus 58 %).

Zu den wichtigsten Highlights zählen die Zulassung von Pombiliti + Opfolda in Japan für erwachsene LOPD-Patienten, Fortschritte in der ACTION3-Studie zu DMX-200 bei FSGS sowie die erwartete GAAP-Rentabilität in der zweiten Hälfte des Jahres 2025. Das Unternehmen bestätigt seine Prognose für 2025 mit einem erwarteten Umsatzwachstum von 15-22 % und rechnet damit, bis 2028 einen Gesamtumsatz von über 1 Milliarde USD zu erzielen.

Der GAAP-Nettogewinn im zweiten Quartal betrug -24,4 Mio. USD (-0,08 USD je Aktie), während der Non-GAAP-Nettogewinn 1,9 Mio. USD (0,01 USD je Aktie) betrug. Die Barbestände beliefen sich zum 30. Juni 2025 auf 231,0 Mio. USD.

Positive
  • Total revenue growth of 18% at CER, marking 17th consecutive quarter of double-digit gains
  • Galafold revenue up 12% to $128.9M driven by new patient starts and strong compliance
  • Pombiliti + Opfolda revenue surged 58% to $25.8M with launches in five countries
  • Japanese regulatory approval obtained for Pombiliti + Opfolda
  • Company expects to achieve GAAP profitability in H2 2025
  • Projected to exceed $1B in total revenue by 2028
Negative
  • GAAP net loss increased to $24.4M from $15.7M year-over-year
  • Operating expenses increased 48% to $148.9M, including $30M upfront payment for DMX-200 licensing
  • Cash position decreased to $231.0M from $249.9M at end of 2024

Insights

Amicus delivers strong 18% growth with both products performing well, maintains guidance including H2 2025 profitability milestone.

Amicus Therapeutics delivered a solid Q2 2025 with $154.7 million in total revenue, representing 18% growth at constant exchange rates. This marks their 17th consecutive quarter of double-digit growth, demonstrating consistent commercial execution across their rare disease portfolio.

Breaking down the revenue components, Galafold generated $128.9 million (12% growth at CER), while Pombiliti+Opfolda contributed $25.8 million (58% growth at CER). The latter is particularly encouraging as it shows accelerating adoption of their newer therapy, which should provide a second growth pillar alongside the more established Galafold franchise.

The company reported a GAAP net loss of $24.4 million ($0.08 per share) for the quarter, compared to a $15.7 million loss in Q2 2024. However, the wider loss is primarily due to the $30 million upfront payment for licensing DMX-200, a Phase 3 asset for FSGS (focal segmental glomerulosclerosis). Excluding this strategic investment, non-GAAP net income was $1.9 million ($0.01 per share), though down from $18.5 million in Q2 2024.

The cash position remains solid at $231 million as of June 30, providing adequate runway as the company approaches GAAP profitability in H2 2025. Management has reiterated its full-year guidance, projecting 15-22% total revenue growth, with Galafold growing 10-15% and Pombiliti+Opfolda increasing 50-65%.

The pipeline is advancing with the ACTION3 study of DMX-200 on track to complete enrollment by year-end, potentially adding a third commercial asset in the medium term. Additionally, Pombiliti+Opfolda received regulatory approval in Japan in June, with up to 10 new launch countries expected in 2025, which should drive further growth.

Looking further ahead, management has set an ambitious goal of exceeding $1 billion in total revenue by 2028, which would represent substantial growth from current levels. With two commercial products gaining traction, a promising pipeline asset, and a clear path to profitability, Amicus is making steady progress in its transformation into a sustainable rare disease biotech company.

Q2 2025 Total Revenue of $154.7M, up 18% at CER

Galafold® Q2 Revenue of $128.9M, up 12% at CER

Pombiliti® + Opfolda® Q2 Revenue of $25.8M, up 58% at CER

Reiterating 2025 Financial Guidance including GAAP Profitability During H2 2025

Conference Call and Webcast Today at 8:30 a.m. ET

PRINCETON, N.J., July 31, 2025 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD), a patient-dedicated global biotechnology company focused on developing and commercializing novel medicines for rare diseases, today announced financial results for the quarter ended June 30, 2025.

"We delivered strong second quarter growth of 18%, marking the seventeenth consecutive quarter of double-digit gains at CER and reflecting excellent commercial execution for both Galafold and Pombiliti + Opfolda. Looking ahead, we expect Galafold to continue its growth trajectory, fueled by underlying patient demand, and Pombiliti + Opfolda to gain momentum with new patient starts across the U.S. and other key markets. Our collaboration with Dimerix on DMX-200 for FSGS is also progressing well, with the pivotal Phase 3 study expected to complete enrollment by year-end. Building on the performance of our two commercial therapies, we are firmly positioned to reach GAAP profitability in the second half of 2025 and to drive continued growth and patient benefit well into the future," said Bradley Campbell, President and Chief Executive Officer of Amicus Therapeutics, Inc. “With our unique, leverageable capabilities, the underlying momentum in our business and the significant remaining unmet patient need across markets in Fabry and Pompe diseases, Amicus anticipates exceeding $1 billion in total revenue in 2028 and furthering our position as a leading rare disease focused biotechnology company.”

Second Quarter 2025 Financial Highlights:

  • Total revenues for the second quarter 2025 were $154.7 million, reflecting strong operational growth measured at constant exchange rates (CER)1 of 18% and a currency tailwind of $5 million or 4%.
(in thousands)Three Months Ended
June 30,
 Year over Year %
Growth
 Six Months Ended
June 30,
 Year over Year %
Growth
  2025  2024 Reported at CER1  2025  2024 Reported at CER1
Galafold®$128,872 $110,817 16% 12% $233,116 $210,176 11% 9%
Pombiliti® + Opfolda®$25,816 $15,852 63% 58% $46,821 $26,896 74% 72%
Net Product Revenues$154,688 $126,669 22% 18% $279,937 $237,072 18% 16%
                        
                        
  • Galafold (migalastat) net product sales for the second quarter 2025 were $128.9 million, representing a year-over-year increase of 16%, or 12% at CER1, driven by continued commercial execution in all markets, net new patient starts, and strong compliance.
  • Pombiliti (cipaglucosidase alfa-atga) + Opfolda (miglustat) net product sales for the second quarter 2025 were $25.8 million, representing a year-over-year increase of 63%, or 58% at CER1, driven by high commercial demand and new launches in five countries.
  • Total GAAP operating expenses, which include the upfront payment of $30 million for the U.S. licensing agreement of DMX-200, of $148.9 million for the second quarter 2025 increased by 48% as compared to $100.4 million for the second quarter 2024. Total non-GAAP operating expenses2, which also include the upfront payment of $30 million for the U.S. licensing agreement of DMX-200, were up 56% to $127.8 million for the second quarter 2025 as compared to $82.1 million for the second quarter 2024.
  • GAAP net loss was $24.4 million, or $0.08 loss per share basic and diluted, for the second quarter 2025, compared to a net loss of $15.7 million, or $0.05 per share basic and diluted, for the second quarter 2024. Non-GAAP net income2,3 was $1.9 million, or $0.01 per share basic and diluted, for the second quarter 2025, compared to non-GAAP net income of $18.5 million, or $0.06 per share basic and diluted, for the second quarter 2024.
  • Cash, cash equivalents, and marketable securities totaled $231.0 million at June 30, 2025 as compared to $249.9 million at December 31, 2024. Current cash position reflects the $30 million upfront payment in the second quarter for the U.S. licensing agreement of DMX-200.

Corporate Updates:

  • Pombiliti + Opfolda regulatory approval granted in Japan for adult LOPD patients in June. The Company also continues to anticipate additional reimbursement agreements throughout the year and remains on track for up to 10 new launch countries in 2025.
  • New analysis of data from the ERT-experienced cohort of the PROPEL study of cipaglucosidase alfa + miglustat published in Muscle and Nerve. As previously announced, in this new publication, based on a within group effect-size analysis, subjects who switched from alglucosidase alfa to cipaglucosidase alfa + miglustat achieved improvements or stability in most of the outcomes measured.
  • ACTION3 Study of DMX-200 is on track for full enrollment by end of year. As announced in May, Amicus entered into a licensing agreement with Dimerix for exclusive rights for the U.S. commercialization of their Phase 3 asset, DMX-200. DMX-200 is a first in class treatment for FSGS, a rare and fatal kidney disease with no approved therapies and significant market potential. The ACTION3 study, being funded and executed by Dimerix, is on track for full enrollment by end of the year.

2025 Financial Guidance

Amicus reiterates its financial guidance for 2025, as follows:

Total Revenue Growth115% to 22% 
Galafold Revenue Growth110% to 15% 
Pombiliti + Opfolda Revenue Growth150% to 65% 
Gross MarginMid 80% 
Non-GAAP Operating Expenses4$380M to $400M(Incl. $30M Upfront License Payment)
GAAP Net IncomePositive during H2 2025 
   

1 In order to illustrate underlying performance, Amicus discusses its results in terms of constant exchange rate (CER) growth. This represents growth calculated as if the exchange rates had remained unchanged from those used in the comparative period.
2 Full reconciliation of GAAP results to the Company’s non-GAAP adjusted measures for all reporting periods appear in the tables to this press release.
3 Amicus defines non-GAAP Net (Loss) Income as GAAP Net (Loss) Income excluding the impact of share-based compensation expense, changes in fair value of contingent consideration, loss on impairment of assets, depreciation and amortization, acquisition related income (expense), loss on extinguishment of debt, restructuring charges and income taxes.
4 A reconciliation of the differences between the non-GAAP expectation and the corresponding GAAP measure is not available without unreasonable effort due to high variability, complexity, and low visibility as to the items that would be excluded from the GAAP measure.

Conference Call and Webcast
Amicus Therapeutics will host a conference call and audio webcast today, July 31, 2025, at 8:30 a.m. ET to discuss the second quarter 2025 financial results and corporate updates. Participants and investors interested in accessing the call by phone will need to register using the online registration form. After registering, all phone participants will receive a dial-in number along with a personal PIN to access the event.

A live audio webcast and related presentation materials can also be accessed via the Investors section of the Amicus Therapeutics corporate website at ir.amicusrx.com. Web participants are encouraged to register on the website 15 minutes prior to the start of the call. An archived webcast and accompanying slides will be available on the Company's website shortly after the conclusion of the live event.

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 approval of our products, commercialization plans, manufacturing and supply plans, financing plans, the collaboration with Dimerix, and the projected revenues 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 the Dimerix license agreement for of DMX-200 may not be successful, including without limitation expectations of the timing of Phase 3 clinical trial evaluating DMX-200; the likelihood of success of such clinical trial; the prospects for FDA approval of DMX-200 for FSGS or other indications; the estimated prevalence of FSGS; the achievement of any milestone and timing of any payments associated with milestones and the success of any efforts to commercialize DMX-200, including any projections of future financial performance or payments; the potential that we may not be able to manufacture or supply sufficient commercial products; and the potential that we will need additional funding to complete 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 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, 2024 and our Quarterly Report on Form 10-Q to be filed today. 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 Affairs and Communications
dmoore@amicusrx.com
(609) 662-5079

FOLD-G


TABLE 1

Amicus Therapeutics, Inc.
Consolidated Statements of Operations
(Unaudited)
(in thousands, except share and per share amounts)
 
 Three Months Ended June 30, Six Months Ended June 30,
  2025   2024   2025   2024 
Net product sales$154,688  $126,669  $279,937  $237,072 
Cost of goods sold 15,217   11,261   26,915   24,828 
Gross profit 139,471   115,408   253,022   212,244 
Operating expenses:       
Research and development 60,848   24,683   88,687   53,012 
Selling, general, and administrative 84,543   73,576   176,370   161,605 
Restructuring charges          6,045 
Loss on impairment of assets 1,702      1,702    
Depreciation and amortization 1,852   2,182   3,689   4,336 
Total operating expenses 148,945   100,441   270,448   224,998 
Loss from operations (9,474)  14,967   (17,426)  (12,754)
Other expense:       
Interest income 843   1,370   1,655   2,910 
Interest expense (11,565)  (12,512)  (23,020)  (24,948)
Other income (expense) 1,015   (3,717)  1,565   (8,683)
Loss before income tax (19,181)  108   (37,226)  (43,475)
Income tax expense (5,239)  (15,805)  (8,880)  (20,641)
Net loss attributable to common stockholders$(24,420) $(15,697) $(46,106) $(64,116)
Net loss attributable to common stockholders per common share — basic and diluted$(0.08) $(0.05) $(0.15) $(0.21)
Weighted-average common shares outstanding — basic and diluted 308,254,256   303,773,922   307,972,054   303,336,787 


TABLE 2

Amicus Therapeutics, Inc.
Consolidated Balance Sheets
(in thousands, except share and per share amounts)
 
 June 30, 2025 December 31, 2024
Assets   
Current assets:   
Cash and cash equivalents$158,702  $213,752 
Investments in marketable securities 72,296   36,194 
Accounts receivable 105,849   101,099 
Inventories 154,875   118,782 
Prepaid expenses and other current assets 46,285   34,909 
Total current assets 538,007   504,736 
Operating lease right-of-use assets, net 21,988   22,278 
Property and equipment, less accumulated depreciation of $30,991 and $28,775 at June 30, 2025 and December 31, 2024, respectively 28,570   29,383 
Intangible assets, less accumulated amortization of $7,430 and $5,802 at June 30, 2025 and December 31, 2024, respectively 15,570   17,198 
Goodwill 197,797   197,797 
Other non-current assets 13,371   13,641 
Total Assets$815,303  $785,033 
Liabilities and Stockholders’ Equity   
Current liabilities:   
Accounts payable$13,893  $12,947 
Accrued expenses and other current liabilities 145,144   127,300 
Operating lease liabilities 8,610   8,455 
Total current liabilities 167,647   148,702 
Long-term debt 391,322   390,111 
Operating lease liabilities 43,383   45,078 
Other non-current liabilities 8,647   7,097 
Total liabilities 610,999   590,988 
Commitments and contingencies   
Stockholders’ equity:   
Common stock, $0.01 par value, 500,000,000 shares authorized, 308,064,329 and 299,041,653 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively 3,016   2,944 
Common stock in treasury, at cost; 7,390 shares as of June 30, 2025 (71)   
Additional paid-in capital 2,956,839   2,926,115 
Accumulated other comprehensive income (loss):   
Foreign currency translation adjustment 30,935   5,302 
Unrealized loss on available-for-sale securities (129)  (207)
Warrants    71 
Accumulated deficit (2,786,286)  (2,740,180)
Total stockholders’ equity 204,304   194,045 
Total Liabilities and Stockholders’ Equity$815,303  $785,033 


TABLE 3

Amicus Therapeutics, Inc.
Reconciliation of Non-GAAP Financial Measures
(in thousands)
(Unaudited)
 
 Three Months Ended
June 30,
 Six Months Ended
June 30,
  2025  2024  2025  2024
Total operating expenses - as reported GAAP$ 148,945 $ 100,441 $ 270,448 $ 224,998
Research and development:       
Share-based compensation 2,393  3,061  6,397  7,932
Selling, general and administrative:       
Share-based compensation 15,166  13,136  36,334  39,068
Loss on impairment of assets 1,702    1,702  
Restructuring Charges       6,045
Depreciation and amortization 1,852  2,182  3,689  4,336
Total operating expense adjustments to reported GAAP 21,113  18,379  48,122  57,381
Total operating expenses - as adjusted$127,832 $82,062 $222,326 $167,617


TABLE 4

Amicus Therapeutics, Inc.
Reconciliation of Non-GAAP Financial Measures
(in thousands, except share and per share amounts)
(Unaudited)
 
  Three Months Ended
June 30,
 Six Months Ended
June 30,
   2025   2024   2025   2024 
         
GAAP net loss $(24,420) $(15,697) $(46,106) $(64,116)
Share-based compensation  17,559   16,197   42,731   47,000 
Depreciation and amortization  1,852   2,182   3,689   4,336 
Loss on impairment of assets  1,702      1,702    
Restructuring charges           6,045 
Income tax expense  5,239   15,805   8,880   20,641 
Non-GAAP net income $1,932  $18,487  $10,896  $13,906 
         
Non-GAAP net income attributable to common stockholders per common share — basic and diluted $0.01  $0.06  $0.04  $0.05 
Weighted-average common shares outstanding — basic  308,254,256   303,773,922   307,972,054   303,336,787 
Weighted-average common shares outstanding — diluted  309,651,693   307,022,626   309,520,474   307,598,542 

FAQ

What were Amicus Therapeutics (FOLD) Q2 2025 earnings results?

Amicus reported total revenue of $154.7M (up 18%), with Galafold revenue of $128.9M (up 12%) and Pombiliti + Opfolda revenue of $25.8M (up 58%). GAAP net loss was $24.4M or $0.08 per share.

What is FOLD's revenue guidance for 2025?

Amicus expects total revenue growth of 15-22% for 2025, with Galafold growth of 10-15% and Pombiliti + Opfolda growth of 50-65%.

When does Amicus Therapeutics expect to become profitable?

The company anticipates achieving GAAP profitability during the second half of 2025.

What is the cash position of Amicus Therapeutics as of Q2 2025?

Amicus reported cash, cash equivalents, and marketable securities of $231.0M as of June 30, 2025.

What are the main revenue drivers for Amicus Therapeutics?

The company's revenue is driven by two commercial therapies: Galafold for Fabry disease ($128.9M in Q2) and Pombiliti + Opfolda for Pompe disease ($25.8M in Q2).
Amicus Therapeut

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1.89B
281.92M
0.83%
100.63%
5.06%
Biotechnology
Pharmaceutical Preparations
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United States
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