2025 Total Revenue of $634M, up 17% Year-over-Year at CER
Cash Position of $294M, a $44M Increase in 2025
Proposed Acquisition by BioMarin Expected to Close in Q2 2026, Subject to Closing Conditions
PRINCETON, N.J., Feb. 20, 2026 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD), a leading, global biotechnology company with a clear and compelling mission to develop and deliver transformative medicines for people living with rare diseases, today announced financial results for the full year ended December 31, 2025.
Full-Year 2025 Financial Highlights:
-- Total revenues for the full year 2025 were $634.2 million, reflecting
strong operational growth measured at constant exchange rates (CER)1 of
17% and a currency tailwind of $14 million. Fourth quarter total
revenues were $185.2 million up 24%, or 20% at CER1.
Twelve Months
Three Months Ended Year over Year % Ended December Year over Year %
(in thousands) December 31, Growth 31, Growth
------------------ ---------------- ------------------ ----------------
at at
2025 2024 Reported CER(1) 2025 2024 Reported CER(1)
Galafold$(R)$ $150,239 $127,497 18% 14% $521,702 $458,054 14% 12%
Pombiliti(R) +
Opfolda(R) $34,974 $22,209 57% 51% $112,508 $70,241 60% 56%
--------------- -------- -------- -------- ------ -------- -------- -------- ------
Net Product
Revenues $185,213 $149,706 24% 20% $634,210 $528,295 20% 17%
--------------- -------- -------- -------- ------ -------- -------- -------- ------
-- Galafold (migalastat) net product sales for the full year 2025 were
$521.7 million, representing a year-over-year increase of 14%, or 12% at
CER1. Fourth quarter net product sales were $150.2 million. Growth was
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 full year 2025 were $112.5 million, representing a
year-over-year increase of 60%, or 56% at CER1. Fourth quarter net
product sales were $35.0 million. Growth was driven by high commercial
demand from established and newly launched countries.
-- Total GAAP operating expenses of $528.5 million for the full year 2025
increased by 17% as compared to $450.5 million for the full year 2024.
Total non-GAAP operating expenses2 were up 24% to $431.9 million for the
full year 2025 as compared to $347.8 million for the full year 2024.
-- GAAP net loss of $27.1 million, or $0.09 per share basic and diluted, was
achieved in the full year 2025, compared to a GAAP net loss of $56.1
million, or $0.18 per share basic and diluted, for the full year 2024.
GAAP net income was $1.7 million, or $0.01 per share basic and diluted,
for the fourth quarter 2025, compared to a net income of $14.7 million,
or $0.05 per share basic and diluted, for the fourth quarter 2024.
-- Non-GAAP net income2,3 was $96.8 million, or $0.31 per share basic and
diluted, for the full year 2025, compared to non-GAAP net income of $73.9
million, or $0.24 per share basic and diluted, for the full year 2024.
Non-GAAP net income was $31.6 million, or $0.10 per share basic and
diluted, for the fourth quarter 2025, compared to a net income of $29.2
million, or $0.10 per share basic and $0.09 per share diluted, for the
fourth quarter 2024.
-- Cash, cash equivalents, and marketable securities increased to $293.5
million at December 31, 2025, as compared to $249.9 million at December
31, 2024.
Corporate Updates:
-- Proposed acquisition of Amicus by BioMarin. In December 2025, Amicus
entered into a definitive agreement to be acquired by BioMarin
Therapeutics for $14.50 per share in an all-cash transaction for a total
equity value of approximately $4.8 billion. The agreement has been
unanimously approved by the Boards of Directors of both companies and the
Amicus Board of Directors unanimously recommended that Amicus'
stockholders vote to adopt the agreement. The transaction is expected to
close in the second quarter of 2026, subject to regulatory clearances,
approval by the stockholders of Amicus and other customary closing
conditions.
-- On January 21, 2026, Amicus and BioMarin each filed a Premerger
Notification and Report Form under the HSR Act with the Antitrust
Division of the U.S. Department of Justice and the U.S Federal Trade
Commission (the "FTC") in connection with the Merger. On February 11,
2026, the FTC granted early termination of the waiting period under the
HSR Act.
-- Two oral presentations and 19 posters highlighting Amicus' development
programs in Fabry disease and Pompe disease presented at the 22nd Annual
WORLDSymposium$(TM)$. New data from clinical and real world evidence
studies support the growing body of evidence for Galafold and Pombiliti +
Opfolda.
(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.
Conference Call and Webcast
Given the pending acquisition of Amicus by BioMarin, Amicus is not providing financial guidance for 2026 and will not be hosting its quarterly conference call to discuss its financial results. Earnings materials are available publicly on the Investor Relations page of its website at ir.amicusrx.com.
About Galafold
Galafold(R) (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 leading, global biotechnology company with a clear and compelling mission: to develop and deliver transformative medicines for people living with rare diseases. With extraordinary patient focus, Amicus strives to redefine expectations in rare disease. For more information please visit the company's website at www.amicusrx.com, and follow on 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 proposed acquisition of Amicus by BioMarin (the "Transaction"), prospects and timing of the potential regulatory and pricing approval of our products, and commercialization plans. The inclusion of forward-looking statements should not be regarded as a representation by us that any of our plans will be achieved or that the conditions to the consummation of the Transaction will be satisfied. 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: uncertainties as to the ability to obtain stockholder approval for the Transaction; the possibility that competing offers will be made; the possibility that various closing conditions for the Transaction may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the Transaction; the effects of the Transaction on relationships with employees, other business partners or governmental entities; 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 DMX-200 may not be successful, including without limitation expectations of the timing of the 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, GAAP and 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, 2025, to be filed today. These risks, as well as other risks associated with the Transaction, are further discussed in the Proxy Statement filed with the U.S. Securities and Exchange Commission on February 2, 2026, in connection with the Transaction. 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
Brendan McEvoy
Executive Director, External Communications
bmcevoy@amicusrx.com
(609) 662-5005
FOLD-G
TABLE 1
Amicus Therapeutics, Inc.
Consolidated Statements of Operations
(in thousands, except share and per share amounts)
Years ended December 31,
2025 2024 2023
----------- ----------- -----------
Net product sales $ 634,210 $ 528,295 $ 399,356
Cost of goods sold 72,929 52,943 37,326
----------- ----------- -----------
Gross profit 561,281 475,352 362,030
Operating
expenses:
Research and
development 135,843 109,362 152,381
Selling,
general, and
administrative 383,487 323,379 275,270
Changes in fair
value of
contingent
consideration
payable -- -- 2,583
Loss on
impairment of
assets 1,702 -- 1,134
Restructuring
charges -- 9,188 --
Depreciation
and
amortization 7,460 8,547 7,873
----------- ----------- -----------
Total operating
expenses 528,492 450,476 439,241
Income (loss) from
operations 32,789 24,876 (77,211)
Other (expense)
income:
Interest income 3,317 5,407 7,078
Interest
expense (46,159) (49,598) (50,149)
Loss on
extinguishment
of debt -- -- (13,933)
Other (expense)
income 10,244 (9,441) (15,886)
----------- ----------- -----------
Income (loss)
before income
tax 191 (28,756) (150,101)
Income tax expense (27,301) (27,350) (1,483)
----------- ----------- -----------
Net loss
attributable to
common
stockholders $ (27,110) $ (56,106) $ (151,584)
=========== =========== ===========
Net loss
attributable to
common
stockholders per
common share --
basic and
diluted $ (0.09) $ (0.18) $ (0.51)
Weighted-average
common shares
outstanding --
basic and
diluted 308,363,768 304,380,502 295,164,515
TABLE 2
Amicus Therapeutics, Inc.
Consolidated Balance Sheets
(in thousands, except share and per share amounts)
December 31,
----------------------------
2025 2024
----------
Assets
Current assets:
Cash and cash equivalents $ 214,010 $ 213,752
Investments in marketable securities 79,526 36,194
Accounts receivable, net 115,307 101,099
Inventories, net 228,819 118,782
Prepaid expenses and other current
assets 38,511 34,909
---------- ----------
Total current assets 676,173 504,736
Operating lease right-of-use assets,
net 21,138 22,278
Property and equipment, less
accumulated depreciation of $31,821
and $28,775 at December 31, 2025 and
2024, respectively 27,108 29,383
Intangible assets, less accumulated
amortization of $9,085 and $5,802 at
December 31, 2025 and 2024,
respectively 13,915 17,198
Goodwill 197,797 197,797
Other non-current assets 13,739 13,641
---------- ----------
Total Assets $ 949,870 $ 785,033
========== ==========
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable $ 28,630 $ 12,947
Accrued expenses and other current
liabilities 200,457 127,300
Operating lease liabilities 8,741 8,455
---------- ----------
Total current liabilities 237,828 148,702
Long-term debt 392,660 390,111
Operating lease liabilities 40,962 45,078
Other non-current liabilities 4,179 7,097
---------- ----------
Total liabilities 675,629 590,988
Stockholders' equity:
Common stock, $0.01 par value,
500,000,000 shares authorized,
310,853,963 and 299,041,653 shares
issued and outstanding at December 31,
2025 and 2024, respectively 3,037 2,944
Common stock in treasury, at cost; 7,390
shares as of December 31, 2025 (71) --
Additional paid-in capital 3,014,456 2,926,115
Accumulated other comprehensive gain
(loss):
Foreign currency translation
adjustment 24,120 5,302
Unrealized loss on available-for-sale
securities (11) (207)
Warrants -- 71
Accumulated deficit (2,767,290) (2,740,180)
---------- ----------
Total stockholders' equity 274,241 194,045
---------- ----------
Total Liabilities and Stockholders'
Equity $ 949,870 $ 785,033
========== ==========
TABLE 3
Amicus Therapeutics, Inc.
Reconciliation of Non-GAAP Financial Measures
(in thousands)
(Unaudited)
Three Months Ended Twelve Months Ended
December 31, December 31,
--------------------- -----------------------
2025 2024 2025 2024
------- --------
Total operating
expenses - as
reported GAAP $ 142,719 $118,899 $ 528,492 $ 450,476
Research and
development:
Share-based
compensation 3,391 3,640 12,156 15,969
Selling, general
and
administrative:
Share-based
compensation 23,199 15,577 75,254 68,936
Loss on
impairment of
assets -- -- 1,702 --
Restructuring
Charges -- -- -- 9,188
Depreciation and
amortization 1,897 2,041 7,460 8,547
------- ------- -------- --------
Total operating
expense adjustments
to reported GAAP 28,487 21,258 96,572 102,640
------- ------- -------- --------
Total operating
expenses - as
adjusted $ 114,232 $ 97,641 $ 431,920 $ 347,836
======= ======= ======== ========
TABLE 4
Amicus Therapeutics, Inc.
Reconciliation of Non-GAAP Financial Measures
(in thousands, except share and per share amounts)
(Unaudited)
Three Months Ended Twelve Months Ended
December 31, December 31,
--------------------------- ------------------------------
2025 2024 2025 2024
----------- ----------- ----------- -----------
GAAP net income
(loss) $ 1,690 $ 14,739 $ (27,110) $ (56,106)
Share-based
compensation 26,590 19,217 87,410 84,905
Depreciation and
amortization 1,897 2,041 7,460 8,547
Loss on
impairment of
assets -- -- 1,702 --
Restructuring
charges -- -- -- 9,188
Income tax
expense
(benefit) 1,453 (6,805) 27,301 27,350
----------- ----------- ----------- -----------
Non-GAAP net
income $ 31,630 $ 29,192 $ 96,763 $ 73,884
=========== =========== =========== ===========
Non-GAAP net
income
attributable to
common
stockholders per
common share --
basic $ 0.10 $ 0.10 $ 0.31 $ 0.24
Non-GAAP net
income
attributable to
common
stockholders per
common share --
diluted $ 0.10 $ 0.09 $ 0.31 $ 0.24
Weighted-average
common shares
outstanding --
basic 309,028,669 306,136,125 308,363,768 304,380,502
Weighted-average
common shares
outstanding --
diluted 314,355,232 310,146,355 310,679,173 308,463,764
(END) Dow Jones Newswires
February 20, 2026 16:01 ET (21:01 GMT)