8-K

AMICUS THERAPEUTICS, INC. (FOLD)

8-K 2026-02-20 For: 2026-02-20
View Original
Added on April 04, 2026

UNITEDSTATES

SECURITIESAND EXCHANGE COMMISSION

WASHINGTON,D.C. 20549

FORM

8-K

CURRENTREPORT PURSUANT TO

SECTION13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): February 20, 2026

AMICUS THERAPEUTICS, INC.

(Exact Name of Registrant as Specified in Its Charter)

Delaware 001-33497 71-0869350
(State or Other Jurisdiction of Incorporation) (Commission File Number) (I.R.S. Employer Identification No.)

47 Hulfish Street,

Princeton, NJ 08542

(Address of PrincipalExecutive Offices, and Zip Code)

609-662-2000

Registrant’sTelephone Number, Including Area Code

(Former Name or Former Address, if Changed Since Last Report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class Trading Symbol(s) Name of each exchange on which registered
Common Stock Par Value $0.01 FOLD NASDAQ

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). Emerging growth company  ¨

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 2.02 – Results of Operationsand Financial Condition


On February 20, 2026, Amicus Therapeutics, Inc. issued a press release announcing its financial results for the fiscal year ended December 31, 2025. A copy of this press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.

In accordance with General Instruction B.2. of Form 8-K, the information in this Current Report on Form 8-K and the Exhibits shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits:


Exhibit No. Description
99.1 Press Release, dated February 20, 2026
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

Signature Page

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

AMICUS THERAPEUTICS, INC.
Date: February 20, 2026 By: /s/ Ellen S. Rosenberg
Name: Ellen S. Rosenberg
Title: Chief Legal Officer and Corporate Secretary

Exhibit 99.1

AmicusTherapeutics Announces Full-Year 2025Financial Results and Corporate Updates

2025Total Revenue of $634M, up 17% Year-over-Year at CER

CashPosition of $294M, a $44M Increase in 2025

ProposedAcquisition by BioMarin Expected to Close in Q2 2026, Subject to Closing Conditions

PRINCETON,NJ, Feb. 20, 2026 – 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-Year2025 Financial Highlights:

· Total revenues for the full year 2025 were $634.2 million, reflecting strong operational growth<br> measured at constant exchange rates (CER)^1^ of 17% and a currency tailwind of ~$14<br> million. Fourth quarter total revenues were $185.2 million up 24%, or 20% at CER.
(in thousands) Three Months Ended December 31, Year over Year % Growth Twelve Months Ended December 31, Year over Year % Growth
--- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- ---
2025 2024 Reported at CER^1^ 2025 2024 Reported at CER^1^
Galafold^®^ $ 150,239 $ 127,497 18 % 14 % $ 521,702 $ 458,054 14 % 12 %
Pombiliti^®^ + Opfolda^®^ $ 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<br> a year-over-year increase of 14%, or 12% at CER^1^. Fourth quarter net product sales<br> were $150.2 million. Growth was driven by continued commercial execution in all markets,<br> 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 CER^1^.<br> Fourth quarter net product sales were $35.0 million. Growth was driven by high commercial<br> demand from established and newly launched countries.
--- ---
· Total GAAP operating expenses of $528.5 million for the full year 2025 increased by 17% as<br> compared to $450.5 million for the full year 2024. Total non-GAAP operating expenses^2^<br> were up 24% to $431.9 million for the full year 2025 as compared to $347.8 million for the<br> full year 2024.
--- ---
· GAAP net loss of $27.1 million, or $0.09 per share basic and diluted, was achieved in the<br> full year 2025, compared to a GAAP net loss of $56.1 million, or $0.18 per share basic and<br> diluted, for the full year 2024. GAAP net income was $1.7 million, or $0.01 per share basic<br> and diluted, for the fourth quarter 2025, compared to a net income of $14.7 million, or $0.05<br> per share basic and diluted, for the fourth quarter 2024.
--- ---
· Non-GAAP net income^2,3^ was $96.8 million, or $0.31 per share basic and diluted, for<br> the full year 2025, compared to non-GAAP net income of $73.9 million, or $0.24 per share<br> basic and diluted, for the full year 2024. Non-GAAP net income was $31.6 million, or $0.10<br> per share basic and diluted, for the fourth quarter 2025, compared to a net income of $29.2<br> 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,<br> 2025, as compared to $249.9 million at December 31, 2024.
--- ---
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CorporateUpdates:

· Proposed acquisition of Amicus by BioMarin. In December 2025, Amicus entered into a definitive<br> agreement to be acquired by BioMarin Therapeutics for $14.50 per share in an all-cash transaction<br> for a total equity value of approximately $4.8 billion. The agreement has been unanimously<br> approved by the Boards of Directors of both companies and the Amicus Board of Directors unanimously<br> recommended that Amicus’ stockholders vote to adopt the agreement. The transaction<br> is expected to close in the second quarter of 2026, subject to regulatory clearances, approval<br> by the stockholders of Amicus and other customary closing conditions.
· On<br> January 21, 2026, Amicus and BioMarin each filed a Premerger Notification and Report<br> Form under the HSR Act with the Antitrust Division of the U.S. Department of Justice<br> and the U.S Federal Trade Commission (the "FTC") in connection with the Merger.<br> On February 11, 2026, the FTC granted early termination of the waiting period under<br> the HSR Act.
--- ---
· Two oral presentations and 19 posters highlighting Amicus’ development programs in Fabry disease and Pompe disease presented at the 22^nd^ Annual WORLDSymposium.<br> New data from clinical and real world evidence studies support the growing body of evidence<br> 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.

ConferenceCall 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.

AboutGalafold

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

ADVERSEREACTIONS: 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 aboutGalafold, including the full U.S. Prescribing Information, please visit https://www.amicusrx.com/pi/Galafold.pdf.

AboutPombiliti + 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.

    2

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).

SAFETYINFORMATION

HYPERSENSITIVITYREACTIONS INCLUDING ANAPHYLAXIS: Appropriate medical support measures, including cardiopulmonary resuscitation equipment, should be readilyavailable. If a severe hypersensitivity reaction occurs, POMBILITI should be discontinued immediately and appropriate medical treatmentshould be initiated. INFUSION-ASSOCIATED REACTIONS (IARs): If severe IARs occur, immediately discontinue POMBILITI and initiate appropriatemedical treatment. RISK OF ACUTE CARDIORESPIRATORY FAILURE IN SUSCEPTIBLE PATIENTS: Patients susceptible to fluid volume overload, orthose with acute underlying respiratory illness or compromised cardiac or respiratory function, may be at risk of serious exacerbationof 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.

AboutAmicus 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-GAAPFinancial 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.

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ForwardLooking 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

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TABLE1

AmicusTherapeutics, Inc.

ConsolidatedStatements of Operations

(inthousands, 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
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TABLE2

AmicusTherapeutics, Inc.

ConsolidatedBalance Sheets

(inthousands, except share and per share amounts)

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

All values are in US Dollars.

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TABLE3

AmicusTherapeutics, Inc.

Reconciliationof Non-GAAP Financial Measures

(inthousands)

(Unaudited)

Three Months Ended December 31, Twelve Months Ended 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
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TABLE4

AmicusTherapeutics, Inc.

Reconciliationof Non-GAAP Financial Measures

(inthousands, except share and per share amounts)

(Unaudited)

Three Months Ended December 31, Twelve Months Ended 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
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