Amicus Therapeutics Announces Full-Year 2024 Financial Results and Corporate Updates

2024 Total Revenue of $528.3M, a 33% Increase Year-over-Year

Projecting 2025 Total Revenue Growth of 17-24% at CER

Anticipate Achieving Positive GAAP Net Income During H2 2025

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

PRINCETON, N.J., Feb. 19, 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 full-year ended December 31, 2024.

"We closed 2024 beating expectations with exceptional revenue growth of 33 percent. With our portfolio and global rare disease capabilities, we have a clear path to deliver continued revenue growth and accelerating profitability in 2025 and the years ahead. We have firmly established Amicus as a unique biotechnology company: two growing medicines with long runways, a leverageable infrastructure with patients at the center, and the financial strength to continue to build the business and our leadership in rare diseases," said Bradley Campbell, President and Chief Executive Officer of Amicus Therapeutics, Inc.

Corporate Highlights:

   -- Total revenues for the full-year 2024 were $528.3 million, reflecting 
      operational growth measured at constant exchange rates $(CER.UK)$1 of 33% and 
      a small currency impact of $1.1 million or 1%. Fourth quarter total 
      revenues were $149.7 million, up 30% as reported and at CER. For the full 
      year 2025, the Company provides total revenue growth guidance of +17% to 
      +24% on a constant currency basis (CER)1. 
 
                   Three Months                         Twelve Months 
                  Ended December    Year over Year %    Ended December    Year over Year % 
(in thousands)          31,              Growth              31,               Growth 
                 -----------------  ----------------  ------------------  ---------------- 
                                                at                                    at 
                  2024      2023    Reported  CER(1)    2024      2023    Reported  CER(1) 
  Galafold$(R)$    127,497   106,601       20%     20%   458,054   387,777       18%     19% 
Pombiliti(R) + 
   Opfolda(R)     22,209     8,481      162%    161%    70,241    11,579      507%    504% 
---------------  -------  --------  --------  ------  --------  --------  --------  ------ 
  Net Product 
    Revenues     149,706   115,082       30%     30%  $528,295  $399,356       32%     33% 
---------------  -------  --------  --------  ------  --------  --------  --------  ------ 
 
   -- 
   -- Galafold (migalastat) net product sales for the full-year 2024 were 
      $458.1 million, representing a year-over-year increase of 18%, or 19% at 
      CER. Fourth quarter net product sales were $127.5 million. At the end of 
      2024, there were 2,730 people living with Fabry disease on Galafold 
      following a year of increased demand. For the full year 2025, the Company 
      provides revenue growth guidance for Galafold of +10% to +15% on a 
      constant currency basis (CER)1. 
 
   -- Pombiliti (cipaglucosidase alfa-atga) + Opfolda (miglustat) net product 
      sales for the full-year 2024 were $70.2 million. Fourth quarter net 
      product sales were $22.2 million. Following a successful commercial 
      launch in the U.S., Germany, Austria, Spain and the U.K., there were 220 
      patients treated or scheduled with commercial product as of the end of 
      2024. For the full year 2025, the Company provides revenue growth 
      guidance for Pombiliti + Opfolda of +65% to +85% on a constant currency 
      basis (CER)1. 
 
   -- Multiple Pombiliti + Opfolda pricing and reimbursement agreements 
      recently achieved. Agreements completed in late 2024 and early 2025 
      include Italy, Sweden, Switzerland, Czech Republic and most recently the 
      Netherlands. First commercial patients from these countries are 
      anticipated to begin treatment over the first half of 2025. Additionally, 
      Pombiliti + Opfolda received regulatory approval in Australia and the 
      Company anticipates new regulatory decisions in Canada and Japan in 2025 
      as well as additional reimbursement agreements throughout the year. 
 
   -- 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 total revenue 
      growth. 
 
   -- Total GAAP operating expenses of $450.5 million for the full year 2024 
      increased by 2.6% as compared to $439.2 million for the full year 2023. 
      Total non-GAAP operating expenses2 were up 1.8% to $347.8 million for the 
      full year 2024 as compared to $341.6 million for the full year 2023. For 
      the full year 2025, the Company provides non-GAAP operating 
      expense4 guidance range of $350 million to $370 million. 
 
   -- GAAP net loss was $56.1 million, or $0.18 per share basic and diluted, 
      for the full year 2024, and was reduced compared to a net loss of $151.6 
      million, or $0.51 per share basic and diluted, for the full year 2023. 
      GAAP net income was $14.7 million, or $0.05 per share basic and diluted, 
      for the fourth quarter 2024, compared to a net loss of $33.8 million, or 
      $0.11 per share basic and diluted, for the fourth quarter 2023. The 
      company anticipates achieving positive GAAP net income during H2 2025. 
 
   -- Non-GAAP net income2,3 was $73.9 million, or $0.24 per share, for the 
      full year 2024, compared to a non-GAAP net loss of $38.5 million, or 
      $0.13 per share basic and diluted, for the full year 2023. Non-GAAP net 
      income was $29.2 million, or $0.10 per share basic and $0.09 per share 
      diluted, for the fourth quarter 2024, compared to a net income of $2.6 
      million, or $0.01 per share basic and diluted, for the fourth quarter 
      2023. 
 
   -- Cash, cash equivalents, and marketable securities totaled $249.9 million 
      at December 31, 2024, compared to $249.8 million at September 30, 2024 
      and $286.2 million at December 31, 2023. 

2025 Financial Guidance

To advance our strategy and expand our leadership in Fabry and Pompe disease, our financial guidance for 2025 is as follows:

 
Total Revenue Growth(1)                       17% to 24% 
Galafold Revenue Growth(1)                    10% to 15% 
Pombiliti + Opfolda Growth(1)                 65% to 85% 
Gross Margin                                     Mid 80% 
Non-GAAP Operating Expenses(4)            $350M to $370M 
GAAP Net Income                  Positive 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, February 19, 2025, at 8:30 a.m. ET to discuss the full-year 2024 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 number 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(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 $(GLA.AU)$ 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

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