FOLD - Amicus Therapeutics Reports Preliminary 2023 Revenue and Provides 2024 Strategic Outlook | Benzinga
2023 Total Revenue of ~$399.4M, a 21% Increase Year-Over-Year
>2,400 People Living with Fabry Disease on Galafold® Following a Year of Increased Demand
Expecting 2024 Galafold Revenue Growth of 11-16% at CER
Successful Launches of Pombiliti™ + Opfolda™ Underway in the U.S., U.K., and Germany
PRINCETON, N.J., Jan. 07, 2024 (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 2023 revenue, corporate updates, and full-year 2024 outlook.
In 2023, Amicus met or exceeded its strategic priorities, highlighted by:
- Sustaining double-digit Galafold revenue growth
- Securing FDA, EMA, and MHRA approvals for Pombiliti + Opfolda
- Initiating successful global launches of Pombiliti + Opfolda
- Advancing next-generation pipeline programs
- On-track to achieving non-GAAP profitability in the fourth quarter of 2023
Preliminary and Unaudited 2023 Revenue:
- Total revenue in 2023 reached ~$399.4 million, representing a year-over-year increase of 21%, reflecting strong operational growth measured at constant exchange rates (CER)1 of 20% and a favorable currency impact of approximately $2.7 million, or 1%. Fourth quarter total revenue was ~$115.1 million.
- Galafold (migalastat) net product sales in 2023 were ~$387.8 million, representing a year-over-year increase of 18%, or 17% at CER. Fourth quarter Galafold net product sales were ~$106.6 million.
- Pombiliti (cipaglucosidase alfa-atga) + Opfolda (miglustat) net product sales in 2023 were ~$11.6 million. The commercial launch of Pombiliti + Opfolda is successfully underway in the three largest markets with ~120 patients on treatment with commercial product or scheduled to be treated as of the end of 2023. Fourth quarter Pombiliti + Opfolda net product sales were ~$8.5 million.
Bradley Campbell, President and Chief Executive Officer of Amicus Therapeutics, Inc., stated, "Last year was an incredible year for Amicus highlighted by the continued double-digit growth of Galafold sales and the global regulatory approvals of our second commercial therapy, which is off to a fantastic launch. We expect 2024 to be a truly transformative year as we continue to drive significant revenue growth by treating an increasing number of Fabry patients globally, executing on the global launches of Pombiliti and Opfolda, which we believe has the potential to become the standard of care in a >$1B market today, and delivering our first full year of non-GAAP profitability. We look forward to reporting on our progress throughout this year as we further our mission for people living with rare diseases."
Amicus is focused on the following four key strategic priorities in 2024:
- Delivering double-digit Galafold revenue growth (11-16% at CER)
- Ensuring the successful global launches of Pombiliti + Opfolda
- Advancing ongoing studies to support medical and scientific leadership in Fabry and Pompe diseases
- Achieving full year non-GAAP profitability2
Mr. Campbell will discuss the Amicus corporate objectives and key milestones in a presentation at the 42nd Annual J.P. Morgan Healthcare Conference on Monday, January 8, 2024, at 2:15 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 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. Full-year 2024 Galafold revenue guidance utilizes actual exchange rate as of December 31, 2023.
2 Non-GAAP Net Income defined as GAAP Net 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, loss on impairment of assets, restructuring charges, and income taxes.
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 drug reactions reported with Galafold (?10 %) are headache, nasopharyngitis, urinary tract infection, nausea, and pyrexia.
DRUG INTERACTIONS
Avoid co-administration of Galafold with caffeine at least 2 hours before and 2 hours after taking Galafold.
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 ...