Amicus Therapeutics Announces Third Quarter 2024 Financial Results and Corporate Updates
Amicus Therapeutics reported strong Q3 2024 financial results with total revenue of $141.5M, up 37% year-over-year. Galafold revenue reached $120.4M (20% increase), while Pombiliti + Opfolda revenue hit $21.1M (33% increase from Q2). The company achieved non-GAAP profitability with net income of $30.8M ($0.10 per share). Based on strong performance, Amicus raised its 2024 total revenue growth guidance to 30-32% and reduced non-GAAP operating expense guidance to $340M-$350M. The company also announced a settlement with Teva regarding Galafold patent litigation, securing market exclusivity until January 2037.
Amicus Therapeutics ha riportato risultati finanziari solidi per il terzo trimestre del 2024, con un fatturato totale di 141,5 milioni di dollari, in aumento del 37% rispetto all'anno precedente. I ricavi di Galafold hanno raggiunto 120,4 milioni di dollari (un incremento del 20%), mentre i ricavi di Pombiliti + Opfolda sono stati di 21,1 milioni di dollari (aumento del 33% rispetto al secondo trimestre). L'azienda ha raggiunto la redditività non-GAAP con un utile netto di 30,8 milioni di dollari (0,10 dollari per azione). In base a questa forte performance, Amicus ha alzato le previsioni di crescita del fatturato totale per il 2024 a una fascia del 30-32% e ha ridotto le stime delle spese operative non-GAAP a 340-350 milioni di dollari. L'azienda ha anche annunciato un accordo con Teva riguardante le controversie sui brevetti di Galafold, assicurando l'esclusività di mercato fino a gennaio 2037.
Amicus Therapeutics reportó resultados financieros sólidos para el tercer trimestre de 2024, con ingresos totales de 141.5 millones de dólares, un aumento del 37% en comparación con el año anterior. Los ingresos de Galafold alcanzaron 120.4 millones de dólares (aumento del 20%), mientras que los ingresos de Pombiliti + Opfolda alcanzaron 21.1 millones de dólares (aumento del 33% desde el segundo trimestre). La compañía logró rentabilidad no-GAAP con un ingreso neto de 30.8 millones de dólares (0.10 dólares por acción). Basándose en un rendimiento sólido, Amicus elevó su guía de crecimiento de ingresos totales para 2024 a un rango del 30-32% y redujo la guía de gastos operativos no-GAAP a 340-350 millones de dólares. La compañía también anunció un acuerdo con Teva sobre el litigio de patentes de Galafold, asegurando exclusividad en el mercado hasta enero de 2037.
아미쿠스 테라퓨틱스는 2024년 3분기 강력한 재무 결과를 보고했으며, 총 수익은 1억 4150만 달러로 전년 대비 37% 증가했습니다. 갈라폴드의 수익은 1억 2040만 달러(20% 증가)에 이르렀고, 폼빌리티 + 오폴다의 수익은 2110만 달러(2분기 대비 33% 증가)를 기록했습니다. 이 회사는 비GAAP 기준으로 3080만 달러(주당 0.10 달러)의 순이익으로 수익성을 달성했습니다. 강력한 성과를 바탕으로 아미쿠스는 2024년 총 수익 성장 전망을 30-32%로 높이고 비GAAP 운영 비용 전망을 3억 4000만~3억 5000만 달러로 줄였습니다. 또한 이 회사는 갈라폴드 특허 소송과 관련하여 테바와의 합의를 발표하여 2037년 1월까지 시장 독점권을 확보했습니다.
Amicus Therapeutics a rapporté de solides résultats financiers pour le troisième trimestre 2024, avec un chiffre d'affaires total de 141,5 millions de dollars, en hausse de 37 % par rapport à l'année précédente. Les revenus de Galafold ont atteint 120,4 millions de dollars (augmentation de 20 %), tandis que les revenus de Pombiliti + Opfolda ont atteint 21,1 millions de dollars (augmentation de 33 % par rapport au deuxième trimestre). L'entreprise a atteint la rentabilité non-GAAP avec un revenu net de 30,8 millions de dollars (0,10 dollar par action). Sur la base de cette performance solide, Amicus a révisé à la hausse ses prévisions de croissance du chiffre d'affaires total pour 2024 à une fourchette de 30-32 % et a réduit ses prévisions de dépenses d'exploitation non-GAAP à 340-350 millions de dollars. L'entreprise a également annoncé un règlement avec Teva concernant le litige sur le brevet de Galafold, lui assurant une exclusivité sur le marché jusqu'en janvier 2037.
Amicus Therapeutics berichtete über starke Finanzkennzahlen für das dritte Quartal 2024, mit einem Gesamtumsatz von 141,5 Millionen Dollar, was einem Anstieg von 37 % im Vergleich zum Vorjahr entspricht. Die Umsätze von Galafold erreichten 120,4 Millionen Dollar (20 % Steigerung), während die Umsätze von Pombiliti + Opfolda bei 21,1 Millionen Dollar lagen (33 % Steigerung gegenüber dem zweiten Quartal). Das Unternehmen erzielte eine Non-GAAP-Rentabilität mit einem Nettogewinn von 30,8 Millionen Dollar (0,10 Dollar pro Aktie). Basierend auf dieser starken Leistung hob Amicus die Prognose für das Umsatzwachstum 2024 auf 30-32 % an und reduzierte die Prognose für die Non-GAAP-Betriebskosten auf 340-350 Millionen Dollar. Das Unternehmen gab außerdem eine Einigung mit Teva bezüglich der Galafold-Patentschutzklage bekannt und sicherte sich damit bis Januar 2037 Marktexklusivität.
- Total revenue increased 37% YoY to $141.5M in Q3 2024
- Galafold revenue grew 20% YoY to $120.4M
- Pombiliti + Opfolda revenue increased 33% QoQ to $21.1M
- Achieved non-GAAP profitability with $30.8M net income
- Raised 2024 revenue growth guidance to 30-32%
- Reduced operating expense guidance to $340M-$350M
- Secured Galafold market exclusivity until January 2037 through Teva settlement
- GAAP net loss of $6.7M in Q3 2024
- Cash position decreased to $249.8M from $286.2M in December 2023
Insights
The Q3 2024 results demonstrate robust financial performance with several positive indicators. Total revenue reached
Notably, the company achieved non-GAAP profitability with net income of
The commercial execution shows strong market penetration. Pombiliti + Opfolda has gained significant traction with 203 patients already treated or scheduled across five markets. The raised revenue guidance for both products indicates growing market acceptance and successful launch strategy. The Teva settlement provides important market exclusivity protection for Galafold through 2037, securing long-term revenue streams.
The reduction in operating expenses while maintaining growth demonstrates effective cost management and improving operational efficiency. The achievement of non-GAAP profitability ahead of schedule positions the company well for sustainable growth.
Q3 2024 Total Revenue of
Galafold® Q3 Revenue of
Pombiliti® + Opfolda® Q3 Revenue of
Raising 2024 Total Revenue Growth Guidance to
Reducing non-GAAP Operating Expense Guidance to
Conference Call and Webcast Today at 8:30 a.m. ET
PRINCETON, N.J., Nov. 06, 2024 (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 third quarter ended September 30, 2024.
“The third quarter of the year was marked by the excellent commercial performance of our two approved therapies and continued financial discipline,” said Bradley Campbell, President and Chief Executive Officer of Amicus Therapeutics, Inc. “Strong patient demand for Galafold drove double digit revenue growth, while the commercial launch of Pombiliti and Opfolda continues to build momentum. We also announced a settlement of the Galafold (migalastat) patent litigation with Teva, which is a major step forward in ensuring Amicus can continue to support the Fabry community with Galafold for many years to come. Importantly, throughout the first nine months of the year, we’ve exceeded expectations, which resulted in the achievement of non-GAAP profitability for the full year 2024 as we closed the third quarter. Amicus continues to be well positioned to drive sustainable shareholder value and further our mission of delivering great medicines for people living with rare diseases.”
Financial and Corporate Highlights:
- Total revenue in the third quarter 2024 was
$141.5 million , a year-over-year increase of37% from total revenue of$103.5 million in the third quarter 2023. On a constant currency basis (CER)1, third quarter 2024 total revenue growth was36% .
| (in thousands) | Three Months Ended September 30, | Year over Year % Growth | Nine Months Ended September 30, | Year over Year % Growth | |||||||||||
| 2024 | 2023 | Reported | at CER1 | 2024 | 2023 | Reported | at CER1 | ||||||||
| Galafold® | |||||||||||||||
| Pombiliti® + Opfolda® | |||||||||||||||
| Net Product Revenues | |||||||||||||||
- Galafold (migalastat) net product sales were
$120.4 million in the third quarter 2024, a year-over-year increase of20% , or19% at constant exchange rates1, reflecting continued strong demand. Given strong performance in the first nine months of 2024, the Company is raising its full year 2024 revenue growth guidance for Galafold to +16% to +18% on a constant currency basis (CER)1. - Pombiliti (cipaglucosidase alfa-atga) + Opfolda (miglustat) net product sales were
$21.1 million in the third quarter 2024, a33% increase from the second quarter of 2024. As of the end of October, 203 patients have been treated or are scheduled to be treated with commercial product in five markets (USA, Germany, UK, Spain, and Austria). Given strong launch momentum, the Company is raising its full year 2024 revenue guidance for Pombiliti + Opfolda to$69 million to$71 million on a constant currency basis (CER)1. - Total GAAP operating expenses of
$106.6 million for the third quarter 2024 decreased by4% as compared to$110.6 million for the third quarter 2023. Total non-GAAP operating expenses of$82.6 million for the third quarter 2024 decreased by8% as compared to$89.8 million for the third quarter 2023. Given continued financial discipline in the first nine months of 2024, the Company is reducing its non-GAAP Operating Expense guidance3 to$340 million to$350 million . - GAAP net loss was
$6.7 million , or$0.02 per share, for the third quarter 2024, and was reduced compared to a net loss of$21.6 million , or$0.07 per share, for the third quarter 2023. - Non-GAAP net income was
$30.8 million , or$0.10 per share, for the third quarter 2024, compared to a non-GAAP net loss of$4.0 million , or$0.01 per share, for the third quarter 20232. Non-GAAP profitability was also achieved in the first nine months of 2024. - Cash, cash equivalents, and marketable securities totaled
$249.8 million at September 30, 2024, compared to$286.2 million at December 31, 2023. - In October 2024, the Company announced that it has entered into a License Agreement with Teva Pharmaceuticals USA, Inc. and Teva Pharmaceuticals, Inc. allowing Teva to market a generic version of Galafold® in the United States beginning on January 30, 2037, if approved by the U.S. Food and Drug Administration (FDA) and unless certain limited circumstances customarily included in these types of agreements occur. Similar patent litigation previously disclosed by the Company will continue against Aurobindo (Aurobindo Pharma LTD and Aurobindo Pharma USA, Inc.) as the remaining active party and the litigation stay remains in place for Lupin (Lupin LTD and Lupin Pharmaceuticals, Inc.).
2024 Financial Guidance:
| Previous | Updated | ||
| Total Revenue Growth1 | → | ||
| Galafold Revenue Growth1 | → | ||
| Pombiliti + Opfolda Revenue1 | → | ||
| Non-GAAP Operating Expense3 | → | ||
Amicus is focused on the following key strategic priorities in 2024:
- Delivering double-digit Galafold revenue growth
- Executing multiple successful launches of Pombiliti + Opfolda
- Advancing ongoing studies to support medical and scientific leadership in Fabry and Pompe diseases
- Achieving full-year non-GAAP profitability4
1 At constant exchange rates (CER). In order to illustrate underlying performance, Amicus discusses its results in terms of CER growth. This represents growth calculated as if the exchange rates had remained unchanged from those used in the comparative period. Full-year revenue guidance utilizes actual exchange rate as of December 31, 2023.
2 Full reconciliation of GAAP results to the Company’s non-GAAP adjusted measures for the reporting period(s) appear in the tables to this press release.
3 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.
4 Based on projections of Amicus’ non-GAAP Net (Loss) Income under current operating plans, which includes successful Pombiliti + Opfolda launch and continued Galafold growth. 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
Amicus Therapeutics will host a conference call and audio webcast today, November 6, 2024, at 8:30 a.m. ET to discuss the third quarter 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 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® (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 (≥
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 ≥
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 preclinical and clinical development of our product candidates, the timing and reporting of results from preclinical studies and clinical trials, the prospects and timing of the potential regulatory approval of our product candidates, commercialization plans, manufacturing and supply plans, financing plans, 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, with respect to 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 results of clinical or preclinical studies indicate that the product candidates are unsafe or ineffective; the potential that it may be difficult to enroll patients in our clinical trials; 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 preclinical and clinical studies could be delayed because we identify serious side effects or other safety issues; the potential that we may not be able to manufacture or supply sufficient clinical or commercial products; and the potential that we will need additional funding to complete all of our studies, 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, 2023, and on Form 10-Q for the quarter ended September 30, 2024, 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 September 30, | Nine Months Ended September 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Net product sales | $ | 141,517 | $ | 103,501 | $ | 378,589 | $ | 284,274 | |||||||
| Cost of goods sold | 13,279 | 9,946 | 38,107 | 26,002 | |||||||||||
| Gross profit | 128,238 | 93,555 | 340,482 | 258,272 | |||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | 26,160 | 40,704 | 79,172 | 117,352 | |||||||||||
| Selling, general, and administrative | 75,106 | 65,651 | 236,711 | 205,031 | |||||||||||
| Changes in fair value of contingent consideration payable | — | 1,995 | — | 2,583 | |||||||||||
| Restructuring charges | 3,143 | — | 9,188 | — | |||||||||||
| Loss on impairment of assets | — | — | — | 1,134 | |||||||||||
| Depreciation and amortization | 2,170 | 2,228 | 6,506 | 5,691 | |||||||||||
| Total operating expenses | 106,579 | 110,578 | 331,577 | 331,791 | |||||||||||
| Income (loss) from operations | 21,659 | (17,023 | ) | 8,905 | (73,519 | ) | |||||||||
| Other expense: | |||||||||||||||
| Interest income | 1,081 | 1,471 | 3,991 | 5,407 | |||||||||||
| Interest expense | (12,692 | ) | (12,986 | ) | (37,640 | ) | (37,322 | ) | |||||||
| Other (expense) income | (3,263 | ) | 3,833 | (11,946 | ) | (13,007 | ) | ||||||||
| Income (loss) before income tax | 6,785 | (24,705 | ) | (36,690 | ) | (118,441 | ) | ||||||||
| Income tax (expense) benefit | (13,514 | ) | 3,128 | (34,155 | ) | 700 | |||||||||
| Net loss attributable to common stockholders | $ | (6,729 | ) | $ | (21,577 | ) | $ | (70,845 | ) | $ | (117,741 | ) | |||
| Net loss attributable to common stockholders per common share — basic and diluted | $ | (0.02 | ) | $ | (0.07 | ) | $ | (0.23 | ) | $ | (0.40 | ) | |||
| Weighted-average common shares outstanding — basic and diluted | 304,690,596 | 295,759,435 | 303,792,479 | 293,314,167 | |||||||||||
TABLE 2
Amicus Therapeutics, Inc.
Consolidated Balance Sheets
(Unaudited)
(in thousands, except share and per share amounts)
| September 30, 2024 | December 31, 2023 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 233,647 | $ | 246,994 | |||
| Investments in marketable securities | 16,110 | 39,206 | |||||
| Accounts receivable | 98,073 | 87,632 | |||||
| Inventories | 115,338 | 59,696 | |||||
| Prepaid expenses and other current assets | 35,306 | 49,533 | |||||
| Total current assets | 498,474 | 483,061 | |||||
| Operating lease right-of-use assets, net | 23,144 | 26,312 | |||||
| Property and equipment, less accumulated depreciation of | 30,438 | 31,667 | |||||
| Intangible assets, less accumulated amortization of | 18,026 | 20,490 | |||||
| Goodwill | 197,797 | 197,797 | |||||
| Other non-current assets | 18,678 | 18,553 | |||||
| Total Assets | $ | 786,557 | $ | 777,880 | |||
| Liabilities and Stockholders’ Equity | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 13,481 | $ | 15,120 | |||
| Accrued expenses and other current liabilities | 136,116 | 144,245 | |||||
| Operating lease liabilities | 8,541 | 8,324 | |||||
| Total current liabilities | 158,138 | 167,689 | |||||
| Long-term debt | 389,494 | 387,858 | |||||
| Operating lease liabilities | 46,623 | 48,877 | |||||
| Other non-current liabilities | 13,477 | 13,282 | |||||
| Total liabilities | 607,732 | 617,706 | |||||
| Commitments and contingencies | |||||||
| Stockholders’ equity: | |||||||
| Common stock, | 2,942 | 2,918 | |||||
| Additional paid-in capital | 2,905,760 | 2,836,018 | |||||
| Accumulated other comprehensive income (loss): | |||||||
| Foreign currency translation adjustment | 25,159 | 5,429 | |||||
| Unrealized loss on available-for-sale securities | (188 | ) | (188 | ) | |||
| Warrants | 71 | 71 | |||||
| Accumulated deficit | (2,754,919 | ) | (2,684,074 | ) | |||
| Total stockholders’ equity | 178,825 | 160,174 | |||||
| Total Liabilities and Stockholders’ Equity | $ | 786,557 | $ | 777,880 | |||
TABLE 3
Amicus Therapeutics, Inc.
Reconciliation of Non-GAAP Financial Measures
(in thousands)
(Unaudited)
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||
| Total operating expenses - as reported GAAP | $ | 106,579 | $ | 110,578 | $ | 331,577 | $ | 331,791 | |||
| Research and development: | |||||||||||
| Stock-based compensation | 4,397 | 4,380 | 12,329 | 16,987 | |||||||
| Selling, general and administrative: | |||||||||||
| Stock-based compensation | 14,291 | 12,131 | 53,359 | 50,995 | |||||||
| Loss on impairment of assets | — | — | — | 1,134 | |||||||
| Changes in fair value of contingent consideration payable | — | 1,995 | — | 2,583 | |||||||
| Restructuring Charges | 3,143 | — | 9,188 | — | |||||||
| Depreciation and amortization | 2,170 | 2,228 | 6,506 | 5,691 | |||||||
| Total operating expense adjustments to reported GAAP | 24,001 | 20,734 | 81,382 | 77,390 | |||||||
| Total operating expenses - as adjusted | $ | 82,578 | $ | 89,844 | $ | 250,195 | $ | 254,401 | |||
TABLE 4
Amicus Therapeutics, Inc.
Reconciliation of Non-GAAP Financial Measures
(in thousands, except share and per share amounts)
(Unaudited)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| GAAP net loss | $ | (6,729 | ) | $ | (21,577 | ) | $ | (70,845 | ) | $ | (117,741 | ) | ||||
| Share-based compensation | 18,688 | 16,511 | 65,688 | 67,982 | ||||||||||||
| Changes in fair value of contingent consideration payable | — | 1,995 | — | 2,583 | ||||||||||||
| Depreciation and amortization | 2,170 | 2,228 | 6,506 | 5,691 | ||||||||||||
| Loss on impairment of assets | — | — | — | 1,134 | ||||||||||||
| Restructuring charges | 3,143 | — | 9,188 | — | ||||||||||||
| Income tax expense (benefit) | 13,514 | (3,128 | ) | 34,155 | (700 | ) | ||||||||||
| Non-GAAP net income (loss) | $ | 30,786 | $ | (3,971 | ) | $ | 44,692 | $ | (41,051 | ) | ||||||
| Non-GAAP net income (loss) attributable to common stockholders per common share — basic and diluted | $ | 0.10 | $ | (0.01 | ) | $ | 0.15 | $ | (0.14 | ) | ||||||
| Weighted-average common shares outstanding — basic and diluted | 304,690,596 | 295,759,435 | 303,792,479 | 293,314,167 | ||||||||||||
FAQ
What was Amicus Therapeutics (FOLD) revenue in Q3 2024?
How much revenue did Galafold generate for FOLD in Q3 2024?
What is FOLD's new revenue guidance for 2024?
When will Teva be allowed to market generic Galafold according to the patent settlement with FOLD?
