Amicus Therapeutics Announces Second Quarter 2024 Financial Results and Corporate Updates
Amicus Therapeutics (Nasdaq: FOLD) reported strong Q2 2024 financial results with total revenue of $126.7 million, a 34% year-over-year increase. Galafold revenue grew by 17% to $110.8 million, and Pombiliti + Opfolda revenue rose 44% from Q1 2024 to $15.9 million. The company raised its 2024 revenue growth guidance to 26%-31% and Galafold growth guidance to 14%-18%. Non-GAAP operating expenses are now expected to be between $345 million to $360 million. For Q2 2024, Amicus achieved non-GAAP profitability with a net income of $18.5 million and a GAAP net loss of $15.7 million. Cash reserves stood at $260.1 million as of June 30, 2024. The company is on track to achieve its Pombiliti + Opfolda revenue target of $62 million to $67 million for 2024.
Amicus Therapeutics (Nasdaq: FOLD) ha riportato risultati finanziari solidi per il secondo trimestre del 2024, con un fatturato totale di $126,7 milioni, in crescita del 34% rispetto all'anno precedente. I ricavi di Galafold sono aumentati del 17% raggiungendo $110,8 milioni, mentre quelli di Pombiliti + Opfolda sono saliti del 44% rispetto al primo trimestre 2024, a $15,9 milioni. L'azienda ha alzato le previsioni di crescita del fatturato per il 2024 al 26%-31% e quelle per la crescita di Galafold al 14%-18%. Le spese operative non-GAAP sono ora attese tra $345 milioni e $360 milioni. Per il secondo trimestre del 2024, Amicus ha raggiunto la redditività non-GAAP con un reddito netto di $18,5 milioni e una perdita netta GAAP di $15,7 milioni. Le riserve di liquidità si attestavano a $260,1 milioni al 30 giugno 2024. L'azienda è sulla buona strada per raggiungere il suo obiettivo di fatturato per Pombiliti + Opfolda di $62 milioni a $67 milioni per il 2024.
Amicus Therapeutics (Nasdaq: FOLD) reportó resultados financieros sólidos para el segundo trimestre de 2024, con ingresos totales de $126.7 millones, un aumento del 34% en comparación con el año anterior. Los ingresos de Galafold crecieron un 17% alcanzando $110.8 millones, y los ingresos de Pombiliti + Opfolda aumentaron un 44% desde el primer trimestre de 2024, alcanzando $15.9 millones. La compañía elevó su guía de crecimiento de ingresos para 2024 al 26%-31% y la guía de crecimiento de Galafold al 14%-18%. Se espera que los gastos operativos no-GAAP estén entre $345 millones y $360 millones. Para el segundo trimestre de 2024, Amicus logró rentabilidad no-GAAP con un ingreso neto de $18.5 millones y una pérdida neta GAAP de $15.7 millones. Las reservas de efectivo se situaron en $260.1 millones al 30 de junio de 2024. La compañía está en camino de alcanzar su objetivo de ingresos de Pombiliti + Opfolda de $62 millones a $67 millones para 2024.
아미쿠스 테라퓨틱스 (Nasdaq: FOLD)는 2024년 2분기 재무 결과를 발표했으며, 총 수익은 $126.7백만으로, 전년 대비 34% 증가했습니다. 갈라폴드의 수익은 17% 증가하여 $110.8백만에 달했으며, 폼빌리티 + 옵폴다의 수익은 2024년 1분기 대비 44% 상승하여 $15.9백만에 도달했습니다. 회사는 2024년 수익 성장 예상을 26%-31%로 상향 조정했으며, 갈라폴드 성장 예상은 14%-18%로 잡았습니다. 비-GAAP 운영비는 현재 $345백만에서 $360백만 사이로 예상됩니다. 2024년 2분기 동안 아미쿠스는 비-GAAP 기준으로 $18.5백만의 순이익을 기록했으며 GAAP 기준으로는 $15.7백만의 순손실을 기록했습니다. 현금 보유고는 2024년 6월 30일 기준으로 $260.1백만이었습니다. 회사는 2024년 $62백만에서 $67백만에 해당하는 폼빌리티 + 옵폴다 수익 목표를 달성할 것으로 보입니다.
Amicus Therapeutics (Nasdaq: FOLD) a rapporté des résultats financiers solides pour le deuxième trimestre de 2024, avec un chiffre d'affaires total de $126,7 millions, soit une augmentation de 34 % par rapport à l'année précédente. Les revenus de Galafold ont augmenté de 17 % pour atteindre $110,8 millions, et les revenus de Pombiliti + Opfolda ont grimpé de 44 % par rapport au premier trimestre 2024 pour atteindre $15,9 millions. La société a relevé ses prévisions de croissance du chiffre d'affaires pour 2024 à 26%-31% et ses prévisions de croissance pour Galafold à 14%-18%. Les dépenses d'exploitation non-GAAP sont maintenant estimées entre $345 millions et $360 millions. Pour le deuxième trimestre 2024, Amicus a atteint la rentabilité non-GAAP avec un bénéfice net de $18,5 millions et une perte nette GAAP de $15,7 millions. Les réserves de liquidités s'élevaient à $260,1 millions au 30 juin 2024. L'entreprise est en bonne voie pour atteindre son objectif de revenus Pombiliti + Opfolda de $62 millions à $67 millions pour 2024.
Amicus Therapeutics (Nasdaq: FOLD) hat für das zweite Quartal 2024 starke finanzielle Ergebnisse gemeldet, mit einem Gesamtumsatz von $126,7 Millionen, was einem Anstieg von 34% im Jahresvergleich entspricht. Der Umsatz von Galafold stieg um 17% auf $110,8 Millionen, und der Umsatz von Pombiliti + Opfolda stieg im Vergleich zum ersten Quartal 2024 um 44% auf $15,9 Millionen. Das Unternehmen hob seine Umsatzwachstum Prognose für 2024 auf 26%-31% an und die Wachstumsprognose für Galafold auf 14%-18%. Die nicht-GAAP Betriebskosten werden nun zwischen $345 Millionen und $360 Millionen erwartet. Für das zweite Quartal 2024 erzielte Amicus eine nicht-GAAP Rentabilität mit einem Nettogewinn von $18,5 Millionen und einem GAAP Nettverlust von $15,7 Millionen. Die Barreserven betrugen am 30. Juni 2024 $260,1 Millionen. Das Unternehmen ist auf dem richtigen Weg, sein Umsatzziel für Pombiliti + Opfolda von $62 Millionen bis $67 Millionen für 2024 zu erreichen.
- Q2 2024 total revenue of $126.7M, a 34% increase YoY
- Galafold Q2 revenue of $110.8M, up 17% YoY
- Pombiliti + Opfolda Q2 revenue of $15.9M, up 44% from Q1 2024
- Increased 2024 revenue growth guidance to 26%-31%
- Non-GAAP net income of $18.5M in Q2 2024
- Q2 2024 GAAP net loss of $15.7M
- Cash reserves decreased to $260.1M from $286.2M as of December 31, 2023
Insights
Amicus Therapeutics' Q2 2024 results demonstrate strong financial performance and commercial execution. Total revenue of
Notably, Amicus achieved non-GAAP profitability in Q2 and H1 2024, with expectations of accelerated profitability in H2. This marks a significant milestone in the company's financial trajectory. The narrowed non-GAAP operating expense guidance of
With a cash position of
Amicus Therapeutics' Q2 results highlight its successful transition from a development-stage to a commercial-stage biotech company. The strong uptake of Galafold and the promising launch of Pombiliti + Opfolda demonstrate the company's ability to effectively commercialize rare disease treatments.
The approval of Pombiliti + Opfolda in Switzerland expands the product's market reach, with potential for further geographic expansion pending regulatory reviews in Australia and Canada. This global expansion strategy is important for maximizing the commercial potential of rare disease therapies.
Amicus' focus on advancing studies to support medical and scientific leadership in Fabry and Pompe diseases indicates a commitment to maintaining a competitive edge in these therapeutic areas. This approach of continual innovation and market expansion is essential for long-term success in the highly specialized rare disease market.
Amicus Therapeutics' Q2 performance suggests a strengthening market position in the rare disease space. The
The company's ability to treat 186 patients with Pombiliti + Opfolda across five markets within a short period demonstrates effective market access and physician adoption. This rapid uptake bodes well for future growth prospects.
Amicus' raised guidance for both total revenue and Galafold growth suggests confidence in market dynamics and the company's competitive positioning. The focus on multiple successful launches for Pombiliti + Opfolda indicates a strategic approach to maximizing market share in the Pompe disease treatment landscape.
Q2 2024 Total Revenue of
Galafold® Q2 Revenue of
Pombiliti® + Opfolda® Q2 Revenue of
Raising 2024 Total Revenue Growth Guidance to
Narrowing non-GAAP Operating Expense Guidance to
Non-GAAP Profitability Achieved in Q2 and H1 2024 with Acceleration Expected in H2
Conference Call and Webcast Today at 8:30 a.m. ET
PRINCETON, N.J., Aug. 08, 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 second quarter ended June 30, 2024.
“In the first half of 2024 we demonstrated strong commercial execution, leading to robust revenue growth and achieving non-GAAP profitability for the period,” said Bradley Campbell, President and Chief Executive Officer of Amicus Therapeutics, Inc. “We are very pleased with the continued global uptake of Galafold and sustained patient demand leading to the increase of our 2024 guidance. The commercial launch of Pombiliti and Opfolda is performing exceptionally well with a steady addition of new patients in each of the approved markets. Looking ahead, we remain confident in our ability to deliver significant revenue growth, accomplish our objective of achieving full-year non-GAAP profitability and continuing to deliver on our mission for people living with rare diseases.”
Financial and Corporate Highlights:
- Total revenue in the second quarter 2024 was
$126.7 million , a year-over-year increase of34% from total revenue of$94.5 million in the second quarter 2023. On a constant currency basis (CER)1, second quarter 2024 total revenue growth was36% . Given strong performance in the first half 2024, the Company is raising its full year 2024 total revenue growth guidance to26% to31% on a constant currency basis (CER)1.
| (in thousands) | Three Months Ended June 30, | Year over Year % Growth | Six Months Ended June 30, | Year over Year % Growth | |||||||||||||||||||
| 2024 | 2023 | Reported | at CER1 | 2024 | 2023 | Reported | at CER1 | ||||||||||||||||
| Galafold® | |||||||||||||||||||||||
| Pombiliti® + Opfolda® | n/a | n/a | n/a | n/a | |||||||||||||||||||
| Net Product Revenues | |||||||||||||||||||||||
- Galafold (migalastat) net product sales were
$110.8 million in the second quarter 2024, a year-over-year increase of17% , or19% at constant exchange rates1, reflecting continued strong demand. As a result of strong performance in the first half 2024, the company is raising its revenue growth guidance for Galafold to14% to18% on a constant currency basis (CER)1. - Pombiliti (cipaglucosidase alfa-atga) + Opfolda (miglustat) net product sales were
$15.9 million in the second quarter 2024, a44% increase from the first quarter of 2024. As of the end of July, 186 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 well on-track to achieve full year 2024 revenue guidance for Pombiliti + Opfolda of$62 million to$67 million on a constant currency basis (CER)1. - Swissmedic in Switzerland approved Pombiliti + Opfolda on July 4th as a long-term enzyme replacement therapy and enzyme stabilizer for adults with late-onset Pompe disease. Additional regulatory reviews are ongoing in Australia and Canada.
- Total GAAP operating expenses of
$100.4 million for the second quarter 2024 decreased by4% as compared to$104.2 million for the second quarter 2023. Total non-GAAP operating expenses of$82.1 million for the second quarter 2024 decreased by2% as compared to$84.0 million for the second quarter 2023. Given our continued financial discipline in the first half of 2024, the Company enhances its non-GAAP Operating Expense guidance3 to$345 million to$360 million . - GAAP net loss was
$15.7 million , or$0.05 per share, for the second quarter 2024, and was reduced compared to a net loss of$43.2 million , or$0.15 per share, for the second quarter 2023. - Non-GAAP net income was
$18.5 million , or$0.06 per share, for the second quarter 2024, compared to a non-GAAP net loss of$20.3 million , or$0.07 per share, for second quarter 20232. Non-GAAP profitability was also achieved in the first half 2024. The Company expects non-GAAP profitability to accelerate in the second half 2024. - Cash, cash equivalents, and marketable securities totaled
$260.1 million at June 30, 2024, compared to$286.2 million at December 31, 2023.
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, August 8, 2024, at 8:30 a.m. ET to discuss the second 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 June 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 June 30, | Six Months Ended June 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Net product sales | $ | 126,669 | $ | 94,503 | $ | 237,072 | $ | 180,773 | |||||||
| Cost of goods sold | 11,261 | 9,114 | 24,828 | 16,056 | |||||||||||
| Gross profit | 115,408 | 85,389 | 212,244 | 164,717 | |||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | 24,683 | 35,149 | 53,012 | 76,648 | |||||||||||
| Selling, general, and administrative | 73,576 | 65,423 | 161,605 | 139,380 | |||||||||||
| Changes in fair value of contingent consideration payable | — | 337 | — | 588 | |||||||||||
| Restructuring charges | — | — | 6,045 | — | |||||||||||
| Loss on impairment of assets | — | 1,134 | — | 1,134 | |||||||||||
| Depreciation and amortization | 2,182 | 2,206 | 4,336 | 3,463 | |||||||||||
| Total operating expenses | 100,441 | 104,249 | 224,998 | 221,213 | |||||||||||
| Income (loss) from operations | 14,967 | (18,860 | ) | (12,754 | ) | (56,496 | ) | ||||||||
| Other expense: | |||||||||||||||
| Interest income | 1,370 | 1,737 | 2,910 | 3,936 | |||||||||||
| Interest expense | (12,512 | ) | (12,492 | ) | (24,948 | ) | (24,336 | ) | |||||||
| Other expense | (3,717 | ) | (10,902 | ) | (8,683 | ) | (16,840 | ) | |||||||
| Income (loss) before income tax | 108 | (40,517 | ) | (43,475 | ) | (93,736 | ) | ||||||||
| Income tax expense | (15,805 | ) | (2,715 | ) | (20,641 | ) | (2,428 | ) | |||||||
| Net loss attributable to common stockholders | $ | (15,697 | ) | $ | (43,232 | ) | $ | (64,116 | ) | $ | (96,164 | ) | |||
| Net loss attributable to common stockholders per common share — basic and diluted | $ | (0.05 | ) | $ | (0.15 | ) | $ | (0.21 | ) | $ | (0.33 | ) | |||
| Weighted-average common shares outstanding — basic and diluted | 303,773,922 | 292,797,002 | 303,336,787 | 292,071,201 | |||||||||||
TABLE 2
| Amicus Therapeutics, Inc. Consolidated Balance Sheets (Unaudited) (in thousands, except share and per share amounts) | |||||||
| June 30, 2024 | December 31, 2023 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 209,335 | $ | 246,994 | |||
| Investments in marketable securities | 50,727 | 39,206 | |||||
| Accounts receivable | 85,174 | 87,632 | |||||
| Inventories | 81,320 | 59,696 | |||||
| Prepaid expenses and other current assets | 35,145 | 49,533 | |||||
| Total current assets | 461,701 | 483,061 | |||||
| Operating lease right-of-use assets, net | 22,611 | 26,312 | |||||
| Property and equipment, less accumulated depreciation of | 31,161 | 31,667 | |||||
| Intangible assets, less accumulated amortization of | 18,853 | 20,490 | |||||
| Goodwill | 197,797 | 197,797 | |||||
| Other non-current assets | 17,361 | 18,553 | |||||
| Total Assets | $ | 749,484 | $ | 777,880 | |||
| Liabilities and Stockholders’ Equity | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 32,057 | $ | 15,120 | |||
| Accrued expenses and other current liabilities | 127,897 | 144,245 | |||||
| Operating lease liabilities | 8,112 | 8,324 | |||||
| Total current liabilities | 168,066 | 167,689 | |||||
| Long-term debt | 388,939 | 387,858 | |||||
| Operating lease liabilities | 47,007 | 48,877 | |||||
| Other non-current liabilities | 12,949 | 13,282 | |||||
| Total liabilities | 616,961 | 617,706 | |||||
| Commitments and contingencies | |||||||
| Stockholders’ equity: | |||||||
| Common stock, | 2,923 | 2,918 | |||||
| Additional paid-in capital | 2,868,925 | 2,836,018 | |||||
| Accumulated other comprehensive income (loss): | |||||||
| Foreign currency translation adjustment | 8,991 | 5,429 | |||||
| Unrealized loss on available-for-sale securities | (197 | ) | (188 | ) | |||
| Warrants | 71 | 71 | |||||
| Accumulated deficit | (2,748,190 | ) | (2,684,074 | ) | |||
| Total stockholders’ equity | 132,523 | 160,174 | |||||
| Total Liabilities and Stockholders’ Equity | $ | 749,484 | $ | 777,880 | |||
TABLE 3
| Amicus Therapeutics, Inc. Reconciliation of Non-GAAP Financial Measures (in thousands) (Unaudited) | |||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Total operating expenses - as reported GAAP | $ | 100,441 | $ | 104,249 | $ | 224,998 | $ | 221,213 | |||||||
| Research and development: | |||||||||||||||
| Stock-based compensation | 3,061 | 4,117 | 7,932 | 12,607 | |||||||||||
| Selling, general and administrative: | |||||||||||||||
| Stock-based compensation | 13,136 | 12,460 | 39,068 | 38,864 | |||||||||||
| Loss on impairment of assets | — | 1,134 | — | 1,134 | |||||||||||
| Changes in fair value of contingent consideration payable | — | 337 | — | 588 | |||||||||||
| Restructuring Charges | — | — | 6,045 | — | |||||||||||
| Depreciation and amortization | 2,182 | 2,206 | 4,336 | 3,463 | |||||||||||
| Total operating expense adjustments to reported GAAP | 18,379 | 20,254 | 57,381 | 56,656 | |||||||||||
| Total operating expenses - as adjusted | $ | 82,062 | $ | 83,995 | $ | 167,617 | $ | 164,557 | |||||||
TABLE 4
| Amicus Therapeutics, Inc. Reconciliation of Non-GAAP Financial Measures (in thousands, except share and per share amounts) (Unaudited) | ||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| GAAP net loss | $ | (15,697 | ) | $ | (43,232 | ) | $ | (64,116 | ) | $ | (96,164 | ) | ||||
| Share-based compensation | 16,197 | 16,577 | 47,000 | 51,471 | ||||||||||||
| Changes in fair value of contingent consideration payable | — | 337 | — | 588 | ||||||||||||
| Depreciation and amortization | 2,182 | 2,206 | 4,336 | 3,463 | ||||||||||||
| Loss on impairment of assets | — | 1,134 | — | 1,134 | ||||||||||||
| Restructuring charges | — | — | 6,045 | — | ||||||||||||
| Income tax expense | 15,805 | 2,715 | 20,641 | 2,428 | ||||||||||||
| Non-GAAP net income (loss) | $ | 18,487 | $ | (20,263 | ) | $ | 13,906 | $ | (37,080 | ) | ||||||
| Non-GAAP net income (loss) attributable to common stockholders per common share — basic and diluted | $ | 0.06 | $ | (0.07 | ) | $ | 0.05 | $ | (0.13 | ) | ||||||
| Weighted-average common shares outstanding — basic and diluted | 303,773,922 | 292,797,002 | 303,336,787 | 292,071,201 | ||||||||||||
FAQ
What were Amicus Therapeutics’ Q2 2024 total revenue and growth?
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How did Pombiliti® + Opfolda® perform in Q2 2024?
