Catalyst Pharmaceuticals Reports Strong Second Quarter 2024 Financial Results and Provides Corporate Update
Catalyst Pharmaceuticals reported strong Q2 2024 financial results, with total revenues of $122.7 million, a 23.2% year-over-year increase. Key highlights include:
- FIRDAPSE net product revenues of $77.4 million (19.2% YoY growth)
- AGAMREE net product revenues of $8.7 million (first full quarter)
- FYCOMPA net product revenues of $36.5 million (5.7% YoY increase)
The company reported GAAP net income of $40.8 million ($0.33 per diluted share) and non-GAAP net income of $69.6 million ($0.56 per diluted share). Catalyst reaffirmed its 2024 total revenue guidance of $455-$475 million, expecting results in the upper range.
Catalyst Pharmaceuticals ha riportato risultati finanziari solidi per il secondo trimestre del 2024, con entrate totali di 122,7 milioni di dollari, un aumento del 23,2% rispetto all'anno precedente. I punti salienti includono:
- Entrate nette da prodotto FIRDAPSE per 77,4 milioni di dollari (crescita del 19,2% su base annua)
- Entrate nette da prodotto AGAMREE per 8,7 milioni di dollari (primo trimestre completo)
- Entrate nette da prodotto FYCOMPA per 36,5 milioni di dollari (aumento del 5,7% su base annua)
L'azienda ha riportato un utile netto GAAP di 40,8 milioni di dollari (0,33 dollari per azione diluita) e un utile netto non-GAAP di 69,6 milioni di dollari (0,56 dollari per azione diluita). Catalyst ha riconfermato la sua guida sui ricavi totali per il 2024 di 455-475 milioni di dollari, prevedendo risultati nella parte superiore di tale intervallo.
Catalyst Pharmaceuticals reportó resultados financieros sólidos para el segundo trimestre de 2024, con ingresos totales de 122,7 millones de dólares, un aumento del 23,2% en comparación con el año anterior. Los aspectos destacados incluyen:
- Ingresos netos de producto FIRDAPSE de 77,4 millones de dólares (crecimiento del 19,2% interanual)
- Ingresos netos de producto AGAMREE de 8,7 millones de dólares (primer trimestre completo)
- Ingresos netos de producto FYCOMPA de 36,5 millones de dólares (aumento del 5,7% interanual)
La compañía reportó ingresos netos GAAP de 40,8 millones de dólares (0,33 dólares por acción diluida) y ingresos netos no GAAP de 69,6 millones de dólares (0,56 dólares por acción diluida). Catalyst reafirmó su guía de ingresos totales para 2024 de 455-475 millones de dólares, esperando resultados en el rango superior.
Catalyst Pharmaceuticals는 2024년 2분기 재무 실적이 강하게 나타났다고 보고하며, 총 수익이 1억 2270만 달러로 전년 대비 23.2% 증가했다고 발표했습니다. 주요 하이라이트는 다음과 같습니다:
- FIRDAPSE의 순 제품 수익이 7740만 달러(19.2%의 연간 성장)
- AGAMREE의 순 제품 수익이 870만 달러(첫 완전 분기)
- FYCOMPA의 순 제품 수익이 3650만 달러(5.7%의 연간 증가)
회사는 GAAP 기준 순소득이 4080만 달러(희석 주당 0.33달러) 및 비 GAAP 기준 순소득이 6960만 달러(희석 주당 0.56달러)라고 보고했습니다. Catalyst는 2024년 총 수익 가이던스를 4억 5500만 - 4억 7500만 달러로 재확인하며, 상위 범위에서 결과를 기대하고 있습니다.
Catalyst Pharmaceuticals a annoncé de solides résultats financiers pour le deuxième trimestre 2024, avec des revenus totaux de 122,7 millions de dollars, soit une augmentation de 23,2 % par rapport à l'année précédente. Les points saillants incluent :
- Revenus nets de produit FIRDAPSE de 77,4 millions de dollars (croissance de 19,2 % d'une année sur l'autre)
- Revenus nets de produit AGAMREE de 8,7 millions de dollars (premier trimestre complet)
- Revenus nets de produit FYCOMPA de 36,5 millions de dollars (augmentation de 5,7 % d'une année sur l'autre)
L'entreprise a rapporté un bénéfice net GAAP de 40,8 millions de dollars (0,33 dollar par action diluée) et un bénéfice net non-GAAP de 69,6 millions de dollars (0,56 dollar par action diluée). Catalyst a confirmé ses prévisions de revenus totaux pour 2024 de 455 à 475 millions de dollars, s'attendant à des résultats dans la fourchette supérieure.
Catalyst Pharmaceuticals berichtete über starke Finanzzahlen im 2. Quartal 2024, mit Gesamtumsätzen von 122,7 Millionen Dollar, was einem Anstieg von 23,2% im Jahresvergleich entspricht. Zu den wichtigsten Highlights gehören:
- Nettoumsätze von FIRDAPSE in Höhe von 77,4 Millionen Dollar (19,2% Wachstum im Jahresvergleich)
- Nettoumsätze von AGAMREE in Höhe von 8,7 Millionen Dollar (erstes volles Quartal)
- Nettoumsätze von FYCOMPA in Höhe von 36,5 Millionen Dollar (5,7% Anstieg im Jahresvergleich)
Das Unternehmen meldete GAAP-Nettogewinn von 40,8 Millionen Dollar (0,33 Dollar pro verwässerter Aktie) und non-GAAP-Nettogewinn von 69,6 Millionen Dollar (0,56 Dollar pro verwässerter Aktie). Catalyst bestätigte seine Umsatzprognose für 2024 in Höhe von 455 bis 475 Millionen Dollar und erwartet Ergebnisse im oberen Bereich.
- Total revenues increased 23.2% YoY to $122.7 million in Q2 2024
- FIRDAPSE net product revenues grew 19.2% YoY to $77.4 million
- Successful U.S. launch of AGAMREE with $8.7 million in net product revenues
- FYCOMPA net product revenues increased 5.7% YoY to $36.5 million
- Non-GAAP net income rose 15.3% YoY to $69.6 million
- Cash and cash equivalents increased to $375.7 million as of June 30, 2024
- FDA approved 100 mg maximum daily dose of FIRDAPSE
- Secured exclusive license for AGAMREE in Canada
- Selling, general, and administrative expenses increased 43.4% YoY to $40.7 million
- GAAP net income per share (basic) decreased 2.8% YoY to $0.35
Insights
Catalyst Pharmaceuticals delivered a strong Q2 2024 performance, with total revenues of
The company's cash position has significantly improved, with
While SG&A expenses increased by
Catalyst's product portfolio demonstrates strong market performance across multiple rare disease treatments. FIRDAPSE, for Lambert-Eaton myasthenic syndrome (LEMS), continues to show impressive growth, indicating successful market penetration and patient adoption. The FDA's approval of a higher maximum daily dose for FIRDAPSE provides enhanced treatment flexibility for LEMS patients.
The successful launch of AGAMREE for Duchenne Muscular Dystrophy (DMD) is particularly noteworthy. Its rapid revenue generation suggests strong initial uptake and potentially addresses an unmet need in DMD treatment. This early success could position Catalyst as a significant player in the DMD market.
The company's strategy of expanding its rare orphan portfolio with innovative products, as seen with the AGAMREE launch and Canadian licensing agreement, indicates a focused approach to addressing underserved patient populations. This strategy could lead to long-term growth and market leadership in rare disease therapeutics.
Catalyst's Q2 results demonstrate strong market positioning in the rare disease space. The
The company's decision to increase AGAMREE's revenue guidance to
Catalyst's robust financial performance and upward guidance revision may positively impact investor sentiment. However, the
Delivered Robust Revenue Performance, Fueled by Exceptional Commercial Execution and Early Success of the U.S. AGAMREE® Product Launch
Reported Record Q2 2024 Total Revenues of
FIRDAPSE® Q2 2024 Net Product Revenues of
AGAMREE® Q2 2024 Net Product Revenues of
FYCOMPA® Q2 2024 Net Product Revenues of
Q2 2024 GAAP Net Income of
Q2 2024 Non-GAAP Net Income of $69.6 Million,
Reaffirming 2024 Total Revenue Guidance of
Conference Call and Webcast to be Held on August 8, 2024, at 8:30 AM ET
CORAL GABLES, Fla., Aug. 07, 2024 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (“Catalyst” or “Company”) (Nasdaq: CPRX) today reported financial results for the second quarter of 2024 and provided a corporate update.
"Since the onset of this year, we have advanced with continued momentum, propelled by the strong performance of our established product portfolio and the successful U.S. commercial launch of AGAMREE. Our accomplishments have significantly strengthened our financial position, aligning with our revenue guidance for the year, and we believe that we are on track to achieve the upper end of our previously provided total revenue forecast,” stated Richard J. Daly, President and CEO of Catalyst. "With unwavering confidence in our ability to execute our strategic objectives, we remain steadfast in our plans to capitalize on new opportunities to broaden our rare orphan portfolio with innovative and differentiated products and expand our market presence, as exemplified by our recent license agreement for AGAMREE in Canada. As we continue to execute our business strategy, we remain focused on enhancing our growth potential and delivering value to our stakeholders, while prioritizing the needs of our patient communities. Backed by our proven track record and dedicated team, we believe that we are well-positioned for sustained success."
Financial Highlights
| For the Three Months Ended June 30, | 2024 | 2023 | % Change | ||||||
| (In thousands, except per share data) | |||||||||
| Product Revenue, Net | $ | 122,653 | $ | 99,477 | 23.3 | % | |||
| FIRDAPSE Product Revenue, Net | $ | 77,372 | $ | 64,898 | 19.2 | % | |||
| FYCOMPA Product Revenue, Net | $ | 36,535 | $ | 34,579 | 5.7 | % | |||
| AGAMREE Product Revenue, Net | $ | 8,746 | N/A | N/A | |||||
GAAP Net Income | $ | 40,794 | $ | 37,762 | 8.0 | % | |||
| Non-GAAP Net Income ** | $ | 69,631 | $ | 60,380 | 15.3 | % | |||
| GAAP Net Income Per Share - Basic | $ | 0.35 | $ | 0.36 | (2.8 | %) | |||
| Non-GAAP Net Income Per Share – Basic** | $ | 0.59 | $ | 0.57 | 3.5 | % | |||
| GAAP Net Income Per Share – Diluted | $ | 0.33 | $ | 0.33 | 0 | % | |||
| Non-GAAP Net Income Per Share – Diluted** | $ | 0.56 | $ | 0.53 | 5.7 | % | |||
| As of June 30, 2024, and December 31, 2023 (In thousands) Cash and Cash Equivalents | $ | 375,693 | $ | 137,636 | 173.0 | % | |||
**Statements made in this press release include non-GAAP financial measures. Such information is provided as additional information and not as an alternative to Catalyst's financial statements presented in accordance with U.S. generally accepted accounting principles (GAAP). These non-GAAP financial measures are intended to enhance an overall understanding of Catalyst's current financial performance. Catalyst believes that the non-GAAP financial measures presented in this press release provide investors and prospective investors with an alternative method for assessing Catalyst's operating results in a manner that Catalyst believes is focused on the performance of ongoing operations and provides a more consistent basis for comparison between periods. Non-GAAP financial measures should not be considered in isolation or as a substitute for comparable GAAP accounting. Further, non-GAAP measures of net income used by Catalyst may be different from and not directly comparable to similarly titled measures used by other companies.
Recent Business Highlights
- Achieved strong results with total net product revenues amounting to
$122.7 million for Q2 2024, reflecting a robust23.3% YoY increase.
- Delivered outstanding FIRDAPSE net product revenues of
$77.4 million for Q2 2024, evidenced by impressive19.2% YoY growth.
- Successfully executed the U.S. commercial launch of AGAMREE, a novel corticosteroid treatment for Duchenne Muscular Dystrophy, yielding solid results and surpassing our initial expectations.
- Reported AGAMREE net product revenues of
$8.7 million for Q2 2024, marking the first full quarter of U.S. commercial availability. - Achieved Q2 2024 FYCOMPA net product revenues of
$36.5 million , representing a5.7% YoY performance.
- On May 30, 2024, the FDA approved the 100 mg maximum daily dose of FIRDAPSE, enhancing treatment flexibility for healthcare providers treating LEMS patients.
- In July 2024, Catalyst secured an exclusive license, supply, and commercialization agreement with KYE Pharmaceuticals, Inc., for AGAMREE in Canada, marking a pivotal strategic milestone in expanding the product's North American footprint.
- Published the Company’s 2023 ESG Report in June 2024, highlighting key achievements and initiatives.
- We currently believe that our total revenue for the year ending December 31, 2024 will be in the upper half of our previously reported total revenue guidance of between
$455 million and$475 million .
- We are reaffirming our full-year 2024 FIRDAPSE net product revenue guidance to be approximately
$295 million to$310 million and our 2024 FYCOMPA net product revenue guidance to be approximately$130 million to$135 million , respectively.
- We are increasing our full-year 2024 net product revenue guidance for AGAMREE to be approximately
$35 million to$40 million , based on the promising demand trend and an encouraging payer landscape.
Second Quarter 2024 Financial Results
Total revenues: In the second quarter of 2024, total revenues were
Product revenue, net: Product revenue, net for the second quarter of 2024 was
Research and development expenses: Research and development expenses for the second quarter of 2024 were
Selling, general, and administrative expenses: Selling, general, and administrative expenses for the second quarter of 2024 were
Amortization of intangible assets: Amortization of intangible assets was
Operating income: Operating income for the second quarter of 2024 was
GAAP net income: GAAP net income for the second quarter of 2024 was
Non-GAAP net income: Non-GAAP net income for the second quarter of 2024 was
Cash and cash equivalents: Cash and cash equivalents were
Our Form 10-Q for the second quarter of 2024, filed with the U.S. Securities and Exchange Commission on August 7, 2024, provides more detailed financial information and analysis of our financial condition and results of operations.
Conference Call & Webcast Details
The Company will host a conference call and webcast on Thursday, August 8, 2024, at 8:30 AM ET to discuss the financial results and provide a business update.
| U.S./Canada Dial-in Number: | (877) 407-8912 |
| International Dial-in Number: | (201) 689-8059 |
A webcast will be accessible under the investor section on the Company's website at www.catalystpharma.com. A webcast replay will be available on the Catalyst website for 30 days after the event.
About Catalyst Pharmaceuticals
With exceptional patient focus, Catalyst is committed to developing and commercializing innovative first-in-class medicines that address rare and difficult-to-treat diseases. Catalyst's flagship U.S. commercial product is FIRDAPSE® (amifampridine) Tablets 10 mg, approved for the treatment of Lambert-Eaton myasthenic syndrome ("LEMS") in adults and pediatric patients 6 years of age and older. Further, Canada's national healthcare regulatory agency, Health Canada, has approved the use of FIRDAPSE for the treatment of adult patients in Canada with LEMS. Most recently, on May 30, 2024, the FDA approved an increased maximum daily dose of 100 mg for FIRDAPSE for adults and pediatric patients weighing more than 45 kg.
In January 2023, Catalyst acquired the U.S. commercial rights to FYCOMPA® (perampanel) CIII, a prescription medicine approved in people with epilepsy aged four and older alone or with other medicines to treat partial-onset seizures with or without secondarily generalized seizures and with other medicines to treat primary generalized tonic-clonic seizures for people with epilepsy aged 12 and older.
On July 18, 2023, Catalyst acquired an exclusive license for North America for AGAMREE® (vamorolone) oral suspension 40 mg/mL, a novel corticosteroid treatment for Duchenne Muscular Dystrophy. AGAMREE previously received FDA Orphan Drug and Fast Track designations and was approved by the FDA for commercialization in the U.S. on October 26, 2023. AGAMREE became commercially available by prescription in the U.S. on March 13, 2024. Further, in July 2024, Catalyst entered into an exclusive license, supply, and commercialization agreement for AGAMREE in Canada.
For more information about Catalyst, please visit the Company's website at www.catalystpharma.com. For Full Prescribing and Safety Information for FIRDAPSE®, please visit www.firdapse.com. For Full Prescribing Information, including Boxed WARNING for FYCOMPA®, please visit www.fycompa.com. For Full Prescribing Information for AGAMREE®, please visit www.agamree.com.
Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst's actual results in future periods to differ materially from forecasted results. A number of factors, including (i) whether the launch of AGAMREE® will continue to surpass initial expectations and exceed 2024 full-year revenue forecasts for sales of the product that were previously published by the Company (ii) whether AGAMREE's commercialization will ultimately be profitable, cash flow positive, and accretive to Catalyst, (iii) Catalyst's ability to continue to successfully sell its current products and continue to be profitable and cash flow positive, (iv) whether Catalyst's total revenue forecast for 2024 included in this press release will prove to be accurate, (v) whether Catalyst will complete additional acquisitions of products, and the timing of any such acquisitions; (vi) the impact of pending Paragraph IV litigation relating to FIRDAPSE® if the results of these litigation matters are adverse, (vii) whether AGAMREE will be approved for commercialization in Canada, and (viii) those factors described in Catalyst's Annual Report on Form 10-K for the 2023 fiscal year, Catalyst's Quarterly Report on Form 10-Q for the second quarter of 2024, and Catalyst's other filings with the SEC, could adversely affect Catalyst. Copies of Catalyst's filings with the SEC are available from the SEC, may be found on Catalyst's website or obtained upon request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date.
| CATALYST PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) (in thousands, except share and per share data) | |||||||||||||||
| For the Three Months Ended June 30, | For the Six Months Ended June 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Product revenue, net | $ | 122,653 | $ | 99,477 | $ | 221,094 | $ | 184,781 | |||||||
| License and other revenue | 57 | 105 | 125 | 167 | |||||||||||
| Total revenues | 122,710 | 99,582 | 221,219 | 184,948 | |||||||||||
| Operating costs and expenses: | |||||||||||||||
| Cost of sales (a) | 15,405 | 12,045 | 27,925 | 21,991 | |||||||||||
| Research and development | 2,985 | 3,954 | 5,566 | 7,516 | |||||||||||
| Selling, general and administrative (a) | 40,730 | 28,396 | 87,668 | 58,114 | |||||||||||
| Amortization of intangible assets | 9,344 | 8,488 | 18,688 | 15,019 | |||||||||||
| Total operating costs and expenses | 68,464 | 52,883 | 139,847 | 102,640 | |||||||||||
| Operating income | 54,246 | 46,699 | 81,372 | 82,308 | |||||||||||
| Other income, net | 1,542 | 1,813 | 3,505 | 3,517 | |||||||||||
| Net income before income taxes | 55,788 | 48,512 | 84,877 | 85,825 | |||||||||||
| Income tax provision | 14,994 | 10,750 | 20,808 | 18,495 | |||||||||||
| Net income | $ | 40,794 | $ | 37,762 | $ | 64,069 | $ | 67,330 | |||||||
| Net income per share: | |||||||||||||||
| Basic | $ | 0.35 | $ | 0.36 | $ | 0.55 | $ | 0.64 | |||||||
| Diluted | $ | 0.33 | $ | 0.33 | $ | 0.52 | $ | 0.59 | |||||||
| Weighted average shares outstanding: | |||||||||||||||
| Basic | 118,180,396 | 106,258,790 | 117,493,257 | 105,911,936 | |||||||||||
| Diluted | 124,655,999 | 113,673,534 | 124,028,752 | 113,840,155 | |||||||||||
(a) exclusive of amortization of intangible assets
| CATALYST PHARMACEUTICALS, INC. RECONCILIATION OF NON-GAAP METRICS (unaudited) (in thousands, except share and per share data) | |||||||||||||||
| For the Three Months Ended June 30, | For the Six Months Ended June 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| GAAP net income | $ | 40,794 | $ | 37,762 | $ | 64,069 | $ | 67,330 | |||||||
| Non-GAAP adjustments: | |||||||||||||||
| Stock-based compensation expense | 4,408 | 3,298 | 12,656 | 6,190 | |||||||||||
| Depreciation | 91 | 82 | 177 | 151 | |||||||||||
| Amortization of intangible assets | 9,344 | 8,488 | 18,688 | 15,019 | |||||||||||
| Income tax provision | 14,994 | 10,750 | 20,808 | 18,495 | |||||||||||
| Non-GAAP net income | $ | 69,631 | $ | 60,380 | $ | 116,398 | $ | 107,185 | |||||||
| Non-GAAP net income per share: | ||||||||||||||||||
| Basic | $ | 0.59 | $ | 0.57 | $ | 0.99 | $ | 1.01 | ||||||||||
| Diluted | $ | 0.56 | $ | 0.53 | $ | 0.94 | $ | 0.94 | ||||||||||
| Weighted average shares outstanding: | ||||||||||||||||||
| Basic | 118,180,396 | 106,258,790 | 117,493,257 | 105,911,936 | ||||||||||||||
| Diluted | 124,655,999 | 113,673,534 | 124,028,752 | 113,840,155 | ||||||||||||||
| CATALYST PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) | |||||||
| June 30, 2024 (unaudited) | December 31, 2023 | ||||||
| Assets | |||||||
| Current Assets: | |||||||
| Cash and cash equivalents | $ | 375,693 | $ | 137,636 | |||
| Accounts receivable, net | 57,172 | 53,514 | |||||
| Inventory | 18,014 | 15,644 | |||||
| Prepaid expenses and other current assets | 23,550 | 12,535 | |||||
| Total current assets | 474,429 | 219,329 | |||||
| Operating lease right-of-use asset | 2,371 | 2,508 | |||||
| Property and equipment, net | 1,227 | 1,195 | |||||
| License and acquired intangibles, net | 175,361 | 194,049 | |||||
| Deferred tax assets, net | 39,889 | 36,544 | |||||
| Investment in equity securities | 13,083 | 16,489 | |||||
| Total assets | $ | 706,360 | $ | 470,114 | |||
| Liabilities and Stockholders’ Equity | |||||||
| Current Liabilities: | |||||||
| Accounts payable | $ | 7,116 | $ | 14,795 | |||
| Accrued expenses and other liabilities | 85,202 | 61,268 | |||||
| Total current liabilities | 92,318 | 76,063 | |||||
| Operating lease liability, net of current portion | 2,991 | 3,188 | |||||
| Other non-current liabilities | 2,396 | 2,982 | |||||
| Total liabilities | 97,705 | 82,233 | |||||
| Total stockholders’ equity | 608,655 | 387,881 | |||||
| Total liabilities and stockholders’ equity | $ | 706,360 | $ | 470,114 | |||
Source: Catalyst Pharmaceuticals, Inc.
FAQ
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