Full Press Release Details
Catalyst Pharmaceuticals Reports Strong Second Quarter 2024 Financial Results and Provides Corporate Update
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 $122.7 Million,
Representing a 23.2% YoY Increase
FIRDAPSE Q2 2024 Net Product Revenues
of $77.4 Million, Reflecting Strong Organic 19.2% YoY Growth
2024 Net Product Revenues of $8.7 Million Demonstrates a Strong Start to U.S. Commercialization
FYCOMPA Q2 2024 Net Product Revenues of $36.5 Million, Representing a 5.7% YoY Increase
Q2 2024 GAAP Net Income of $40.8 Million, $0.33 Per Share Diluted
Q2 2024 Non-GAAP Net Income of $69.6 Million, $0.56 Per Share Diluted
Reaffirming 2024 Total Revenue Guidance of $455 Million $475 Million, Expecting Results in the Upper
Range of the Guidance
Conference Call and Webcast to be Held on August 8, 2024, at 8:30 AM ET
CORAL GABLES, Fla., August 7, 2024- 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 | % |
Recent Business Highlights
Total revenues: In the second quarter of 2024, total revenues were $122.7 million, compared to $99.6
million for the second quarter of 2023, representing an increase of approximately 23.2%.
Product revenue, net: Product revenue, net for the
second quarter of 2024 was $122.7 million, compared to $99.5 million for the second quarter of 2023, representing an increase of approximately 23.3%.
Research and development expenses: Research and development expenses for the second quarter of 2024 were $3.0 million, compared to
$4.0 million for the second quarter of 2023, representing a decrease of approximately 24.5%.
Selling, general, and administrative expenses:
Selling, general, and administrative expenses for the second quarter of 2024 were $40.7 million, compared to $28.4 million for the second quarter of 2023, representing an increase of approximately 43.4%, primarily relating to
our preparation for and commercial launch of AGAMREE.
Amortization of intangible assets: Amortization of intangible assets was $9.3 million in the
second quarter of 2024, compared to $8.5 million in the second quarter of 2023, representing an increase of approximately 10.1%.
income: Operating income for the second quarter of 2024 was $54.2 million, compared to $46.7 million for the second quarter of 2023, representing an increase of approximately 16.2%.
GAAP net income: GAAP net income for the second quarter of 2024 was $40.8 million ($0.35 per basic and $0.33 per diluted share), compared to GAAP
net income of $37.8 million ($0.36 per basic and $0.33 per diluted share) for the second quarter of 2023.
Non-GAAP net income: Non-GAAP net income for the second quarter of 2024
was $69.6 million ($0.59 per basic and $0.56 per diluted share), compared to non-GAAP net income of $60.4 million ($0.57 per basic and $0.53 per diluted share) for the second quarter of 2023.
Cash and cash equivalents: Cash and cash equivalents were $375.7 million as of June 30, 2024.
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.
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.
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
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 |
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
| 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.
Contact information:
Catalyst Pharmaceuticals, Inc.