Catalyst Pharmaceuticals Reports Strong Third Quarter 2024 Financial Results and Provides Corporate Update
Reports Q3 2024 Total Revenues of $128.7 Million, Representing a 25.3% YoY Increase
Record Revenues Driven by Continued Organic Growth in its Rare Disease Franchise
Robust Financial Performance Highlights Operational Excellence and Strong Commercial Execution
FIRDAPSE® Q3 2024 Net Product Revenues of $79.3 Million, Representing a 19.7% YoY Increase
AGAMREE® Q3 2024 Net Product Revenues of $15.0 Million, Demonstrating Early
FYCOMPA® Q3 2024 Net Product Revenues of $32.1 Million
Q3 2024 GAAP Net Income of $43.9 Million,
Q3 2024 Non-GAAP Net Income of $71.1 Million,
Updating 2024 Full Year Total Revenue Guidance to Between
Conference Call and Webcast to be Held on
"Our strong financial performance reflects our unwavering commitment to operational and commercial excellence, driving sustained momentum and long-term growth. The early success of our newest product, AGAMREE®, along with the continued robust organic growth of our flagship product, FIRDAPSE®, highlights the strength of our
Financial Highlights
| For the Three Months Ended |
2024 | 2023 | % Change | ||||
| (In thousands, except per share data) | |||||||
| Product Revenue, Net | 23.2% | ||||||
| FIRDAPSE Product Revenue, Net | 19.7% | ||||||
| FYCOMPA Product Revenue, Net | (11.9%) | ||||||
| AGAMREE Product Revenue, Net | N/A | N/A | |||||
| GAAP Net Income (Loss) | ( |
242.6% | |||||
| Non-GAAP Net Income (Loss)** | ( |
377.2% | |||||
| GAAP Net Income (Loss) Per Share – Basic | ( |
227.6% | |||||
| Non-GAAP Net Income (Loss) Per Share – Basic** | ( |
350.0% | |||||
| GAAP Net Income (Loss) Per Share – Diluted | ( |
220.7% | |||||
| Non-GAAP Net Income (Loss) Per Share – Diluted** | ( |
337.5% | |||||
| As of (In thousands) Cash and Cash Equivalents |
221.4% | ||||||
**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.
Beginning with the third quarter of 2024, Catalyst will no longer include acquisition in-process research and development ("IPR&D") in its non-GAAP financial measures. Previously reported non-GAAP net income for the third quarter of 2023 included
Recent Business Highlights
- Achieved total revenues of
$128.7 million , including net product revenues of$126.4 million for the third quarter (“Q3”) of 2024, reflecting a 23.2% increase over net product revenues for Q3 of 2023.
- Reported record quarterly FIRDAPSE net product revenues of
$79.3 million for Q3 2024, reflecting a 19.7% increase over Q3 2023, driven by sustained organic growth.
- Achieved robust AGAMREE net product revenues of
$15.0 million for Q3 2024, demonstrating continued momentum in its second full quarter ofU.S. commercial availability.
- Reported FYCOMPA® net product revenues of
$32.1 million for Q3 2024, an 11.9% decrease compared to Q3 2023 revenues of$36.4 million .
- Announced that
DyDo Pharma, Inc. (Catalyst’s sub-licensee inJapan ), received regulatory approval inJapan to commercialize FIRDAPSE 10 mg tablets for the treatment of Lambert-Eaton myasthenic syndrome inJapan , marking a key milestone in expanding the product’s commercial footprint. DyDo has advised Catalyst that it expects to launch inJapan by the end of Q4 2024.
- Announced an exclusive agreement with
KYE Pharmaceuticals, Inc. for the Canadian commercial rights to AGAMREE for Duchenne muscular dystrophy and other potential indications, further expanding Catalyst’s North American footprint. This marks the licensing of Catalyst’s second rare disease product inCanada , and KYE has advised us that it expects to file aHealth Canada application for AGAMREE by early 2025.
- Expect total revenues for the full year 2024 to be between
$475 million and$485 million , which includes the$2.1 million milestone payment received from DyDo that is included in License and other revenue.
- Revising full-year 2024 net product revenue guidance for FIRDAPSE to be between
$300 million and$310 million ; reaffirming FYCOMPA net product revenue guidance to be between$130 million and$135 million ; and increasing AGAMREE net product revenue guidance to be between$40 million and$45 million , respectively.
- Revising full year research and development (“R&D”) expense guidance to less than
$15 million due to delays in the timing of certain R&D related initiatives.
Third Quarter 2024 Financial Results
Total revenues: Total revenues during the third quarter of 2024 were $128.7 million, compared to $102.7 million for the third quarter of 2023, representing an increase of approximately 25.3%.
Product revenue, net: Product revenue, net for the third quarter of 2024 was
License and other revenue: License and other revenue includes
Research and development expenses: Research and development expenses for the third quarter of 2024 were $3.3 million, compared to
Selling, general and administrative expenses: Selling, general and administrative expenses for the third quarter of 2024 were $45.9 million, compared to
Amortization of intangible assets: Amortization of intangible assets was
Operating income (loss): Operating income (loss) for the third quarter of 2024 was $50.9 million, compared to
GAAP net income (loss): GAAP net income (loss) for the third quarter of 2024 was
Non-GAAP net income (loss): Non-GAAP net income (loss) for the third quarter of 2024 was
Cash and cash equivalents: Cash and cash equivalents were
Catalyst’s Form 10-Q for the third quarter of 2024, filed with the
Conference Call & Webcast Details
The Company will host a conference call and webcast on
| 800-715-9871 | |
| International Dial-in Number: | 646-307-1963 |
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
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 have been 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 that is 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
CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) (in thousands, except share and per share data) |
|||||||||||||
| For the Three Months Ended |
For the Nine Months Ended |
||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||
| Product revenue, net | $ | 126,424 | $ | 102,617 | $ | 347,518 | $ | 287,398 | |||||
| License and other revenue | 2,271 | 71 | 2,396 | 238 | |||||||||
| Total revenues | 128,695 | 102,688 | 349,914 | 287,636 | |||||||||
| Operating costs and expenses: | |||||||||||||
| Cost of sales (a) | 19,277 | 14,167 | 47,202 | 36,158 | |||||||||
| Research and development | 3,284 | 83,662 | 8,850 | 91,178 | |||||||||
| Selling, general and administrative (a) | 45,880 | 33,560 | 133,548 | 91,674 | |||||||||
| Amortization of intangible assets | 9,345 | 8,487 | 28,033 | 23,506 | |||||||||
| Total operating costs and expenses | 77,786 | 139,876 | 217,633 | 242,516 | |||||||||
| Operating income (loss) | 50,909 | (37,188 | ) | 132,281 | 45,120 | ||||||||
| Other income (expense), net | 6,296 | (833 | ) | 9,801 | 2,684 | ||||||||
| Net income (loss) before income taxes | 57,205 | (38,021 | ) | 142,082 | 47,804 | ||||||||
| Income tax provision (benefit) | 13,321 | (7,257 | ) | 34,129 | 11,238 | ||||||||
| Net income (loss) | $ | 43,884 | $ | (30,764 | ) | $ | 107,953 | $ | 36,566 | ||||
| Net income (loss) per share: | |||||||||||||
| Basic | $ | 0.37 | $ | (0.29 | ) | $ | 0.92 | $ | 0.34 | ||||
| Diluted | $ | 0.35 | $ | (0.29 | ) | $ | 0.87 | $ | 0.32 | ||||
| Weighted average shares outstanding: | |||||||||||||
| Basic | 118,931,153 | 106,568,137 | 117,976,056 | 106,133,077 | |||||||||
| Diluted | 125,407,279 | 106,568,137 | 124,519,838 | 113,751,370 | |||||||||
(a) exclusive of amortization of intangible assets
RECONCILIATION OF NON-GAAP METRICS (unaudited) (in thousands, except share and per share data) |
||||||||||||
| For the Three Months Ended |
For the Nine Months Ended |
|||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||
| GAAP net income (loss) | $ | 43,884 | $ | (30,764 | ) | $ | 107,953 | $ | 36,566 | |||
| Non-GAAP adjustments: | ||||||||||||
| Stock-based compensation expense | 4,424 | 3,810 | 17,080 | 10,000 | ||||||||
| Depreciation | 106 | 81 | 283 | 232 | ||||||||
| Amortization of intangible assets | 9,345 | 8,487 | 28,033 | 23,506 | ||||||||
| Income tax provision (benefit) | 13,321 | (7,257 | ) | 34,129 | 11,238 | |||||||
| Non-GAAP net income (loss) | $ | 71,080 | $ | (25,643 | ) | $ | 187,478 | $ | 81,542 | |||
| Non-GAAP net income (loss) per share: | ||||||||||||||||
| Basic | $ | 0.60 | $ | (0.24 | ) | $ | 1.59 | $ | 0.77 | |||||||
| Diluted | $ | 0.57 | $ | (0.24 | ) | $ | 1.51 | $ | 0.72 | |||||||
| Weighted average shares outstanding: | ||||||||||||||||
| Basic | 118,931,153 | 106,568,137 | 117,976,056 | 106,133,077 | ||||||||||||
| Diluted | 125,407,279 | 106,568,137 | 124,519,838 | 113,751,370 | ||||||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) |
|||||
2024 (unaudited) |
2023 |
||||
| Assets | |||||
| Current Assets: | |||||
| Cash and cash equivalents | $ | 442,331 | $ | 137,636 | |
| Accounts receivable, net | 58,266 | 53,514 | |||
| Inventory | 20,017 | 15,644 | |||
| Prepaid expenses and other current assets | 18,384 | 12,535 | |||
| Total current assets | 538,998 | 219,329 | |||
| Operating lease right-of-use asset, net | 2,301 | 2,508 | |||
| Property and equipment, net | 1,380 | 1,195 | |||
| License and acquired intangibles, net | 166,016 | 194,049 | |||
| Deferred tax assets, net | 48,473 | 36,544 | |||
| Investment in equity securities | 14,842 | 16,489 | |||
| Total assets | $ | 772,010 | $ | 470,114 | |
| Liabilities and Stockholders’ Equity | |||||
| Current Liabilities: | |||||
| Accounts payable | $ | 11,563 | $ | 14,795 | |
| Accrued expenses and other liabilities | 93,832 | 61,268 | |||
| Total current liabilities | 105,395 | 76,063 | |||
| Operating lease liability, net of current portion | 2,889 | 3,188 | |||
| Other non-current liabilities | 2,785 | 2,982 | |||
| Total liabilities | 111,069 | 82,233 | |||
| Total stockholders’ equity | 660,941 | 387,881 | |||
| Total liabilities and stockholders’ equity | $ | 772,010 | $ | 470,114 | |
Source:
Contact information:
Investor Contact
(305) 420-3200
mcoleman@catalystpharma.com
Media Contact
(858) 717-2310
david.schull@russopartnersllc.com
Source: Catalyst Pharmaceuticals, Inc.