Core Insights - Catalyst Pharmaceuticals reported record total revenues of $122.7 million for Q2 2024, reflecting a 23.2% year-over-year increase, driven by strong commercial execution and the successful launch of AGAMREE [1][10] - The company reaffirmed its total revenue guidance for 2024, expecting results in the upper range of $455 million to $475 million [1][8] Financial Performance - Q2 2024 net product revenues for FIRDAPSE were $77.4 million, showing a robust organic growth of 19.2% year-over-year [1][5] - AGAMREE generated net product revenues of $8.7 million in its first full quarter of U.S. commercialization [1][6] - FYCOMPA's net product revenues reached $36.5 million, representing a 5.7% year-over-year increase [1][6] - GAAP net income for Q2 2024 was $40.8 million, or $0.33 per diluted share, compared to $37.8 million, or $0.33 per diluted share, in Q2 2023 [1][14] - Non-GAAP net income for Q2 2024 was $69.6 million, or $0.56 per diluted share, compared to $60.4 million, or $0.53 per diluted share, in Q2 2023 [1][15] Business Developments - The company successfully launched AGAMREE, a novel corticosteroid treatment for Duchenne Muscular Dystrophy, which exceeded initial expectations [2][5] - Catalyst secured an exclusive license agreement for AGAMREE in Canada, expanding its North American market presence [2][7] - The FDA approved an increased maximum daily dose of FIRDAPSE, enhancing treatment options for healthcare providers [6][17] Expense Management - Research and development expenses decreased to $3.0 million in Q2 2024 from $4.0 million in Q2 2023, a reduction of approximately 24.5% [11] - Selling, general, and administrative expenses increased to $40.7 million in Q2 2024 from $28.4 million in Q2 2023, reflecting a rise of approximately 43.4% due to preparations for AGAMREE's launch [12] Cash Position - As of June 30, 2024, cash and cash equivalents stood at $375.7 million, a significant increase of 173% from $137.6 million at the end of 2023 [4][15]

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section presents the company's unaudited financial statements, management's analysis, market risk, and internal controls [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20FINANCIAL%20STATEMENTS) This section presents Catalyst Pharmaceuticals' unaudited consolidated financial statements and detailed notes for the period [Consolidated Balance Sheets](index=3&type=section&id=Consolidated%20Balance%20Sheets) This section presents the company's financial position, detailing assets, liabilities, and equity Consolidated Balance Sheets Highlights | Balance Sheet Highlights (in thousands) | June 30, 2024 (unaudited) | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $375,693 | $137,636 | | Total current assets | $474,429 | $219,329 | | Total assets | $706,360 | $470,114 | | **Liabilities & Equity** | | | | Total current liabilities | $92,318 | $76,063 | | Total liabilities | $97,705 | $82,233 | | Total stockholders' equity | $608,655 | $387,881 | | Total liabilities and stockholders' equity | $706,360 | $470,114 | - Total assets increased significantly to **$706.4 million** from **$470.1 million**, primarily driven by a substantial rise in cash and cash equivalents, which grew to **$375.7 million** from **$137.6 million**[5](index=5&type=chunk) [Consolidated Statements of Operations and Comprehensive Income](index=4&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income) This section outlines the company's financial performance, including revenues, expenses, and net income Consolidated Statements of Operations and Comprehensive Income Highlights | Income Statement Highlights (in thousands) | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | | :--- | :--- | :--- | | Total revenues | $122,710 | $99,582 | | Operating income | $54,246 | $46,699 | | Net income | $40,794 | $37,762 | | Diluted EPS | $0.33 | $0.33 | Consolidated Statements of Operations and Comprehensive Income Highlights | Income Statement Highlights (in thousands) | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :--- | :--- | :--- | | Total revenues | $221,219 | $184,948 | | Operating income | $81,372 | $82,308 | | Net income | $64,069 | $67,330 | | Diluted EPS | $0.52 | $0.59 | - For the three months ended June 30, 2024, total revenues grew **23.2%** YoY to **$122.7 million**, and net income increased to **$40.8 million** from **$37.8 million** For the six-month period, revenues grew **19.6%** YoY to **$221.2 million**, while net income slightly decreased to **$64.1 million** from **$67.3 million**[8](index=8&type=chunk) [Consolidated Statements of Cash Flows](index=7&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) This section details the company's cash inflows and outflows from operating, investing, and financing activities Consolidated Statements of Cash Flows Highlights | Cash Flow Highlights (in thousands) | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :--- | :--- | :--- | | Net cash provided by operating activities | $96,060 | $42,824 | | Net cash provided by (used in) investing activities | $(209) | $(162,367) | | Net cash provided by (used in) financing activities | $142,206 | $(65) | | Net increase (decrease) in cash | $238,057 | $(119,608) | | Cash and cash equivalents – end of period | $375,693 | $178,787 | - Cash from operations more than doubled to **$96.1 million** for the first six months of 2024 compared to **$42.8 million** in the prior year period Financing activities provided **$142.2 million**, primarily from a common stock issuance of **$141.0 million**, a significant change from the prior year[14](index=14&type=chunk) [Notes to Unaudited Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures supporting the unaudited consolidated financial statements - The company is a commercial-stage biopharmaceutical firm marketing three products: FIRDAPSE®, FYCOMPA®, and AGAMREE® AGAMREE® was commercially launched in the U.S. on March 13, 2024, for the treatment of Duchenne muscular dystrophy (DMD)[16](index=16&type=chunk) - In January 2024, the company completed a public offering of **10 million shares** of common stock, raising net proceeds of approximately **$140.7 million** to potentially acquire new products and for general corporate purposes[16](index=16&type=chunk)[78](index=78&type=chunk) Net Product Revenue by Product (in thousands) | Net Product Revenue by Product (in thousands) | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | | :--- | :--- | :--- | | FIRDAPSE® | $77,372 | $64,898 | | FYCOMPA® | $36,535 | $34,579 | | AGAMREE®* | $8,746 | $— | | **Total** | **$122,653** | **$99,477** | *AGAMREE® launched commercially on March 13, 2024. - The company is involved in Paragraph IV patent litigation against four generic drug manufacturers that filed ANDAs for FIRDAPSE® Lawsuits were filed in March and November 2023, triggering a statutory stay One lawsuit was settled in July 2024[63](index=63&type=chunk)[83](index=83&type=chunk) - Subsequent to the quarter's end, in July 2024, the company paid the final **$10 million** installment for its 2022 acquisition of RUZURGI® and entered into an agreement with KYE Pharmaceuticals for the exclusive Canadian commercial rights to AGAMREE®[83](index=83&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=44&type=section&id=Item%202.%20MANAGEMENT'S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) Management discusses the company's business, financial condition, and operational results, highlighting product performance and liquidity [Overview](index=44&type=section&id=Overview) This section provides a general business overview, highlighting key products and strategic initiatives - The company's business is centered on commercializing three products: FIRDAPSE® for LEMS, FYCOMPA® for epilepsy, and AGAMREE® for Duchenne muscular dystrophy (DMD)[86](index=86&type=chunk) - The FDA approved an increased maximum daily dosage for FIRDAPSE® from **80 mg** to **100 mg** on May 30, 2024, offering greater treatment flexibility[87](index=87&type=chunk) - AGAMREE® was commercially launched in the U.S. on March 13, 2024, for the treatment of DMD in patients aged two years and older The company added approximately **10 commercial team members** to support the launch[86](index=86&type=chunk)[92](index=92&type=chunk) - The company is actively pursuing business development to expand its rare neurology product portfolio through potential partnerships, licensing, and asset acquisitions[94](index=94&type=chunk) [Results of Operations](index=54&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance, focusing on revenue, costs, and profitability Revenue Analysis (in millions) | Revenue Analysis (in millions) | Q2 2024 | Q2 2023 | % Change | | :--- | :--- | :--- | :--- | | FIRDAPSE® Net Sales | $77.4 | $64.9 | 19.2% | | FYCOMPA® Net Sales | $36.5 | $34.6 | 5.5% | | AGAMREE® Net Sales | $8.7 | $0.0 | N/A | | **Total Revenue** | **$122.7** | **$99.6** | **23.2%** | - Selling, General and Administrative (SG&A) expenses increased by **43.4%** to **$40.7 million** in Q2 2024 from **$28.4 million** in Q2 2023 The increase was primarily due to higher employee compensation from increased headcount, commercialization expenses for the AGAMREE® launch, and increased stock-based compensation[109](index=109&type=chunk)[110](index=110&type=chunk) - Research and Development (R&D) expenses decreased by **24.5%** to **$3.0 million** in Q2 2024, primarily due to costs in 2023 related to closing out sites for the MuSK-MG clinical trial[107](index=107&type=chunk)[108](index=108&type=chunk) - Amortization of intangible assets increased to **$9.3 million** in Q2 2024 from **$8.5 million** in Q2 2023, reflecting the amortization of assets related to FYCOMPA®, RUZURGI®, and the capitalized milestone payment for AGAMREE®[106](index=106&type=chunk) [Liquidity and Capital Resources](index=59&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the company's ability to meet obligations and fund operations through its cash and capital - As of June 30, 2024, the company had cash and cash equivalents of **$375.7 million** and working capital of **$382.1 million**, up from **$137.6 million** and **$143.3 million**, respectively, at year-end 2023[114](index=114&type=chunk) - Net cash from operating activities for the first six months of 2024 was **$96.1 million**, a significant increase from **$42.8 million** in the same period of 2023[115](index=115&type=chunk) - In January 2024, the company raised approximately **$140.7 million** in net proceeds from a public offering of **10 million shares** of common stock[114](index=114&type=chunk) - The company believes its current cash position is sufficient to support operations for at least the next 12 months[114](index=114&type=chunk) [Item 3. Quantitative and Qualitative Disclosure About Market Risk](index=65&type=section&id=Item%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURE%20ABOUT%20MARKET%20RISK) The company's primary market risk exposure is related to interest rate fluctuations on its cash and cash equivalents These funds are invested in highly liquid money market funds and U.S. Treasuries, with the main objective being capital preservation - The company's market risk is limited to interest rate risk on its cash and cash equivalents The investment policy prioritizes liquidity and preservation of principal over yield[126](index=126&type=chunk) [Item 4. Controls and Procedures](index=65&type=section&id=Item%204.%20CONTROLS%20AND%20PROCEDURES) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective as of June 30, 2024 There were no material changes to the company's internal control over financial reporting during the quarter - The Principal Executive Officer and Principal Financial Officer concluded that the company's disclosure controls and procedures were effective as of the end of the period[127](index=127&type=chunk) - No changes in internal controls occurred during the quarter that have materially affected, or are reasonably likely to materially affect, internal control over financial reporting[127](index=127&type=chunk) [PART II. OTHER INFORMATION](index=66&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section covers legal proceedings, risk factor updates, and equity security sales and repurchases [Item 1. Legal Proceedings](index=66&type=section&id=Item%201.%20LEGAL%20PROCEEDINGS) The company is engaged in Paragraph IV patent litigation against generic drug manufacturers that have filed ANDAs seeking to market generic versions of FIRDAPSE® Lawsuits have been filed, triggering a statutory stay on FDA approval One of these lawsuits was settled in July 2024 Similar litigation regarding FYCOMPA® was settled in June 2024 - The company is litigating against three generic drug manufacturers challenging its FIRDAPSE® patents A fourth lawsuit was settled on July 30, 2024, with the filer acknowledging patent validity and agreeing not to commercialize its product until patent expiration or other specified conditions are met[129](index=129&type=chunk) - In June 2024, the company settled a lawsuit with a generic manufacturer for both the oral suspension and tablet formulations of FYCOMPA® The settlement prevents the commercialization of the generic products until at least December 15, 2025[129](index=129&type=chunk) [Item 1A. Risk Factors](index=66&type=section&id=Item%201A.%20RISK%20FACTORS) There have been no material changes to the risk factors previously disclosed in the company's 2023 Annual Report on Form 10-K - The company refers investors to the risk factors section of its 2023 Annual Report on Form 10-K for a description of significant factors that could impact its business[131](index=131&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=66&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company did not repurchase any of its common stock during the three months ended June 30, 2024 Approximately $21 million remains available under the current share repurchase program, but the company is prioritizing cash for business development activities - No shares were repurchased during the three months ended June 30, 2024 The company is currently retaining cash for business development rather than executing share repurchases[132](index=132&type=chunk)[133](index=133&type=chunk)

"Our expanded partnership with Catalyst highlights the intrinsic value of our collaboration in developing innovative treatments for rare diseases, including DMD, and exemplifies our shared dedication to improving health outcomes across the U.S. and Canada. Together, we are committed to delivering novel therapies and bridging clinically significant treatment gaps," stated John McKendry, CEO and President of Kye Pharmaceuticals. About AGAMREE® (vamorolone) "We are pleased to enter into this agreement with Kye ...

Company Overview - Catalyst Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients with rare and difficult-to-treat diseases [4]. - The company's flagship product is FIRDAPSE® (amifampridine) Tablets 10 mg, approved for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults and pediatric patients aged 6 and older [6]. - In January 2023, Catalyst acquired the U.S. commercial rights to FYCOMPA® (perampanel), a medication for epilepsy [6]. - Catalyst also acquired an exclusive license for AGAMREE® (vamorolone), a treatment for Duchenne Muscular Dystrophy, which received FDA approval for commercialization in the U.S. on October 26, 2023 [6]. Financial Results Announcement - Catalyst Pharmaceuticals will release its second quarter 2024 financial results after the market close on August 7, 2024 [4]. - A conference call and webcast to discuss the financial results and provide a business update will be held on August 8, 2024, at 8:30 AM ET [1][5]. Accessibility of Information - The webcast will be accessible under the Investors section on the company's website, and a replay will be available for at least 30 days following the event [5].

CORAL GABLES, Fla., July 22, 2024 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst" or "Company") (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare and difficult-to-treat diseases, today announced that it will release its second quarter 2024 financial results after the market close on Wednesday, August 7, 2024. Conference Call & Webcast Details The webcast will be accessible under t ...

A month has gone by since the last earnings report for Catalyst Pharmaceutical (CPRX) . Shares have added about 0.7% in that time frame, underperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is Catalyst due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its most recent earnings report in order to get a better handle on the important drivers. Catalyst Q1 Earnings Top, Firdapse Sales ...

Core Insights - The FDA has approved Catalyst Pharmaceuticals' supplemental New Drug Application (sNDA) to increase the maximum daily dose of FIRDAPSE® (amifampridine) for treating Lambert-Eaton myasthenic syndrome (LEMS) from 80 mg to 100 mg for patients over 45 kg [1][2][3] - This approval enhances treatment flexibility for healthcare providers and patients managing LEMS, a rare autoimmune disorder characterized by muscle weakness and fatigue [2][3] Company Overview - Catalyst Pharmaceuticals is a commercial-stage biopharmaceutical company focused on developing and commercializing novel medicines for rare and difficult-to-treat diseases [1][5] - FIRDAPSE is currently the only FDA-approved treatment for LEMS, and the recent approval broadens the dosing options available to prescribers [2][5] - The company has also acquired U.S. commercial rights to FYCOMPA® and AGAMREE®, expanding its product portfolio in the neurology and rare disease sectors [5] Patient Support Initiatives - Catalyst offers the Catalyst Pathways® Patient Assistance Program for FIRDAPSE®, providing comprehensive support to eligible patients and their families throughout the treatment journey [3]

CORAL GABLES, Fla., May 30, 2024 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst" or "Company") (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare and difficult-to-treat diseases, today announced that the U.S. Food and Drug Administration ("FDA") has approved its supplemental New Drug Application ("sNDA") increasing the indicated maximum daily dose of FIRDAPSE® (amifampridine) for a ...

Catalyst Pharmaceuticals, Inc. (CPRX) reported adjusted earnings of 38 cents per share for the first quarter of 2024, beating the Zacks Consensus Estimate of 34 cents. The company reported adjusted earnings of 41 cents in the year-ago quarter.Total revenues amounted to $98.5 million in the reported quarter, which surpassed the Zacks Consensus Estimate of $97 million. Total product revenues climbed 15.4% to $98.4 million, from the year-ago quarter’s $85.3 million. The top line primarily comprised product sal ...

Financial Data and Key Metrics Changes - Total revenues for Q1 2024 were $98.5 million, a 15% increase compared to $85.4 million in Q1 2023 [96] - Net income before income taxes for Q1 2024 was $29.1 million, a 22% decrease year-over-year from $37.3 million in Q1 2023 [13] - GAAP net income for Q1 2024 was $23.3 million, or $0.20 per basic share, down 21% from $29.6 million, or $0.28 per basic share in Q1 2023 [13] - SG&A expenses for Q1 2024 totaled $46.9 million, up from $29.7 million in Q1 2023, representing 66% of total operating expenses [12] Business Line Data and Key Metrics Changes - FIRDAPSE net sales for Q1 2024 were $66.8 million, a 16% increase from $57.5 million in Q1 2023, driven by new patient starts and high compliance [31] - FYCOMPA net revenues increased to $30.4 million in Q1 2024 from $27.8 million in the same quarter of 2023 [35] - AGAMREE generated $1.2 million in product revenue net during its initial launch period in Q1 2024 [73] Market Data and Key Metrics Changes - Prescription approval rates for FIRDAPSE were greater than 90%, with an average approval time of less than 30 days [32] - 63% of DMD Centers of Excellence have enrolled at least one patient on AGAMREE [33] - The company reported the highest total of new patients in Q1 2024 since Q1 2022, indicating strong market demand [92] Company Strategy and Development Direction - The company aims to expand its portfolio in the orphan CNS and adjacent spaces, focusing on strategic partnerships and business development opportunities [4][10] - The Summit Study for AGAMREE is designed to evaluate long-term safety and quality-of-life benefits, aligning with FDA guidance [29] - The company is actively pursuing partnerships for FIRDAPSE in the APAC region and AGAMREE in North America [90] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving full-year 2024 total revenue guidance of $455 million to $475 million [5] - The company anticipates continued organic growth for FIRDAPSE and stable revenues for FYCOMPA, with expectations for AGAMREE to see significant growth in Q2 and beyond [79][94] - Management noted that the current payer landscape is expected to improve, potentially reducing the time from enrollment to reimbursement [146] Other Important Information - The company ended Q1 2024 with cash and cash equivalents of $310.4 million, significantly up from $137.6 million at the end of 2023, largely due to a capital raise [125] - Research and development expenses for Q1 2024 were $2.6 million, slightly down from $3.6 million in Q1 2023 [123] Q&A Session Summary Question: Can you provide insights on AGAMREE patient enrollments? - Management indicated that 47% of new enrollments for AGAMREE were from patients previously on Emflaza, and 43% from those on prednisone [131] Question: What is the expected impact of the PDUFA date for FIRDAPSE? - The company is eagerly awaiting the June 4, 2024 PDUFA date for a supplemental new drug application to increase the maximum daily dose of FIRDAPSE, which could enhance therapeutic flexibility [115] Question: How does the company view business development opportunities? - The company is focused on opportunities that are immediately accretive and is looking for assets that can enhance its balance sheet [24]