Core Insights - Catalyst Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on developing and commercializing novel medicines for rare and difficult-to-treat diseases [1][3] - The company will participate in several upcoming investor conferences, including the Wells Fargo Healthcare Conference, H.C. Wainwright Global Investment Conference, and Cantor Global Healthcare Conference [2] Company Developments - Catalyst's flagship product, FIRDAPSE® (amifampridine) Tablets 10 mg, is approved for treating Lambert-Eaton myasthenic syndrome (LEMS) in patients aged 6 and older, with a recent FDA approval increasing the maximum daily dose to 100 mg for certain patients [3] - In January 2023, Catalyst acquired U.S. commercial rights to FYCOMPA® (perampanel), a medication for treating partial-onset seizures and primary generalized tonic-clonic seizures in patients aged 4 and older [4] - The company 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, and became available by prescription on March 13, 2024 [5]

Catalyst Pharmaceutical (CPRX) closed the last trading session at $19.24, gaining 13.9% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $30.14 indicates a 56.7% upside potential. The average comprises seven short-term price targets ranging from a low of $26 to a high of $38, with a standard deviation of $3.89. While the lowest estimate indicates an increase of 35.1% from the curren ...

Most of us have heard the dictum "the trend is your friend." And this is undeniably the key to success when it comes to short-term investing or trading. But it isn't easy to ensure the sustainability of a trend and profit from it. Often, the direction of a stock's price movement reverses quickly after taking a position in it, making investors incur a short-term capital loss. So, it's important to ensure that there are enough factors -- such as sound fundamentals, positive earnings estimate revisions, etc. - ...

Financial Data and Key Metrics Changes - In Q2 2024, Catalyst Pharmaceuticals reported total revenues of $122.7 million, a 23.2% increase compared to Q2 2023, driven by strong organic growth from FIRDAPSEE and AGAMREE [4][12][19] - Net income before income taxes was $55.8 million, a 15% increase from $48.5 million in Q2 2023, with GAAP net income of $40.8 million or $0.33 per diluted share, an 8% year-over-year increase [19][20] - 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 [20] Business Line Data and Key Metrics Changes - FIRDAPSEE achieved Q2 net sales of $77.4 million, a 19.2% increase year-over-year, attributed to steady new patient enrollments and a low discontinuation rate [13][14] - FYCOMPA generated Q2 net revenues of $36.5 million, with expectations for stable revenues in the second half of 2024 [15] - AGAMREE reported Q2 product net revenues of $8.7 million, exceeding initial launch expectations, with 46% of new enrollments transitioning from EMFLAZA [16][17] Market Data and Key Metrics Changes - The company received US approval for FIRDAPSEE's expanded maximum daily dose of 100 milligrams, enhancing treatment flexibility for healthcare professionals [6] - The ongoing collaboration with DyDo Pharma in Japan is expected to yield a NDA decision for FIRDAPSEE by the end of Q3 or early Q4 2024 [7] Company Strategy and Development Direction - The company is focused on a threefold growth strategy: outstanding execution, portfolio diversification, and targeted ex-US partnerships [10][11] - Catalyst aims to continue its buy and build plan, enhancing its capabilities in identifying and launching products that deliver value [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving total revenue at the upper end of the previously guided range of $455 million to $475 million for 2024, driven by strong performance across its product portfolio [5][19] - The company remains committed to advancing patient care and unlocking growth potential while maintaining a strong balance sheet [24] Other Important Information - The company ended Q2 2024 with cash and cash equivalents of $375.7 million, significantly up from $137.6 million at the end of 2023, driven by a capital raise and operational cash generation [22][23] - Research and development expenses decreased to $3 million in Q2 2024 from $4 million in Q2 2023, while SG&A expenses increased due to the launch of AGAMREE [22] Q&A Session Summary Question: Was there a bolus in AGAMREE sales due to pent-up demand? - Management confirmed significant pent-up demand leading to strong sales in Q2, with expectations for continued interest moving forward [25][26] Question: How will the new higher dose of FIRDAPSEE impact patient discontinuation rates? - Management does not expect an increase in discontinuation rates due to the new dosing flexibility, as the majority of discontinuations occur within the first six months of therapy [30][31] Question: What is the company's strategy for business development? - The company is focused on orphan and differentiated orphan products, with a broad approach to potential opportunities in the neuro space and beyond [31] Question: How is the patient mix for AGAMREE expected to evolve? - Management anticipates the patient mix will remain stable, with no significant impact from the generic entrance of EMFLAZA observed so far [34][36] Question: What is the status of ongoing litigation related to FIRDAPSEE? - Management is working diligently to resolve ongoing litigation favorably but refrained from commenting in detail [37] Question: What is the company's approach to future business development deals? - The company is inclined to pursue deals that enhance income diversity, with a preference for cash-funded deals initially, followed by potential leverage for larger transformational opportunities [39][40]

Catalyst Pharmaceuticals, Inc. (CPRX) reported adjusted earnings of 56 cents per share for the second quarter of 2024, beating the Zacks Consensus Estimate of 42 cents. The company reported adjusted earnings of 53 cents in the year-ago quarter. Total revenues, the majority of which comprised product revenues, amounted to $122.7 million in the reported quarter, representing growth of 23% year over year. The recorded figure also surpassed the Zacks Consensus Estimate of $111.6 million. Catalyst's top line pri ...

Core Insights - Catalyst Pharmaceutical (CPRX) reported $122.71 million in revenue for Q2 2024, a year-over-year increase of 23.2% [1] - The earnings per share (EPS) for the same period was $0.56, up from $0.33 a year ago, indicating a strong performance [1] - The reported revenue exceeded the Zacks Consensus Estimate of $111.76 million by 9.80%, and the EPS also surpassed the consensus estimate of $0.42 by 33.33% [1] Revenue Breakdown - Product revenue, net was $122.65 million, compared to the average estimate of $111.57 million from five analysts [3] - License and other revenue was $0.06 million, falling short of the average estimate of $0.32 million from three analysts [4] - FYCOMPA product revenue, net reached $36.54 million, exceeding the average estimate of $33.21 million from two analysts [5] - AGAMREE product revenue, net was $8.75 million, surpassing the average estimate of $5.98 million from two analysts [6] - FIRDAPSE product revenue, net totaled $77.37 million, compared to the average estimate of $72.53 million from two analysts [7] Stock Performance - Catalyst shares have returned +3.7% over the past month, contrasting with the Zacks S&P 500 composite's -5.9% change [7] - The stock currently holds a Zacks Rank 3 (Hold), suggesting it may perform in line with the broader market in the near term [7]

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 AGAMREE® Q2 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% Y ...

[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].