Catalyst Pharmaceuticals(CPRX)

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Catalyst Pharmaceuticals: Undervalued Future With Multiple Upside Catalysts
Seeking Alpha· 2025-03-11 08:05
Core Insights - The individual investor emphasizes a strategic analysis approach to stock picking, focusing on management's ability to reinvest profits rather than dividends [1] - The investor's primary decision trigger is valuation, rejecting the "quality at reasonable price" philosophy in favor of a more rigorous value assessment [1] - The blog serves as a documentation of the investor's journey and aims to enhance investment intuition through shared insights [1] Group 1 - The investor is sector agnostic, indicating a broad approach to identifying investment opportunities across various industries [1] - There is a willingness to consider growth stocks if they present an attractive risk/reward profile, categorizing them as value opportunities [1] - The investor expresses a desire to exchange ideas with others in the investment community, highlighting a collaborative approach to learning [1]
Catalyst Pharmaceuticals to Participate in the Barclays 27th Annual Global Healthcare Conference
Newsfilter· 2025-03-04 13:03
Core Insights - Catalyst Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing and commercializing treatments for rare and difficult-to-treat diseases [1][3] - The company will participate in the Barclays 27th Annual Global Healthcare Conference on March 11, 2025, in Miami, Florida [1][2] - Catalyst has been recognized on the Forbes 2025 list as one of America's Most Successful Mid-Cap Companies and on the 2024 Deloitte Technology Fast 500™ list as one of North America's Fastest-Growing Companies [3] Company Overview - Catalyst Pharmaceuticals is headquartered in Coral Gables, Florida, and is committed to improving the lives of patients with rare diseases [3] - The company focuses on in-licensing, commercializing, and developing innovative therapies, ensuring patient accessibility through a comprehensive suite of support services [3] - Catalyst aims to expand its global commercial footprint through strategic partnerships while maintaining a strong presence in the U.S. market [3]
Catalyst Pharmaceuticals: Stable Firdapse, Promising Agamree, Fycompa Challenges
Seeking Alpha· 2025-03-03 19:39
Company Overview - Catalyst Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical firm focused on therapies for rare muscular and neurological conditions [1] - The company's portfolio includes three main products: Firdapse, Agamree, and Fycompa [1] - Firdapse is the core product, indicated for Lambert-Eaton Myasthenic Syndrome (LEMS) [1] Product Details - Firdapse is specifically designed for the treatment of LEMS, a rare autoimmune disorder [1] - The company aims to address unmet medical needs in the rare disease space with its specialized therapies [1]
Here's What's Driving Catalyst Pharmaceuticals Stock 8% Higher Today
The Motley Fool· 2025-02-27 19:35
The drugmaker confirmed there's a strong market for two of its treatments.Shares of drugmaker Catalyst Pharmaceuticals (CPRX 4.67%) are up a little more than 8% as of midday on Thursday, down slightly from an intraday peak gain of nearly 13%. The company's fourth-quarter results posted after Wednesday's close were markedly better than expected.Encouraging numbers from CatalystCatalyst Pharmaceuticals' specialty is treating rare diseases, which inherently leaves it off of most investors' radars.Nevertheless, ...
Catalyst Pharmaceuticals(CPRX) - 2024 Q4 - Earnings Call Transcript
2025-02-27 17:29
Catalyst Pharmaceuticals, Inc. (NASDAQ:CPRX) Q4 2024 Earnings Conference Call February 27, 2025 8:30 AM ET Company Participants Michael Kalb - Executive Vice President & Chief Financial Officer Richard Daly - President and Chief Executive Officer Jeff Del Carmen - Executive Vice President, Chief Commercial Officer Steven Miller - Executive Vice President, Chief Operating Officer and Chief Scientific Officer Gary Ingenito - Chief Medical and Regulatory Officer Conference Call Participants Charles Duncan - Ca ...
Catalyst Pharmaceuticals(CPRX) - 2024 Q4 - Earnings Call Transcript
2025-02-27 14:32
Catalyst Pharmaceuticals (CPRX) Q4 2024 Earnings Call February 27, 2025 08:30 AM ET Company Participants Michael Kalb - Executive VP & CFORichard Daly - President & CEOJeff Del Carmen - Chief Commercial OfficerGary Ingenito - Chief Medical & Regulatory OfficerBenjamin Paluch - Equity Research Senior AssociateRohan Mathur - Equity Research AssociateFelix Ampomah - Senior Associate Conference Call Participants Charles Duncan - AnalystPavan Patel - AnalystAsim Rana - Equity AnalystJoseph Catanzaro - Director & ...
Catalyst Pharmaceuticals(CPRX) - 2024 Q4 - Earnings Call Transcript
2025-02-27 14:30
Catalyst Pharmaceuticals (CPRX) Q4 2024 Earnings Call February 27, 2025 08:30 AM ET Company Participants Michael Kalb - Executive VP & CFORichard Daly - President & CEOJeff Del Carmen - Chief Commercial OfficerGary Ingenito - Chief Medical & Regulatory OfficerBenjamin Paluch - Equity Research Senior AssociateRohan Mathur - Equity Research AssociateFelix Ampomah - Senior Associate Conference Call Participants Charles Duncan - AnalystPavan Patel - AnalystAsim Rana - Equity AnalystJoseph Catanzaro - Director & ...
Catalyst (CPRX) Q4 Earnings: How Key Metrics Compare to Wall Street Estimates
ZACKS· 2025-02-27 02:30
Core Insights - Catalyst Pharmaceutical (CPRX) reported a revenue of $141.82 million for the quarter ended December 2024, reflecting a year-over-year increase of 28.3% and surpassing the Zacks Consensus Estimate by 6.87% [1] - The earnings per share (EPS) for the quarter was $0.70, which is an increase from $0.53 in the same quarter last year, resulting in an EPS surprise of 34.62% compared to the consensus estimate of $0.52 [1] Revenue Breakdown - Product revenue from FIRDAPSE was $82.52 million, exceeding the average estimate of $81.54 million from five analysts [4] - Product revenue from FYCOMPA reached $38.22 million, surpassing the average estimate of $32.83 million [4] - Product revenue from AGAMREE was reported at $21.08 million, exceeding the estimated $17.84 million [4] - Total product revenue was $141.81 million, which is a 30% increase compared to the year-ago quarter and also above the average estimate of $132.21 million [4] - Revenue from licenses and other sources was only $0.01 million, significantly below the average estimate of $0.85 million, marking a drastic year-over-year decline of 99.3% [4] Stock Performance - Over the past month, shares of Catalyst have returned -8.9%, underperforming the Zacks S&P 500 composite, which saw a -2.3% change [3] - The stock currently holds a Zacks Rank 4 (Sell), indicating potential underperformance in the near term [3]
Catalyst Pharmaceuticals Reports Record Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update
Newsfilter· 2025-02-26 21:13
Core Insights - Catalyst Pharmaceuticals reported total revenues of $491.7 million for the full year 2024, reflecting a year-over-year growth of 23.5% driven by strong commercial performance [1][11][12] - The company expects total revenues for 2025 to be between $545 million and $565 million, indicating confidence in continued growth momentum [1][22] Financial Performance - Full year 2024 product revenue, net was $489.3 million, a 23.4% increase from $396.5 million in 2023 [3][12] - Q4 2024 net product revenue was $141.8 million, representing a 28.3% increase compared to Q4 2023 [1][11] - GAAP net income for 2024 was $163.9 million, a significant increase of 129.5% from $71.4 million in 2023 [3][17] - Non-GAAP net income for 2024 was $276.3 million, up 95.1% from $141.6 million in 2023 [3][18] Product Performance - FIRDAPSE product revenue for 2024 was $306.0 million, an 18.4% increase year-over-year [1][9] - AGAMREE product revenue for 2024 was $46.0 million, reflecting a successful commercial launch [1][9] - FYCOMPA product revenue for 2024 was $137.3 million, showing a slight decline of 0.6% compared to 2023 [3][9] Strategic Developments - Catalyst successfully launched AGAMREE in the U.S. on March 13, 2024, for the treatment of Duchenne muscular dystrophy [9][10] - The company received FDA approval for an increased maximum daily dose of FIRDAPSE to 100 mg on May 30, 2024 [9] - Catalyst entered into a settlement agreement with Teva Pharmaceuticals regarding FIRDAPSE patent litigation, preventing Teva from marketing a generic version until February 25, 2035 [9][10] Future Outlook - For 2025, FIRDAPSE's product revenue is expected to range between $355 million and $360 million, while AGAMREE's revenue is anticipated to be between $100 million and $110 million [22][24] - FYCOMPA's product revenue is forecasted to be between $90 million and $95 million, influenced by the anticipated loss of patent exclusivity [25] - Research and development expenses for 2025 are expected to be between $15.0 million and $20.0 million, depending on ongoing studies and potential acquisitions [27]
Catalyst Pharmaceuticals(CPRX) - 2024 Q4 - Annual Report
2025-02-26 21:05
[Business Overview](index=6&type=section&id=Item%201.%20Business) Catalyst Pharmaceuticals is a commercial-stage biopharmaceutical company focused on rare diseases, marketing FIRDAPSE®, FYCOMPA®, and AGAMREE®, and actively seeking to acquire additional late-stage products to drive future growth [Company and Product Portfolio Overview](index=6&type=section&id=Overview) Catalyst Pharmaceuticals is a commercial-stage biopharmaceutical company focused on rare diseases, marketing FIRDAPSE®, FYCOMPA®, and AGAMREE®, and actively seeking to acquire additional late-stage products to drive future growth - The company markets three drug products: **FIRDAPSE®** (amifampridine), **FYCOMPA®** (perampanel), and **AGAMREE®** (vamorolone)[20](index=20&type=chunk) - The company's strategy is to **expand its drug portfolio** by acquiring rights to late-stage products for orphan and rare diseases[20](index=20&type=chunk)[62](index=62&type=chunk) - In early **2025**, the company decided to **split its field-based forces into two dedicated units**, one for FIRDAPSE® and one for AGAMREE®, to better focus its sales efforts. This division is expected to be complete in **Q2 2025**[23](index=23&type=chunk) [FIRDAPSE® (amifampridine)](index=6&type=section&id=FIRDAPSE%C2%AE) - FIRDAPSE® is approved for treating LEMS in adults and children (6+ years). In **May 2024**, the FDA approved an increased maximum daily dosage from **80 mg to 100 mg**[21](index=21&type=chunk) - The company is expanding FIRDAPSE®'s global footprint, with commercialization in Canada via KYE and in Japan via DyDo, which launched the product in **January 2025**[28](index=28&type=chunk)[29](index=29&type=chunk) - Catalyst is defending its FIRDAPSE® patents against generic challengers. It has settled with Teva and Inventia, securing the market until at least **February 2035** against Teva. Litigation with Hetero and Lupin is ongoing[31](index=31&type=chunk)[33](index=33&type=chunk)[36](index=36&type=chunk) [FYCOMPA® (perampanel)](index=10&type=section&id=FYCOMPA%C2%AE) - The company acquired the U.S. rights to FYCOMPA®, a treatment for epilepsy, from Eisai in **January 2023** for an upfront payment of **$160 million**[38](index=38&type=chunk)[39](index=39&type=chunk) - Patent protection for FYCOMPA® is set to expire, with the tablet version losing exclusivity on **May 23, 2025**, and the oral suspension on **December 15, 2025**. The company expects generic competition thereafter[42](index=42&type=chunk)[121](index=121&type=chunk) [AGAMREE® (vamorolone)](index=11&type=section&id=AGAMREE%C2%AE) - In **July 2023**, Catalyst acquired the exclusive North American license for AGAMREE® from Santhera for a **$75 million** upfront payment and a **$36 million** milestone payment upon FDA approval[47](index=47&type=chunk)[48](index=48&type=chunk)[50](index=50&type=chunk) - AGAMREE® was approved by the FDA on **October 26, 2023**, for treating DMD in patients aged two and older, and was commercially launched in the U.S. on **March 13, 2024**[50](index=50&type=chunk)[51](index=51&type=chunk) - The company is exploring additional indications for AGAMREE® and is conducting a Phase 1 study to define its immunosuppressive dose for potential use with gene therapies[57](index=57&type=chunk) - AGAMREE® has robust intellectual property protection, including New Chemical Entity exclusivity until **October 2028**, Orphan Drug Exclusivity until **October 2030**, and patents extending to **2040**[59](index=59&type=chunk) [Company Strategy](index=13&type=section&id=Our%20Strategy) The company's strategy focuses on a "buy-and-build" model, prioritizing commercial success of FIRDAPSE® and AGAMREE®, geographic expansion, and acquiring additional rare disease products to diversify its portfolio - Continue to commercialize FIRDAPSE® for LEMS and AGAMREE® for DMD, while improving disease awareness and patient support through the Catalyst Pathways® program[66](index=66&type=chunk) - Seek to expand the market for FIRDAPSE® into Asia and Latin America and for AGAMREE® into Japan[66](index=66&type=chunk) - Actively pursue acquisitions of early and/or late-stage products, companies, or technology platforms in the rare disease space to broaden and diversify the product portfolio[66](index=66&type=chunk) [Manufacturing and Supply](index=30&type=section&id=Manufacturing%20and%20Supply) Catalyst operates as a virtual manufacturer, relying entirely on third-party CMOs for all products, including FIRDAPSE®, FYCOMPA®, and AGAMREE®, under various supply agreements - The company has no in-house manufacturing capacity and relies on contract manufacturers for all products[137](index=137&type=chunk) - FYCOMPA® is manufactured by Eisai under a seven-year supply agreement running through at least the end of **2029**[139](index=139&type=chunk) - AGAMREE® is supplied by Santhera, an obligation that runs until **January 1, 2026**, after which Catalyst has the right to contract with other third-party manufacturers[140](index=140&type=chunk) [Competition](index=31&type=section&id=Competition) The company faces intense competition across its product lines, including unapproved therapies for FIRDAPSE®, established anti-epileptic drugs and generics for FYCOMPA®, and other corticosteroids and gene therapies for AGAMREE® - FIRDAPSE® competes with unapproved treatments like steroids and immunosuppressants, as well as amifampridine from compounding pharmacies[145](index=145&type=chunk)[146](index=146&type=chunk) - FYCOMPA® faces competition from numerous other anti-epileptic drugs and expects significant competition from generic manufacturers after its patent expiration in **2025**[147](index=147&type=chunk)[148](index=148&type=chunk) - AGAMREE®'s main competitors in the DMD market are other corticosteroids like Emflaza and new gene therapies such as Sarepta's Elevidys[149](index=149&type=chunk)[150](index=150&type=chunk) [Regulatory Matters](index=32&type=section&id=Regulatory%20Matters) The company's operations are subject to extensive FDA and global regulations covering product development, manufacturing, marketing, and pricing, including NDA approval, orphan drug exclusivity, Hatch-Waxman Act, and government pricing programs - The FDA drug approval process is rigorous, involving preclinical studies and three phases of human clinical trials to establish safety and efficacy before an NDA can be approved[155](index=155&type=chunk)[161](index=161&type=chunk)[162](index=162&type=chunk) - The Hatch-Waxman Act provides pathways for generic drug approval (ANDA) and sets rules for patent challenges (Paragraph IV certifications), which can trigger a **30-month** stay on FDA approval of the generic[174](index=174&type=chunk)[176](index=176&type=chunk) - Orphan Drug Designation provides **seven years** of market exclusivity in the U.S. for the approved indication, a critical protection for FIRDAPSE® and AGAMREE®[201](index=201&type=chunk)[202](index=202&type=chunk) - The company is subject to numerous government pricing programs, including Medicaid Drug Rebate Program, 340B Drug Pricing Program, and Medicare Part D, which involve mandatory rebates and discounts[219](index=219&type=chunk)[221](index=221&type=chunk)[223](index=223&type=chunk) - The Inflation Reduction Act of **2022** (IRA) introduces significant changes, including Medicare price negotiation for certain high-expenditure drugs and inflation-based rebates, which could impact future revenues[196](index=196&type=chunk)[224](index=224&type=chunk) [Human Capital Management](index=51&type=section&id=Human%20Capital%20Management) As of **February 24, 2025**, Catalyst employed **181** people, primarily in commercial roles, focusing on attracting and retaining talent through competitive compensation and a culture of integrity and diversity - As of **February 24, 2025**, the company had **181** employees, with **127** in commercial, **11** in R&D, and the remainder in G&A[234](index=234&type=chunk) - The compensation package is designed to be competitive and includes base salary, annual performance bonuses, and stock option grants. Benefits include comprehensive health coverage and a 401(k) with employer match[235](index=235&type=chunk) [Risk Factors](index=53&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks, including dependence on product commercial success, intense competition, reliance on third-party manufacturing, stringent regulatory environment, pricing pressures, and intellectual property litigation [Marketing and Commercialization Risks](index=53&type=section&id=Risks%20Related%20to%20the%20Marketing%20of%20Approved%20Products) The company's success depends on the commercial performance of its products, facing risks from market acceptance, intense competition, profitability challenges for small patient populations, and FYCOMPA®'s boxed warning - The company's success hinges on the successful commercialization of its products, and any failure to do so would materially harm the business[244](index=244&type=chunk) - The small patient populations for FIRDAPSE® and AGAMREE® require achieving significant market share and high per-patient prices to be profitable[244](index=244&type=chunk)[262](index=262&type=chunk) - FYCOMPA® carries a boxed warning for serious psychiatric and behavioral changes, which may cause reluctance among patients and providers to use the drug[244](index=244&type=chunk)[264](index=264&type=chunk) [Development and Operational Risks](index=54&type=section&id=Risks%20Related%20to%20the%20Development%20of%20Additional%20Drug%20Products%20and%20Indications) The company faces drug development and operational risks, including clinical trial failures, heavy reliance on third-party CROs and CMOs, supply chain disruptions, managing growth, and navigating third-party payor pressures on reimbursement and pricing - The company relies on third parties for all pre-clinical and clinical studies, as well as for all manufacturing, which reduces control and introduces risk if these partners fail to perform[245](index=245&type=chunk)[268](index=268&type=chunk)[271](index=271&type=chunk) - The company is dependent on its licensing partners, Eisai for FYCOMPA® and Santhera for AGAMREE®, for product supply[245](index=245&type=chunk)[276](index=276&type=chunk) - Pressure from third-party payors on coverage, reimbursement, and pricing, along with healthcare reforms like the IRA, may impair the company's ability to achieve profitable pricing[246](index=246&type=chunk)[279](index=279&type=chunk)[284](index=284&type=chunk) [Regulatory Risks](index=54&type=section&id=Risks%20Related%20to%20Government%20Regulation) The company faces significant regulatory risks, including uncertain drug approval, loss of orphan drug exclusivity, generic competition, impact of the IRA on pricing, and complex compliance with anti-kickback and fraud laws - Failure to obtain or maintain orphan drug exclusivity for FIRDAPSE® and AGAMREE® would expose them to competition and significantly harm revenues[247](index=247&type=chunk)[305](index=305&type=chunk) - The approval of generic versions of the company's products, particularly after patent expiry, would lead to significant price erosion and loss of market share[247](index=247&type=chunk)[310](index=310&type=chunk) - The company is subject to complex anti-kickback, fraud and abuse, and transparency laws, violations of which could lead to significant penalties and reputational harm[247](index=247&type=chunk)[318](index=318&type=chunk)[319](index=319&type=chunk) [Intellectual Property Risks](index=56&type=section&id=Risks%20Related%20to%20our%20Intellectual%20Property) The company's success relies on its intellectual property, facing risks from failing to secure or maintain patent protection, inability to prevent generic competition, and high costs and uncertainty of patent litigation - The company's ability to compete effectively depends on maintaining patent protection; failure to do so would open the company to competition[249](index=249&type=chunk)[328](index=328&type=chunk) - There is a risk that the company's patents may not adequately protect its products from generic competition, as evidenced by the ongoing Paragraph IV challenges for FIRDAPSE®[249](index=249&type=chunk)[310](index=310&type=chunk) - The company may incur substantial costs from litigation related to intellectual property, such as defending its patents or claims of infringing on others' patents[249](index=249&type=chunk)[340](index=340&type=chunk) [Cybersecurity](index=85&type=section&id=Item%201C.%20Cybersecurity) Catalyst integrates cybersecurity into its risk management, with Board oversight and CLCO/COO responsibility, engaging third-party experts for assessments, and has not experienced material incidents to date - The Board of Directors, with its Audit Committee, provides oversight for cybersecurity risks[378](index=378&type=chunk) - The Chief Legal and Compliance Officer (CLCO) and Chief Operating Officer (COO), along with IT personnel, are primarily responsible for assessing and managing cybersecurity risks[374](index=374&type=chunk) - The company engages external experts for regular audits and threat assessments to ensure its strategies align with industry best practices[369](index=369&type=chunk)[370](index=370&type=chunk) - To date, the company has not encountered any cybersecurity incidents that have materially affected its operations or financial condition[372](index=372&type=chunk) [Legal Proceedings](index=89&type=section&id=Item%203.%20Legal%20Proceedings) The company is engaged in ongoing Paragraph IV patent litigation to defend FIRDAPSE® against generic manufacturers Hetero and Lupin, having settled with Teva and Inventia, with no other material litigation pending - The company is engaged in ongoing patent litigation against Hetero and Lupin, who have filed ANDAs to market generic versions of FIRDAPSE®[380](index=380&type=chunk)[680](index=680&type=chunk) - In **January 2025**, the company settled with Teva, which agreed not to market a generic FIRDAPSE® version before **February 25, 2035**, under most circumstances[679](index=679&type=chunk) - In **July 2024**, the company settled with Inventia, which acknowledged the validity and infringement of FIRDAPSE® patents and agreed not to commercialize its product until patent expiration or other specified conditions[681](index=681&type=chunk) [Management's Discussion and Analysis (MD&A)](index=92&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) In **FY2024**, total revenues grew **23.5%** to **$491.7 million**, driven by FIRDAPSE® sales and AGAMREE® launch, leading to a net income of **$163.9 million** and a strengthened financial position with **$517.6 million** in cash [Results of Operations (2024 vs. 2023)](index=106&type=section&id=Results%20of%20Operations) Total revenues increased to **$491.7 million** in **2024**, driven by FIRDAPSE® and AGAMREE® sales, leading to operating income of **$195.1 million** and net income of **$163.9 million**, primarily due to revenue growth and lower R&D expenses Product Revenue, Net (in millions) | Product | 2024 | 2023 | | :--- | :--- | :--- | | FIRDAPSE® | $306.0 | $258.4 | | FYCOMPA® | $137.3 | $138.1 | | AGAMREE® | $46.0 | $0.0 | | **Total** | **$489.3** | **$396.5** | Key Operating Results (in millions) | Metric | 2024 | 2023 | | :--- | :--- | :--- | | Total Revenues | $491.7 | $398.2 | | Cost of Sales | $68.8 | $52.0 | | R&D Expenses | $12.6 | $93.2 | | SG&A Expenses | $177.7 | $133.7 | | Operating Income | $195.1 | $86.8 | | Net Income | $163.9 | $71.4 | | Diluted EPS | $1.31 | $0.63 | - The decrease in R&D expenses from **$93.2 million** in **2023** to **$12.6 million** in **2024** was primarily due to the **$81.5 million** in-process research and development (IPR&D) expense recognized for the AGAMREE® acquisition in **2023**[468](index=468&type=chunk) - Selling, general and administrative (SG&A) expenses increased by **$44.0 million**, or **32.9%**, primarily due to increased headcount and commercialization expenses related to the launch of AGAMREE®[470](index=470&type=chunk) [Liquidity and Capital Resources](index=108&type=section&id=Liquidity%20and%20Capital%20Resources) The company's financial position strengthened, with cash and equivalents increasing to **$517.6 million** by **end of 2024**, driven by **$239.8 million** in operating cash flow and **$140.7 million** from an equity offering, ensuring sufficient liquidity for the next **12 months** Financial Position (in millions) | Metric | Dec 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $517.6 | $137.6 | | Working Capital | $502.9 | $143.3 | - In **January 2024**, the company completed a public offering of **10 million** shares of common stock, raising net proceeds of approximately **$140.7 million**[481](index=481&type=chunk)[576](index=576&type=chunk) Cash Flow Summary (in millions) | Cash Flow | 2024 | 2023 | | :--- | :--- | :--- | | Net cash from operating activities | $239.8 | $143.6 | | Net cash used in investing activities | ($0.6) | ($293.5) | | Net cash from (used in) financing activities | $140.7 | ($10.9) | [Critical Accounting Policies and Estimates](index=102&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) The company's critical accounting policies involve significant judgment, including revenue recognition (gross-to-net adjustments), valuation of intangible assets (discounted cash flow), and stock-based compensation (Black-Scholes model) - Revenue Recognition: Product sales are recorded at a net price, which requires estimating variable consideration for items like government rebates, chargebacks, and product returns[454](index=454&type=chunk) - Valuation of Intangible Assets: Acquired intangible assets are recorded at fair value, determined using a discounted cash flow analysis that requires assumptions about future cash flows, risk, and cost of capital[456](index=456&type=chunk) - Stock-Based Compensation: The fair value of stock options is calculated using the Black-Scholes model, which requires estimates for stock price volatility, option life, and interest rates[457](index=457&type=chunk) [Controls and Procedures](index=114&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were effective as of **December 31, 2024**, with Grant Thornton LLP issuing an unqualified opinion on internal control effectiveness - Management, including the principal executive and financial officers, concluded that disclosure controls and procedures were effective as of **December 31, 2024**[510](index=510&type=chunk) - Management concluded that the company's internal control over financial reporting was effective as of **December 31, 2024**, based on the COSO **2013** framework[513](index=513&type=chunk) - The independent registered public accounting firm, Grant Thornton LLP, issued a report concurring with management's assessment of effective internal control over financial reporting[514](index=514&type=chunk)[540](index=540&type=chunk)