Catalyst Pharmaceuticals, Inc. · NASDAQ:CPRX
Catalyst Pharmaceuticals — Investor Presentation (September 2023)
25 slides from Catalyst Pharmaceuticals's investor presentation, Sep 26, 2023
Slide 1: Dedicated to Making a Meaningful Difference in the Lives of Patients
NASDAQ: CPRX Dedicated to Making a Meaningful Difference in the Lives of Patients Suffering from Rare and Difficult to Treat Diseases September 2023 Exhibit 99.1
Slide 2: Safe Harbor
Safe Harbor This presentation contains forward-looking statements that are subject to a number of risks and uncertainties, many of which are outside our control. All statements regarding our strategy, future operations, financial position, estimated revenues or losses, projected costs, prospects, pl
Slide 3: Catalyst Pharmaceuticals: An Emerging Leader in Rare Diseases
Catalyst Pharmaceuticals An Emerging Leader in Rare Diseases Nasdaq: CPRX Execution Excellence Proven track record in development and commercialization Patient Focus Dedicated to making a meaningful difference in the lives of patients suffering from rare diseases Positioned For Growth Focused on opt
Slide 4: Catalyst Pharmaceuticals Significant Growth Potential
Catalyst Pharmaceuticals Significant Growth Potential Record total Revenues of $99.6M for Q2 2023 Record Net Income of $37.8M for Q2 2023 Proven commercial capabilities Full year 2023 total revenue guidance of $380M - $390M Dedicated to investing in both internal and external opportunities that will
Slide 5: Growing Revenue With A Diversified Portfolio
Proprietary marketed products Substantial product portfolio synergy opportunity Proven U.S. commercial capabilities Targeted run rate for FY 2023 of between $380M - $390M Strong FIRDAPSE® Q2 23 net revenues of $64.9M Compelling FYCOMPA® Q2 23 net revenues of $34.6M Primary focus is targeting neurolo
Slide 6: FIRDAPSE – Successfully Commercialized
FIRDAPSE® – Successfully Commercialized FIRDAPSE® (amifampridine) Tablets 10mg Approved in the U.S. in Nov 2018; Launched - Q1 2019 Orphan Drug Exclusivity through 2025 Expanded pediatric indication - Sept 2022 Strong intellectual property estate enhances durability IP protection to 2037; Six patent
Slide 7: Lambert-Eaton Myasthenic Syndrome (LEMS)
Lambert-Eaton Myasthenic Syndrome (LEMS) A Rare Neuromuscular Disease & Profound Effect on Mobility & QoL Affects Nerve-Muscle Communication May cause: Weakening of upper arms and shoulders muscles Severe, debilitating, and progressive weakness in the upper legs and hips Life-threatening weakness in
Slide 8: FIRDAPSE - U.S. LEMS Market Opportunity
FIRDAPSE - U.S. LEMS Market Opportunity Significant Unmet Need >1100 LEMS-diagnosed patients ever treated with FIRDAPSE 2 ˜800 LEMS patients diagnosed but not yet treated with FIRDAPSE > 2,900 LEMS undiagnosed patients Making A Meaningful Difference In Patients’ Lives Research indicates that LEMS af
Slide 9: Multiple Growth Drivers For FIRDAPSE
Multiple Growth Drivers For FIRDAPSE Proven Commercial Execution Amplifying HCP, patient education, and communication programs Expanding disease awareness, including physicians treating LEMS patients with small-cell lung cancer (SCLC) Targeting approach to reach LEMS patients that are comorbid with
Slide 10: Many SCLC LEMS patients are undiagnosed with LEMS
Many SCLC LEMS patients are undiagnosed with LEMS and are being treated by oncologists Oncologists typically refer SCLC patients diagnosed with LEMS to neurologists or neuromuscular specialists ~ 1,000 new potential SCLC LEMS patients each year (includes diagnosed and undiagnosed) Small Cell Lung Ca
Slide 11: Portfolio Expansion: FYCOMPA (perampanel) CIII
Established, First-In-Class Commercial Epilepsy Asset Portfolio Expansion: FYCOMPA® (perampanel) CIII Acquired U.S. rights in Jan 2023 Synergistic product expanding neurology presence Provides substantial revenue addition Compelling product net revenue for Q2 ‘23 FYCOMPA commercial and medical affai
Slide 12: FYCOMPA – Epilepsy Franchise
FYCOMPA® – Epilepsy Franchise First and Only Non-competitive AMPA Receptor Antagonist U.S. approved in 2012* For the treatment of partial-onset seizures with or without secondarily generalized seizures in patients ages ≥ 4 years Adjunctive therapy in the treatment of primary generalized tonic-clonic
Slide 13: FYCOMPA – Significant Market Opportunity
FYCOMPA – Significant Market Opportunity Epilepsy - High Unmet Medical Need 1England MJ, Liverman CT, Schultz AM, Strawbridge LM, eds. Epilepsy Across the Spectrum: Promoting Health and Understanding. Washington, DC: National Academies Press (US); 2012. 2CDC Epilepsy Data and Statistics; Epilepsy Pr
Slide 14: Expanded Product Portfolio Growth Sustained Commercial Execution
Expanded Product Portfolio Growth Sustained Commercial Execution H1 22 vs H1 23 Revenue Performance Forecast 2023 total revenues of between $380M - $390M
Slide 15: Portfolio Expansion - Vamorolone
If Approved: Expect a commercial launch in Q1 2024 Provides a near-term inflection point for continued growth Adds a therapeutic advancement in the SoC treatment of DMD Addresses an important unmet need for DMD patients Best-in-Class Dissociative Anti-Inflammatory Steroid Asset Portfolio Expansion -
Slide 16: Vamorolone – Potential Best-In-Class Dissociated Steroid
Vamorolone – Potential Best-In-Class Disassociated Anti-Inflammatory Steroid Currently treated DMD patients receive concomitant steroid treatment DMD patients treated with corticosteroids at some point DMD diagnosis rate; typically occurs at ages 2 - 5 years ~ 95% ˜ 90% ˜ 70% U.S. DMD patient preval
Slide 17: Vamorolone Accounting Treatment Q3 2023 & Q4 2023
(In $ Millions) FY Dec-19 FY Dec-20 FY Dec-21 Cash & Cash Equivalents 55.2 130.0 171.1 Firdapse 100.8 117.6 138.2 Revenue 101.6 118.3 140.7 Vamorolone Accounting Treatment Q3 2023 & Q4 2023 Q3 2023 $81.6M total transaction costs1 $75M all-cash license cost ˜$6.6M transaction-related costs ˜ $15M str
Slide 18: Expanding the Global Reach - FIRDAPSE Global Expansion Initiatives
Expanding the Global Reach - FIRDAPSE Global Expansion Initiatives Underway Canada Japan *DyDo, our partner in Japan, will submit their NDA for FIRDAPSE (amifampridine) to the Pharmaceuticals and Medical Devices Agency, (“PMDA”). Upon submitting the NDA for FIRDAPSE in Japan, our territorial rights
Slide 19: FIRDAPSE approved in the U.S. for LEMS
*FIRDAPSE is currently approved in the U.S. for the treatment of LEMS in patients 6 years of age and older
Slide 20: Strategic Growth Initiatives
Strategic Growth Initiatives Expand Commercial Footprint Invest in Portfolio Diversification Expand Portfolio in Rare & Orphan Diseases Explore commercial add-on assets both in the US & Globally Synergistic expertise to foster innovations Harness operational capabilities and industry expertise Stron
Slide 21: Strong Foundation to Deliver Long-Term Growth
Strong Foundation to Deliver Long-Term Growth Achievements Completed the U.S. acquisition of FYCOMPA in Jan 2023 Expanded focus on small-cell lung cancer patients comorbid with LEMS in Q1 23 Completed the seamless U.S. FYCOMPA commercial and MSL team integration in May 2023 Launched Environmental, S
Slide 22: Q2 2023 Financial Highlights
Q2 2023 Financial Highlights FY 2023 Total Revenue Guidance of Between $380M - $390M For the Three Months Ended June 30, 2023 2022 % Change Total Net Product Revenues $99.5 $53.0 87.5% FIRDAPSE Net Product Revenues $64.9 $53.0 22.3% FYCOMPA Net Product Revenues $34.6 N/A N/A GAAP Net Income $37.8 $2
Slide 23: Strong Financial Position
Underscores Successful Execution of Strategic Initiatives (In $ Millions) FY Dec-19 FY Dec-20 FY Dec-21 Cash & Cash Equivalents 55.2 130.0 171.1 Firdapse 100.8 117.6 138.2 Revenue 101.6 118.3 140.7 Strong Financial Position *Cash as of June 30, 2023. Post June 30, 2023, $75M for North American licen
Slide 24: Founded 2002, IPO 2006, Market Cap
Founded 2002 IPO 2006 Market Cap ~ $1.5B as of Aug 4, 2023 Basic Shares Outstanding ~ 106.5M as of August 7, 2023 NASDAQ: CPRX
Slide 25: Sy ¥2C
Sy ¥2C 2-Catalyst Ye NASDAQ: CPRX
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