Foresee Pharmaceuticals Co., Ltd. · TPEX:6576
Foresee Pharmaceuticals — Investor Presentation (February 2023)
37 slides from Foresee Pharmaceuticals's investor presentation, Feb 23, 2023
Slide 1: Corporate Presentation
Corporate Presentation Ticker number: TPEx: 6576.TWO February 2023 1
Slide 2: Forward-Looking Statements and Disclaimer
Forward-Looking Statements and Disclaimer This presentation is a summary and evaluation of Foresee Pharmaceuticals Co., Ltd.’s past, current and future operation. It is based on the subjective/objective factors at the moment the presentation is made. This presentation contains forward-looking statem
Slide 3: Capitalizing on near term recurring revenue and a high value pipeline
Capitalizing on near term recurring revenue and a high value pipeline R&D Focused in Two Key Late Stage and Early Stage Creating Value Through Areas Programs Strategic Partnerships Stabilized injectable depot CAMCEVI (Leuprolide Mesylate) CAMCEVI commercial formulation 42 mg (6-month dosage) partner
Slide 4: Capitalizing on a seasoned team and a semi-virtual model
Capitalizing on a seasoned team and a semi-virtual model Leadership Ben Chien, Ph.D. – Founder, Chairman & CEO Yisheng Lee, M.D., Ph.D., MBA – Chief Medical Officer Max Chan, B.Eng., M.S., MBA – Chief Financial Officer Mathieu Boudreau, Ph.D. – Chief Business Officer Wenjin Yang, Ph.D. – Chief Scien
Slide 5: SIF Technology Pipeline
SIF Technology Pipeline Key Focus on CAMCEVI (FP-001) as Recurring Revenue Generator
Slide 6: SIF Product Pipeline
SIF Product Pipeline Program Diseases Research Preclinical/P1 Phase 3 Regulatory CAMCEVI 42 mg (FP-001 50 mg, 6-month dosage) US NDA approved May 2021; CA NDS approved Nov. 2021 ; EU MAA approved May 2022 ; Under regulatory review in Israel, Taiwan and UK *US launch in April 2022 Prostate Cancer (FP
Slide 7: CAMCEVI 42 mg & 21 mg (FP-001 50 mg & 25 mg)
CAMCEVI 42 mg & 21 mg (FP-001 50 mg & 25 mg) In April 2022, CAMCEVI (Leuprolide) 42 mg injection emulsion launched in the U.S. for the treatment of advanced prostate cancer (J1952)
Slide 8: First-ever ready-to-inject leuprolide depot injections in a pre-filled syringe
First-ever ready-to-inject leuprolide depot injections in a pre-filled syringe with no pre-mixing required, for the treatment of advanced prostate cancer Ready-to-use Ready-to-use product: First and only pre-filled syringe product, stable, no pre-mixing required Stabilized formulation No restriction
Slide 9: Foresee developed CAMCEVI 42 mg, completed Phase 3, received 505(b)(2) NDA approval
Foresee developed CAMCEVI 42 mg, completed Phase 3, submitted NDA, and received 505(b)(2) NDA approval letter from US FDA 9
Slide 10: CAMCEVI global licensing deals upfront and milestones up to $417 million plus sales royalties
CAMCEVI global licensing deals upfront and milestones up to $417 million plus sales royalties Feb. 2019 - EU and RoW market CAMEVI Financial Highlights Upfront, regulatory milestones and sales milestones • Brought in more than NT$1,000 million totaling up to $86 million from 2019~2022, of which more
Slide 11: American Cancer Society lists CAMCEVI; unique J-code J1952
The American Cancer Society has listed CAMCEVI (leuprolide mesylate) along with other major LHRH agonists; a great advantage in pricing strategy from a unique J-code: J1952 by CMS
Slide 12: Leuprolide for advanced prostate cancer in the US: J1952 ASP significantly higher than J9217
Leuprolide for advanced prostate cancer in the US : J1952 ASP (Camcevi) significantly higher than J9217 ASP (Lupron Depot / Eligard) Payment Allowance Limits for Medicare Part B Drugs Effective January 1, 2023 through March 31, 2023 HCPCS Code Short Description HCPCS Code Dosage Payment Limit Notes
Slide 13: Targeting unmet medical needs: EMA PRAC Assessment Report on leuprorelin depot products
Targeting unmet medical needs: Assessment Report on leuprorelin-containing depot products (EMA PRAC, 14 May 2020) • “The presentations as well as the preparation, reconstitution and administration process vary among the products. There have been numerous reports of medication errors (MEs) leading to
Slide 14: Positive EMA/CHMP opinion on CAMCEVI 42 mg
Positive EMA/CHMP opinion on CAMCEVI 42 mg (March 24, 2022) – differentiated from ELIGARD, CAMCEVI’s reference product for the EU 14
Slide 15: CAMCEVI market opportunity: advanced prostate cancer
CAMCEVI market opportunity: advanced prostate cancer Prostate Cancer: Large Growing Market 9.4% CAGR (Nova One Advisor) Standard of Care for advanced prostate cancer The U.S. market is dominated by Lupron Depot and Eligard ; According to Bloomberg, sales units of leuprolide 6-month formulation was a
Slide 16: FP-001 42 mg Phase 3 study in central precocious puberty (CPP)
FP-001 42 mg Phase 3 study in central precocious puberty (CPP) An open-label, single-arm, multinational, multicenter study; approximately 98 subjects will be enrolled from sites in the US, Europe, China and Taiwan; clinical study report and licensing discussion in 2025 • CPP－ a condition that causes
Slide 17: Stabilized Injectable Formulation (SIF) Platform: Sustainable & Expandable Revenue Streams
Stabilized Injectable Formulation (SIF) Platform Sustainable & Expandable Revenue Streams！ New US Launch New Market New Indication New Areas Camcevi 42 mg Camcevi 42 mg Formulation The phase 3 trial for Various 505(b)(2) drugs Regulatory the treatment of CPP anticipated to proceed Launched in April
Slide 18: Small Molecule NCE Programs
Small Molecule NCE Programs First-in-Class/Best-in-Class Clinical Stage Programs Targeting Immune-Fibrotic and Mitochondrial Diseases
Slide 19: NCE Product Pipeline
NCE Product Pipeline Mechanism Program Diseases Preclinical Phase 1 Phase 2 Allergic Asthma First PoC (Proof of Concept) (Short-term treatment) FP-025 MMP-12 COPD (aderamastat) Inhibitors (Long-term treatment) COPD or Asthma or Inflammatory Bowel Diseases Sarcoidosis, Idiopathic pulmonary FP-020 fib
Slide 20: MMP-12 Inhibitor Program
MMP-12 Inhibitor Program 1. FP-025 2. FP-020
Slide 21: MMP-12 – a Unique Highly Regulated MMP and Compelling Therapeutic Target
MMP-12 – a Unique Highly Regulated MMP and Compelling Therapeutic Target LUNG • Higher concentrations of MMP12 significantly associated • MMP-12 gene and protein expression increased in with lower diffusion capacity of the lung for carbon bronchoalveolar lavage samples from patients with monoxide (D
Slide 22: FP-025 Allergic Asthma – Phase 2a allergen challenge study (PoC)
FP-025 Allergic Asthma – Phase 2a allergen challenge study (PoC) Top line results March 2023 • MMP-12 plays a key role in airway inflammation, airway hyper-responsiveness and airway remodeling in inflammatory airway • MMP-12 is upregulated in allergic asthmatic patients following allergen challenge
Slide 23: FP-025 Allergen challenge study (PoC) Interim Analysis (Nov 2021)
FP-025 Allergen challenge study (PoC) Interim Analysis (Nov 2021) FEV1 Measurements in Interim Analysis Showed Positive Trend FEV1 : Forced Expiratory Volume in 1 second Primary Endpoint : Late asthmatic response (LAR) is defined as FEV1 AUC3-8h; differences between FP025 400 mg and placebo 23
Slide 24: Effects of an Anti-TSLP Antibody (TEZSPIRE) on Allergen-Induced Asthmatic Responses
Effects of an Anti-TSLP Antibody (TEZSPIRE) on Allergen- Induced Asthmatic Responses INDICATIONS AND USAGE TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. N Engl J Med 2014;370:2102-1024 24
Slide 25: FP-025 Phase 2/3 COVID-19 associated ARDS
FP-025 Phase 2/3 COVID-19 associated ARDS Phase 2 top line results demonstrated no statistically significant benefit ; additional biomarker data has been analyzed • MMP-12 is upregulated in lung injury and fibrotic conditions Rationale • FP-025, a specific and potent MMP-12 inhibitor, was shown to h
Slide 26: Literature supporting Neutrophils-to-Lymphocytes Ratio as a prognostic marker
Literature supporting Neutrophils-to-Lymphocytes Ratio as a prognostic marker in severe Covid-19 / ARDS patients Toori KU, et al. Pak J Med Sci. 2021 Sep-Oct;37(5):1435-1439 26
Slide 27: Biomarker analysis from COVID-19/ARDS trial
Biomarker analysis from COVID-19/ARDS trial Neutrophils/Lymphocytes ratio reduced more rapidly in high dose group (FP-025 300 mg) Neutrophils/Lymphocytes ratio 20 18 16 14 Sample Size 12 D1 D7 D14 D28 D60 Placebo 26 23 8 17 15 10 FP-025 27 19 10 14 13 8 100 mg FP-025 26 18 12 16 15 6 300 mg 4 2 0 Pl
Slide 28: Literature supporting correlation between D-dimer and Covid-19 Mortality
Literature supporting correlation between D-dimer and Covid-19 Mortality The D-dimer Level on Admission is Associated with the Risks of Death in Severe COVID-19 Patients (Analyzed by D-dimer ≤ 1 or > 1 µg/mL) Liu J, et al. Ann Intensive Care. 2020 Jul 31;10(1):99. 28
Slide 29: Biomarker analysis from COVID-19/ARDS trial: Probability of Survival
Biomarker analysis from COVID-19/ARDS trial The Survival Rate of High D-dimer Group (>1 µg/mL) after Treatment Survival of D-dimer > 1µg/mL FP-025 FP-025 placebo Survival of D-Dimer >13g/mL 300 mg 100 mg N 100 Placebo Probability of Survival 30 28 30 (administered study drug) 100 mg # with high D-di
Slide 30: ALDH2 Activator Program
ALDH2 Activator Program 1. FP-045 2. FP-040
Slide 31: FP-045 Phase 2 Fanconi Anemia
FP-045 Phase 2 Fanconi Anemia Phase 2 study being initiated in Turkey and US sites • Incidence at ~ 1/130,000 live births Epidemiology • Prevalence at ~ 5,000 – 8,000 patients in US, EU, JP and China • Recessive genetic disease affecting DNA repair pathways About FA • Most diagnosed between age of 2
Slide 32: Statistics of FA patients in Japan: ALDH2 deficiency and progression of FA
Statistics of FA patients in Japan: ALDH2 deficiency was associated with a more rapid progression of FA Blood. 2013 Oct 31;122(18):3206-9C 32
Slide 33: Summary
Summary
Slide 34: Anticipated 2022/2023 value inflection points
Anticipated 2022/2023 value inflection points 2022 2023 CAMCEVI 42 mg : Registration clinical trial approved in CAMCEVI 42 mg: EU launch China : March FP-001 42 mg: Initiate CPP global phase 3 study CAMCEVI 42 mg : U.S. launch : April CAMCEVI 21 mg: US NDA in preparation CAMCEVI 42 mg : EU MAA appro
Slide 35: Financials
Financials
Slide 36: 2022 Financials (YTD)
2022 Financials (YTD) TPEx Ticker 6576.TWO Total Shares Outstanding ~118 mn shares Cash Balance (Dec. 31, 2022) NT$690 mn (~US$22.5 mn) Operating Revenues NT$302 mn Operating Expenses NT$745 mn 36
Slide 37: Delivers Comfort, Compliance, Convenience, and Cure to better patients' lives
Delivers Comfort, Compliance, Convenience, and Cure to better patients’ lives
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