Pharma Mar Sa · BME:PHM
Pharma Mar Sa — Investor Presentation (December 2021)
28 slides from Pharma Mar Sa's investor presentation, December 2021
Slide 1: Corporate Presentation
Corporate Presentation World leader in the development and commercialization of anticancer drugs of marine origin December 2021
Slide 2: Disclaimer
Disclaimer This presentation contains forward-looking statements that include information about possible or assumed future results of the business, financial condition, liquidity, results of operation, clinical program, plans and objectives of Pharma Mar, S.A. ("PharmaMar" or the "Company"). These f
Slide 3: Management Team
Management Team We are inspired by the sea, driven by science, and motivated to improve the lives of cancer patients by delivering novel medicines. We intend to continue D. José María Luis Mora to be the world leader in marine medicinal Fernández, Ph.D Managing Director discovery, development and in
Slide 4: Corporate Overview
Corporate Overview Global Fully Integrated 3 Approved Oncology Commercial Stage Biotech Products Yondelis® Developing marine-inspired Aplidin® oncology drugs Zepzelca® Established European Oncology Sales Force Revenue Generating Discovery Platform & Profitable Strengthening Oncology Pipeline FY 2020
Slide 5: The Plan for Growth
The Plan for Growth On Track to Deliver Value to Shareholder FURTHER • Phase 3 trial with lurbinectedin in SCLC for EU approval and US confirmatory DEVELOPMENT WITH • Phase 3 trial with lurbinectedin in other indications LURBINECTEDIN • Potential lurbinectedin approvals in other countries OTHER DRUG
Slide 6: Pipeline – Expanding our Expertise in Oncology
Pipeline – Expanding our Expertise in Oncology Phase 1 Phase 2 Phase 3 Market Soft tissue sarcoma 2nd/3rd line Monotherapy Ovarian cancer 2nd/3rd line1 + Doxil2 Aplidin® R/R Multiple Myeloma 3rd/4th line3 + dexamethasone (plitidespsin) Small cell lung cancer 2nd line US Monotherapy Lurbi vs. Lurbi+
Slide 7: Zepzelca – A Transcription Inhibitor Leading to Tumor Inhibition
Zepzelca® – A Transcription Inhibitor Leading to Tumor Inhibition Primary Effect Secondary Effect Cancer is frequently a transcriptional disease caused by By inhibiting active transcription in Tumor Associated deregulated oncogenic transcription factors Macrophages (TAMs), lurbinectedin downregulate
Slide 8: SCLC: Becoming the Treatment of Choice
SCLC • 1st Relapsed Small Cell Lung Cancer (SCLC) NCE1 approved by FDA since 1996 • Becoming the Treatment of Choice for 2L SCLC Patients 1 – New Chemical Entity 8
Slide 9: Zepzelca: Transformative for PharmaMar
Zepzelca®: Transformative for PharmaMar License agreement in the US metrics US/Canada • FDA Accelerated Approval June 2020 in metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy $200m $100m Potential up to $700m received received in regulatory an
Slide 10: Small Cell Lung Cancer (SCLC) – An Underserved High Unmet Medical Need
Small Cell Lung Cancer (SCLC) – An Underserved High Unmet Medical Need • SCLC accounts for 13%-15% of total lung cancers • Highly aggressive tumor • 5-year survival rate 5-10%1 • Limited treatment options in both the US and Europe • 30,000 newly diagnosed patients in 20192 • Limited approved treatme
Slide 11: Small Cell Lung Cancer Development Lagging Behind NSCLC
Small Cell Lung Cancer (SCLC) Development Lagging Behind NSCLC Durv or Atezo+ 1st Line Cisplatin+ Carboplatin+ Carboplatin+ SCLC Etoposide Etoposide Etoposide 2nd Line Topotecan Pre-1993 2019 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2012 2013 2014 201
Slide 12: Zepzelca (Lurbinectedin) – The SCLC Treatment Paradigm
Zepzelca® (Lurbinectedin) – The SCLC Treatment Paradigm Strong Positioning Opportunity 1st Line 2nd Line 3rd Line 1st Line 2nd Line 3rd Line • Platinum/ • Platinum/ Etoposide + • Zepzelca® Etoposide + FDA EMA • Topotecan • Topotecan Approved • Atezolizumab Approved • Atezolizumab or Durvalumab (sens
Slide 13: Zepzelca Demonstrated Efficacy in Sensitive and Resistant SCLC
Zepzelca® Demonstrated Efficacy in Sensitive and Resistant Small Cell Lung Cancer In relapsed SCLC as monotherapy under accelerated approval based on Phase 2 monotherapy data1 Overall Resistant Sensitive (n=105) CTFI< 90 days CTFI= 90 days Decrease in tumor size in 65% patients2 (n=45) (n=60) ORR 35
Slide 14: Zepzelca (Lurbinectedin) – Safety Data in Phase 2 Monotherapy
Zepzelca® (Lurbinectedin) – Safety Data in Phase 2 Monotherapy Low Rate and Manageable Hematological Safety Profile Despite Low Use of G-CSF1,2 Safety: Related or Unknown Treatment Related (or Unknown) Adverse Adverse Events Events (AEs) ( >5% or Gr 3-4) Overall (n=105) n (%) Gr 1-2 Gr 3-4 Overall (
Slide 15: Malignant Pleural Mesothelioma
MPM Malignant Pleural Mesothelioma 15
Slide 16: Zepzelca – Relapsed Malignant Pleural Mesothelioma
Zepzelca® (Lurbinectedin) – Relapsed Malignant Pleural Mesothelioma A Rare Disease with Limited Available Therapeutic Options MPM Aggressively growing tumor ~ 80% of cases related to asbestos exposure Incidence ~3,0001 patients diagnosed in the US per year and ~11,000 in Europe2 1st Line 2nd Line 1s
Slide 17: Zepzelca – PFS Benefit in Malignant Pleural Mesothelioma
Zepzelca® (Lurbinectedin) – PFS Benefit in Malignant Pleural Mesothelioma Phase 2 Study1 MPM • Primary endpoint PFS at 12 weeks: o Primary endpoint met • 42 patients progression (p=0.015) on 1 prior platinum based therapy • mPFS 4.1 months • Lurbinectedin at 3.2 Phase 3 • mOS 11.1 months mg/m2 every
Slide 18: Leveraging Commercial Infrastructure in Europe
Leveraging Commercial Infrastructure in Europe PharmaMar positioned as a partner of choice in Europe to develop and distribute drugs 19 Regional Partners for Global and Local distribution Leveraging our European experience: • Strong KOL connections in solid tumors • Navigation of EU, UK and CH regul
Slide 19: Zepzelca – Protected by Strong Intellectual Property and Data Protection
Zepzelca® (Lurbinectedin) – Protected by Strong Intellectual Property and Data Protection 2021 2022 2023 2024 2025 2026 2027 2028+ Orphan Drug Exclusivity in SCLC New Chemical Entity Potential 5 year extension Composition of Matter Patent to 2029 (filed) Orphan Drug Exclusivity in SCLC + 10 YEARS pr
Slide 20: Other Opportunities
OTHER OPPORTUNITIES Pharma Mar.
Slide 21: Plitidepsin Extension in COVID-19 Patients Following Positive Multi-Center Clinical Trial
Plitidepsin Extension in COVID-19 Patients Following Positive Multi-Center Clinical Trial • SARS-COV2 cells co-opt EF1A from host to replicate1 Significant proportion of COVID-19 patients discharged from hospital as early as minimum stay • Positive multi-center clinical trial • Safety primary endpoi
Slide 22: Plitidepsin COVID-19 Phase 3 Study Design
Plitidepsin COVID-19 Phase 31 Study Design in COVID-19 Adult Patients with Moderate Disease Hospitalized moderate COVID-19 adult patients requiring O2 supplementation n=203 plitidepsin 2.5mg IV per day dexamethasone 6mg/day patients + dexamethasone 8mg/day Primary endpoint Day 8 ± 1 n=609 patients n
Slide 23: Financials
FINANCIALS Pharma Mar.
Slide 24: Financials: Well Financed to Support Next Stages of Development
Financials Well Financed to Support Next Stages of Development Robust Cash Position (€m) Profitable (€m) 250 300 200 250 150 200 150 100 100 50 50 0 0 (50) (50) (100) (100) (150) (150) 2017 2018 2019 2020 2017 2018 2019 2020 Debt Cash Revenues EBITDA 24
Slide 25: Delivering on Our 2020-2021 Objectives
Delivering on Our 2020-2021 Objectives Initiation of Validation of two Phase 2 with Zepzelca® PM14 (lurbinectedin) Aplidin® POC trial in confirmatory trial COVID-19 plans Zepzelca® approved in SCLC monotherapy Zepzelca® launched in the US Partnering with Jazz Initiation of lurbinectedin in other ind
Slide 26: Key Events – Catalyst Calendar
Key Events Catalyst Calendar • First Patient in 2nd line SCLC trial 2021 • PM14 FPI Phase 2 2021 and beyond • Potential lurbinectedin approvals in other countries 2021 and beyond • Lurbi Combo Pembro or Atezo data 2021 • Lurbi+Irinotecan Phase 2 update 2022 • Potential first Zepzelca sales milestone
Slide 27: Investment Case – Building the Next Phase of Growth
Investment Case – Building the Next Phase of Growth 2020-2025 Strong Zepzelca® Leveraging proven oncology drugs Intellectual in new indications and expanding Property into new territories Zepzelca® expected Clinical data Financial capabilities to approvals and launches IP 2022-25 broaden and acceler
Slide 28: www.pharmamar.com
“A www.pharmamar.com Pharma Mar.