Pharma Mar Sa · BME:PHM
Pharma Mar Sa — Investor Presentation (January 2022)
35 slides from Pharma Mar Sa's investor presentation, January 2022
Slide 1: Corporate Presentation
Corporate Presentation World leader in the development and commercialization of anticancer drugs of marine origin January 2022
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 & Profitable Discovery Platform Strengthening Oncology FY 2020 Revenues
Slide 5: The Plan for Growth
The Plan for Growth On Track to Deliver Value to Shareholder FURTHER DEVELOPMENT • Phase 3 trial with lurbinectedin in SCLC for EU approval and US confirmatory WITH LURBINECTEDIN • Phase 3 trial with lurbinectedin in other indications • 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 Small cell lung c
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: First FDA approved drug in over 24 years in relapsed SCLC
SCLC • 1st FDA approved drug in over 24 years in Relapsed Small Cell Lung Cancer (SCLC) • New Standard of Care in 2L SCLC in the US 8
Slide 9: Zepzelca: Transformative for PharmaMar
Zepzelca®: Transformative for PharmaMar License agreement in the US/Canada US metrics • FDA Accelerated Approval June 2020 in metastatic small cell lung cancer (SCLC) with disease $200m $100m progression on or after platinum-based Potential up to $700m chemotherapy received received upfront approval
Slide 10: Small Cell Lung Cancer: An Underserved High Unmet Medical Need
Small Cell Lung Cancer (SCLC) An Underserved High Unmet Medical Need SCLC Low survival rate at 5 years Limited treatment options in both the US and Europe Among all Lung Cancers NSCLC: 85% 61,300 in 20183 SCLC: 15% 30,000 in 20183 • Highly aggressive tumor • 5-year survival rate 5-10%1 Newly diagnos
Slide 11: SCLC Development Lagging Behind NSCLC
Small Cell Lung Cancer (SCLC) Development Lagging Behind NSCLC SCLC 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 201
Slide 12: Zepzelca – 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 Already Treatment of Choice in 2L SCLC
Zepzelca® Already Treatment of Choice in 2L SCLC With Significant Room to Grow SCLC Other I/O Topotecan % Market Share in 2L SCLC in the US 40 37% 35 Non-platinum Chemo 30 25 Platinum 20 retreatment 15 10 Q3 2020 Q4 2020 Q1 2021 Q2 2021 Q3 2021 1. Adapted from Jazz Pharmaceuticals Q3 2021 presentati
Slide 14: 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 15: Zepzelca – 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 16: Zepzelca: Pathway to 2nd line in SCLC in Europe and confirmatory in US
Zepzelca: Pathway to 2nd line in SCLC in Europe and confirmatory in US Phase 3 (LAGOON) randomized trial in SCLC Arm A Lurbinectedin 3.2 mg/m 2 every 3 weeks • Relapsed SCLC Arm B • One prior platinum Randomization Lurbinectedin 2 mg/m 2 every 3 weeks Primary Endpoint: containing regimen 1:1:1 Arm A
Slide 17: 1st line-Maintenance Study in SCLC
SCLC 1st line-Maintenance Study in SCLC Standard of treatment in 2nd line US 17
Slide 18: Lurbinectedin: First line positioning, Phase 3 IMforte trial
Lurbinectedin: First line positioning Phase 3 IMforte trial for First line-Maintenance SCLC SCLC Induction Phase Maintenance Phase Atezolizumab + Atezolizumab 1,200 mg every 3 weeks Carboplatin + + Etoposide Lurbinectedin 3.2 mg/m 2 every 3 weeks • Extensive-stage SCLC (ES-SCLC) Endpoints: • Ongoing
Slide 19: Strategic importance of Zepzelca Phase 3s in SCLC
Zepzelca® (Lurbinectedin) – Strategic importance of Zepzelca Phase 3s in SCLC Potential treatment landscape after Phase 3s SCLC 1st Line- 1st Line- 1st Line 2nd Line 1st Line 2nd Line Mantenance Mantenance • Platinum/ • Platinum/ • Zepzelca® • Zepzelca® • Zepzelca® FDA Etoposide + EMA Etoposide + •
Slide 20: Zepzelca in Maintenance Could Broaden Addressable Patients
Zepzelca® (Lurbinectedin) in Maintenance Could Broaden Addressable Patients and Extend Duration of Treatment SCLC % Treated ~90% ~80% ~70% 2nd Line 2nd Line Maintenance Combo PD-1/L1 Monotherapy Expected PFS PFS increased PFS 4.9 months1 3.5 months2 Expect longer duration of treatment as Zepzelca pr
Slide 21: Potential for growth
Potential for growth Targeted step-wise increases in n, share, and cycles SCLC Today Step 1 Step 2 Step 3 Ultimate Target 70%1 of 1L SCLC 75% of 2L SCLC patients treated in 2L patients treated = = 21,000 patients 22,500 patients Leverage 1L Maintenance to get to Zepzelca: 35%2 Market share 8 cycles
Slide 22: Malignant Pleural Mesothelioma: Finalizing Trial Strategy
MPM Malignant Pleural Mesothelioma Finalizing Trial Strategy 22
Slide 23: 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 24: 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 Planning Phase 3 • Lurbinectedin at 3.2 combo with IO • mOS
Slide 25: 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 26: Zepzelca – Life Cycle Management Plans Under Way
Zepzelca® (Lurbinectedin) – Life Cycle Management Plans Under Way 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 protection Composition of
Slide 27: Other Opportunities
OTHER OPPORTUNITIES Pharma Mar.
Slide 28: Plitidepsin Extension in COVID-19 Patients
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 29: 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 30: Financials
FINANCIALS Pharma Mar.
Slide 31: Well Financed to Support Next Stages of Development
Financials Well Financed to Support Next Stages of Development Robust Cash Position (€m) Profitable (€m) 250 300 200 250 150 200 100 150 50 100 0 (50) 50 (100) 0 (150) (50) 2017 2018 2019 2020 2017 2018 2019 2020 Debt Cash Revenues EBITDA 31
Slide 32: Delivering on Our 2020-2022 Objectives
Zepzelca® Delivering on Our 2020-2022 Objectives (lurbinectedin) maintenance SCLC trial initiated Initiation of Zepzelca ® two Phase 2 with (lurbinectedin) PM14 confirmatory SCLC Aplidin® POC trial in trial initiated COVID-19 Zepzelca® approved in SCLC monotherapy Zepzelca® launched in the US Partne
Slide 33: Key Events
Key Events Catalyst Calendar • Lurbi Combo Atezo data presented at SITC • Zepzelca approved in additional countries • UAE, Singapore, Australia, Canada • 2nd line Phase 3 SCLC trial initiation • PM14 “First Patient In” Phase 2 2022 • Potential lurbinectedin approvals in other countries 2022 and beyo
Slide 34: 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 Solid financial capabilities to new approvals and launches in non-EMA IP 2022-2
Slide 35: www.pharmamar.com
‘4 www.pharmamar.com Pharma Mar.