Pharma Mar Sa · BME:PHM
Pharma Mar Sa — Investor Presentation (April 2024)
29 slides from Pharma Mar Sa's investor presentation, April 2024
Slide 1: Corporate Presentation
April 2024 Corporate Presentation World leader in the development and commercialization of anticancer drugs of marine origin
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: Our vision
Our vision 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 to be the world leader in marine medicinal discovery, development and innovation. 3
Slide 4: Corporate Overview
Corporate Overview Global Fully Integrated 3 Approved Oncology Products Commercial Stage Biotech Developing marine-inspired oncology drugs Established European oncology sales force Revenue Generating & Discovery Platform Profitable Strengthening Oncology Pipeline Revenues in 2023 €158.2m Diversified
Slide 5: The Plan for growth
The Plan for growth Continue delivering value to shareholders Lurbinectedin Other drugs Corporate development development development ✦ Phase 3 trials with lurbinectedin ✦ 1 Phase 2 trial for ecubectedin ✦ Looking for in-licensing in SCLC for EU approval and enrolling products to market confirmatory
Slide 6: Zepzelca: Transformative for PharmaMar
Zepzelca: Transformative for PharmaMar License agreement in the US/Canada $200m received upfront ✦ High teens to 30% Royalties on $100m US/Canada sales received approval ✦ Phase 3 in 1L maintenance ES-SCLC in $25m combination with Tecentriq® in received commercial milestone collaboration with Roche.
Slide 7: Pipeline – Expanding our Expertise in Oncology
Pipeline – Expanding our Expertise in Oncology Phase 1 Phase 2 Phase 3 Market Soft tissue Sarcoma Monotherapy 2nd/3rd line + PLD (pegylated liposomal Ovarian cancer 2nd/3rd line doxorubicin) R/R Multiple Myeloma1 + dexamethasone 3rd/4th line Small cell lung cancer Monotherapy 2nd line US / other cou
Slide 8: Zepzelca – A Transcription Inhibitor Leading to Tumour Inhibition
Zepzelca – A Transcription Inhibitor Leading to Tumour Inhibition Primary Effect Secondary Effect Cancer is frequently a transcriptional disease caused by Marked effect on the tumour microenvironment by deregulated oncogenic transcription factors inhibiting the transcription and secretion of tumour-
Slide 9: 1st FDA approved drug in over 24 years for relapsed SCLC
1st FDA approved drug in over 24 years for Relapsed Small Cell Lung Cancer (SCLC) Standard of Care in 2L SCLC in the US 9
Slide 10: Small Cell Lung Cancer (SCLC)
Small Cell Lung Cancer (SCLC) A high unmet medical need Among all Lung Cancers Low survival rate at 5 years Limited treatment options in both the US and Europe SCLC ~15% ✦ Highly aggressive tumour ~ 62,000 in 20202 ✦ 5-year survival rate 5-10%1 ~ 30,000 in 20202 Newly diagnosed patients each year 1.
Slide 11: Development lagging behind NSCLC; FDA approvals
Small Cell Lung Cancer (SCLC) Development lagging behind NSCLC; FDA approvals Cisplatin + Carboplatin + Durv or atezo + 1st Line etoposide etoposide carboplatin + etoposide SCLC 2nd Line Topotecan Pre - 1993 1996 24 years 2020 NSCLC 11
Slide 12: Zepzelca (Lurbinectedin) – The SCLC Treatment Paradigm
Zepzelca (Lurbinectedin) – The SCLC Treatment Paradigm Strong positioning opportunity 1st Line Maintenance 2nd Line 3rd Line 1st Line 2nd Line 3rd Line • Platinum/ • Platinum/ FDA Etoposide + • Zepzelca EMA Etoposide + • Atezolizumab • Topotecan • Atezolizumab • Topotecan Approved Approved or (sensi
Slide 13: Zepzelca Already Treatment of Choice in 2L SCLC
Zepzelca Already Treatment of Choice in 2L SCLC Zepzelca Demonstrated Efficacy in Sensitive and Resistant Small Cell Lung Cancer patients In relapsed SCLC as monotherapy under accelerated approval based on Phase 2 monotherapy data1 Overall Resistant Sensitive Decrease in tumour size in 65% patients2
Slide 14: Zepzelca Already Treatment of Choice in 2L SCLC (safety)
Zepzelca Already Treatment of Choice in 2L SCLC Low rate of AEs and manageable hematological safety profile despite low use of G-CSF 1,2 Safety: Related or Unknown Treatment Related (or Unknown) Adverse Events Adverse Events (AEs) ( >5% or Gr 3-4) Overall (n=105) n (%) Gr 1-2 Gr 3-4 Overall (n=105)
Slide 15: Zepzelca: Pathway to 2nd line in SCLC by EMA and Full Approval by FDA
Zepzelca: Pathway to 2nd line in SCLC by EMA and Full Approval by FDA Phase 3 (LAGOON) randomized trial Arm A Lurbinectedin 3.2 mg/m2 every 3 weeks Primary Endpoint: ✦ Relapsed SCLC Arm B ✦ One prior platinum Randomization Overall Survival containing regimen 1:1:1 Arm A vs. C ✦ CTFI ≥30 days 705 pat
Slide 16: Positioning LAGOON for success
Positioning LAGOON for success • 70% of patients to have had prior IO. There is no evidence of additive or synergistic benefit for control arm. For lurbinectedin, there are data from different trials. • In a prior trial, we allowed stable brain mets. Partly due to protocol violations this proved the
Slide 17: 1st line-Maintenance Study in SCLC
1st line-Maintenance Study in SCLC 17
Slide 18: SITC 2021
SITC 2021 Combo with IO delivers efficacy not seen for either drug as single agent Response N=26 CR 7.7% (2) PR 50% (13) ORR 57.7% (15) SD 26.9% (6) DCR 84.6% PD 11.5% (3) mPFS (8 censored) 4.93m (3.37-7.47m) • Phase I open label dose ranging trial in pts who had progressed on platinum. ECOG 0-1 • F
Slide 19: Lurbinectedin: evidences of additive/synergistic benefit with or post IO
Lurbinectedin: evidences of additive/synergistic benefit with or post IO Basket trial: 6 of 8 had lurbi PFS ≥ PFS with prior IO including 5 CRs, 2 of which happened in 2L post PD Source: Paz-Ares, L et al. Efficacy and safety profile of lurbinectedin in 2nd-line SCLC patients: Results from a phase I
Slide 20: Lurbinectedin: First-line maintenance positioning
Lurbinectedin: First-line maintenance positioning Phase 3 trial for first line-maintenance SCLC Induction Phase Maintenance Phase Atezolizumab 1,200 mg q3wk + lurbinectedin 3.2 mg/m2 q3wk Endpoints: Atezolizumab + ✦ Extensive-stage carboplatin + Randomization SCLC (ES-SCLC) 1:1 Co-Primary: Etoposide
Slide 21: Leiomyosarcoma
Q ZEPZELCA (lurbinectedin) Leiomyosarcoma 21
Slide 22: Leiomyosarcoma
Leiomyosarcoma Incidence and treatment paradigm One of the most common soft tissue sarcoma (STS) accounting for ~ 10%-20% of all STS Incidence ~2,100(1) in USA Incidence and ~4,500(2) in Europe 1st Line 2nd Line 1st Line 2nd Line FDA ✦ Doxorubicin ✦ Trabectedin EMA ✦ Doxorubicin ✦ Trabectedin Approv
Slide 23: Leiomyosarcoma
Leiomyosarcoma Randomized P3 comparing doxorubicin +/- trabectedin in 1L metastatic or unresectable LMS 23
Slide 24: Leiomyosarcoma
Leiomyosarcoma Randomized P3 comparing doxorubicin +/- trabectedin in 1L metastatic or unresectable LMS (BICR) 24
Slide 25: Zepzelca (lurbinectedin)-Leiomyosarcoma
Zepzelca (lurbinectedin)-Leiomyosarcoma Phase IIb/III adaptive trial Phase IIb Phase III Doxo 50 mg/m2 + Selected • Metastatic Lurb 2.2 mg/m2 + combination* Uterine/ST LMS GCSF, D1 q3w • No prior chemo • ECOG 0-1 Primary endpoint: Doxo 25 mg/m2 + IDMC PFS by IRC Interim N based 1:1:1(**) Lurb 3.2 mg
Slide 26: Financials
Financials Profitable and solid and stable financial position Robust cash position (€ mn) Historical revenues evolution (€ mn) 2021 2022 2023(*) Recurring revenues 164.8 155.9 123.7 Oncology sales 118.9 100.7 70.7 Other sales 4.9 4.9 1.2 216.5 231.8 Royalties 41.0 50.3 52.3 212.6 168.6 Non-recurring
Slide 27: Key Events
Key Events Catalyst Calendar Zepzelca approved in Switzerland for SCLC Potential lurbinectedin approvals and Ongoing launches in other countries Lurbi + Irinotecan Phase 2 topline data 2024 Potential in-licensing Ongoing IMforte PFS top line data ~YE24/1Q25 27
Slide 28: Building the Next Phase of Growth
Building the Next Phase of Growth 2021-2026 Financial strength allows Strong Zepzelca I.P broadening and exclusivity period Profitable Biotech with accelerating R&D engine 3 commercial assets and cash to support growth Zepzelca expected approvals/launches Leveraging proven in EMA and non-EMA oncolog
Slide 29: www.pharmamar.com
www.pharmamar.com . ve an ies