Pharma Mar Sa · BME:PHM
Pharma Mar Sa — Investor Presentation (February 2025)
23 slides from Pharma Mar Sa's investor presentation, February 2025
Slide 1: Corporate Presentation
February 2025 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 & Profitable Revenues 9m 2024 €126.5m Discovery Platform Strengthening Oncology Pipeline EBITDA 9m 2
Slide 5: The Plan for growth
The Plan for growth Continue delivering value to shareholders Lurbinectedin Other drugs Corporate development development development ✦ Fully enrolled Phase 3 trial with ✦ 2 Phase 2 trials with ecubectedin ✦ Looking for in-licensing lurbinectedin in SCLC for EU enrolling products to market approval
Slide 6: 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 7: Standard of Care in 2L SCLC in the US
Standard of Care in 2L SCLC in the US Emerging in 1L maintenance US and EU 7
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: 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 10: Zepzelca (Lurbinectedin) – The Extensive Stage SCLC Treatment Paradigm
Zepzelca (Lurbinectedin) – The Extensive Stage SCLC Treatment Paradigm Strong positioning opportunity 1st line 1st line Subsequent Therapy Subsequent Therapy Induction Maintenance Induction Maintenance • Platinum/ • Zepzelca • Platinum/ Etoposide + Etoposide + FDA • Topotecan (sensitive) EMA • Atezo
Slide 11: Development Plan: 2nd line SCLC, 1st line-Maintenance Study in SCLC
Development Plan: 2nd line SCLC 1st line-Maintenance Study in SCLC 11
Slide 12: 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. Recruitment ended December 2024. 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 A
Slide 13: 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 ≥SD Co-Primary: SCLC (ES-SCLC) Etoposide
Slide 14: Positive results from the IMforte Phase 3 clinical trial
Positive results from the IMforte Phase 3 clinical trial Statistically significant and clinically meaningful OS & PFS benefit • The combination of lurbinectedin and atezolizumab demonstrated a positive, statistically significant and clinically meaningful improvement in the two primary endpoints of o
Slide 15: Lurbinectedin. Pathway to market in EU
Lurbinectedin. Pathway to market in EU Key events 2024 2025 2026 2027 2028 IMforte trial 1Q: End of 1H: Expected EU Lurbinectedin + atezolizumab recruitment 1H: Expected marketing regulatory submission authorization Market access 1st line maintenance 4Q: Positive results SCLC of PFS and OS 2H: Marke
Slide 16: Lurbinectedin: Commercial outlook
Lurbinectedin: Commercial outlook Global presence European Union Rest of the world PHM territories Partner territories • Western EU. US and rest of the word Commercial agreements • UK, Scandinavia and Eastern Europe: Inmedica Pharma • Greece, Cyprus and Balkans: Genesis Pharma 16
Slide 17: Lurbinectedin - European incidence SCLC in EU10
Lurbinectedin - European incidence SCLC in EU10 Total lung cancer incidence in Europe 484,306 patients (1) SCLC 13%-15% NSCLC 87% 62,960 patients 421,346 patients Population Lung Cancer SCLC Country / Area (2022) Incidence incidence(3) (million) (2022) Germany 83.8 62,025 8,063 Italy 59.0 43,808 5,6
Slide 18: Leiomyosarcoma
Q ZEPZELCA (lurbinectedin) Leiomyosarcoma 18
Slide 19: Leiomyosarcoma: Incidence and treatment paradigm
Leiomyosarcoma Incidence and treatment paradigm One of the most common soft tissue sarcomas (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 Appro
Slide 20: 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 1:1:1 Interim Lurb 3.2 mg/m2 + 168 pt
Slide 21: Financials
Financials Profitable and solid and stable financial position Robust cash position (€ mn) Total sales by product(€ mn) 2022 2023 1% 3% 29% 44% €196.3 €158.2 216,5 231,8 53% 212,6 168,6 70% 21,3 Zepzelca Yondelis Other Zepzelca Yondelis Other -53,0 -45,6 -39,0 -39,9 -82,7 2022 Zepzelca (€mn) 2023 Zep
Slide 22: Key Events
Key Events Catalyst Calendar Positive IMforte PFS & OS top line data ✓ Lurbinectedin approval in China ✓ End of recruitment LAGOON ✓ Expected regulatory submission IMforte EU & US 2025 Potential out-license 2025 Potential lurbinectedin approvals and launches Ongoing in other countries Pipeline Data
Slide 23: www.pharmamar.com
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