Pharma Mar Sa · BME:PHM
Pharma Mar Sa — Investor Presentation (June 2018)
31 slides from Pharma Mar Sa's investor presentation, Jun 12, 2018
Slide 1: Significant event filing to the CNMV
National Securities Market Comission Markets Directorate General c/ Edison núm. 4 28006 Madrid Colmenar Viejo (Madrid), June 12, 2018 Pursuant to article 228 of the consolidated text of the Spanish Securities Market Act, we hereby inform you of the following SIGNIFICANT EVENT: “Please find attached
Slide 2: Corporate presentation June 2018
= June 2018
Slide 3: Forward-looking statements disclaimer
This document includes only summary information and uncertainty as to whether adequate reimbursement for is not intended to be comprehensive. This document these products will exist from the government, private includes "forward-looking statements" that are based on healthcare insurers and third-par
Slide 4: Investment Highlights
INVESTMENT HIGHLIGHTS Leader in development & commercialization of marine -inspired oncology drugs Global integrated biotech developing marine-inspired and novel MoA oncology drugs. • From discovery to commercialization. Established oncology sales force in Europe. • Strong partners in the US (Jansse
Slide 5: Yondelis: commercial expansion worldwide
Y O N D E L I S ® - C O M M E R C I A L E X PA N S I O N W O R L D W I D E Yondelis Sales 2017: €132,5MN EU (PHM): €85MN ROW: €48MN PHM Territories / Partner Territories / Partner Territories / PharmaMar Subsidiaries / • WESTERN EU. USA and rest of the world JAPAN / Taiho • Scandinavia and Eastern E
Slide 6: Unique fully integrated platform
U N I Q U E F U L LY I N T E G R AT E D P L AT F O R M Discovery Development Chemistry Clinical Commercial • Marine inspired • Molecule optimization. • Patent protection. • Pre-clinical trials. • Oncology-focused products. • c.200,000 samples. • Synthesis. • Clinical trials. sales force in Europe •
Slide 7: The plan for growth
THE PLAN FOR GROWTH Potential to commercialize new oncology products in more indications PM184 • 2 or more clinical products. PM14 • Multiple indications. • 2 marketed products Zepsyre® • Small Cell Lung cancer. (Lurbinectedin) • 1 marketed product • 2 indications Yondelis® • Soft Tissue Sarcoma. •
Slide 8: Our oncology portfolio
OUR ONCOLOGY PORTFOLIO: Data Clinical Program / Indication Phase I Phase II Phase III Market Partner timing J&J (US) Soft Tissue Sarcoma 2nd/3rd line Single agent EU, US, Japan Taiho (Japan) Yondelis® Ovarian Cancer 2nd/3rd line Yondelis®+Doxil EU/Others SCLC Relapsed Zepsyre®+Doxo 2H 2019 Global Ze
Slide 9: Zepsyre (Lurbinectedin)
ZEPSYRE ® (Lurbinectedin) Key oncology compound– accelerating growth Zepsyre, a second generation Yondelis®, with improved PK, absorption and other attributes. DIFFERENT PK PROFILE • Zepsyre is administered as a 1h peripheral • 4x tolerated dose. infusion versus 24h continuous • 15x exposure at RD.
Slide 10: MoA - Zepsyre (Lurbinectedin)
M o A - Z E P S Y R E ® ( Lurbinectedin) Targeted transcription Inhibitor as a cancer therapeutic Zepsyre only affects activated transcription. Does not affect basal transcription* Generates double strand DNA breaks. Some tumors are addicted to transcription (SCLC, Ovarian Cancer, etc...) Effect on
Slide 11: Pipeline - Zepsyre (Lurbinectedin)
PIPELINE- ZEPSYRE® (Lurbinectedin) Development and commercial strategy ClinicalPROGRAM/ CLINICAL Program /INDICATION Indication PHASE Phase I I Phase II II PHASE PHASE Market Phase IIIIII MARKET Data DATAtiming TIMING ZEPSYRE® SCLC Combo 2H 2019 Relapsed Doxorubicin Basket trial Single agent Ongoing
Slide 12: Zepsyre: Small Cell Lung Cancer (SCLC)
Z E P S Y R E ®: S M A L L C E L L L U N G C A N C E R ( S C L C ) Market overview: Orphan Indication US/EU 1 In the US per annum 2: In EU-28 per annum 2: ~ 33,200 new cases of small cell lung cancer ~ 46,645 new cases of small cell lung cancer ~ 24,040 deaths from small cell lung cancer ~ 40,700 de
Slide 13: Small Cell Lung Cancer over the years
Small Cell Lung Cancer over the years1; it’s not NSCLC! Alkyliting N S Amtimetabolites C Antiangiogenesis L Microtubule C IO EGFR 12 > TKI Source; Sabari et al, Clinical Oncology; September 2017
Slide 14: Why is SCLC so hard to target?
DNCOIOUY Why is SCLC so hard to target? ecooooy oooo°0 RBI IERERT TP TBE HBT °o PTEN : CREBSP _6> + Most common genomic EPs00 alterations are in tumor MLL suppressor genes COBL . _ - EPHA7 + Turning off an “off switch” is MYCL1 a real challenge MYC FGFRI CCNET Peifer et al Nature Genetics 2012
Slide 15: Zepsyre: SCLC current and emerging treatment paradigm
Z E P S Y R E ®: S M A L L C E L L L U N G C A N C E R Current and Emerging reatment paradigm FIRST LINE MAINTENANCE 2nd LINE 3rd LINE • Platinum/Etoposide • Nivolumab1* • Topotecan • Nivo/Ipi1* • CAV (off label)* • Trials - Zepsyre®* Nivolumab2 * - Rova –T * - Others * * Investigational drug or not
Slide 16: Zepsyre: Phase I/II relapsed SCLC
Z E P S Y R E ®: P H A S E I / I I R E L A P S E D S M A L L C E L L L U N G C A N C E R Cohort A: ASCO 2015 n=21 Best RECIST v.1.1 overall response Kaplan-Meier global PFS and according to CTFI (n=21) During treatment (n=21) PFS: 4.6 months (95%CI: 3.3-8.0 months) ORR: 67% (95%CI: 43-85) Global (N=
Slide 17: Zepsyre: Phase I/II 2nd line SCLC combo and monotherapy data
Z E P S Y R E ®: P H A S E I / I I 2 n d L I N E S M A L L C E L L L U N G C A N C E R Combo and Monotherapy latest data Sensitive Resistant n=61 CR 2 (10%) 1 (4%) - PR 12 (57%) 9 (33%) 24 (39%) ORR 14 (67%) 10 (37%) 24 (39%) SD 3 (14%) 9 (33%) 21 (34%) PD 4 (19%) 8 (30%) 16 (26%) Combined Cohorts A
Slide 18: Cohorts A & B, maximal tumor reduction and PFS
Z E P S Y R E ®: P H A S E I / I I 2 nd L I N E S M A L L C E L L L U N G C A N C E R Cohorts A & B, maximal tumor reduction according to CTFI and PFS (n=21, 27) PFS: 4.7m PFS: 5.3m Median DOR:4.5mo Median DOR:5.2mo 17 >
Slide 19: What does ovarian Phase III tell us re SCLC?
W H AT D O E S O VA R I A N P H A S E I I I T E L L U S R E S C L C ? OVARIAN: SCLC: • Drug is active • Monotherapy also shows activity, could offer alternative, • Drug is tolerated especially for older/frailer or with cardio co-morbidities • Phase III BSA DOSE ~75% OF Phase II Fixed Dose • Phase II
Slide 20: Non head-to-head comparisons
N O N H E A D - T O - H E A D C O M PA R I S O N S Cohort A, Cohort B, n=27 Monotherap Topotecan CAV (from n=21 BSA combo y n=61 label Topo label), FD combo doxo N=107 n=104 doxo ORR 67% 37% 39% 24% 18% DCR 81% 70% 74% PFS CTFI>30d 4.7m 5.3m 4.1m 3.1m 2.8m (CTFI>30d) (CTFI>30d) OS World Lung 2018 11
Slide 21: Zepsyre: Phase III relapsed SCLC ATLANTIS trial design
Z E P S Y R E ®: P H A S E I I I R E L A P S E D S M A L L C E L L L U N G C A N C E R ATLANTIS Trial Design SCLC (Trial initiated August 2016); Anticipate data 2019 • Primary endpoint: median OS HR ≤ 0.75 with 90% power (10m vs. 7.5m) • Key secondary endpoints: - PFS • Registration Strategy - Inter
Slide 22: Zepsyre: ATLANTIS trial primary endpoint change
Z E P S Y R E ® : AT L A N T I S T R I A L Change primary endpoint from PFS to OS • PharmaMar recently received the OS analysis for cohort B of the combo Phase I/II (submitted to IASLC World conference on Lung Cancer) which prompted the change • Regulators prefer OS vs. surrogate endpoints, especial
Slide 23: Key IP and barriers to entry
KEY IP AND BARRIERS TO ENTRY Yondelis: • EU: Sarcoma orphan expired 9/17, ovarian orphan 2019, use 2022, formulation 2025# • US: Sarcoma orphan 2022, formulation 2025# • Japan: Sarcoma orphan 2022, formulation 2025#. Ovarian 10 years from approval orphan • Manufacturing US/EU/Japan 2031 Zepsyre
Slide 24: 2014 2015 2016 2017 2014 2015 2016 2017 >
177 2014 2015 2016 2017 2014 2015 2016 2017 23 >
Slide 25: Key facts and current shareholders
K E Y FA C T S A N D C U R R E N T S H A R E H O L D E R S KEY FACTS FERNÁNDEZ FAMILY 22% ROSP CORUNA PARTICIP. 5% BOARD MEMBERS/EMPLOYEES 3% • Ticker: PHM SM FREE FLOAT 70% • Market Cap*: C. € 330 million NORGES BANK 1.76% • 2017 Total Income: € 179 million VANGUARD 1.69% • 2017 EBITDA: € -7.4 mill
Slide 26: Key events: transformative times for Pharma Mar
KEY EVENTS Transformative times for Pharma Mar; catalyst 2018 • SCLC futility analysis • Zepsyre® Phase III platinum-resistant ovarian cancer 1H ’18; primary endpoint not met • ASCO Zepsyre® : Monotherapy SCLC, TiP ATLANTIS, Ewing’s sarcoma • Zepsyre® SCLC ATLANTIS Phase III complete enrolment mid’
Slide 27: Slide 27
Slide 28: Contextual comparative data, reading across trials
C O N T E X T U A L C O M PA R AT I V E D ATA , R E A D I N G A C R O S S T R I A L S .
Slide 29: Standard of care for relapsed small cell lung cancer
STANDARD OF CARE FOR RELAPSED SMALL CELL LUNG CANCER Competitive Landscape after first line treatment: Platinum/Etoposide 2nd line 3rd line N PFS (ORR%) Notes ASCO 2015/ Zepsyre/Doxo 48 5.0 (50%) ESMO 2017 Nature Reviews Paclitaxel Literature (29) Glisson,20111 Topo Literature 3.0 (24) Glisson,20111
Slide 30: SCLC: A history of failure
SCLC: A history of failure MoA Drug Study Setting N Outcome PARP Olaparib PII RDB vs. pbo 2L 220 Inferior to pbo PARP Veliparib PI/II +/- Cis/Etop Extensive 128 PFS 6.1 vs. 5.5 OS 10.3m vs. 8.9m Aurora Alisertib PII solids Refractory 48 ORR 21% Aurora Alisertib PII +/- paclitax 2L 178 PFS 87d vs. 50
Slide 31: Zepsyre vs Yondelis
Plasma concentration (ngim2) ZEPSYRE® vs YONDELIS® Different pharmacological profile Better safety profile Porcentage of patients 1 180 °° 90 Yondelis 80 10 50 67 30 PMo01183 20 7 10 2) Yondelis 10 67 PMo1183 7 7 10 0123456789 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Hours after infusion ALT ===