Slide 1: Devyser Capital markets day – November 25, 2024
Devyser Capital markets day – November 25, 2024
Slide 2: Today's speakers
CMD Today’s speakers Fredrik Alpsten Michael Uhlin Theis Kipling Jeff Salzman Dr. Jakob Nilsson CEO CSO CCO VP Market access Head of Transplant Professor, Karolinska & Public affairs Immunology, Institutet University of Zurich In order of appearance at Today’s CMD
Slide 3: Today's agenda
CMD Today’s agenda 13.30 - 13.45 1 Welcome & introduction Fredrik Alpsten CEO 13.45 - 14.00 2 Product portfolio overview Michael Uhlin CSO & Professor, Karolinska Institutet 14.00 - 14.20 3 The Devyser commercialization plan Theis Kipling CCO 14.20 - 14.40 4 Market Access & reimbursement North Ameri
Slide 4: The value of correct and fast diagnosis
The value of correct and fast diagnosis Waiting for test results is a stressful experience for patients and their families The outcome can be life-changing
Slide 5: Our mission, our vision
Our mission Be the pioneering leader of diagnostic solutions and provide fast, accurate, and easy-to-use solutions to labs worldwide. Our vision A world where personalized medicine is universally available thanks to simplified and reliable genetic tests.
Slide 6: A new level of certainty
A new level of certainty — enabling patients access to early detection and prevention · Devyser is a pioneer in utilizing Next-Generation Sequencing (NGS) technology · Our NGS tests enable highly accurate, rapid, and sensitive testing
Slide 7: Simplified lab workflows — faster, better, safer
CMD Simplified lab workflows — faster, better, safer Traditional solutions Devyser solution Multi-step and multi-tube process One-tube solution FASTER ✓ <45 minutes hands-on time BETTER ✓ Achieve turnaround time of 2-3 days Library SAFER ✓ STEP 1 STEP 2 purification Easy to use, minimize risk of sam
Slide 8: Devyser a pioneering leader
CMD Devyser a pioneering leader Since 2004, Devyser is developing and commercializing tests that are fast, accurate, and easy to use for diagnostic laboratories worldwide. 2004 | Company founded 2006 | ISO13485 certified and first CE-IVD product 2015 | Devyser started collaboration with notified bod
Slide 9: Our diagnostic areas
CMD Our diagnostic areas ~10% ~20% ~70% Of our Of our Of our total sales total sales total sales HEREDITARY DISEASES
Slide 10: Outstanding track record of double-digit growth
CMD Outstanding track record of double-digit growth Revenue development M SEK 198,1 169,3 +35% CAGR 126,6 (’15 –’24) 93,5 64,3 65,7 48,1 35,4 26,2 14,4 2015 2016 2017 2018 2019 2020 2021 2022 2023 LTM Q3, 2024
Slide 11: Product portfolio overview
CMD Product portfolio overview
Slide 12: Introducing: Michael Uhlin
CMD Introducing: Michael Uhlin Michael is the CSO with To take us responsibility for research and development at Devyser since through the 2023. Product portfolio Also, Michael is professor and principal investigator at overview Karolinska Institutet. Former head of Clinical Immunology at Karolinska
Slide 13: Devyser Product Portfolio
Devyser Product Portfolio HEREDITARY DISEASES Categorization Products Hereditary Hereditary Stem cell Kidney Hereditary Non-invasive breast and hematology Aneuploidy Male infertility CFTR Devyser CVD transplantation transplantation colon cancer fetal screening ovarian cancer testing Devyser FH Devys
Slide 14: Our products are based on three types of technologies
CMD Our products are based on three types of technologies and each technology is applied in several applications New tech Legacy Technology Technology Real-time PCR Next generation sequencing (NGS) Fragment analysis (FA) Variant analysis Marker analysis QF-PCR Allele-specific PCR Products Products B
Slide 15: New products 2025: A lot of exciting actions
CMD New products 2025: A lot of exiting actions Regulatory upgrades New products (To be unfolded in the next slides) CFTR to IVDR Genomic blood group typing Thalassemia V2 all the way to IVDR RHD to IVDR (Class D) Foetal typing Software highlights AI based tool for organ transplantation to complemen
Slide 16: New products: Genomic blood group typing
CMD New products: Genomic blood group typing The field of transfusion medicine is taking the step Devyser is helping it happen into the future by introducing molecular technology We have prepared several potential Advances of NGS enables accurate blood group phenotype predictions in both products to
Slide 17: New products: Foetal typing
CMD New products: Foetal typing Hemolytic disease of the newborn is when Devyser has developed a comprehensive NGS based the immune system of the mother sees the kit and software that can predict the risk for this baby as something dangerous disease During the first pregnancy there is a risk that th
Slide 18: New products: HLA Loss
CMD New products: HLA Loss Tumors escape the immune system by Devyser has developed a complementary assay and getting rid of parts of the chromosomes software to Chimerism to detect this common escape mechanism Will be used after Haplo and mismatched allogeneic hematopoetic stem cell transplantation
Slide 19: Devyser is developing both in the short- and long-term
CMD Devyser is developing both in the short- and long-term For the long run we go for Innovation to improve our technology • We are advancing Amplicon based Technology by adding a concept for absolute quantification of Cell free DNA Short-term strategy Long-term strategy Building a solid foundation
Slide 20: We might have a new engine but what 'car' shall we put it in?
CMD Getting the most out of our new technology leap We might have a new engine but what ‘car’ shall we put it in? Inflammatory Transplantation Oncology Etc. diseases Areas of potential
Slide 21: Extensive clinical study program
CMD In order to obtain regulatory approval and win clinical and scientific acceptance Devyser has an extensive Clinical study program By initiating and sponsoring clinical studies Devyser gains entry and “stickiness” with future customers Across numerous renowned institutions Devyser is actively inv
Slide 22: Devyser products getting more scientific traction and depth
CMD Devyser products is getting more scientific traction and depth Many of the stakeholders and decision Examples of mentionable publications makers for Devyser products are scientists 1 One Lambda Devyser Accept cfDNA: Hence, we had a focus on establishing connections by Pettersson L, Frischknecht
Slide 23: The Devyser commercialization plan
CMD The Devyser commercialization plan
Slide 24: Introducing: Theis Kipling
CMD Introducing: Theis Kipling Theis is the CCO and head of To take us business development at Devyser since 2022. through the Devyser commerciali- Former CCO at Atlas Antibodies and has held international zation plan management positions in marketing/sales at Agilent, Global Brand Management at Lun
Slide 25: All three application segments are growing fast
CMD All three application segments are growing fast, oncology is the most competitive and transplantation the one with highest growth Total Addressable Market (TAM) & Serviceable Addressable Market (SAM) by application segment ONCOLOGY HEREDITARY POST-TRANSPLANTATION ~ 857 mEUR ~3,158 mEUR ~1,526 mE
Slide 26: All three application segments are growing fast
CMD All three application segments are growing fast, oncology is the most competitive and transplantation the one with highest growth Total Addressable Market (TAM) & Serviceable Addressable Market (SAM) by application segment ONCOLOGY HEREDITARY POST-TRANSPLANTATION 21% of revenues Q3 YTD 67% of re
Slide 27: We have four main channels
CMD We have four main channels, and we use the channel that best serves our objective Direct sales Partners Lab services Distributors • We use Direct sales for • Partners take a larger • Pharmaceutical companies • We have approx. 50 established countries responsibility for regulatory and other Labor
Slide 28: The opportunity in Transplantation
CMD The opportunity in Transplantation
Slide 29: We are pursuing FDA approval in the US for Accept cfDNA
CMD We are pursuing FDA approval in the US for Accept cfDNA to disrupt the market Why pursue FDA approval Why pursue FDA approval for Accept cfDNA FDA is expected to have oversight of laboratory-developed tests Today's market in the US for Accept cfDNA-type products as well as (LDTs) reimbursement i
Slide 30: Changing market dynamics opens opportunities in the US
CMD Changing market dynamics opens opportunities for Devyser in the US An upcoming change to market dynamics Offering centralized CLIA testing (US) The current market for post-transplant monitoring of solid organs relies on CLIA services, with reimbursement of ~2.800 USD per test No FDA-cleared test
Slide 31: An FDA approval will change the revenue flow
CMD An FDA approval will change the revenue flow and disrupt the market Current Market Model New Market Model (FDA-Approved Test Advantage) Payors Payors Invoice Payment Invoice Payment In-house testing Patient sample CLIA laboratories Transplant centers CLIA laboratories Transplant centers - Revenu
Slide 32: Two indicative scenarios: 2% vs 25% market share in the US
CMD Two indicative scenarios: 2% vs 25% market share in the US assuming a reimbursement at 2.000 USD per test New Transplantations Total Patients Yearly Revenue per area | M SEK Yearly Revenue per area | M SEK 2% market share 25% market share 2% market share 25% market share 960,3 174,0 247,2 610,7
Slide 33: Technology and product growth
CMD Technology and product growth
Slide 34: Each vertical and technology is outperforming the market
CMD Each vertical and technology is outperforming the market and taking market share By Vertical By Technology M SEK 28% M SEK CAGR Based on 2022-2024 CAGR CAGR Based on 2022-2024 34% (Q3 2024 YTD extrapolated to full year) (Q3 2024 YTD extrapolated to full year) CAGR 114,3 101,6 102,2 14% 94,7 88,7
Slide 35: Individual products outperforming the market
CMD A cross section of verticals and technology shows how individual products are outperforming the market By Product M SEK 26% CAGR Based on 2022-2024 CAGR (Q3 2024 YTD extrapolated to full year) 19% 28% 53,8 CAGR CAGR 47,9 73% 41,7 37,2 53% CAGR 34,6 31,8 32,0 CAGR 32,0 27,6 43% CAGR 17,3 17,2 15,
Slide 36: Market access & reimbursement in North America
CMD Market access & reimbursement in North America
Slide 37: Today's agenda
CMD Today’s agenda 13.30 - 13.45 1 Welcome & introduction Fredrik Alpsten CEO 13.45 - 14.00 2 Product portfolio overview Michael Uhlin CSO & Professor, Karolinska Institutet 14.00 - 14.20 3 The Devyser commercialization plan Theis Kipling CCO 14.20 - 14.40 4 Market Access & reimbursement North Ameri
Slide 38: Monitoring of donor derived cell free DNA post transplantation
CMD Monitoring of donor derived cell free DNA post transplantation
Slide 39: Introducing: Jakob Nilsson
CMD Introducing: Jakob Nilsson Jakob Nilsson is Ph.D. Dr. Med. To take us and Head of Transplant Immunology at University of through the Zurich. monitoring of donor derived Former Senior Consultant Physician and Principal cell free DNA Investigator, Department of Department of Infectious post Diseas
Slide 40: Monitoring of donor derived cell free DNA post transplantation
Monitoring of donor derived cell free DNA post transplantation Jakob Nilsson MD, PhD 2024
Slide 41: Background donor derived cell free DNA (dd-cfDNA)
Background donor derived cell free DNA (dd-cfDNA) Jakob Nilsson | 2024 41
Slide 42: Cell free DNA
Cell free DNA Jakob Nilsson | 2024 42
Slide 43: Cell free DNA – liquid biopsy
Cell free DNA – liquid biopsy Lo, YM Dennis, et al. "Epigenetics, fragmentomics, and topology of cell-free DNA in liquid biopsies." Science 372.6538 (2021): eaaw3616. Jakob Nilsson | 2024 43
Slide 44: Cell free DNA (dd-cfDNA)
Cell free DNA (dd-cfDNA) Oellerich M et. al. Nature Reviews Nephrology. 2021 Sep;17(9):591-603. Jakob Nilsson | 2024 44
Slide 45: Donor derived cell free DNA (dd-cfDNA)
Donor derived cell free DNA (dd-cfDNA) Oellerich M et. al. Nature Reviews Nephrology. 2021 Sep;17(9):591-603. Jakob Nilsson | 2024 45
Slide 46: dd-cfDNA detection
dd-cfDNA detection Keller M et. al. Current Transplantation Reports. 2021 Dec;8(4):351-8. Jakob Nilsson | 2024 46
Slide 47: Post transplant monitoring in solid organ transplantation
Post transplant monitoring in solid organ transplantation Jakob Nilsson | 2024 47
Slide 48: Transplant loss (kidney)
Transplant loss (kidney) Coemans, Maarten, et al. "Analyses of the short-and long-term graft survival after kidney transplantation in Europe between 1986 and 2015." Kidney international 94.5 (2018): 964-973. Jakob Nilsson | 2024 48
Slide 49: Improvement in Transplant Outcome (Kidney)
Improvement in Transplant Outcome (Kidney) Coemans, Maarten, et al. "Analyses of the short-and long-term graft survival after kidney transplantation in Europe between 1986 and 2015." Kidney international 94.5 (2018): 964-973. Jakob Nilsson | 2024 49
Slide 50: Transplant loss (kidney)
Transplant loss (kidney) Coemans, Maarten, et al. "Analyses of the short-and long-term graft survival after kidney transplantation in Europe between 1986 and 2015." Kidney international 94.5 (2018): 964-973. Jakob Nilsson | 2024 50
Slide 51: Reason for transplant loss (Kidney)
Reason for transplant loss (Kidney) Sellares J et al. American Journal of Transplant 12 389–399 (2014) Jakob Nilsson | 2024 51
Slide 52: Early detection of graft injury
Early detection of graft injury Herath S et. al. Molecular diagnosis & therapy. 2019 Jun 1;23(3):333-51. Jakob Nilsson | 2024 52
Slide 53: Clinical utility of dd-cfDNA
Clinical utility of dd-cfDNA Jakob Nilsson | 2024 53
Slide 54: One Lambda Devyser Accept cfDNA
Asinglo-tube NGS assay for dotection of dd-cfDNA, with high sensitivity. In collaboration with Thermo Fishor Sciontific, this product is now availablo as One Lambda™ Devyser Accept efDNA in the USA, Canada, and Europo. Request more information Lae iY Dvysr. WAS 4. ONE LAMBDA A Thermo Fisher Scientif
Slide 55: Workflow
Workflow Jakob Nilsson | 2024 55
Slide 56: Software evaluation
Software evaluation Jakob Nilsson | 2024 56
Slide 57: Indels versus SNPs
Indels versus SNPs Advantages with the use of indels · Highly discriminative indel markers give a robust analysis · 50 indel markers on autosomal chromosomes, ranging between 2-6 bp · One reaction mix for both screening and monitoring · Population independent 50 indel markers on autosomal chromosome
Slide 58: Assay application – skipping graft biopsies
Assay application – skipping graft biopsies – screening for early detection of rejection Jakob Nilsson | 2024 58
Slide 59: Invasive graft diagnostic - biopsies
Invasive graft diagnostic - biopsies Jakob Nilsson | 2024 59
Slide 60: Evaluation of graft biopsies
Evaluation of graft biopsies Molecular microscope MMDx – 58 000 Probes (RNA) Banff scoring system - pathologist Jakob Nilsson | 2024 60
Slide 61: Negative predictive value – dd-cfDNA
Negative predictive value – dd-cfDNA Heart transplantation – cut off 0.13% Negative predictive value 97% for rejection Deshpande, Shriprasad R., et al. Pediatric transplantation 26.4 (2022): e14264. Jakob Nilsson | 2024 61
Slide 62: dd-cfDNA – saving biopsies and resources
dd-cfDNA – saving biopsies and resources Heart biopsies in pediatric recipients Predicted savings per patient Feingold, Brian, et al. Clinical Transplantation 37.5 (2023): e14933. Jakob Nilsson | 2024 62
Slide 63: Early detection of graft injury
Early detection of graft injury Herath S et. al. Molecular diagnosis & therapy. 2019 Jun 1;23(3):333-51. Jakob Nilsson | 2024 63
Slide 64: Early detection of rejection – ProActive Study
Early detection of rejection – ProActive Study Bromberg JS, et. Al. Transplantation. 2024 Apr 1;108(4):898-910. Jakob Nilsson | 2024 64
Slide 65: Assay application – evaluation of therapy response
Assay application – evaluation of therapy response Jakob Nilsson | 2024 65
Slide 66: Rapid turnover of cfDNA
Rapid turnover of cfDNA Minutes - Hours Jakob Nilsson | 2024 66
Slide 67: Clinical utility of dd-cfDNA
Clinical utility of dd-cfDNA Jakob Nilsson | 2024 67
Slide 68: Felzartamab for ABMR
Felzartamab for ABMR Jakob Nilsson | 2024 68
Slide 69: Felzartamab for ABMR
Felzartamab for ABMR Jakob Nilsson | 2024 69
Slide 70: Felzartamab for ABMR
Felzartamab for ABMR Jakob Nilsson | 2024 70
Slide 71: Summary
Summary Jakob Nilsson | 2024 71
Slide 72: dd-cfDNA in post-transplant monitoring summary
dd-cfDNA in post-transplant monitoring • dd-cfDNA has been established as a reliable robust assay for detecting graft damage in the setting of solid organ transplantation. • The assay has a high negative predictive value which allows for modified non-invasive post-transplant monitoring with less rel
Slide 73: He's
He's USZ Universitats Spital Zurich Cy tr
Slide 74: Closing remarks
CMD Closing remarks
Slide 75: Closing remarks: Our financial targets
CMD Closing remarks Our financial targets (Since November 2021) ORGANIC GROWTH: +30% annual organic growth GROSS MARGIN: +80% in gross margin by 2024-2026 EBIT MARGIN: +20% in EBIT margin by 2024-2026 + DIVIDEND DISTRIBUTION: 30-50% of the net profit (long-term), considering the group’s financial po
Slide 76: CMD Q&A
CMD ' Q&A Dvysr.