Bioporto A/s · OMXCOP:BIOPOR
Bioporto A/s — Shareholder Meeting (March 2019)
47 slides from Bioporto A/s's shareholder meeting presentation, Mar 18, 2019
Slide 1: BioPorto A/S Annual General Meeting March 18, 2019
BIOPORTO A/S ANNUAL GENERAL MEETING MARCH 18, 2019 1
Slide 2: Agenda
Agenda 1. REPORT OF THE COMPANY’S ACTIVITIES DURING THE PAST YEAR 2. PRESENTATION OF THE ANNUAL REPORT FOR APPROVAL AND ALLOCATION OF PROFIT OR COVERING OF LOSS 3. RESOLUTION TO GRANT DISCHARGE OF LIABILITY TO THE BOARD OF DIRECTORS AND EXECUTIVE MANAGEMENT 4. APPROVAL OF REMUNERATION FOR THE BOARD
Slide 3: Agenda
Agenda 1. REPORT OF THE COMPANY’S ACTIVITIES DURING THE PAST YEAR 2. PRESENTATION OF THE ANNUAL REPORT FOR APPROVAL AND ALLOCATION OF PROFIT OR COVERING OF LOSS 3. RESOLUTION TO GRANT DISCHARGE OF LIABILITY TO THE BOARD OF DIRECTORS AND EXECUTIVE MANAGEMENT 4. APPROVAL OF REMUNERATION FOR THE BOARD
Slide 4: Annual General Meeting by Chairman Thomas Magnussen
BIOPORTO A/S ANNUAL GENERAL MEETING MARCH 18, 2019 BY CHAIRMAN THOMAS MAGNUSSEN 4
Slide 5: AKI in the US: 230% increase in 10 years
2018 reinforced BioPorto’s strong value proposition for a major public health concern: AKI AKI IN THE US ONLY 230% Increase 2 Million Deaths $10 Billion Increase in 10 Years1 Each Year2 in U.S. Hospital Costs3 More In-hospital Higher Higher AKI Mortality Costs 1) Increase from 2004-2014 in the rate
Slide 6: The NGAL Test addresses a massive global market of $5bn+
Intact business case: The NGAL Test™ addresses a massive global market of $5bn+ Trauma, Cancer treatment etc. (New indications) Exclusion of AKI in the ED +100M Test ~$2B (Label expansion) Monitoring of AKI (Label expansion) Pediatric Patients 5-10M Tests ~$100-200M (Retrospective trial initiated Q4
Slide 7: Highlights of 2018: Challenging FDA approval process
Highlights of 2018 Challenging FDA approval process BioPorto’s challenges with FDA no different from other IVD companies’ challenges with FDA “In vitro diagnostics (IVD) companies today are facing a number of challenges related to FDA regulation of their products and tests. And many of these chall
Slide 8: Highlights of 2018: Highly positive business perspectives
Highlights of 2018 Highly positive business perspectives for BioPorto Adding to the business case: Significant potential with limited competition Strong support from key opinion leaders in the U.S. Leading medical experts in kidney disease Prominent hospitals Powerful patient organizations
Slide 9: BioPorto has reached far on an extremely low burn rate
BioPorto has reached far on an extremely low burn rate According to LifeScienceVC.com, capital injected in IVD startup companies was between $100 and $600 million $600M Range of investments in IVD startup companies: $100M - $600M Astute Medical Inc. (BioMerieux) Investment: $209M $100M BioPorto A/S
Slide 10: Conclusions
Conclusions BioPorto has – with a fraction of the budget of other companies developing new diagnostic biomarkers – brought NGAL to the doorstep of an FDA approval 2018 has been another busy year demanding hard work from the tiny organization As chairman, I extend my gratitude to everybody on t
Slide 11: Annual General Meeting by CEO Peter Mørch Eriksen
BIOPORTO A/S ANNUAL GENERAL MEETING MARCH 18, 2019 BY CEO PETER MØRCH ERIKSEN 11
Slide 12: Agenda
12 AGENDA Highlights from 2018 2018 financial result Business development of The NGAL Test™ 2019 milestones and financial guidance 12
Slide 13: Highlights of 2018
Highlights of 2018 Revenue from The NGAL Test™ up 43% - total revenue of DKK 26m Strong increase in revenue from The NGAL Test™ driven by solid RUO sales in U.S. (up by 80% YoY) Antibody and ELISA kits revenue down due to market conditions and lower bulk orders Two separate FDA applications
Slide 14: Agenda
14 AGENDA Highlights from 2018 2018 financial result Business development of The NGAL Test™ 2019 milestones and financial guidance 14
Slide 15: Modest growth after solid Q4 2018
Modest growth after solid Q4 2018 Revenue up 31% in Q4 2018 driven by strong performance of The NGAL Test™ For FY2018, revenue totaled DKK 26m – an increase of 3.4% over 2017 Guidance of DKK 30m – difference due to unfavorable market conditions and fewer bulk orders in antibodies and ELISA kit
Slide 16: Strong increase in NGAL sales offset by decrease in antibodies/ELISA kits
Strong increase in NGAL sales offset by decrease in antibodies/ELISA kits 43% Revenue by product category (DKKm) NGAL 2017 2018 12.2 9.2 9.4 DKK Increase in revenue from The NGAL Test™ from 2017 to 2018 6.4 4m & kits Antibodies 5.7 4.8 2.6 Decrease in revenues from 0.8 antibodies and ELISA kits from
Slide 17: Momentum in revenue from The NGAL Test driven by RUO sales in U.S.
Momentum in revenue from The NGAL Test™ driven by ROU sales in U.S. 80% Quarterly revenue from The NGAL Test™ (DKKm) U.S. sales +47% 2017 2018 +40% 3.3 2.8 Increase in RUO sales of The +139% NGAL Test™ in the U.S. from 2.2 2.3 2017 to 2018 18% 2.0 Rest of the World -30% 1.2 0.9 0.9 Increase in sales
Slide 18: Allocation of considerable resources to U.S. market awareness of NGAL
Allocation of considerably resources to U.S. market awareness of NGAL U.S. performance result of Building Awareness investment in past years to National build awareness of medical Kidney Foundatio need for NGAL as biomarker ns for safe and efficient Direct & diagnosis of AKI. Distributor Scientifi
Slide 19: Increased cash burn due to ramp-up of staff and slightly lower GM
Increased cash burn due to ramp-up of staff and slightly lower GM EBIT (DKKm) Cash flow and cash holdings (DKKm) Cash flow from operations and investments (net) Cash holdings (year-end) 47.1 46.7 35.6 -25.0 -20.1 -36.5 -29.5 -41.8 -39.7 2016 2017 2018 2016 2017 2018 EBIT effected by higher staff cos
Slide 20: Agenda
20 AGENDA Highlights from 2018 2018 financial result Business development of The NGAL Test™ 2019 milestones and financial guidance 20
Slide 21: AKI is a Major Public Health Concern
AKI is a Major Public Health Concern 230% Increase 2 Million Deaths $10 Billion Increase AKI in 10 Years1 Each Year2 in U.S. Hospital Costs3 in U.S. More In-hospital Higher Higher AKI Mortality Costs AKI is common, complex and lacking diagnostic tools to help quickly identify kidney injury Why? and
Slide 22: Strong KOL support for NGAL as mean to improve health care
Strong KOL support for NGAL as mean to improve health care Dr. Peter McCullough, Baylor “The incorporation of a structural biomarker indicating active kidney damage such as NGAL will greatly enhance our understanding of AKI/CKD and allow us to devise prevention and management strategies.” Dr. Jonath
Slide 23: The NGAL Test addresses a massive global market
The NGAL Test™ addresses a massive global market Trauma, Cancer treatment etc. (New indications) Exclusion of AKI in the ED +100M Test ~$2B (Label expansion) Monitoring of AKI (Label expansion) Pediatric Patients 5-10M Tests ~$100-200M (Retrospective trial initiated Q4 2018) Risk Prediction in ICU +
Slide 24: BioPorto submits two separate applications for The NGAL Test in 2019
BioPorto submits two separate applications for The NGAL Test™ in 2019 XXX Adult plasma Adults Children Indication Risk use with AKI Risk use with AKI Additional data with high Based on Plasma Urine prevalence to be collected in measurements 2019 to support existing in clinical trials Clinical stud
Slide 25: Clinical Applications of NGAL
Clinical Applications of NGAL Applications in Adult Populations & Settings Pediatric Indication “The limitation in AKI detection may be limiting 1 in 3 children is doctors’ abilities to get 1 in 5 adults is affected affected with AKI ahead of injury... with AKI during a hospital during a hospital ep
Slide 26: NGAL Intellectual Property rights further strengthened in 2018
NGAL Intellectual Property rights further strengthened in 2018 Patents protected until 2024-2028 BioPorto’s NGAL Patents In-licensed NGAL Patents Indication Granted Pending Indication Granted Pending EU, Canada, Australia, China, CCH Kidney NGAL Cutoff India, Japan, U.S. U.S. None Dysfunction Singap
Slide 27: Distribution agreement for NGAL with Roche signed in 2018
Distribution agreement for NGAL with Roche signed in 2018 BioPorto has secured critical distribution Top 10 IVD Companies 2017 Revenue Roche agreements with top IVD players to market and sell Diagnostic The NGAL Test s Siemens 23% 28% Roche: exclusive global distribution Abbott agreement for use of
Slide 28: Agenda
28 AGENDA Highlights from 2018 2018 financial result Business development of The NGAL Test™ 2019 milestones and financial guidance 28
Slide 29: Targeted 2019 milestones
Targeted 2019 milestones • Supplementary data to FDA to support initial FDA clearance in adults of The NGAL Test™ • Approval of The NGAL Test™ (plasma) in adults • Submission of urinary The NGAL Test™ for pediatric population • Approval of The NGAL Test™ in pediatrics Clinical and • Review new oppor
Slide 30: Considerable growth in NGAL sales in 2019 expected to boost revenues
DKK Considerably growth in NGAL sales in 2019 expected to boost revenues DKK 40m 6m Cost for FDA ns Revenue applicatio DKK Revenue expected to increase Expected total cost in 2019 for considerably from increased sales of filing two FDA applications for The The NGAL Test™ in U.S. and ROW NGAL Test™ 4
Slide 31: Agenda
Agenda 1. REPORT OF THE COMPANY’S ACTIVITIES DURING THE PAST YEAR 2. PRESENTATION OF THE ANNUAL REPORT FOR APPROVAL AND ALLOCATION OF PROFIT OR COVERING OF LOSS 3. RESOLUTION TO GRANT DISCHARGE OF LIABILITY TO THE BOARD OF DIRECTORS AND EXECUTIVE MANAGEMENT 4. APPROVAL OF REMUNERATION FOR THE BOARD
Slide 32: Agenda
Agenda 1. REPORT OF THE COMPANY’S ACTIVITIES DURING THE PAST YEAR 2. PRESENTATION OF THE ANNUAL REPORT FOR APPROVAL AND ALLOCATION OF PROFIT OR COVERING OF LOSS 3. RESOLUTION TO GRANT DISCHARGE OF LIABILITY TO THE BOARD OF DIRECTORS AND EXECUTIVE MANAGEMENT 4. APPROVAL OF REMUNERATION FOR THE BOARD
Slide 33: Approval of Remuneration for Directors
APPROVAL OF REMUNERATION FOR THE BOARD OF DIRECTORS The Board of Directors proposes that the remuneration for the Board of Directors for the financial year 2019 is determined as a base fee of DKK 250,000 for board members, DKK 350,000 for the Vice Chairman and DKK 500,000 for the Chairman of the Boa
Slide 34: Agenda
Agenda 1. REPORT OF THE COMPANY’S ACTIVITIES DURING THE PAST YEAR 2. PRESENTATION OF THE ANNUAL REPORT FOR APPROVAL AND ALLOCATION OF PROFIT OR COVERING OF LOSS 3. RESOLUTION TO GRANT DISCHARGE OF LIABILITY TO THE BOARD OF DIRECTORS AND EXECUTIVE MANAGEMENT 4. APPROVAL OF REMUNERATION FOR THE BOARD
Slide 35: Evaluation Process of Performance of Directors
EVALUATION PROCESS OF PERFORMANCE OF THE BOARD OF DIRECTIORS Process Annual structured process based on questionnaires and follow-up interviews with Chairman and individual members of the Board of Directors. Focus on cooperation with the executive management, contribution and results of the
Slide 36: Election of Members to Directors
ELECTION OF MEMBERS TO THE BOARD OF DIRECTORS The Board of Directors proposes re-election of the following board members: Thomas Magnussen Torben Arnth Nielsen Kirsten Aarup Drejer. The background of each candidate is included in the annual report for 2018. All candidates are considered to be
Slide 37: Agenda
Agenda 1. REPORT OF THE COMPANY’S ACTIVITIES DURING THE PAST YEAR 2. PRESENTATION OF THE ANNUAL REPORT FOR APPROVAL AND ALLOCATION OF PROFIT OR COVERING OF LOSS 3. RESOLUTION TO GRANT DISCHARGE OF LIABILITY TO THE BOARD OF DIRECTORS AND EXECUTIVE MANAGEMENT 4. APPROVAL OF REMUNERATION FOR THE BOARD
Slide 38: Proposals from Directors, item A)
PROPOSALS FROM THE BOARD OF DIRECTORS, item A) A) Proposal to amend Article 16 in the Articles of Association to renew the authorisation to increase the Company’s share capital The Board of Directors proposes that the authorisation in Article 16 to increase the Company’s share capital is extended, s
Slide 39: Proposals from Directors, item A)
PROPOSALS FROM THE BOARD OF DIRECTORS, item A) Article 16 will hereinafter have the following wording: “Article 16 Increase of the share capital Article 16a The Board of Directors is authorised until March 18, 2022, to increase the share capital of the Company on one or more occasions, with preempti
Slide 40: Proposals from Directors, item B)
PROPOSALS FROM THE BOARD OF DIRECTORS, item B) B) Proposal to amend Article 18 in the Articles of Association to renew the authorisation to issue warrants The Board of Directors proposes that the authorisation in Article 18 in the Articles of Association to issue warrants to the Executive Management
Slide 41: Proposals from Directors, item B)
PROPOSALS FROM THE BOARD OF DIRECTORS, item B) Article 18 will subsequently have the following wording: “Article 18 - Warrants Until March 18, 2020, the Board of Directors is authorised to issue warrants, on one or more occasions, entitling the holder(s) to subscribe for up to DKK 6,600,000 shares.
Slide 42: Proposals from Directors, item B) (con't)
PROPOSALS FROM THE BOARD OF DIRECTORS, item B) (con’t) Article 18 a In accordance with the authorisation previously approved by the general meeting, the Company’s Board of Directors has by decision of June 15, 2018, August 20, 2018, and December 20, 2018 issued warrants that permit subscription of a
Slide 43: Proposals from Directors, item C)
PROPOSALS FROM THE BOARD OF DIRECTORS, item C) C) Proposal to amend Article 11 in the Articles of Association to delete age limit The Board of Directors proposes that the age limit of 70 years for board members in Article 11 of the Articles of Association be deleted, as the Danish Recommendations on
Slide 44: Proposals from Directors, item D)
PROPOSALS FROM THE BOARD OF DIRECTORS, item D) D) Proposal for approval of the Company’s amended Remuneration Policy and Guidelines for Incentive Pay The Board of Directors proposes that the general meeting approves the Company's revised Remuneration Policy and Guidelines for Incentive Pay in order
Slide 45: Agenda
Agenda 1. REPORT OF THE COMPANY’S ACTIVITIES DURING THE PAST YEAR 2. PRESENTATION OF THE ANNUAL REPORT FOR APPROVAL AND ALLOCATION OF PROFIT OR COVERING OF LOSS 3. RESOLUTION TO GRANT DISCHARGE OF LIABILITY TO THE BOARD OF DIRECTORS AND EXECUTIVE MANAGEMENT 4. APPROVAL OF REMUNERATION FOR THE BOARD
Slide 46: Election of Auditor
ELECTION OF AUDITOR The Board of Directors proposes re-election of PricewaterhouseCoopers Statsautoriseret Revisionspartnerselskab, company registration number 33771231, as the Company’s auditor. The proposal is based on the recommendation from the Audit Committee. The Audit Committee’s proposal has
Slide 47: Agenda
Agenda 1. REPORT OF THE COMPANY’S ACTIVITIES DURING THE PAST YEAR 2. PRESENTATION OF THE ANNUAL REPORT FOR APPROVAL AND ALLOCATION OF PROFIT OR COVERING OF LOSS 3. RESOLUTION TO GRANT DISCHARGE OF LIABILITY TO THE BOARD OF DIRECTORS AND EXECUTIVE MANAGEMENT 4. APPROVAL OF REMUNERATION FOR THE BOARD