bioporto a/s · 2019-02-22 · intensive care setting for pediatrics - urine - predict stage 2...
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BIOPORTO A/SANNUAL REPORT 2018
FEBRUARY 22, 2019
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Forward-Looking Statements
This presentation contains forward-looking statements. Words such as “believe”, “expect”, “may”, “plan”, “strategy”,“estimate”, “target” and similar expressions identify such forward-looking statements. Statements other than historical factsincluded in this presentation concerning our plans, objectives, goals, future events and performance are forward-lookingstatements. They involve risks, uncertainties and other factors, which may cause actual results, performance and achievementsto differ materially from the results discussed in the forward-looking statements. We undertake no obligation to publicly updateor revise forward-looking statements to reflect subsequent events or circumstances after the date of this presentation.
This presentation is for information purposes only and does not constitute an offer to sell or a solicitation of any offer to buy anysecurities issued by BioPorto A/S (the “Company”) in any jurisdiction. The information contained herein is not for distribution inthe United States of America. This document does not constitute, or form part of, an offer to sell, or a solicitation of an offer topurchase, any securities in the United States. The Company’s securities have not been and will not be registered under the U.S.Securities Act of 1933, as amended (the “Securities Act”) and may not be offered or sold within the United States absentregistration or pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the SecuritiesAct. There is no intention to offer or solicit an offer to buy any securities in the Company in the United States or to make a publicoffering of the securities in the United States. Company securities may be sold only to qualified institutional buyers (as defined inRule 144A under the Securities Act) in reliance on Rule 144A.
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AGENDA
3
Highlights from 2018
2018 financial result
Business development of
The NGAL Test™
2019 milestones and
financial guidance
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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 for The NGAL Test™ in process
Application for adult plasma-based test with expected regulatory clearance in 2H 2019 and application for urine-based test in children will be submitted in 1H 2019
Paving the road for U.S. post-clearance market entry of The NGAL Test™ in focus
Build-up in U.S. of awareness and knowledge continues with strong focus
High interest to use NGAL as biomarker in drug development and in new indications
Strong increase in sales of The NGAL Test™ will drive revenue to DKK 40m in 2019 (+50% YoY growth)
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AGENDA
5
Highlights from 2018
2018 financial result
Business development of
The NGAL Test™
2019 milestones and
financial guidance
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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 kits
Revenue (DKKm, LTM)
Q2Q1 Q3
7.1
Q4
5.76.6
4.6
6.05.4
6.8
8.92017 2018
Quarterly revenue (DKKm)
2120 20
21
23
2525
2425
26
16
18
20
22
24
26
28
Q4
2016
Q3
2017
Q1
2016
Q2
2018
Q2
2016
Q3
2016
Q1
2017
Q2
2017
Q4
2017
Q1
2018
24
Q3
2018
Q4
2018
21
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Strong increase in NGAL sales offset by decrease in antibodies/ELISA kits
Revenue by product category (DKKm)
9.2
The NGAL
Test™
Other products
and licenses
ELISA kits
6.4
Antibodies
5.7
4.8
12.2
9.4
0.8
2.6
20182017
NG
AL
43%Increase in revenue from The NGAL
Test™ from 2017 to 2018
An
tib
od
ies
& k
its
DKK 4mDecrease in revenues from antibodies
and ELISA kits from 2017 to 2018
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Momentum in revenue from The NGAL Test™ driven by ROU sales in U.S.
Quarterly revenue from The NGAL Test™ (DKKm)
U.S
. sal
es
80%Increase in RUO sales of The NGAL
Test™ in the U.S. from 2017 to 2018
Re
st o
f th
e
Wo
rld
18%Increase in sales of The NGAL Test™ in
ROW from 2017 to 2018
2.3
Q1 Q2 Q3 Q4
1.2
0.9
2.22.0
2.8
0.9
3.3
-30%
+40%
+139%
+47%
2017 2018
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Allocation of considerably resources to U.S. market awareness of NGAL
U.S. performance result of investment in past years to build awareness of medical need for NGAL as biomarker for safe and efficient diagnosis of AKI.
U.S. focus has been on RUO clinics and engagement with KOL and stakeholders to build knowledge in patient and health care benefits.
Number of RUO clinics using the test up from approx. 15 in 2017 to 35 end-2018 – will provide solid basis to increase revenues post FDA clearance.
National Kidney
Foundations
Research Use Only at 25-40 U.S.
Sites
Distribution Partners
KDIGO Guidelines as early as 2020
Scientific Journals and
Papers
Building
Awareness
Direct &
Distributor Sales
Direct Target
Marketing &
Demand Creation
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Increased cash burn due to ramp-up of staff and slightly lower GM
EBIT effected by higher staff costs, fluctuating exchange rates and changes to product mix.
-36.5
-25.0
20182016 2017
-41.8
2016 20182017
35.6
-20.1
-39.7
-29.5
47.1 46.7
Cash flow from operations and investments (net)
Cash holdings (year-end)
EBIT (DKKm)
Solid cash position year-end after successful private placement with DKK 40m in proceeds in Nov. 2018.
Cash flow and cash holdings (DKKm)
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AGENDA
11
Highlights from 2018
2018 financial result
Business development of
The NGAL Test™
2019 milestones and
financial guidance
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AKI is a Major Public Health Concern
1) Increase from 2004-2014 in the rate of AKI hospitalizations among US adults without diabetes. Pavkov ME, Trends in Hospitalizations for Acute Kidney Injury. MMWR Morb Mortal Wkly Rep 2018;67:289–293.
2) Murugan R, Kellum JA. Acute kidney injury: what’s the prognosis? Nat Rev Nephrol. 2011;7:209–217.
3) Chertow G, Burdick E, Honour M, Bonventre J, Bates D. Acute Kidney Injury, Mortality, Length of Stay, and Costs in Hospitalized Patients. J Am Soc Nephrol 16: 3365–3370, 2005.
Higher
Mortality
$10 Billion Increase
in U.S. Hospital Costs3
2 Million Deaths
Each Year2
230% Increase
in 10 Years1
AKIin U.S.
More
In-hospital
AKIHigher
Costs
AKI is common, complex and lacking diagnostic tools to help quickly identify kidney injury
and aid clinicians in determining the best treatment to preserve kidney function.
Why?
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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. Jonathan Barash, Columbia
“The use of NGAL in patients with elevated serum creatinine levels provides valuable clinical information to identify patients more likely to have sustained AKI.”
Dr. Prasad Devarajan, Cincinnati Childrens
”At CCH we firmly believe that the implementation of NGAL as an early predictive biomarker of AKI severity after cardiopulmonary bypass surgery in our pediatric patients has significant clinical impact.”
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The NGAL Test™ addresses a massive global market
Trauma, Cancer treatment etc.(New indications)
Exclusion of AKI in the ED(Label expansion)
Monitoring of AKI(Label expansion)
Pediatric Patients 5-10M Tests ~$100-200M(Retrospective trial initiated Q4 2018)
Risk Prediction in ICU +150M Tests ~$3B(Under FDA Review)
Research Use Only +5M Tests ~$100M(Currently ~40 U.S. Hospitals)
Estimated Global Market Opportunity
1. During an average course of illness, 4-5 tests is assumed to be used to diagnose AKI
2. Source: CDC, AHA, Ciccla 2017 and Lameire NH, Bagga A, Cruz D, et al. Acute kidney injury: an increasing global concern.
Lancet 2013; 382: (9887) 170–9
+100M Test ~$2B
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BioPorto submits two separate applications for The NGAL Test™ in 2019
XXX
Adults Children
Indication Risk use with AKI Risk use with AKI
Based on measurements in
Plasma Urine
Clinical study Enrolment of up to 200 patients with AKI from 3-5 sites in the U.S.
Retrospective study based on existing US data
Key dates Expected clearance in 2H 2019
Application expected to by submitted in 1H 2019
Estimated costs in 2019 for study and application
DKK 3.5m DKK 2.5m
Ad
ult
pla
sma
Additional data with high prevalence to be collected in 2019 to support
existing clinical trials
Ch
ildre
n u
rin
e
Retrospective study for fast and cost efficient process – central testing and
validation will allow for fast roll-out to +200 pediatric U.S. hospitals and clinics
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Predict AKI Risk inIntensive Care Setting
- Plasma
- Predict Stage 2 & 3 AKI
Exclude AKI in Emergency
Department
- Plasma
- Rule out AKI to improve triage & care
Monitoring of AKI
- Plasma
- Use NGAL to evaluate efficacy of interventions
Predict AKI Risk inIntensive Care Setting
for Pediatrics
- Urine
- Predict Stage 2 & 3 AKI
Clinical Applications of NGAL
1 in 5 adults is affected with AKI during a hospital episode of
care1
1. Susantitaphong, P et al. World Incidence of AKI: A Meta-Analysis. Clin J Am Soc Nephrol. 2013 Sep;8(9):1482-93.
1 in 3 children is affected with AKI during a hospital episode of care1
Applications in Adult Populations & Settings Pediatric Indication
“The limitation in AKI
detection may be limiting
doctors’ abilities to get
ahead of injury...
NGAL is a real-time tool,
potentially allowing
us to be
proactive instead of
reactive.” - Rajit Basu, MD,
Dir. of Research, Critical Care Medicine
Associate Professor of Pediatrics,
Children’s Healthcare of Atlanta
FDA clearance
expected in 2H 2019
Will be initiated after
FDA clearance of
prediction
Will be initiated after
FDA clearance of
prediction
FDA application
expected to be
submitted in 1H
2019
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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
NGAL Cutoff
EU, Canada, Australia, S. Korea, China, India, Japan, Singapore, Hong Kong
U.S.CCH Kidney Dysfunction
U.S. None
NGAL Exclusion EU U.S.CCH Serum/Plasma
EU, Canada, Australia, Japan
U.S., EU
NGAL Forms EU U.S. CCH UrineEU, Australia, China, Japan, Mexico, New Zealand
EU, Brazil, Hong Kong
NGAL Trauma EU, U.S. U.S. CCH Chronic EU U.S.
NGAL Ratio EU, U.S. N/A CCH Blood EU None
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Distribution agreement for NGAL with Roche signed in 2018
BioPorto has secured critical distribution agreements with top IVD players to market and sell The NGAL Test
Roche: exclusive global distribution agreement for use of a customized NGAL Test on Cobas c501/c502 systems
Siemens: exclusive global distribution of the NGAL Test on Siemens’ BN platforms
Together, BioPortos partners account for an estimated 41% of total revenues of the Top 10 IVD players
1) Kalorama Information, The Worldwide Market for In Vitro Diagnostic Tests, 11th Edition. August 2018.
29%
12%
15%
13%
8%
23%
Top 10 IVD Companies2017 Revenue
RocheDiagnostics
Siemens
Abbott
Danaher
ThermoFisherScientificOthers, Top10
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AGENDA
19
Highlights from 2018
2018 financial result
Business development of
The NGAL Test™
2019 milestones and
financial guidance
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Targeted 2019 milestones
Clinical and
Regulatory
• 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
• Review new opportunities for NGAL and the antibody library to create pipeline of
potential new assays and biomarkers
Commercial
• Increase RUO sales and number of customers is U.S.
• Increase awareness of The NGAL Test™ and the NGAL technology
• Strengthen U.S. organization by onboarding U.S. commercial leadership and hire core team
of medical liaisons
• Prepare with partners for U.S. launch of The NGAL Test™
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Considerably growth in NGAL sales in 2019 will boost revenues
Co
st f
or
FDA
ap
plic
atio
ns
DKK 6mExpected total cost in 2019 for filing two
FDA applications for The NGAL Test™
Un
de
rlyi
ng
assu
mp
tio
ns
Guidance for 2019 is based on assumptions of FDA clearance of The
NGAL Test™ to adults and children in 2019 and minor decrease in revenue from
antibodies (compared to 2018)
Rev
en
ue
DKK 40mRevenue to increase considerably from increased
sales of The NGAL Test™ in U.S. and ROW
EBIT
loss
DKK 45mOperating loss at level of 2018 as U.S.
organization will be expanded
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FINANCIAL CALENDAR 2019
BIOPORTO A/S MARCH 18 ANNUAL GENERAL MEETING
MAY 9 Q1 2019 FINANCIAL RESULTS
AUGUST 15 Q2 2019 FINANCIAL RESULTS
NOVEMBER 7 Q3 2019 FINANCIAL RESULTS