bioporto a/s · 2019-02-22 · intensive care setting for pediatrics - urine - predict stage 2...

22
1 BIOPORTO A/S ANNUAL REPORT 2018 FEBRUARY 22, 2019

Upload: others

Post on 31-Jul-2020

3 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: BIOPORTO A/S · 2019-02-22 · Intensive 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

1

BIOPORTO A/SANNUAL REPORT 2018

FEBRUARY 22, 2019

Page 2: BIOPORTO A/S · 2019-02-22 · Intensive 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

2

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.

Page 3: BIOPORTO A/S · 2019-02-22 · Intensive 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

3

AGENDA

3

Highlights from 2018

2018 financial result

Business development of

The NGAL Test™

2019 milestones and

financial guidance

Page 4: BIOPORTO A/S · 2019-02-22 · Intensive 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

4

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)

Page 5: BIOPORTO A/S · 2019-02-22 · Intensive 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

5

AGENDA

5

Highlights from 2018

2018 financial result

Business development of

The NGAL Test™

2019 milestones and

financial guidance

Page 6: BIOPORTO A/S · 2019-02-22 · Intensive 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

6

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

Page 7: BIOPORTO A/S · 2019-02-22 · Intensive 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

7

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

Page 8: BIOPORTO A/S · 2019-02-22 · Intensive 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

8

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

Page 9: BIOPORTO A/S · 2019-02-22 · Intensive 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

9

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

Page 10: BIOPORTO A/S · 2019-02-22 · Intensive 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

10

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)

Page 11: BIOPORTO A/S · 2019-02-22 · Intensive 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

11

AGENDA

11

Highlights from 2018

2018 financial result

Business development of

The NGAL Test™

2019 milestones and

financial guidance

Page 12: BIOPORTO A/S · 2019-02-22 · Intensive 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

12

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?

Page 13: BIOPORTO A/S · 2019-02-22 · Intensive 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

13

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.”

Page 14: BIOPORTO A/S · 2019-02-22 · Intensive 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

14

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

Page 15: BIOPORTO A/S · 2019-02-22 · Intensive 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

15

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

Page 16: BIOPORTO A/S · 2019-02-22 · Intensive 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

16

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

Page 17: BIOPORTO A/S · 2019-02-22 · Intensive 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

17

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

Page 18: BIOPORTO A/S · 2019-02-22 · Intensive 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

18

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

Page 19: BIOPORTO A/S · 2019-02-22 · Intensive 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

19

AGENDA

19

Highlights from 2018

2018 financial result

Business development of

The NGAL Test™

2019 milestones and

financial guidance

Page 20: BIOPORTO A/S · 2019-02-22 · Intensive 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

20

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™

Page 21: BIOPORTO A/S · 2019-02-22 · Intensive 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

21

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

Page 22: BIOPORTO A/S · 2019-02-22 · Intensive 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

22

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