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”A good diagnosis is half the cure”

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Presentation on theme: "”A good diagnosis is half the cure”"— Presentation transcript:

1 ”A good diagnosis is half the cure”
Interim report - First nine months of 2017 November 7, 2017

2 Forward looking statements
This presentation contains forward-looking statements. Words such as “believe”, “expect”, “may”, “plan”, “strategy”, “estimate”, “target” and “plan” and similar expressions identify such forward-looking statements. Statements other than historical facts included in this presentation concerning our plans, objectives, goals, future events and performance are forward looking statements. They involve risks, uncertainties and other factors, which may cause actual results, performance and achievements to differ materially from the results discussed in the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date of this presentation.

3 Highlights 1-9M 2017 (Q3) Progress on FDA process Future focus and 2017 milestones

4 Highlights for first nine months of 2017 (Q3)
Very strong revenue growth continues Revenue of DKK 18.3m in first nine months of 2017, equal 27% growth (Q3: 30%) Strong sales momentum in NGAL (9M: +84%) and antibodies (9M: +33%) EBIT of DKK -28.3m, against DKK -20.3m last year High activity related to FDA process and US organization Continued strong news flow New AKI article published in Canada FDA process on track More than 60% of patients enrolled by end-October 2017 New share issue strengthens liquidity in preparation for US commercial roll-out Cash position of September 30, 2017 of DKK 13.3m In October 2017, a direct share issue with net proceeds of DKK 41.0m was conducted

5 Strong sales momentum sustained in Q3 2017
BioPorto continued to expand sales in Q3 2017, mainly within The NGAL Test™ and antibodies Revenue in Q of DKK 6.0m, corresponding to growth of 30% and in 9M 2017 of DKK 18.3m, corresponding to growth of 27% Quarterly revenue (DKKm) Revenue (DKKm, LTM) 2016 2017 23 6.6 6.3 5.7 6.0 5.2 4.7 21 4.6 18 Q1 Q2 Q3 Q4 Q1 2015Q1 2015 Q2 2015Q2 2015 Q3 2015Q3 2015 Q4 2015Q4 2015 Q1 2016Q1 2016 Q2 2016Q2 2016 Q3 2016Q3 2016 Q4 2016Q4 2016 Q1 2017Q1 2017 Q2 2017Q2 2017 Q3 2017Q3 2017

6 US sales increase of +388% YoY of The NGAL Test™ and bulk-orders of antibodies drives growth
Revenue by product (DKKm), first nine months 2017 +31% 2016 2017 9.4 7.2 +84% -2% 4.2 4.2 4.1 2.3 -19% 0.8 0.6 The NGAL Test™ ELISA kits Antibodies Other products and licensesOther products and licenses

7 US is driving growth in sales of The NGAL Test™ backed by solid performance in ROW
Sales to Research Use Only (RUO) continues to be the most important growth-driver for The NGAL Test™ - has increase sales by +388% YTD YoY Knowledge of solution is increasing among US clinics and physicians Local presence support educational efforts and academic position 16 US hospitals and clinics as regular users by end-September 2017 YTD sales of The NGAL Test™ outside US has increased an healthy 33%

8 New strategy delivers growth in antibodies
Antibody sales was up 58% in Q and 31% in the first nine months of 2017 – result of impact strategy focused at assay developers and large quantity orders Sales of ELISA kits on par YTD but down 27% in Q3 2017, as ELISA Human NGAL kits are experiencing a shift towards turbidimetry platforms

9 Strong support for NGAL and improved AKI treatment
: NGAL Demonstrates Positive Economic Outcomes: Greatly Reduces Costs Associated With Diagnosis and Treatment of Acute Kidney Injury. : Strong data from previous NGAL study provides the basis for new protocol and FDA registration application. : Impact of Near Real-Time NGAL assessment on Clinical Practice. : Health care resource use associated with AKI is needed to frame the investment and cost-effectiveness of strategies to prevent AKI and promote kidney recovery (Clinical Journal of the American Society of Nephrology)

10 High activity related to FDA process and US organization increase operating loss
EBIT of DKK -28.3m, against DKK -20.3m last year Capacity cost was DKK 41.6m YTD against DKK 30.9m last year due to US clinical studies and higher operational costs in US subsidiary Cash position end-September 2017 at DKK 13.3m Quarterly EBIT (DKKm) 2016 2017 -4.8 -5.4 -7.1 -7.7 -8.4 -9.2 -10.7 Q1 Q2 Q3 Q4

11 New share issue with net proceeds of DKK 41
New share issue with net proceeds of DKK 41.0m to prepare for commercial roll-out in US In October 2017 a direct share issue of 13,015,625 new shares was conducted (9.13% of outstanding share capital prior to increase) at an offering price of 3.20 with gross proceeds of DKK 41.7m Net proceeds will be allocated to Support existing uptrend shown in current sales Addition of extra resources in US and ROW Launch activities in connection with expected FDA-approval Bring BioPorto’s processes and procedures up to FDA requirement level Build stronger instrument platform to support business growth Strengthen BioPorto’s overall liquidity

12 Highlights 1-9M 2017 (Q3) Progress on FDA process Future focus and 2017 milestones

13 Majority of patients enrolled in US clinical study for The NGAL Test™
17 clinical sites participating in clinical trials First patients recruited in April 2017 By mid-August 25% had been enrolled By end-October +60% are recruited Enrollment expected to be finalized by late-2017 or early-2018 Application expected to be submitted to FDA in Q1 2018

14 Process for FDA approval of The NGAL TestTM
Nov. 2016 Jan. 2017 Q2 2017 Financing Finalize design of protocol after feedback from FDA Clinical trials to commence Questions from FDA Submission of application Clinical studies finalized Q2 2018 Q1 2018 End-2017 Answers to FDA Approval expected Q2 2018 Mid-2018

15 Highlights 1-9M 2017 (Q3) Progress on FDA process Future focus and 2017 milestones

16 On track for FY2017 guidance - focus on sustaining strategic momentum and sales in 2017
2018 and on Primary targets Completion of protocol for FDA study in Q1 Initiate enrolment of patients for clinical trials for The NGAL Test™ in Q2 Increase number of users of NGAL in Europe and Asia Increase number or RUO of NGAL in US Launch new NGAL and innate immune defense products Submit FDA registration of The NGAL Test™ in Q2 Registration approval mid-2018 Increase number of distribution agreements for NGAL Secondary targets Increase sales of ELISA kits Expand portfolio of antibodies New license and OEM agreements Continued expansion of antibody and ELISA portfolio Growth 20-35% Maintain high growth rates

17 Sales and EBIT guidance maintained for 2017
Turnover expected in DKK 26-28m range Growth of 25-35% primarily driven by higher sales of The NGAL Test™ (RUO in US, Siemens and own sales in Europe/Asia) Healthy growth of antibodies and ELISA kits EBIT loss of DKK 28-35m

18 Financial calendar: Annual report: March 8 2018
Q&A Financial calendar: Annual report: March


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