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BioPorto Interim / Quarterly Report 2016
3424_rns_2016-11-03_481bffaa-b9de-4d04-9f13-54ad21895249.pdf
Interim / Quarterly Report
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Interim Report
First 9 months of 2016, BioPorto Group
November 3, 2016
Announcement no. 19
BIOPORTO®
BioPorto A/S CVR DK-17500317
Highlights
Pre-Sub application for The NGAL Test™ to the FDA marks official start of new process
After four months of preparation, BioPorto submitted the pre-submission to obtain FDA feedback on the proposed clinical trial protocol and the application for regulatory approval of The NGAL Test™ for clinical use (IVD) in the USA in the beginning of October 2016. BioPorto has been in close dialogue with the FDA to discuss and fully understand the issues with the first application and remains confident that these issues are addressed in the new pre-submission. In this process, BioPorto has involved world-leading specialists and consultants. Given the timeframe of a pre-submission with the FDA and allowing for any changes to the protocol, enrollment of patients is expected to commence in second quarter of 2017. BioPorto maintains the expectation that an approval can be obtained by mid-2018.
Workload associated with FDA process in USA leads to temporary slow down in revenue growth for all segments other than The NGAL Test™
The uptake of the NGAL Test™ in South Korea (clinical use) and in USA (research use only) are progressing as planned and by the end of 2016, around 15 RUO users in the USA are expected to have the test running. Following a strong first quarter performance, sales have been stagnant in the other segments compared to 2015, as resources have been allocated to the pre-submission application for The NGAL Test™.
The collaboration with Siemens is progressing according to plan, however, the launch will take place in 2017 due to ongoing shelf life testing. Also, a significant OEM order has been postponed to 2017. As both sales and EBIT has fallen short of expectations, management has initiated a restructuring activity, which has led to a head count reduction in the Danish organization of 20% and will reduce cost by DKK 4 million when fully implemented.
NGAL Forms patent upheld and progress in NGAL Cutoff patent application
In the third quarter, The European Patent Office (EPO) confirmed that they had not received an appeal from the opponent regarding BioPorto's NGAL Forms patent. This means that the patent remains valid. BioPorto has appealed EPO's decision on the Exclusion patent, which was ruled invalid earlier this year. The NGAL Cutoff patent application has been amended according to the response from the EPO and BioPorto expects an approval to issue the patent within months.
Options on future financing being evaluated
BioPorto has initiated a process of evaluating options for raising additional capital for financing the company's increased activities related to the FDA process. The Board's intention is to implement a directed share issue before year-end.
Revenue and profit/loss
In the third quarter 2016, BioPorto's revenue totaled DKK 4.6 million against DKK 4.7 million in the third quarter of 2015. Revenue in the first nine months of 2016 was DKK 14.4 million against DKK 14.6 in the same period in 2015, corresponding to a 1% decline. Revenues have not developed as projected except for The NGAL Test™ as management and resources were reallocated to focus on the FDA process.
Revenue from the NGAL product portfolio in the first nine months of 2016 was DKK 4.7 million against DKK 4.5 million in 2015. Of this, revenues of The NGAL Test™ amounted to DKK 2.3 million compared to DKK 1.9 million the year before. Sales of MBL kits, antibodies and other products and licenses have declined moderately from DKK 10.1 in the period January to September 2015 to DKK 9.8 in the same period 2016.
This brought BioPorto's operating result before interest and tax (EBIT) to DKK -20.3 million in the first nine months of 2016 compared to DKK -10.6 million in the previous year. Capacity costs in the first nine months of 2016 amount to DKK 30.9 million compared to DKK 21.5 million last year. Costs are higher predominantly due to the establishment of the US subsidiary, costs related to the FDA resubmission process, and the hiring of a COO and CFO. Furthermore, in the first nine months of 2016, EBIT was also impacted by non-liquidity affecting costs of DKK 1.6 million in expensing of a warrant program to management and key employees.
Guidance for 2016
As a consequence of the turnover and restructuring costs, BioPorto's expectations for turnover in 2016 is adjusted to DKK 21.5 million corresponding to a growth of 5% (previously DKK 23-25). Correspondingly, expectations for EBIT for the full year 2016 is adjusted to a loss of DKK 23.5 million and profit after tax at DKK -21.5 million (previously a loss of DKK 19-21 and loss after tax of DKK 17-19 respectively).
Peter M. Eriksen, CEO comments:
"I am very pleased that our new application process for The NGAL Test™ with the FDA is proceeding according to plan with the ground work laid in Q3 2016 resulting in a new Pre-Sub in the beginning of October 2016. We are receiving very strong support for The NGAL Test™ from leading kidney specialists in the USA who recognize the urgent need for the test. We are confident that once FDA approval is achieved, we will experience a rapid uptake of sales in the USA. Having said that, our daily business has been impacted by this workload and we are not performing as planned. Accordingly, we have decided to implement some changes and reorganize, especially within our sales department, to ensure that our costs are in line with our revenues. With our new COO in front, we are working on initiatives that should get sales back on track for next year and continue to trend positively over the future years."
Investor meeting
In connection with the release of the interim report, BioPorto hosts an investor meeting on November 3, 2016 at 3 pm. Note that this meeting is held at Danske Bank, Åboulevarden 69, 8000 Aarhus C. Please sign up at [email protected].
Interim Report BioPorto, first 9 months of 2016
Financial highlights
| | 2016
3rd quarter
DKK thou-sand | 2015
3rd quarter
DKK thou-sand | 2016
9 months
DKK thou-sand | 2015
9 months
DKK thou-sand | 2015
12 months
DKK thou-sand |
| --- | --- | --- | --- | --- | --- |
| Revenue | 4,606 | 4,684 | 14,442 | 14,617 | 20,383 |
| Operating profit/loss (EBIT) | (7,126) | (2,108) | (20,284) | (10,573) | (12,759) |
| Net financials | (36) | (159) | (139) | (217) | (255) |
| Operating profit/loss before tax | (7,162) | (2,267) | (20,423) | (10,790) | (13,014) |
| Profit/loss for the period | (6,662) | (1,710) | (18,825) | (8,877) | (10,732) |
| Comprehensive income | (6,667) | (1,710) | (18,782) | (8,877) | (10,732) |
| Non-current assets | 1,785 | 1,476 | 1,785 | 1,476 | 1,676 |
| Current assets | 30,632 | 53,727 | 30,632 | 53,727 | 47,317 |
| Total assets | 32,417 | 55,203 | 32,417 | 55,203 | 48,993 |
| Share capital | 129,599 | 129,599 | 129,599 | 129,599 | 129,599 |
| Equity | 27,153 | 46,353 | 27,153 | 46,353 | 44,485 |
| Non-current liabilities | 46 | 70 | 46 | 70 | 64 |
| Current liabilities | 5,218 | 8,780 | 5,218 | 8,780 | 4,444 |
| Total equity and liabilities | 32,417 | 55,203 | 32,417 | 55,203 | 48,993 |
| Cash flows from operating activities | (5,059) | (3,360) | (15,344) | (10,594) | (16,574) |
| Cash flows from investing activities, net | 0 | 0 | (516) | (230) | (517) |
| Of which investment in property, plant and equipment | 0 | 0 | (157) | (50) | (50) |
| Cash flows from financing activities | (6) | 26,538 | (16) | 26,529 | 26,511 |
| Total cash flows | (5,065) | 23,178 | (15,876) | 15,705 | 9,420 |
| Revenue growth | -2% | 2% | -1% | 6% | 9% |
| Gross margin | 70% | 79% | 74% | 75% | 76% |
| EBIT margin | -155% | -45% | -140% | -72% | -63% |
| Equity ratio (solvency) | 84% | 84% | 84% | 84% | 91% |
| Return on equity | Negativ | Negativ | Negativ | Negativ | Negativ |
| Average number of employees | 27 | 22 | 27 | 23 | 22 |
| Average number of shares (1,000) | 129,599 | 121,261 | 129,599 | 119,003 | 121,652 |
| Earnings per share (EPS), DKK | (0.05) | (0.01) | (0.15) | (0.07) | (0.09) |
| Net asset value per share, year-end, DKK | 0.21 | 0.38 | 0.21 | 0.36 | 0.34 |
| Share price, period-end, DKK | 1.92 | 2.66 | 1.92 | 2.66 | 4.82 |
Interim Report BioPorto, first 9 months of 2016
Management review
Pre-Sub application for The NGAL Test™ to the FDA marks official start of new process
FDA approval is of significant importance to the commercialization of BioPorto's The NGAL Test™ for clinical routine use in the US. When FDA rejected the company's application for approval of The NGAL Test™ earlier this year as the submitted clinical data did not adequately support the claims, especially for mild cases of acute kidney injury, BioPorto immediately initiated a process to clarify the conditions under which a new application could be submitted.
In the third quarter, BioPorto initiated work on the protocol for a pre-submission to the FDA as the basis for a discussion prior to the initiation of clinical studies and preparation of the final application. In this process, BioPorto has involved world-leading specialists and consultants including Precision for Medicine and top-tier lawyers Hyman, Phelps & McNamara, P.C., www.hpm.com. In parallel, BioPorto has worked on identifying sites for the clinical trials. To manage the process, Elisabeth Erhardtsen was hired as VP Clinical and Regulatory Affairs. She has extensive experience with international regulatory affairs and the FDA in particular from Novo Nordisk, Baxter and Bayer.
In the beginning of October, BioPorto submitted the pre-submission to obtain FDA feedback on the proposed clinical trial protocol and the application for regulatory approval of The NGAL Test™ for clinical use in the USA. Given the timeframe of a pre-submission with the FDA and allowing for any changes to the protocol, enrollment of patients is expected to commence in second quarter of 2017. BioPorto maintains the expectation that an approval could be obtained by mid-2018.
The new application process is expected to generate additional costs of up to DKK 3 million in 2016, while the costs for the entire process has not yet been finally determined.
Preparations for RUO sales in the US
Over the last two quarters, the US organization has readjusted its efforts from preparing the market for an FDA approved clinical diagnostics tool to targeting hospitals and institutions with The NGAL Test™ as a Research Use Only (RUO) tool. Alongside this readjustment, the US staff has been involved in the new FDA application process. Traction has been obtained specifically in pediatrics and several major hospitals are currently reviewing The NGAL Test™ with plans to implement the test in the coming months. A symposium on NGAL hosted by Cincinnati's Children's Hospital and attended by leading clinicians as well as BioPorto in September 2016 has been instrumental in facilitating current sales efforts.
Siemens collaboration progresses as planned, however, launch is postponed to 2017 due to shelf life testing
Under the distribution agreement entered with Siemens this year, ongoing efforts to adapt BioPorto's NGAL test to Siemens' BN systems is progressing according to plan. Currently ongoing shelf-life testing of the product should allow for the first delivery early 2017, whereas launch was previously expected late 2016.
Sales in existing markets does not meet expectations
Over the last two quarters, turnover has been stagnant in most areas, except for The NGAL Test™, compared to 2015. The uptake of the NGAL Test™ in South Korea (clinical use) and in USA (research use only) are progressing as planned and by the end of 2016, around 15 RUO users in the USA are expected to have the test running. Within research markets, new antibodies have been launched in the third quarter and are beginning to bring in revenue, although overall antibody sales are not satisfactory. Also, a significant OEM order has been postponed to 2017. BioPorto continues to develop and expand its portfolio of antibodies, as this serves as an incubator for new significant biomarkers to support research and assay development sales. The MBL kit for detection of immune deficiencies continues to show a slight yet stable growth.
Slow down in turnover leads to restructuring and reduced cost base for 2017
Both turnover and EBIT are below expectations, and management has therefore initiated a restructuring of BioPortos organization. The restructuring has lead to a head count reduction in the Danish Organization of 20% which will reduce annual staff cost with DKK 4 million when fully implemented.
New COO appointed
Jan Kuhlmann Andersen, Ph.D., M.Sc. Biology/Immunology, joined BioPorto in the third quarter 2016 as Chief Operation Officer (COO). Jan's focus is currently on getting sales back on track and ensuring an alignment of efforts between the DK and US organizations.
As a consequence, he retired from the Board of Directors of BioPorto for which he was elected in 2015. The Board of Directors now consists of Thomas Magnussen (chairman), Torben A. Nielsen (Vice Chairman) and Niels Christian Nielsen.
Options on future financing being evaluated
BioPorto has initiated a process of evaluating options for raising additional capital for financing the company's increased activities related to the FDA process. The Board's intention is to implement a directed share issue before year-end.
Status on issued patents and progress in Cutoff patent application
In the third quarter, The European Patent Office (EPO) confirmed that no appeal had been received from the opponent regarding BioPorto's NGAL Forms patent, which was upheld as valid in opposition proceedings earlier this year. This means that the patent remains valid and that oppositions within EPO system are no longer possible. In other opposition proceedings, EPO ruled that BioPorto's NGAL Exclusion patent was invalid. This decision has been appealed by BioPorto. Finally, the NGAL Cutoff patent application has been amended according to the response from EPO and BioPorto expects an approval for issue of the patent within months. The company estimates that its entire portfolio of patents and patent applications provides a sufficient coverage of the NGAL area.
Interim Report BioPorto, first 9 months of 2016
Financial review
Revenue
In the third quarter, BioPorto's revenue totaled DKK 4.6 million against DKK 4.7 million in the third quarter of 2015. Revenue in the first nine months of 2016 was DKK 14.4 million against DKK 14.6 in the same period in 2015. Revenue has not developed as expected, as turnover has been stagnant in most areas.
Revenue from the NGAL product portfolio in the first nine months of 2016 was DKK 4.7 million against DKK 4.5 million in 2015. Of this, revenues of The NGAL Test™ amounted to DKK 2.3 million compared to DKK 1.9 million the year before. Sales of MBL kits, antibodies and other products and licenses have declined from DKK 10.1 million in the period January to September 2015 to DKK 9.8 million in the same period 2016. The decline is primarily due to a change in the financial recognition for a research collaboration on antibodies, so that the income in 2016 is recognized on an ongoing basis, while in 2015 it was recognized as one payment. The change means that revenue in the first nine months of 2016 is DKK 0.3 million lower compared to the same period of 2015.
Figure 1. Revenue by quarter (DKKm)
Figure 2. Revenue, Last Twelve Months (DKKm)
Operating costs and operating results
In the first nine months of 2016, production costs totaled DKK 3.8 million, which translates into a gross profit of DKK 10.6 million and a gross margin of 74%. This is a marginal decline compared to the same period in 2015, in which gross margin was 75%.
Capacity costs in the first nine months of 2016 amount to DKK 30.9 million compared to DKK 21.5 million last year. Costs are higher predominantly as the result of the establishment of the US subsidiary, costs related to the FDA application process, and the hiring of a COO and CFO as of January 1, 2016. Furthermore, in the first nine months of 2016, EBIT was also impacted by non-liquidity affecting costs of DKK 1.6 million in connection with the expensing of a warrant program to management and key employees.
This brought BioPorto's operating loss before interest and tax (EBIT) to DKK -20.3 million in the first nine months of 2016 compared to DKK -10.6 million the previous year.
Profit/loss before and after tax
Net financials in the first nine months of 2016 were an expense of DKK 0.1 million. The expenses are predominantly currency adjustments. Pre-tax loss for the first nine months of 2016 is thus DKK 20.4 million compared to a loss of DKK 10.8 million in the first nine months of 2015.
After income recognition of tax of DKK 1.6 million in the period, the net profit for the period amounts to a loss of DKK 18.8 million compared to a loss of DKK 8.9 million last year.
Balance sheet
At the end of September 2016, BioPorto's balance sheet totaled DKK 32.4 million. Long-term assets totaled DKK 1.8 million, which is an increase of DKK 0.1 million compared to December 31, 2015. The increase is due to investment in new lab equipment and the continued development of a new US-based antibody webshop.
Inventories and receivables amounted to DKK 11.6 million at the end of September 2016, which is DKK 0.8 million less than the amount at December 31, 2015. The cash position was DKK 19.0 million at September 30, 2016.
At the end of September 2016, equity amounted to DKK 27.2 million compared to DKK 44.5 million at the beginning of the year. Liabilities at September 30, 2016 totaled DKK 5.3 million and consisting primarily of trade payables and other debt.
Cash flow statement
Cash flows generated by operating activity were DKK - 15.3 million in the first nine months of 2016 (first nine months 2015: DKK -10.6 million). Investments in the period amounted to DKK 0.5 million (2015: DKK 0.2 million) and cash flows generated by financing activities were DKK 0.0 million (2015: DKK +26.5 million). The cash flows for the period thus ended up at DKK -15.9 million compared to DKK +15.7 million in first nine months of 2015.
Interim Report BioPorto, first 9 months of 2016
Interim Report BioPorto, first 9 months of 2016
Significant events after the end of the period
No significant events have occurred that are not described in this interim report.
Accounting policies
The interim report is presented in accordance with the accounting policies applied in the Group's annual report for 2015 and the following additions:
Foreign currency translation
Income statements of subsidiaries with a functional currency other than the Group's presentation currency are translated into the Group presentation currency at the year's weighted average exchange rate, and the balance sheets are translated at the exchange rate at the balance sheet date.
Exchange differences on translation of foreign subsidiaries' equity at the beginning of the year and exchange rate differences, arising from foreign subsidiaries' income statements are translated at average exchange rates, are shown as other comprehensive income and currency translation adjustments in equity.
Focus on reapplication and sales
The management priorities for the remaining part of 2016 comprise:
- Preparation of the clinical trial protocol for The NGAL Test™ after receiving feedback on the pre-submission from the FDA
- Sales of The NGAL Test™ for research use in the US
- Evaluation of financing options
- Restructuring and implementation of new initiatives especially in sales
Guidance for 2016
As a consequence of the turnover and restructuring costs, BioPorto's expectations for turnover in 2016 is adjusted to DKK 21.5 million corresponding to a growth of 5% (previously DKK 23-25). Correspondingly, expectations for EBIT for the full year 2016 is adjusted to a loss of DKK 23.5 million and profit after tax at DKK -21.5 million (previously a loss of DKK 19-21 and loss after tax of DKK 17-19 respectively).
Forward-looking statements
This interim report contains forward-looking statements, including forecasts of future revenue and net profit/loss. Such statements are subject to risks and uncertainties, as various factors, many of which are beyond BioPorto's control, may cause actual results and performance to differ materially from the forecasts made in this interim report
For further information, please contact:
Peter Mørch Eriksen, CEO
Christina Thomsen, Investor Relations Manager
Tel: +45 4529 0000
E-mail: [email protected]
About BioPorto
BioPorto Diagnostics A/S is an in-vitro diagnostics company that provides healthcare professionals in clinical and research settings with a range of diagnostic tests and antibodies. Our pioneering product portfolio includes assays for underdiagnosed diseases, including our NGAL tests for acute kidney injury. BioPorto is headquartered in Copenhagen, Denmark and is listed on the Nasdaq Copenhagen stock exchange.
Statement by the management
The Board of Directors and the Management Board today considered and approved the interim report of the BioPorto Group for the period January 1, 2016 – September 30, 2016.
The interim report, which is unaudited and has not been reviewed by the company's auditors, is presented in accordance with IAS 34 "Interim financial reporting" as adopted by the EU and additional Danish disclosure requirements for interim reports of listed companies.
In our opinion, the interim report gives a true and fair view of the Group's assets, liabilities and financial position at September 30, 2016 and of the results of the Group's operations and cash flows for the period January 1, 2016 – September 30, 2016.
Furthermore, in our opinion the management's report includes a fair review of the development and performance of the business, the results for the period and the Group's financial position in general and describes the principal risks and uncertainties that it faces.
Hellerup, November 3, 2016
Management board:
Peter Mørch Eriksen
CEO
Board of Directors:
Thomas Magnussen
Chairman
Torben A. Nielsen
Vice chairman
Niels Christian Nielsen
Interim Report BioPorto, first 9 months of 2016
Statement of comprehensive income (condensed)
Income statement
| 3rd quarter DKK thousand | 3rd quarter DKK thousand | 9 months DKK thousand | 9 months DKK thousand | 12 months DKK thousand | |
|---|---|---|---|---|---|
| Revenue | 4,606 | 4,684 | 14,442 | 14,617 | 20,383 |
| Gross profit/loss | 3,203 | 3,713 | 10,639 | 10,947 | 15,481 |
| Profit/loss before financial items (EBIT) | (7,126) | (2,108) | (20,284) | (10,573) | (12,759) |
| Profit/loss before tax | (7,162) | (2,267) | (20,423) | (10,790) | (13,014) |
| Profit/loss for the period | (6,662) | (1,710) | (18,825) | (8,877) | (10,732) |
| DKK | DKK | DKK | DKK | DKK | |
| Profit/loss / comprehensive income per share (EPS & DEPS) | (0.05) | (0.01) | (0.15) | (0.07) | (0.09) |
Statement of comprehensive income
| | 2016
3rd quarter DKK thousand | 2015
3rd quarter DKK thousand | 2016
9 months DKK thousand | 2015
9 months DKK thousand | 2015
12 months DKK thousand |
| --- | --- | --- | --- | --- | --- |
| Profit/loss for the period | (6,662) | (1,710) | (18,825) | (8,877) | (10,732) |
| Exchange rate adjustment: foreign subsidiaries | (5) | 0 | 43 | 0 | 0 |
| Comprehensive income | (6,667) | (1,710) | (18,782) | (8,877) | (10,732) |
Interim Report BioPorto, first 9 months of 2016
Balance
| ASSETS | 2016
30 September
DKK thousand | 2015
30 September
DKK thousand | 2015
31 December
DKK thousand |
| --- | --- | --- | --- |
| Non-current assets | | | |
| Property, plant and equipment and intangible assets | | | |
| Fixtures and fittings, tools and equipment | 453 | 499 | 451 |
| Rights and software | 622 | 313 | 559 |
| Total financial assets | 710 | 664 | 666 |
| Total non-current assets | 1,785 | 1,476 | 1,676 |
| Current assets | | | |
| Total inventories and receivables | 11,641 | 12,575 | 12,450 |
| Cash | 18,991 | 41,152 | 34,867 |
| Total current assets | 30,632 | 53,727 | 47,317 |
| TOTAL ASSETS | 32,417 | 55,203 | 48,993 |
Interim Report BioPorto, first 9 months of 2016
Balance
| LIABILITIES | 2016 | 2015 | 2015 |
|---|---|---|---|
| 30 September DKK thousand | 30 September DKK thousand | 31 December DKK thousand | |
| Equity | |||
| Share capital | 129,599 | 129,599 | 129,599 |
| Share-based payments | 1,934 | 648 | 568 |
| Treasury shares | 0 | 0 | 0 |
| Retained earnings | (104,380) | (83,894) | (85,682) |
| Total equity | 27,153 | 46,353 | 44,485 |
| Liabilities | |||
| Non-current liabilities | |||
| Lease obligation | 46 | 70 | 64 |
| Non-current liabilities | 46 | 70 | 64 |
| Current liabilities | |||
| Current portion of non-current liabilities | 24 | 21 | 22 |
| Trade payables | 1,103 | 2,017 | 1,227 |
| Other payables | 4,091 | 6,742 | 3,195 |
| Current liabilities | 5,218 | 8,780 | 4,444 |
| Total liabilities | 5,264 | 8,850 | 4,508 |
| TOTAL LIABILITIES | 32,417 | 55,203 | 48,993 |
Interim Report BioPorto, first 9 months of 2016
Statement of changes in equity
| | Share capital
DKK thou-sand | Treasury shares
DKK thou-sand | Share premium
DKK thou-sand | Share-based payments
DKK thou-sand | Retained earnings
DKK thou-sand | Total
DKK thou-sand |
| --- | --- | --- | --- | --- | --- | --- |
| Equity | | | | | | |
| 1 January 2016 | 129,599 | 0 | 0 | 568 | (85,682) | 44,485 |
| Comprehensive income | 0 | 0 | 0 | 1,565 | (18,782) | (17,217) |
| Transferred to Retained earnings | 0 | 0 | 0 | (199) | 199 | 0 |
| Other changes in equity | 0 | 0 | 0 | 0 | (115) | (115) |
| Equity at 30
September 2016 | 129,599 | 0 | 0 | 1,934 | (104,380) | 27,153 |
| | Share capital
DKK thou-sand | Treasury shares
DKK thou-sand | Share premium
DKK thou-sand | Share-based payments
DKK thou-sand | Retained earnings
DKK thou-sand | Total
DKK thou-sand |
| Equity | | | | | | |
| 1 January 2015 | 117,874 | 0 | 0 | 648 | (89,836) | 28,686 |
| Profit/loss for the year/
comprehensive income | 0 | 0 | 0 | 0 | (8,877) | (8,877) |
| Share emission | 11,725 | 0 | 16,415 | 0 | 0 | 28,140 |
| Emission costs | 0 | 0 | (1,596) | 0 | 0 | (1,596) |
| Transferred to "retained income" | 0 | 0 | (14,819) | 0 | 14,819 | 0 |
| Equity at 30
September 2015 | 129,599 | 0 | 0 | 648 | (83,894) | 46,353 |
Interim Report BioPorto, first 9 months of 2016
11
Cash flow statement
| | 2016
9 months
DKK thou-sand | 2015
9 months
DKK thou-sand | 2015
12 months
DKK thou-sand |
| --- | --- | --- | --- |
| Profit/loss before financial items | (20,284) | (10,573) | (12,759) |
| Amortisation, depreciation and impairment losses | 292 | 212 | 300 |
| Warrants | 1,565 | 0 | 0 |
| Cash generated from operations before working capital | (18,427) | (10,361) | (12,459) |
| Changes in working capital | 3,179 | (16) | (6,012) |
| Cash generated from operations | (15,248) | (10,377) | (18,471) |
| Financial income, received | 120 | 254 | 308 |
| Financial expenses, paid | (216) | (471) | (564) |
| Tax refund | 0 | 0 | 2,153 |
| Cash flows from operating activities | (15,344) | (10,594) | (16,574) |
| Purchase of operating equipment | (157) | (50) | (50) |
| Purchase of rights and software | (200) | (180) | (464) |
| Purchase of financial assets | (159) | 0 | (21) |
| Sale of operating equipment | 0 | 0 | 18 |
| Cash flows from investing activities | (516) | (230) | (517) |
| Capital increases | 0 | 26,544 | 26,531 |
| Reduction of lease obligation | (16) | (15) | (20) |
| Cash flows from financing activities | (16) | 26,529 | 26,511 |
| Net cash flow from operating, investing and financing activities | (15,876) | 15,705 | 9,420 |
| Cash and cash equivalents at 1 January | 34,867 | 25,447 | 25,447 |
| Cash and cash equivalents 30 September (31 December) | 18,991 | 41,152 | 34,867 |
Interim Report BioPorto, first 9 months of 2016
Segments
| GEOGRAPHIC DISTRIBUTION: | 2016
3rd quarter
DKK thou-sand | 2015
3rd quarter
DKK thou-sand | 2016
9 months
DKK thou-sand | 2015
9 months
DKK thou-sand | 2015
12 months
DKK thou-sand |
| --- | --- | --- | --- | --- | --- |
| Denmark | 386 | 55 | 1,254 | 1,504 | 1,783 |
| Rest of Europe | 1,982 | 1,383 | 5,821 | 5,063 | 7,195 |
| North America | 1,718 | 1,859 | 5,445 | 5,583 | 7,634 |
| Asia | 465 | 554 | 1,640 | 1,268 | 2,448 |
| Other countries | 55 | 833 | 282 | 1,199 | 1,323 |
| Revenue | 4,606 | 4,684 | 14,442 | 14,617 | 20,383 |
| PRODUCT GROUPS | 2016
3rd quarter
DKK thou-sand | 2015
3rd quarter
DKK thou-sand | 2016
9 months
DKK thou-sand | 2015
9 months
DKK thou-sand | 2015
12 months
DKK thou-sand |
| --- | --- | --- | --- | --- | --- |
| The NGAL test | 454 | 605 | 2,280 | 1,907 | 3,747 |
| ELISA Human NGAL kits | 557 | 962 | 1,378 | 1,951 | 2,554 |
| ELISA Animal NGAL kits | 426 | 175 | 1,012 | 672 | 920 |
| ELISA MBL kits | 784 | 777 | 1,791 | 1,871 | 2,530 |
| Antibodies* | 1,983 | 1,880 | 7,034 | 7,393 | 9,489 |
| Other products and licenses | 403 | 285 | 947 | 823 | 1,143 |
| Revenue | 4,606 | 4,684 | 14,442 | 14,617 | 20,383 |
- In the first 9 months of 2016, public innovation assistance of DKK 850 thousand relating to the development and production of a new antibody is included as revenue (9 months 2015: DKK 1075 thousand and 2015 (12 months): DKK 1,075 DKK thousand).
Interim Report BioPorto, first 9 months of 2016