Interim / Quarterly Report • Sep 10, 2015
Interim / Quarterly Report
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| 1 | Message from the CEO | 4 | ||
|---|---|---|---|---|
| 2 | Responsibility statement | 5 | ||
| 3 | Principal risks related to the business activity | 5 | ||
| 4 | Business review of the first half of 2015 | 6 | ||
| 5 | Condensed consolidated interim financial statements for the period ended 30 June | |||
| 201511 | ||||
| 5.1 | Condensed Consolidated balance sheet11 | |||
| 5.2 | Condensed Consolidated income statement 12 |
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| 5.3 | Condensed Consolidated statement of other comprehensive income13 | |||
| 5.4 | Condensed Consolidated statement of changes in equity14 | |||
| 5.5 | Consolidated cash flow statement15 | |||
| 6 | Notes to the condensed consolidated interim financial statements 16 |
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| 6.1 | General Information16 | |||
| 6.2 | Summary of significant accounting policies16 | |||
| 6.2.1 | Statement of compliance and basis of preparation 16 | |||
| 6.2.2 6.3 |
Segment reporting17 Critical accounting judgments and key sources of estimation uncertainty 17 |
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| 6.4 | Revenue18 | |||
| 6.4.1 | Collaboration revenue 18 | |||
| 6.4.2 | Product sales revenue18 | |||
| 6.4.3 | Revenues by region and major customers19 | |||
| 6.5 | Other operating income19 | |||
| 6.6 | Cost of Goods Sold19 | |||
| 6.7 | Research and development expenses20 | |||
| 6.8 | Marketing and Distribution expenses20 | |||
| 6.9 | General and administrative expenses 21 |
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| 6.10 | Personnel expenses21 | |||
| 6.11 | Taxes | 21 | ||
| 6.12 | Discontinued operations22 | |||
| 6.13 | Earnings per share22 | |||
| 6.14 | Property, plant and equipment 23 |
| 6.15 Financial participation 23 |
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| 6.16 Trade and other receivables23 |
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| 6.17 Other current assets24 |
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| 6.18 Equity 25 |
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| 6.19 Share based compensation26 |
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| 6.20 Deferred income 27 |
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| 6.21 Other disclosures 28 |
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| 6.21.1 Fair value28 |
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| 6.21.2 Contingencies 30 |
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| 6.21.3 Commitments30 |
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| 6.21.3.1 Capital commitments 30 |
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| 6.21.4 Related-party transactions 30 |
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| 6.22 Events after the balance sheet date31 |
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| 7 | Limited review report of the auditor 32 |
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| 8 | Disclaimer and additional information 34 |
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| 9 | Glossary 36 |
Dear Stakeholder,
We are very pleased with the progress we made during the first six months of the year, both operationally and financially.
Thanks to the efforts of all employees at Biocartis in the first half of 2015, we managed to successfully expand our installed base, resulting in 32 new Idylla™ instruments sold to various larger and smaller hospitals and distributors in and outside Europe in H1 2015, bringing our total installed base to 114 and thereby increasingly enabling more patients to benefit from the unique features our products offers.
I am especially proud of our IPO that was the largest Life Sciences transaction of 2015 on the European markets, ranking amongst the 10 largest IPOs the last 10 years on Euronext.
On the one hand this IPO has been another milestone in realizing the vision of Biocartis, to transform the global diagnostics market by providing instant access to personalized medicine for all patients worldwide. However, it is also the start of a new era as a publicly listed company. We are committed to demonstrate that we can execute upon the promises that we have made to all participating investors.
Our company is moving to a next stage of growth. This is why we have decided to strengthen our management team with, amongst others, the appointments of Hilde and Ewoud. Hilde plays a crucial leadership role within Biocartis and the new title of Deputy CEO better fits the significant contribution she continues to make in the day-to-day running of the company. We are delighted to welcome Ewoud to Biocartis. With a strong background in corporate finance, his extensive knowledge of capital markets will be of great value to the company as we continue our strong growth trajectory. As announced, we have also strengthened our management team through a number of other appointments. I wish everybody all the best in their new roles.
Finally, I would like to mention that I am pleased that we can reiterate our guidance of selling 75 instruments in 2015. This in my view, once more underlines the potential of our Idylla™ platform.
Rudi Pauwels CEO
Biocartis Group NV – condensed consolidated interim financial statements period ended 30 June 2015
The undersigned hereby declare that, to the best of their knowledge, the condensed consolidated interim financial statements for the six-months period ended 30 June 2015, which have been prepared in accordance with the IAS 34 'Interim Financial Reporting' as adopted by the European Union, give a true and fair view of the equity, the financial situation and the results of Biocartis Group NV and the companies that are included in the consolidation scope.
The undersigned also declare that, to the best of their knowledge, the interim financial report provides a true and fair review of the important events that have occurred during the first six months of the financial year and of the other legally required information.
In the name and for the account of the Board of Directors,
Rudi Pauwels Hilde Windels
CEO CFO
The principal risks related to Biocartis' business activities have been outlined in the April 2015 IPO Prospectus ('IPO Prospectus'), which is available on the internet at https://investors.biocartis.com. The principal risks have not materially changed from the ones outlined in the IPO Prospectus.
1.2 Menu highlights
During H1 2015, Biocartis sold a total of 32 IdyllaTM commercial instruments to its customers, boding well for realizing the guided 75 IdyllaTM instrument sales in 2015.
The IdyllaTM installed base amounted to 114 instruments in different continents worldwide per 30 June 2015.
During the reporting period, Biocartis continued to move forward in establishing a strong global sales and distribution network that now covers more than 50 countries through direct and indirect sales channels.
A total of nine new distribution contracts were signed in H1 2015 with renowned distributors, covering 12 additional countries in Europe, Middle East and Asia Pacific. These new distribution contracts include minimum purchase obligations for over 100 IdyllaTM instruments in the coming 3 years period.
Biocartis also continued to strengthen its direct sales force in H1 2015 by attracting key talent from the industry and which is now covering 16 European countries.
At the end of the reporting period, Biocartis' sales and marketing organization, including amongst others customer service and business development, amounted to 24 FTEs.
During the first half of 2015, Biocartis has been strongly focused on expanding use of its current test menu and bringing to market new tests for IdyllaTM, its fully automated sample-to-result, real-time system that offers accurate, highly reliable molecular information from virtually any biological sample in virtually any setting. In line with this, Biocartis has expanded it R&D team in H1 2015 to a total of 96 FTEs.
Biocartis is focused on addressing key unmet clinical needs in oncology and infectious diseases, which represent respectively the fastest growing and largest segments of the molecular diagnostic market worldwide.
During H1 2015, Biocartis continued to accelerate the commercialisation of its IdyllaTM BRAF Mutation Test with, amongst others, the support from key opinion leaders. Post the period end, on 27 July 2015, Dr. Filip Janku, MD from MD Anderson (Houston, United States) published a research study on the analytical sensitivity and specificity of the IdyllaTM BRAF Mutation Test. This research study showed that the IdyllaTM BRAF Mutation Test is rapid and has high concordance with other routinely used
but more complex BRAF mutation–detecting tests1 .
In June 2015, Biocartis received CE-IVD marking for its KRAS Mutation Test, the world's first fully automated CE-IVD KRAS test for routine use to match novel guidelines that is capable of detecting an extended panel of 21 KRAS mutations with high sensitivity. It detects all clinically relevant driver mutations of the KRAS oncogene in tissue of colorectal cancers and provides results in an unprecedented timeframe of approximately two hours. The IdyllaTM KRAS Test is the second test launched by Biocartis and is a cornerstone in a set of highly standardized and sensitive tests around metastatic colorectal cancer.
Further progress is being made with extended NRAS panels currently in development for which CE-IVD marking is now expected in H1 2016. The NRAS test detects 19 mutations in the NRAS gene. When used in combination, the IdyllaTM KRAS and NRAS tests enable testing an extended set of 40 clinically actionable RAS mutations. Next to the NRAS panel, Biocartis has progressed development of its NRAS/BRAF test (detecting BRAF codon 600 mutations in addition to the 19 NRAS mutations) as well as its NRAS/BRAF/EGFR492 (which also detects the EGFR S492R mutation) along the same timelines.
Significant progress was also made in the field of liquid biopsies. In June 2015, Biocartis presented positive results of a research study in collaboration with Prof. Bart Neyns from the University Hospital Brussels at the American Society for Clinical Oncology, demonstrating that BRAF mutant tumour DNA levels circulating in blood of metastatic melanoma patients were associated with disease progression.
In H1 2015, Biocartis successfully finalized a study on microsatellite instability (MSI), demonstrating the possibility of fully automated Polymerase Chain Reaction (PCR) detection of these mutational signatures found in colorectal cancers. Testing for MSI mutations is currently under-utilized, as these markers are currently only detectable with complex workflows using capillary electrophoresis. The ability to detect this important class of biomarkers in a user friendly manner is expected to boost adoption of MSI testing.
Post the period end, on 17 July 2015, Biocartis signed a partnership agreement with ETPL (Exploit Technologies Pte. Ltd.), the commercialisation arm of the Agency for Science, Technology and Research (A*STAR, based in Singapore). A*STAR is Singapore's lead public sector agency that spearheads economic oriented research to advance scientific discovery and develop innovative technologies. Under the partnership, Biocartis has access to novel biomarkers (including those discovered within A*STAR's research institutes) from the Diagnostics Development Hub under ETPL. The aim of the partnership is to jointly develop of a range of proprietary tests for the Idylla™ platform with a main focus on cancer biomarkers.
Biocartis has continued to make strong progress with its Rapid Ebola Virus Triage Test that it is developing in association with Janssen Diagnostics and the Institute for Tropical Medicine in Antwerp (Belgium) for its Idylla™ system. The formal Emergency Use Authorization' (EUA) submission process to the FDA for the Idylla™ platform and Rapid Ebola Virus Triage Test has been
1 The IdyllaTM System and IdyllaTM BRAF Test are currently not available in the USA.
initiated and is expected to be completed in the beginning of Q4 2015.
Biocartis also made strong progress with its first respiratory panel test, known as IFV-RSV. This test, which is being developed in collaboration with Janssen Diagnostics, is aimed at the detection of influenza A, influenza B, RSV (respiratory syncytial virus) A and RSV B in nasopharyngeal swabs from patients with influenza-like illness. CE-IVD marking of the IFV-RSV test is expected at the end of Q4 2015.
In March 2015, Biocartis signed a worldwide license and collaboration agreement with Microbiome, a spin-off of the VU University Medical Center Amsterdam (the Netherlands), aimed at developing a test for the rapid detection of bloodstream infections, such as sepsis. This test is aimed to be used in conjunction with Biocartis' Idylla™-Enrich platform, a dedicated preenrichment platform for bloodstream infections that is under development by Biocartis.
In addition, in May 2015 a strategic partnership was signed with Fast-track diagnostics (Luxembourg) aimed at the development of a broad range of Idylla™ infectious disease tests based on the new approach of 'syndromic multiplex testing', meaning the identification of a broader range of disease pathogens in a single test.
On 28 April 2015, Biocartis raised gross proceeds of EUR 115m in a 6.5x oversubscribed successful Initial Public Offering (IPO) on Euronext Brussels, underpinning the strong belief of institutional and retail investors in the potential of Biocartis. The IPO attracted a wide interest from a mix of long-term, specialist investors across continental Europe, the UK and the US. Total IPO costs amounted to EUR 9.2m.
In H1 2015, Biocartis generated total operating income of EUR 7.2m compared to EUR 2.5m in H1 2014. Total product sales revenues amounted to EUR 1.7m of which EUR 1.3m is generated by IdyllaTM system sales and EUR 0.4m by cartridge revenues. Upfront license and milestone revenues amounted to EUR 4.6m. Grant income amounted to EUR 0.6m and is mainly related to grants for R&D projects received from the Institute for the promotion of Innovation by Science and Technology in Flanders (IWT). After the reporting date, in July 2015, Biocartis was awarded a new IWT R&D grant for the development of novel molecular diagnostic solutions for bloodstream infections on the IdyllaTM platform for a total amount of EUR 1.5m.
As a result of the series F round financing (second tranche of EUR 21.5m was received in January 2015) and the IPO, Biocartis is able to report a solid cash position that amounts to EUR 128.5m per 30 June 2015.
During the first six months of 2015 total operating income increased to EUR 7.2m compared to EUR 2.5m in H1 2014. Revenues increased to EUR 6.6m as compared to EUR 1.1m in H1 2014. This EUR 5.5m increase is driven by increased collaboration revenues received under the license and development agreements with Janssen Pharmaceutica for an amount of EUR 4.6m and by an increase in product sales of EUR 0.9m. Other operating income decreased from EUR 1.4m to EUR 0.6m and mainly consists of R&D project support grants received from the IWT.
Operating expenses have increased with EUR 6.0m to EUR 24.0m in H1 2015 compared to EUR 18.1m in H1 2014. This increase in spending is first of all driven by an increase in research and development expenses for an amount of EUR 3.3m in view of the continued development and preparation for launch of new IdyllaTM tests and further IdyllaTM system developments. Secondly, this increase is driven by higher marketing and distribution expenses of EUR 2.1m as the result of an expanded sales and marketing team following the commercialization of the IdyllaTM platform since September 2014.
General and administrative expenses increased from EUR 3.1m in H1 2014 to EUR 3.6m in H1 2015 and include non-capitalized expenses related to the IPO in April 2015 of EUR 1.1m. The remaining IPO costs of EUR 8.1m are allocated to equity. Biocartis' operational result consequently decreased from EUR -15.6m in H1 2014 to EUR -16.8m in H1 2015.
Biocartis' net financial result improved to a loss of EUR 0.4m in H1 2015 compared to EUR 0.5m in H1 2014. Taking into account positive income taxes for a net amount of EUR 0.3m in H1 2015 (EUR 0.4m in H1 2014) originating from R&D tax credits, the net loss for H1 2015 after taxes from continuing operations amounts to EUR 16.9m (EUR 15.7m in H1 2014).
Property, plant and equipment decreased with EUR 0.3m to EUR 8.9m per 30 June 2015 from EUR 9.2m per 31 December 2014 driven by CAPEX in H1 2015 of EUR 1.6m and depreciations of EUR 1.9m. Per 30 June 2015, a financial participating of EUR 5.1m was included on the balance sheet as the result of the acquisition of a participation in MyCartis NV on 15 January 2015 following the exercise by Debiopharm Diagnostics SA of a put option in December 2014. Biocartis currently holds an 11.2% participation in MyCartis NV.
Inventory has increased from EUR 3.6m per 31 December 2014 to EUR 6.4m per 30 June 2015, caused by higher inventory levels in view of the further commercialization of the IdyllaTM platform. Trade receivables have decreased significantly with EUR 12.7m to EUR 3.1m per 30 June 2015 because of the collection of receivables from Janssen Pharmaceutica. Trade payables decreased from EUR 4.3m per 31 December 2014 to EUR 3.9m per 30 June 2015. Deferred income has decreased to EUR 7.0m per 30 June 2015 from EUR 9.6m per 31 December 2014 because of the recognition of upfront payments from Janssen Pharmaceutica in relation to the strategic licensing, development and commercialization collaborations.
Driven by the second tranche of the series F round financing and the IPO, the cash position of the Group increased with EUR 117.6m from EUR 10.9m per 31 December 2014 to EUR 128.5m per 30 June 2015.
| The cash flow from operating activities | |||||
|---|---|---|---|---|---|
| significantly | improved | in | H1 | 2015 | to |
EUR -8.7m compared to EUR -16.8m in H1 2014, as did the cash flow from investing activities, which amounted to EUR -1.7m in H1 2015 compared to EUR -2.0m in H1 2014. The cash flow from financing activities in H1 2015 amounted to EUR 128.0m, mainly thanks to the cash inflow from the IPO (EUR 107.0m) and the capital increase of the second tranche of the series F round (EUR 21.5m). The Group's net cash flow in H1 2015 amounted to EUR 117.6m.
| As of | |||||
|---|---|---|---|---|---|
| In €000 | Notes | 30 June 2015 | 31 Dec 2014 | ||
| Assets | |||||
| Non-current assets | |||||
| Intangible assets | 9,218 | 9,652 | |||
| Property plant and equipment | 6.14 | 8,880 | 9,154 | ||
| Financial participation | 6.15 | 5,052 | - | ||
| Other long term receivables | 11 | 117 | |||
| Deferred tax assets | 6.11 | 1,474 | 947 | ||
| 24,635 | 19,870 | ||||
| Current assets | |||||
| Inventory | 6,415 | 3,583 | |||
| Trade receivables | 6.16 | 3,105 | 15,793 | ||
| Other receivables | 6.16 | 1,484 | 148 | ||
| Other current assets | 6.17 | 1,997 | 2,700 | ||
| Cash and cash equivalents | 128,477 | 10,919 | |||
| 141,478 | 33,142 | ||||
| Total assets | 166,113 | 53,012 | |||
| Equity and liabilities | |||||
| Capital and reserves | |||||
| Legal share capital | 6.18 | 405 | 222,268 | ||
| Historical share capital adjustment | 6.18 | -221,232 | -221,232 | ||
| Share premium | 6.18 | 522,067 | 166,592 | ||
| Share based payment reserve | 6.19 | 1,211 | 1,166 | ||
| Accumulated deficit | 6.18 | -165,428 | -148,513 | ||
| Total equity attributable to owners of | |||||
| the Company | 137,022 | 20,280 | |||
| Non-current liabilities | |||||
| Financial debt | 8,347 | 8,528 | |||
| Deferred income | 6.20 | 2,021 | 4,534 | ||
| Accrued charges | 2,486 | 1,955 | |||
| 12,855 | 15,017 | ||||
| Current liabilities | |||||
| Financial debt | 5,016 | 5,057 | |||
| Trade payables | 3,866 | 4,265 | |||
| Deferred income | 6.20 | 5,025 | 5,100 | ||
| Other current liabilities | 2,329 | 3,293 | |||
| 16,236 | 17,714 | ||||
| Total equity and liabilities | 166,113 | 53,012 |
| For the 6 months ended | |||
|---|---|---|---|
| In €000 | Notes | 30 June 2015 | 30 June 2014 |
| Revenue | |||
| Collaboration revenue | 6.4 | 4,866 | 283 |
| Product sales revenue | 6.4 | 1,663 | 829 |
| Service revenue | 6.4 | 48 | 12 |
| 6,578 | 1,124 | ||
| Other operating income | |||
| Grants and other income | 6.5 | 646 | 1,379 |
| Total operating income | 7,224 | 2,503 | |
| Operating expenses | |||
| Cost of goods sold | 6.6 | -1,158 | -1,000 |
| Research and development expenses | 6.7 | -16,092 | -12,768 |
| Marketing and distribution expenses | 6.8 | -3,219 | -1,158 |
| General and administrative expenses | 6.9 | -3,578 | -3,139 |
| -24,047 | -18,066 | ||
| Operating loss for the period | |||
| -16,823 | -15,563 | ||
| Financial income | 31 | 35 | |
| Financial expense | -440 | -495 | |
| Foreign exchange gains/(losses), net | -20 | -52 | |
| Financial result, net | -429 | -512 | |
| Loss for the year before taxes from | |||
| continuing operations | -17,252 | -16,075 | |
| Income taxes | 6.11 | 337 | 421 |
| Loss for the year after taxes from | |||
| continuing operations | -16,915 | -15,654 | |
| Gain (loss) for the year after taxes from | 6.12 | - | -4,092 |
| discontinued operations | |||
| Loss for the year | -16,915 | -19,746 | |
| attributable to owners of the Company | -16,915 | -19,746 | |
| attributable to non-controlling interest | |||
| Earnings per share | |||
| basic and diluted loss per share from | |||
| continuing and discontinued operations | 6.13 | -0.50 | -0.80 |
| basic and diluted loss per share from | |||
| continuing operations | -0.50 | -0.63 |
| As of | |||
|---|---|---|---|
| In €000 | Notes | 30 June 2015 | 30 June 2014 |
| Loss for the year | -16,915 | -19,746 | |
| Other comprehensive income (loss), not to be reclassified to profit or loss Other comprehensive gain (loss) for the year, that may be reclassified to profit and loss |
- - |
- - |
|
| Total comprehensive loss for the year | -16,915 | -19,746 | |
| Attributable to owners of the Company Attributable to non-controlling interest |
-16,915 - |
-19,746 - |
| Attributable to owners of the Company | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| in $\epsilon$ 000 | Notes | Legal share capital |
Historical share capital adjustment |
Share premium |
Share based payment reserve |
Gains and losses on defined benefit plans |
Accumulated deficit |
Total equity attributable to the owners of the Company |
Non- controlling interest |
Total equity |
| Balance as at 31 December 2013 | 926 | 175,946 | 1,023 | $-309$ | $-145,631$ | 31,955 | 31,955 | |||
| Loss for the period Share-based payment expense |
6.19 | 87 | $-19,746$ | $-19.746$ 87 |
$-19,746$ 87 |
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| Balance as at 30 June 2014 | 926 | 175,946 | 1,110 | $-309$ | $-165,377$ | 12,296 | 12,296 | |||
| Balance as at 31 December 2014 | 222,268 | $-221.232$ | 166,592 | 1,166 | $-148,513$ | 20,280 | 20,280 | |||
| Loss for the period Share issue - tranche 2 of round F on 15 January 2015 |
$-16.915$ | $-16.915$ | $-16.915$ | |||||||
| 6.18 | 20,488 | 1,025 | 21,513 | 21,513 | ||||||
| Share issue - contribution in kind of the participation in Mycartis on 15 January 2015 Capital increase by incorporation of share premium on |
6.18 | 4.812 | 241 | 5,052 | 5.052 | |||||
| 15 January 2015 Capital decrease by conversion into share premium on |
6.18 | 8 | $-8$ | |||||||
| 13 April 2015 | 6.18 | $-247.271$ | 247,271 | |||||||
| Share issue - Initial Public Offering on 28 April 2015 Share issue - exercise of over-allotment warrant on 19 |
6.18 | 87 | 99,913 | 100,000 | 100,000 | |||||
| May 2015 | 6.18 | 13 | 14,987 | 15,000 | 15,000 | |||||
| Cost related to Initial Public Offering Share issue - exercise of stock options on 3 June 2015 |
6.18 | $-8.124$ | $-8.124$ | $-8.124$ | ||||||
| 6.18 | 171 | 171 | 171 | |||||||
| Share-based payment expense | 6.19 | 45 | 45 | 45 | ||||||
| Balance as at 30 June 2015 | 404 | $-221.232$ | 522,067 | 1,211 | $-165,428$ | 137,022 | 137,022 |
| As of | |||
|---|---|---|---|
| in €000 | Notes | 30 June 2015 | 30 June 2014 |
| operating activities | |||
| Loss for the period | -16,915 | -19,746 | |
| Adjustments for | |||
| Depreciation and amortization | 2,417 | 2,096 | |
| Depreciation and amortization included | 6.12 | - | 81 |
| in discontinued operations | |||
| Impairments Tax income in profit and loss |
6.11 | - -338 |
20 -421 |
| Financial result, net | 419 | 504 | |
| Net movement in retirement benefit | |||
| obligation | - | 56 | |
| Share based payment expense | 6.19 | 45 | 87 |
| Changes in working capital | |||
| Net movement in inventories | -2,832 | -1,574 | |
| Net movement in trade and other | 6.16 | 12,160 | 3,450 |
| receivables and other current assets Net movement in trade payables & |
|||
| other current liabilities | -1,021 | -931 | |
| Net movement in deferred income | 6.20 | -2,587 | -349 |
| Interests paid | -67 | -81 | |
| Cash flow from operating activities | -8,719 | -16,808 | |
| Investing activities | |||
| Interest received | 30 | 34 | |
| Purchases of property, plant & | 6.14 | -1,620 | -723 |
| equipment Purchases of intangible assets |
-89 | -492 | |
| Cash reclassified to assets held for sale | - | -855 | |
| Cash flow from investing activities | -1,679 | -2,036 | |
| Financing activities | |||
| Proceeds from issue of preference | |||
| shares F | 6.18 | 21,513 | - |
| Proceeds from the issue of common shares, net of transaction costs |
6.18 | 107,047 | - |
| Repayment of borrowings | -576 | -557 | |
| Bank charges | -7 | -9 | |
| Cash flow from financing activities | 127,977 | -566 | |
| Net increase in cash and cash equivalents |
117,579 | -19,410 | |
| Cash and cash equivalents at the | 10,919 | 29,047 | |
| beginning of the period | |||
| Effects of exchange rate changes on the balance of cash held in foreign |
-20 | -52 | |
| currencies | |||
| Cash and cash equivalents at the end of | |||
| the period | 128,477 | 9,585 |
Biocartis Group NV (the "Company"), a company incorporated in Belgium with corporate address Generaal De Wittelaan 11 B, 2800 Mechelen in Belgium and its subsidiaries (together, the "Group") have developed an innovative and proprietary molecular diagnostics ("MDx") platform that offers accurate, highly-reliable molecular information from any biological sample, enabling fast and effective diagnostics treatment selection and treatment progress monitoring. The Company is using its CE-IVD marked IdyllaTM platform to develop and market a broad set of high value clinical assays in the oncology and infectious diseases segments.
The Group's mission is to become a global, fully-integrated provider of novel molecular diagnostics solutions with industry-leading, high clinical value tests.
The Group has established subsidiaries in Mechelen (Belgium), Eindhoven (The Netherlands) and Lausanne (Switzerland).
The Group has so far been funded by a combination of private and public equity, upfront licensing fees and contract R&D income from collaborations, mainly from related parties. Several grants have been awarded to the Group to support its R&D activities.
The condensed consolidated interim financial statements have been authorized for issue on 10 September 2015 by the board of directors of the Company (the "Board of Directors").
The principal accounting policies for preparing these condensed consolidated interim financial statements are explained below.
These condensed consolidated interim financial statements for the six months ended 30 June 2015 have been prepared in accordance with IAS 34 'Interim financial reporting' as adopted by the EU. The statements should be read in conjunction with the annual financial statements for the year-ended 31 December 2014, which have been prepared in accordance with IFRS as adopted by the EU.
The accounting policies adapted in the preparation of the condensed consolidated interim financial statements are consistent with those applied in the special purpose preparation of the financial statements for the year ended 31 December 2014. New standards or interpretations applicable from 1 January 2015 have not had any impact on the condensed consolidated interim financial statements.
All amounts are presented in thousands of Euro, unless otherwise indicated, rounded to the nearest EUR '000.
These condensed consolidated interim financial statements have been subject to a limited review.
The following new standards and amendments to standards are mandatory for the first time for the financial year beginning 1 January 2015:
The segment information is represented in a consistent manner with the internal reporting to the executive management, enabling decision making of allocating resources to the segment and evaluating financial performances of the segment.
At this moment, all of the Group's activities relate to "Idylla™" and as such there is only 1 operating segment. The reporting to the key decision makers is currently done at the global level.
In addition, all non-current assets of the Group are located in the country of domicile per 30 June 2015.
In the application of the Company's accounting policies, which are described above, the Company is required to make judgments, estimates and assumptions about the carrying amounts of assets and liabilities that are not readily apparent from other sources. The estimates and associated assumptions are based on historical experience and other factors that are considered to be relevant. Actual results may differ from these estimates.
The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognised in the period in which the estimate is revised if the revision affects only that period or in the period of the revision and future periods if the revision affects both current and future periods.
The following areas are areas where key assumptions concerning the future, and other key sources of estimation uncertainty at the end of the reporting period, have a significant risk of causing a material adjustment to the carrying amounts of assets and liabilities within the next financial year:
Going concern: the interim results for the six months ended 30 June 2015 show a negative result, and the balance sheet includes a loss carried forward. The Board has examined the statements and accounting standards. Taking into account the solid cash position, and the fact that in April 2015 a successful IPO was completed, the Board is of the opinion that it can submit the interim financial statements on a going concern basis.
The Group's revenues are summarized in the table below:
| For the 6 months ended | |||
|---|---|---|---|
| In €000 | 30 June 2015 | 30 June 2014 | |
| Collaboration revenue | |||
| R&D services | 354 | - | |
| Upfront license revenues | 2,512 | 283 | |
| Milestone revenues | 2,000 | - | |
| 4,866 | 283 | ||
| Product sales revenue | |||
| System Sales | 1,246 | - | |
| Cartridge Sales | 416 | 829 | |
| 1,663 | 829 | ||
| Service revenue | |||
| Service revenue | 48 | 12 | |
| 48 | 12 | ||
| Total | 6,578 | 1,124 |
License fees and milestone payments were generated under the Group's collaboration and development agreements with JPNV, an entity linked to a shareholder of the Group. This agreement was initially signed on 20 December 2010 and subsequently amended on 9 October 2014. Under this agreement, the Group commits to further develop its IdyllaTM platform and parties agree upon a non-disclosed assay development collaboration. In return, the Group is entitled to non-refundable upfront payments, performance milestones and royalties on certain future assay sales.
The product sales relate to IdyllaTM system sales (instruments and consoles) and test sales (cartridges) to customers and collaboration partners. The total product sales can be categorized in commercial sales and research and development sales.
| For the 6 months ended | ||||
|---|---|---|---|---|
| 30 June 2015 | 30 June 2014 | |||
| Commercial | 1,272 | - | ||
| Research and development | 391 | 829 | ||
| Total | 1,663 | 829 |
| For the 6 months ended | |||
|---|---|---|---|
| In €000 | 30 June 2015 | 30 June 2014 | |
| Country of domicile | 57 | - | |
| Belgium | 57 | - | |
| Total all foreign countries, of which | 6,520 | 1,124 | |
| United states of America | 5,082 | 1,124 | |
| Rest of the world | 1,438 | - | |
| Total | 6,578 | 1,124 |
Revenues in the above table are assigned according to the location of the group or parent company of the customer.
The Group has recognized revenues from one customer representing at least 10% of the total revenues. This customer accounts for € 5.0 million of the revenues in the first half of 2015 (first half of 2014: € 1.1 million).
| For the 6 months ended | |||
|---|---|---|---|
| In €000 | 30 June 2015 | 30 June 2014 | |
| R&D project support (IWT grants) | 639 | 1,078 | |
| Other project grants | - | 297 | |
| Other income | 8 | 4 | |
| Total | 646 | 1,379 |
The Cost of goods sold in relation to the product sales is as follows:
| For the 6 months ended | ||||
|---|---|---|---|---|
| In €000 | 30 June 2015 | 30 June 2014 | ||
| Staff costs | -413 | -480 | ||
| Material, lab consumables & small | ||||
| equipment | -536 | -189 | ||
| Depreciation and amortization | -204 | -305 | ||
| Other | -4 | -25 | ||
| Total | -1,158 | -1,000 | ||
| For the 6 months ended | ||||
|---|---|---|---|---|
| In €000 | 30 June 2015 | 30 June 2014 | ||
| Staff costs | -7,984 | -6,631 | ||
| Subcontracting | -2,696 | -2,329 | ||
| Laboratory expenses | -734 | -403 | ||
| Cartridge, instrument and consoles | -5 | -22 | ||
| Consultancy | -761 | -580 | ||
| Quality and regulatory | - | -39 | ||
| Intellectual property | -447 | -301 | ||
| Facilities | -1,089 | -456 | ||
| Travel, training, office & other | -969 | -731 | ||
| Depreciation and amortization | -2,176 | -1,557 | ||
| Internally capitalized instruments | 770 | 280 | ||
| Total | -16,092 | -12,768 |
Subcontracting includes expenses in relation to services provided by research and development providers such as services related to the development of the assay cartridge, instrument and console of the various diagnostic platforms, manufacturing equipment design and engineering services.
| For the 6 months ended | |||
|---|---|---|---|
| In €000 | 30 June 2015 | 30 June 2014 | |
| Staff costs | -1,706 | -871 | |
| Subcontracting | -480 | -41 | |
| Sales and marketing | -37 | -12 | |
| Business development | -110 | -34 | |
| Travel, training, office & other | -852 | -195 | |
| Depreciation and amortization | -34 | -4 | |
| Total | -3,219 | -1,158 |
Sales and marketing expenses relate to costs of external market research, advertisement, and promotional activities related to the Group's products.
| For the 6 months ended | |||
|---|---|---|---|
| In €000 | 30 June 2015 | 30 June 2014 | |
| Staff costs | -1,400 | -1,401 | |
| External advice | -1,018 | -608 | |
| Facilities | -165 | -454 | |
| ICT | -3 | -57 | |
| Travel, training, office and other | -988 | -390 | |
| Depreciation and amortization expenses |
-4 | -230 | |
| Total | -3,578 | -3,139 |
External advice expenses include fees, service and consulting expenses related to legal, human resources, investor relations, accounting, audit and tax services. Other expenses include office, insurance and other miscellaneous expenses used in general and administrative activities.
| For the 6 months ended | ||||
|---|---|---|---|---|
| In €000 | 30 June 2015 | 30 June 2014 | ||
| Staff costs | -11,503 | -9,383 | ||
| Average number of full time equivalents | 204 | 162 |
| For the 6 months ended | |||
|---|---|---|---|
| In €000 | 30 June 2015 | 30 June 2014 | |
| Current income taxes | -190 | - | |
| Deferred income taxes | 527 | 421 | |
| Total | 337 | 421 |
Current income taxes for € 0.2 million were recorded in the frame of the disposal of the EvalutionTM branch in 2014. The deferred income taxes of € 0.5 million relate to the R&D tax credit carry-forwards in Belgium for the first half of 2015.
The Group has tax losses available to carry forward of € 116.8 million per 30 June 2015 (31 December 2014: € 86.8 million). Due to uncertainty surrounding the Group's ability to realise taxable profits in the foreseeable future, the Group has not recognised any deferred tax assets on tax loss carry forwards.
The discontinued operations in the first half of 2014 relate to the results of the EvalutionTM business. The branch was contributed to the share capital of MyCartis NV per 1 July 2014.
| For the 6 months ended | |||
|---|---|---|---|
| In €000 | 30 June 2015 | 30 June 2014 | |
| Revenue | |||
| Collaboration revenue | - | 133 | |
| Service revenue | - | 1 | |
| - | 134 | ||
| Other operating income | |||
| Grants and other income | - | 29 | |
| Operating expenses | |||
| Research and development expenses | - | -3,368 | |
| Marketing and distribution expenses | - | -384 | |
| General and administrative expenses | - | -492 | |
| - | -4,244 | ||
| Operating loss for the period | - | -4,080 | |
| Foreign exchange gains/(losses), net | - | -11 | |
| Financial result, net | - | -11 | |
| Loss before taxes | - | -4,092 | |
| Taxes | |||
| Net loss for the year from discontinuing | |||
| operations | - | -4,092 | |
| attributable to owners of the Company | - | -4,092 | |
| - | - | ||
| attributable to non-controlling interest |
The company has stock options plans that may be settled in common shares of the Company and which are considered anti-dilutive given that the Group's operations were loss making over the reporting period. As such, the basic and diluted earnings per share are equal.
| For the 6 months ended | |||
|---|---|---|---|
| 30 June 2015 | 30 June 2014 | ||
| Profit/loss for the period attributable to the owners of the Company (in €000) |
-16,915 | -19,746 | |
| Weighted average number of ordinary shares for basic loss per share (in number of shares) |
33,557,321 | 24,690,864 | |
| basic loss per share (€) | -0.50 | -0.80 | |
The table below provides an overview of the investments per subcategory. Total additions amount to € 1.6 million in the first half of 2015 and mainly concern investments in cartridge molds (€ 0.5 million), 15 internally produced IdyllaTM consoles (€ 0.1 million) and 50 internally produced IdyllaTM instruments (€ 0.7 million) for internal use.
| As of | |
|---|---|
| In €000 | 30 June 2015 |
| Investments | |
| ICT equipment | 95 |
| Laboratory equipment | 130 |
| Manufacturing equipment | 547 |
| Internally produced systems | 770 |
| Furniture and fixtures | 63 |
| Leasehold improvements | 35 |
| Total | 1,640 |
On 15 January 2015, the Group acquired a financial participation of 13.5% (per 30 June 2015: 11,2 %) in MyCartis NV through a contribution in kind for an amount of € 5.1 million through the conversion of the share put option held by Debiopharm Diagnostics SA. The participation is accounted for at cost as the Group has no significant influence over MyCartis NV. No impairment has been recorded per 30 June 2015.
| As of | |||
|---|---|---|---|
| In €000 | 30 June 2015 | 31 Dec 2014 | |
| Initial recognition amount | 5,052 | - | |
| Total | 5,052 | 0 | |
Trade receivables have decreased from € 15.8 million per 31 December 2014 to € 3.1 million per 30 June 2015. The decrease of € 12.7 million results from the payment of JPNV receivables in 2015.
| As of | ||||
|---|---|---|---|---|
| In €000 | 30 June 2015 | 31 Dec 2014 | ||
| Trade receivables | 3,105 | 15,793 | ||
| Allowance for doubtful receivables | - | - | ||
| Total | 3,105 | 15,793 |
The other receivables show an increase by € 1.3 million compared to 31 December 2014, which is explained by higher VAT receivables.
| As of | ||
|---|---|---|
| In €000 | 30 June 2015 | 31 Dec 2014 |
| VAT receivables | 1,471 | 116 |
| Other receivables | 13 | 32 |
| Total | 1,484 | 148 |
| As of | ||||
|---|---|---|---|---|
| In €000 | 30 June 2015 | 31 Dec 2014 | ||
| Accrued grant income | 986 | 2,168 | ||
| Accrued other income | 79 | - | ||
| Deferred charges | 932 | 533 | ||
| Total | 1,997 | 2,700 |
Other current assets include accrued grant income for € 1.0 million mainly related to Flemish government grants for IWT R&D projects and deferred charges of € 0.9 million.
Biocartis Group NV – condensed consolidated interim financial statements period ended 30 June 2015
The table below summarises the share capital and the outstanding shares of Biocartis Group NV.
| Biocartis Group NV | |||
|---|---|---|---|
| Number of common shares issued |
Number of preferred F shares issued |
||
| and outstanding |
and outstanding |
Share capital in '000€ |
|
| At 31 December 2014 | 24,690,864 | 2,645,868 | 222,268 |
| Share issue - tranche 2 of round F on 15 January | |||
| 2015 | - | 2,519,855 | 20,488 |
| Share issue - contribution in kind of the | |||
| participation in MyCartis on 15 January 2015 Capital increase by incorporation of share |
591,774 | - | 4,811 |
| premium on 15 January 2015 | - | - | 8 |
| Capital decrease by conversion into share | |||
| premium on 13 April 2015 | - | - | -247,271 |
| Conversion preferred F shares into common | |||
| shares on 28 April 2015 Share issue -Initial Public Offering on 28 April |
5,165,723 | -5,165,723 | - |
| 2015 | 8,695,652 | - | 87 |
| Share issue - exercise of over-allotment warrant | |||
| on 19 May 2015 | 1,304,347 | - | 13 |
| Share issue - exercise of stock options on 3 June 2015 |
21,000 | - | - |
| At 30 June 2015 | 40,469,360 | - | 405 |
The following capital transactions took place at Biocartis Group NV from 1 January 2015 until 30 June 2015:
On 28 April 2015, Biocartis Group NV raised € 100.0 million following an Initial Public Offering, fully paid by an increase in share capital of € 0.1 million and an increase in share premium by € 99.9 million.
On 19 May 2015, Biocartis Group NV raised € 15.0 million following the execution of the IPO over-allotment warrant. The amount was fully paid by an increase in share capital by € 0.013 million and by an increase in share premium by € 15.0 million.
The Group has incurred € 9.2 million expenses in connection with the IPO consisting of underwriting fees, legal costs, investor relations costs, accounting and audit fees and share registration and other regulatory costs.
Underwriting fees and investor relations costs are fully attributable to the issuance of the new shares and were entirely deducted from the funds raised.
Legal costs, accounting and audit fees and share registration and other regulatory costs were incurred for both the issuance of new shares and the listing of the existing shares and were not fully deducted from equity. The Group deems that the best allocation is based on the ratio of new equity funding (€ 115.0 million) versus total equity funding (€ 296.4 million), being 38.8%. The 61.2% remaining portion of the costs incurred related to the listing of the existing shares are expensed. As such, in total € 8.1 million was deducted from equity and € 1.1 million was expensed.
The 2008 Plan is a non-dilutive stock option plan, implying that no new shares are issued upon the exercise of the respective stock options. In total 19,160 options were exercised in the first half of 2015 at CHF 4.14 exercise price and € 13.08 share price at the moment of the exercise of the options. A total of 75,172 options are still outstanding per 30 June 2015.
The 2013 Plan is a dilutive option plan, implying that new shares are issued upon the exercise of the respective stock options. In total 21,000 options were exercised in the first half of 2015, of which 1,000 options at € 8.1308 exercise price and 20,000 options at € 8.1309 exercise price, with € 13.79 average share price at the moment of the exercise of the options. A total of 699,340 options are outstanding per 30 June 2015. A total number of 279,660 stock options can still be granted under the 2013 Plan.
The 2015 Plan is a dilutive option plan, implying that new shares are issued upon the exercise of the respective stock options. Biocartis Group NV is allowed to grant a maximum of 262,934 stock options to selected staff members and directors. No stock options have been granted per 30 June 2015 under the 2015 plan.
In execution of a decision of the board of directors of Biocartis S.A. of 24 April 2014, 100,000 options on shares of the Company were granted by the Company to Whitemarsh Capital LLC, a commercial partner of the Company that assists in brokering agreements for the Company with US governmental institutions for the payment of its products. In the first half of 2015, 33,000 options were forfeited. None of the remaining 67,000 options granted have been vested to this date and it is uncertain if this will occur in the near future. No share-based compensation was recorded as per 30 June 2015.
| SOP 2008 | SOP 2013 | SOP 2015 | SOP WHC | Total | ||
|---|---|---|---|---|---|---|
| Total outstanding at 31 December | ||||||
| 2014 | 94,362 | 720,340 | - | - | 814,702 | |
| Options granted | + | - | - | - | 100,000 | 100,000 |
| Options exercised | - | 19,160 | 21,000 | - | - | 40,160 |
| Options forfeited | - | - | - | - | 33,000 | 33,000 |
| Options cancelled | - | - | - | - | - | - |
| Total outstanding at 30 June 2015 | 75,202 | 699,340 | - | 67,000 | 841,542 |
The shared-based compensation expense recognized in the income statement is given below:
| For the 6 months ended | |||
|---|---|---|---|
| In €000 | 30 June 2015 | 30 June 2014 | |
| Share based compensation | 45 | 87 | |
| Total | 45 | 87 |
| As of | ||
|---|---|---|
| In €000 | 30 June 2015 | 31 Dec 2014 |
| Grants | - | 75 |
| Partner income | 7,046 | 9,559 |
| Total | 7,046 | 9,634 |
| current | 5,025 | 5,100 |
| Non-current | 2,021 | 4,534 |
Deferred partner income includes upfront payments received from JPNV in relation to the strategic licensing, development and commercialisation collaborations. This amount will be recognized as collaboration revenue in the following 2.5 years with a majority in 2015 and 2016.
Deferred partner income
| As per 31 December 2013 | 2,270 |
|---|---|
| Invoiced | 7,860 |
| Recognized in profit or loss | -571 |
| As per 31 December 2014 | 9,559 |
| Recognized in profit or loss | -2,512 |
| As per 30 June 2015 | 7,046 |
The fair value of the financial assets has been determined on the basis of the following methods and assumptions:
The fair value of the financial liabilities has been determined on the basis of the following methods and assumptions:
The Group uses the following hierarchy for determining and disclosing the fair value of financial instruments by valuation technique:
The Group has no financial instruments carried at fair value in the condensed consolidated balance sheet on 30 June 2015 and 31 December 2014.
| Carrying value | Fair value | |||
|---|---|---|---|---|
| in '000 € | 30 June 2015 | 31 Dec 2014 | 30 June 2015 | 31 Dec 2014 |
| Financial assets | ||||
| Loans and receivables measured at amortised cost | ||||
| Trade and other receivables (current) | 4,589 | 15,941 | 4,589 | 15,941 |
| Other financial assets (non-current) | 11 | 117 | 11 | 117 |
| Other current assets | 1,997 | 2,700 | 1,997 | 2,700 |
| Total loans and other receivables | 6,597 | 18,757 | 6,597 | 18,757 |
| Cash & cash equivalents | ||||
| cash & cash equivalents | 128,477 | 10,919 | 128,477 | 10,919 |
| Total cash & cash equivalents | 128,477 | 10,919 | 128,477 | 10,919 |
| Financial liabilities measured at amortized cost | ||||
| Loans & Borrowings | 13,364 | 13,585 | 13,933 | 14,077 |
| Trade payables | 3,866 | 4,265 | 3,866 | 4,265 |
| Other liabilities and accrued charges | 4,815 | 5,248 | 4,815 | 5,248 |
| Total financial liabilities measured at amortized cost | 22,045 | 23,098 | 22,614 | 23,590 |
For a description of outstanding contingencies, please refer to the annual report per 31 December 2014.
The Group has € 4.2 million capital commitments mainly related to investments in the cartridge manufacturing facilities in Mechelen.
The table below provides an overview of the transactions with non-executive directors and shareholders during the period under review:
| In €000 | Sales of goods and services |
Purchase of good and services |
Interest cost |
|---|---|---|---|
| 30 June 2015 | 5,285 | -1,130 | -235 |
| 30 June 2014 | 1,124 | -18 | -219 |
| In €000 | Trade receivables | Trade payables | Financial Debt |
| 30 June 2015 | 2,306 | 81 | 6,942 |
| 31 December 2014 | 15,723 | - | 6,707 |
Transactions with related parties are made at arm's length. The main transactions are described below:
In July 2015, the Group has been awarded an R&D project grant from IWT (Institute for the promotion of Innovation by Science and Technology in Flanders) for the development of novel molecular diagnostic solutions for bloodstream infections on the IdyllaTM platform. The grant amounts to € 1,461,565 and the project term is 12 months as of March, 2015.
In August 2015, the Group has signed a strategic collaboration agreement with Exploit Technologies/A*Star, an organization representing 14 academic research centers in Singapore. The parties aim to jointly develop a range of multiplex tests on the IdyllaTM platform. The initial focus will be on lung and liver cancer biomarkers.
Biocartis is pleased to announce it has strengthened its senior management team by the promotion of the current CFO to Deputy CEO and the appointment of a new CFO.
Hilde Windels will assume the new title of Deputy CEO, a title that better fits the significant contribution she continues to make to the company. As Deputy CEO, Hilde will continue to work closely alongside the CEO, Rudi Pauwels, focusing on the day-to-day operational management of Biocartis. Rudi will continue to lead the company on a daily basis in its implementation of its mission, strategy and targets set by the Board of Directors, with a focus on the long-term future growth of the business.
Ewoud Welten will join Biocartis as CFO, a role previously assumed by Hilde Windels, from international investment bank Kempen & Co. He brings in extensive experience of the healthcare sector as a corporate financier in which position he managed numerous capital market transactions including IPOs, secondary fundraisings and M&A transactions. Ewoud will also have a key role in reinforcing Investor Relations (IR), together with Renate Degrave, who is joining from EY and will be heading Corporate Communications & IR.
In view of the next critical steps Biocartis has to take in becoming a world leader in molecular diagnostics, it has been decided to strengthen positions at its senior management level, besides the appointments of Hilde and Ewoud, to provide the company with the expertise needed for the execution of its strategy. Biocartis' senior management team going forward consists of the following members: Rudi Pauwels (CEO), Hilde Windels (Deputy CEO), Ewoud Welten (CFO), Ulrik Cordes (CCO), Caroline Collard (Marketing), Erwin Sablon (R&D and Alliance Management), Patrick Hofkens (General Counsel) and Susy Spruyt (Human Resources).
Biocartis Group NV – condensed consolidated interim financial statements period ended 30 June 2015
Report on review of the condensed consolidated interim financial statements for the six-month period ended 30 June 2015
To the board of directors
In the context of our appointment as the company's statutory auditor, we report to you on the condensed consolidated interim financial statements. These condensed consolidated interim financial statements comprise the condensed consolidated balance sheet as at 30 June 2015, the condensed consolidated income statement, the condensed consolidated statement of other comprehensive income, the condensed consolidated statement of changes in equity and the condensed consolidated cash flow statement for the period of six months then ended, as well as selective notes 6.1 to 6.22.
We have reviewed the condensed consolidated interim financial statements of Biocartis Group NV ("the company") and its subsidiaries (jointly "the group"), prepared in accordance with International Financial Reporting Standard IAS 34 – Interim Financial Reporting as adopted by the European Union.
The condensed consolidated balance sheet shows total assets of 166.113 (000) EUR and the condensed consolidated income statement shows a consolidated loss (group share) for the period then ended of 16.915 (000) EUR.
The board of directors of the company is responsible for the preparation and fair presentation of the condensed consolidated interim financial statements in accordance with IAS 34 – Interim Financial Reporting as adopted by the European Union. Our responsibility is to express a conclusion on these condensed consolidated interim financial statements based on our review.
We conducted our review of the condensed consolidated interim financial statements in accordance with International Standard on Review Engagements (ISRE) 2410 – Review of interim financial information performed by the independent auditor of the entity. A review of interim financial information consists of making inquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review is substantially less in scope than an audit performed in accordance with the International Standards on Auditing (ISA) and consequently does not enable us to obtain assurance that we would become aware of all significant matters that might be identified in an audit. Accordingly, we do not express an audit opinion on the condensed consolidated interim financial statements.
Biocartis Group NV – condensed consolidated interim financial statements period ended 30 June 2015
Based on our review, nothing has come to our attention that causes us to believe that the condensed consolidated interim financial statements of Biocartis Group NV have not been prepared, in all material respects, in accordance with IAS 34 – Interim Financial Reporting as adopted by the European Union.
Diegem, 10 September 2015
The statutory auditor
DELOITTE Bedrijfsrevisoren / Reviseurs d'Entreprises
BV o.v.v.e. CVBA / SC s.f.d. SCRL
Represented by Gert Vanhees
Biocartis Group NV is a limited liability company organized under the laws of Belgium and has its registered office at Generaal De Wittelaan 11 bus B, 2800 Mechelen, Belgium.
As defined by Belgian law, Biocartis has to publish its financial report in the English and Dutch language. In case of difference in interpretation, the English version takes precedence.
An electronic version of the Half year financial report 2015 is available on the website of Biocartis at www.biocartis.com.
Other information on the website of Biocartis or on other websites is not a part of this Half-year Report.
Biocartis Investor Relations Generaal De Wittelaan 11 B3 2800 Mechelen Belgium +32 15 632 600 [email protected]
Biocartis is listed on Euronext Brussels under symbol BCART. Biocartis' ISIN code is BE0974281132.
Q3 2015 Business Update: Thursday 19 November 2015
Full year 2015 financial results: Thursday 17 March 2016
The financial year starts on 1 January and ends on 31 December.
Deloitte Bedrijfsrevisoren B.V. o.v.v.e. CVBA, represented by Gert Vanhees Berkenlaan 8b 1931 Diegem, Belgium
Certain statements, beliefs and opinions in this report are forward-looking, which reflect the Company or, as appropriate, the Company directors' current expectations and projections concerning future events such as the Company's results of operations, financial condition, liquidity, performance, prospects, growth, strategies and the industry in which Company operates. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in
demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward-looking statements contained in this report regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this report, those results or developments may not be indicative of results or developments in future periods. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this report as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forwardlooking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this report or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this report.
| Assay | In the field of diagnostics, an assay is a process or method aimed at determining the presence or amount (quantitative assay) of a certain substance in a sample. |
|---|---|
| Serine/threonine protein kinase B-raf (BRAF) |
BRAF is a protein that, in humans, is encoded by the BRAF gene. The BRAF protein is involved in sending signals within cells and in cell growth. Certain inherited BRAF mutations cause birth defects. Alternatively, other acquired mutations in adults may cause cancer. |
| Biomarker | |
| A Biomarker is any molecular characteristic, feature or parameter that can be objectively measured through an assay and evaluated as an indicator of: (i) normal biologic processes; (ii) abnormal biologic processes; (iii) pathogenic processes; or (iv) pharmacologic responses to a therapeutic intervention or other action/intervention. |
|
| CE-mark | The CE-mark is a mandatory conformance mark on many products placed on the market in the European Union. With the CE-marking on a product, the manufacturer ensures that the product is in conformity with the essential requirements of the applicable European Union directives. The letters "CE" stand for "Conformité Européenne" ("European Conformity"). |
| Deoxyribonucleic acid (DNA) |
DNA is a nucleic acid molecule that contains the genetic instructions used in the development and functioning of living organisms. |
| Epidermal growth factor receptor (EGFR) |
EGFR is a protein found on the surface of certain cells which can cause them to divide. It is found in abnormally high levels on the surface of many types of cancer cells. |
| Emergency Use Authorisation (EUA) |
This is an authorisation given by the FDA Commissioner pursuant to section 564 of the US Federal Food, Drug, and Cosmetic Act, as amended (the "FD&C Act"), which allows unapproved medical products or unapproved uses of approved medical products to be used in the United States in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by chemical, biological, radiological or nuclear threat agents when there are no adequate, approved, and available alternatives. |
| Formalin fixed, paraffin embedded (FFPE) |
FFPE tissues are samples, typically from suspected tumours, that are fixed or mixed with formalin to preserve the structural integrity of the sample. The sample is then embedded into a type of paraffin wax so that it can be sliced into very fine slices, 5-10 microns thick. Treating samples in this manner enables the samples to be stained with dyes to analyse abnormalities in tissue that is suspected of cancer. |
| US Food and Drug Administration (FDA) |
The FDA is a federal agency of the United States Department of Health and Human Services responsible for protecting and promoting public health through the regulation and supervision of, among other things, medical devices. |
|---|---|
| Influenza | Also known as "the flu" is a highly contagious respiratory tract infection caused by the family of influenza viruses. |
| In vitro diagnostics or In vitro diagnosis (IVD) |
IVD is a diagnostic test outside of a living body in contrast to "in vivo", in which tests are conducted in a living body (for example an X-ray or CT-scan). |
| Kirsten rat sarcoma-2 virus oncogene (KRAS) |
KRAS is a protein that, in humans, is encoded by the KRAS gene. Like other members of the Ras family, the KRAS protein is a GTPase (a large family of hydrolase enzymes that can bind and hydrolyse guanosine triphosphate), and is an early player in many signal transduction pathways. The protein product of the normal KRAS gene performs an essential function in normal tissue signalling, and the mutation of a KRAS gene is associated with the development of many cancers. |
| Molecular diagnostics (MDx) |
MDx is a form of diagnostic testing used to detect specific sequences in DNA or RNA that may or may not be associated with disease. Clinical applications of MDx include infectious disease testing, oncology, pharmacogenomics and genetic disease screening. |
| Micro satellite instability (MSI) |
MSI is a genetic hyper-mutability condition resulting from MMR that is functioning abnormally. |
| Multiplexing | The simultaneous detection of more than one analyte or biomarker from a single sample. |
| Neuroblastoma RAS viral (v-ras) oncogene (NRAS) |
NRAS is an protein that is encoded, in humans, by the NRAS gene. Like other members of the Ras family, the NRAS protein is a GTPase (a large family of hydrolase enzymes that can bind and hydrolyse guanosine triphosphate), and is an early player in many signal transduction pathways. The protein product of the normal NRAS gene performs an essential function in normal tissue signaling, and the mutation of a NRAS gene is associated with the development of many cancers. |
| Polymerase chain reaction (PCR) |
The specific and exponential amplification of DNA sequences by consecutive thermal cycling steps. Real-time PCR is a form of PCR whereby the amplified sequences are made visible by means of fluorescent labelling in real time, i.e., as they become synthesized. Real-time PCR can be used to estimate the quantity of target DNA sequences in a multiplexed way. PCR and real-time PCR can also be used to detect and quantify RNA sequences after a DNA copy has been made from the RNA sequence by means of a reverse transcriptase enzyme. |
| Protein | Polypeptide chain built from the 20 natural amino acids. Proteins are synthesized from a messenger RNA copy of a gene and can have many functions in the cytoskeleton of the cell, enzymatic, messenger functions in cells and blood such as immune cytokines, DNA binding proteins that regulate expression, etc. |
|---|---|
| Respiratory Syncytial Virus (RSV) |
RSV is a major cause of lower respiratory tract infection that is a frequent infection in children. |
| Research Use Only (RUO) |
This is a category of non-approved (i.e. no CE-marking and FDA approval) medical device products that can solely be used for research purposes. Many producers introduce their products first as RUO and/or IUO products, prior to obtaining 510(k) clearance or PMA approval. |
| Sepsis | Severe overall inflammatory response of the body to an infection. |
Biocartis Group NV Generaal De Wittelaan 11 B3 2800 Mechelen – Belgium
wwww.biocartis.com
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