Earnings Release • Sep 6, 2016
Earnings Release
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Mechelen, Belgium, 6 September 2016 – Biocartis Group NV (the 'Company' or 'Biocartis'), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces its operational highlights and financial results for the first half of 2016, prepared in accordance with the IAS 34 Interim Financial Reporting as adopted by the European Union. Furthermore, the Company provides an updated outlook for 2016.
The Biocartis management team will host a conference call with live webcast presentation today at 14:00 CEST / 13:00 BST (UK) / 08:00 EDT (US) to discuss the H1 2016 results. The live webcast may be accessed by clicking here.
To participate in the questions and answers session, please dial 5-10 minutes prior to the start time the number +44(0)20 3427 1908 (standard international), followed by the confirmation code 6014209.
The conference call and webcast will be conducted in English. A replay of the webcast will be available on the Biocartis investors' website shortly after.
Biocartis commercialises its proprietary molecular diagnostics platform Idylla™ via direct representations in key European countries and via distribution partners in other geographies.
During H1 2016, Biocartis further advanced the development of new tests for its Idylla™ platform with a focus on completing its core menu for oncology (i.e. tests for melanoma, colon and lung cancer) and launching its second infectious disease test.
Biocartis currently markets five oncology tests, consisting of four solid biopsy tests and one liquid biopsy test. To date, these tests generate most of the commercial cartridge revenues.
1 Epidermal Growth Factor Receptor. The Idylla™ EGFR Mutation Assay is intended for Research Use Only (RUO), not for diagnostic procedures. Not for sale in the USA and Canada. European Society for Medical Oncology. Source: E. Van Cutsem et al, 'ESMO consensus guidelines for the management of patients with metastatic colorectal cancer', Annals of Oncology, published July 5, 2016.
3 Diaz LA, Jr., Bardelli A. Liquid biopsies: genotyping circulating tumor DNA. J Clin Oncol 2014; 32: 579–586; Siravegna G, Bardelli A. Genotyping cell-free tumor DNA in the blood to detect residual disease and drug resistance. Genome Biol 2014; 15: 449; and Montagut C, Dalmases A, Bellosillo B et al. Identification of a mutation in the extracellular domain of the Epidermal Growth Factor Receptor conferring cetuximab resistance in colorectal cancer. Nat Med 2012; 18: 221–223. 4 American Society of Clinical Oncology.
5 Intended for Research Use Only, not for diagnostic procedures. Not for sale in the USA and Canada.
6 Janku et al. BRAF Mutation Testing in Cell-Free DNA from the Plasma of Patients with Advanced Cancers Using a Rapid, Automated Molecular Diagnostics System. Mol Cancer Ther (2016) 15(6): 1–8.
perfectly suited for treatment monitoring. Similar findings were reported by Prof. Bart Neyns (Head of Medical Oncology, University Hospital Brussels, Belgium) and his team7 .
Biocartis' focus within infectious diseases is on offering highly sensitive syndromic panel tests (initial focus on respiratory diseases), tests that support Biocartis' disease surveillance strategy and tests for fast monitoring of bloodstream infections ('BSI', including sepsis).
Total operating income: Total operating income in H1 2016 amounted to EUR 6.8m in H1 2016 compared to EUR 7.2m in H1 2015, representing a decrease of 7% due to increased product revenues that were offset by lower collaboration revenues. Collaboration revenues in H1 2016 included higher recognised upfront payments
9 Reijans et al. ESMO 2016, to be published on 6 October 2016.
Schreuer et al. Quantitative assessment of BRAF V600 mutant cell-free tumor DNA from plasma as a diagnostic and therapeutic biomarker in patients with BRAF V600 mutant melanoma. ASCO 2015. 8 De Biase et al. 'Fully Automated PCR detection of KRAS Mutations on Pancreatic Endoscopic Ultrasound Fine Needle Aspirates'. J Clin Pathol 2016.
11 E. Van Cutsem et al, ESMO consensus guidelines for the management of patients with metastatic colorectal cancer, Annals of Oncology Advance Access published July 5, 2016.
12 510k clearance is a requirement by the FDA before a product is allowed on the US market. It requires a number of technical or clinical studies. 13 Cnops et al. Development, Evaluation, and Integration of a Quantitative Reverse-Transcription Polymerase Chain Reaction Diagnostic Test for Ebola Virus on a Molecular Diagnostics Platform. J Inf Dis 2016. doi: 10.1093/infdis/jiw150.
from strategic partners compared to H1 2015 (increase of 30%) but lower milestone payments (decrease of 100%) since one-off milestone payments of EUR 2m were received in H1 2015 whereas no milestone payments were collected in H1 2016.
Commenting on the H1 2016 results, Rudi Pauwels, Chief Executive Officer of Biocartis, said: "The year 2016 for Biocartis is focused on translating our investments in installed base growth and menu expansion to exponentially increase the number of patients that can be helped by our solutions. I am pleased to see first evidence of this materialising in H1 2016. We managed to strengthen our financial position with a new nondilutive financing of EUR 55m that we announced in July 2016. This financing will further support us in realising our ambitious growth trajectory that is aimed at making high quality molecular diagnostic solutions available everywhere and every time healthcare workers and patients interact and need to make clinical and therapeutic decisions."
The tables below show an overview of the key figures and a breakdown of operating income for H1 2016. Consolidated financial statements including notes are included in Biocartis' financial report for H1 2016 that can be downloaded from the Company's website here.
| Key figures (EUR 1,000) | H1 2016 | H1 2015 | % Change |
|---|---|---|---|
| Total operating income | 6,750 | 7,224 | -7% |
| Cost of sales | -1,921 | -1,158 | 66% |
| Research & Development expenses | -20,699 | -16,092 | 29% |
| Marketing & Distribution expenses | -5,259 | -3,219 | 63% |
| General & Administrative expenses | -2,874 | -3,578 | -20% |
| Operating expenses | -30,754 | -24,047 | 28% |
| Operational result | -24,003 | -16,823 | 43% |
| Net financial result | -282 | -429 | -34% |
| Income tax | 501 | 337 | 49% |
| Net result | -23,784 | -16,915 | 41% |
| Cash flow from operating activities | -25,345 | -8,719 | 191% |
| Cash flow from investing activities | -6,912 | -1,679 | 312% |
| Cash flow from financing activities | 3,919 | 127,977 | -97% |
| Net cash flow | -28,338 | 117,579 | -124% |
| Cash and cash equivalents1 | 75,757 | 128,477 | -41% |
| Financial debt | 16,544 | 10,815 | 53% |
1 Including EUR 1.2m of restricted cash (as a guarantee for KBC lease financing)
| Breakdown operating income (EUR 1,000) | H1 2016 | H1 2015 | % Change |
|---|---|---|---|
| Collaboration revenue | 3,377 | 4,866 | -31% |
| Idylla™ System Sales | 988 | 1,246 | -21% |
| Cartridge Sales | 1,723 | 416 | 314% |
| Product sales revenue | 2,711 | 1,663 | 63% |
| Service revenue | 20 | 48 | -58% |
| Total revenue | 6,109 | 6,577 | -7% |
| Grants and other income | 641 | 646 | -1% |
| Total operating income | 6,750 | 7,224 | -7% |
Collaboration revenues in H1 2016 showed an increase of recognised upfront payments that were received from strategic partners compared to H1 2015 (increase of 30%). No milestone payments were collected in H1 2016 compared to the EUR 2m of one-off milestone payments that were collected in H1 2015. This caused total collaboration revenues to decrease in H1 2016 to EUR 3.4m (EUR 4.9m in H1 2015). Product sales in H1 2016 increased with 63% compared to H1 2015 to EUR 2.7m. Grants and other income in H1 2016 consisted of various R&D project grants. Total operating income in H1 2016 amounted consequently to EUR 6.8m versus EUR 7.2m in H1 2015.
Total operating expenses in H1 2016 equalled EUR 30.8m compared to EUR 24.0m in H1 2015, an increase of 28% driven by higher expenses in R&D as well as in Marketing and Distribution. R&D expenses increased from EUR 16.1m in H1 2015 to EUR 20.7m in H1 2016 (increase of EUR 4.6m) as consequence of a growth of the R&D team to support continued menu and platform expansion as well as to support life cycle management for the increased number of on-market products. Marketing and distribution expenses increased from EUR 3.2m in H1 2015 to EUR 5.3m in H1 2016 (increase of EUR 2.0m) as consequence of an expansion of the sales team and higher sales and promotional expenses. G&A expenses decreased in H1 2016 to EUR 2.9m compared to EUR 3.6m in H1 2015, driven by one-off expenses for external advice in H1 2015 related to the Company's initial public offer (IPO) on Euronext Brussels. The above resulted in an operational result for H1 2016 equal to EUR - 24.0m compared to EUR 16.8m in H1 2015 (decrease of EUR -7.2m). Following a net financial result for H1 2016 of EUR -0.3m and positive income taxes of EUR 0.5m, the net result for H1 2016 equalled to EUR -23.8m compared to EUR -16.9m for the same period in 2015.
Property, plant and equipment increased in H1 2016 to EUR 17.0m from EUR 14.2m at the end of 2015 (increase of EUR 2.8m) driven by capital expenditure additions in H1 2016 of EUR 4.8m and a depreciation charge of around EUR 2.0m.
Inventory increased from EUR 5.8m per 31 December 2015 to EUR 9.0m per 30 June 2016 (increase of EUR 3.2m) driven by an overall higher instrumentation and cartridge inventory in light of expected increased commercialisation in H2 2016 and due to Idylla™ systems that are placed at customers under the Company's early adopter program. Trade receivables in H1 2016 decreased from EUR 5.9m end of 2015 to EUR 2.1m due to the collection of upfront and milestone payments from strategic partners recorded end of 2015. Trade payables end of H1 2016 amounted to EUR 6.7m which is a decrease of 7.3m compared to the EUR 13.9m as per 31 December 2015, mainly driven by the payment of advance invoices in relation to the second cartridge manufacturing line that were recorded end of 2015. Deferred income has decreased to EUR 3.6m per 30 June 2016, from EUR 5.2m per 31 December 2015, mainly because of recognised upfront payments from Janssen Pharmaceutica in relation to the strategic licensing, development and commercialisation collaborations.
Total financial debt increased from EUR 10.8m as of 31 December 2015, to EUR 16.5m per 30 June 2016 (an increase of EUR 5.7m) driven by the new lease and bank financings for the manufacturing expansion. The cash position of the Group on 30 June 2016 amounted to EUR 75.8m compared to EUR 104.1m per 31 December 2015.
The cash flow from operating activities in H1 2016 amounted to EUR -25.3m compared to EUR -8.7m H1 2015. This increase is the result of higher operating expenses and investments in working capital for H1 2016 compared to significant positive movements in working capital for H1 2015. The cash flow from investing activities in H1 2016 amounted to EUR -6.9m compared to EUR -1.7m in H1 2015 principally driven by the increased capital expenditure for the cartridge manufacturing expansion. The cash flow from financing activities in H1 2016 amounted to EUR 3.9m, mainly driven by proceeds of the lease and bank financing for the cartridge manufacturing equipment. In H1 2015 the cash flow from financing activities amounted to EUR 128.0m thanks to the cash inflow from the IPO (EUR 107.0m) in April 2015 and the capital increase of the second tranche of the series F round (EUR 21.5m) in January 2015. The Group's net cash flow in H1 2016 amounted to EUR -28.3m.
The Biocartis management team will host a conference call with live webcast, during which the H1 2016 results will be presented, followed by a Q&A session. This event will be held today, 6 September 2016 at 14:00 CEST. The webcast can be accessed by clicking here. If you would like to participate in the Q&A, please dial +44(0)20 3427 1908 (standard international) with confirmation code 6014209. A replay of the webcast will be available on the Biocartis investors' website shortly after.
The condensed consolidated financial statements for the six month's period ended 30 June 2016 have been prepared in accordance with IAS 34 'Interim Financial Reporting' as adopted by the European Union. They do not include all the information required for the full annual financial statements and should therefore be read in conjunction with the financial statements for the year ended 31 December 2015. The condensed consolidated financial statements are presented in thousands of Euros (unless stated otherwise). The condensed consolidated financial statements have been approved for issue by the Board of Directors on 1 September 2016. The statutory auditor, Deloitte Bedrijfsrevisoren/Reviseurs d'Entreprises, represented by Gert Vanhees, has performed a limited review, which did not reveal any significant adjustments to the condensed consolidated financial statements. The interim financial report 2016 and the limited review opinion of the auditor are available on www.biocartis.com.
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Renate Degrave Manager Corporate Communications & Investor Relations e-mail [email protected] tel +32 15 631 729 mobile +32 471 53 60 64 @Biocartis\_ www.linkedin.com/Biocartis
Biocartis (Euronext Brussels: BCART) is an innovative molecular diagnostics (MDx) company providing next generation diagnostic solutions aimed at improving clinical practice for the benefit of patients, clinicians, payers and industry. Biocartis' proprietary MDx Idylla™ platform is a fully automated sample-to-result, real-time PCR (Polymerase Chain Reaction) system that offers accurate, highly reliable molecular information from virtually any biological sample in virtually any setting. Biocartis launched the Idylla™ platform in September 2014. Biocartis is developing and marketing a rapidly expanding test menu addressing key unmet clinical needs in oncology and infectious diseases. These areas represent respectively the fastest growing and largest segments of the MDx market worldwide. Today, Biocartis has five oncology tests and two infectious disease tests on the market. More information: www.biocartis.com. Press Photo Library available here. Follow us on Twitter: @Biocartis_.
Certain statements, beliefs and opinions in this press release 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 the 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 press release 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 press release, 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 press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking 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 press release 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 press release.
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