Press Release Biocartis NV: Biocartis announces H1 2019 results

September 5, 2019 1:01 AM

PRESS RELEASE: REGULATED INFORMATION
Thursday, 5 September 2019, 07:00 CEST


BIOCARTIS ANNOUNCES H1 2019 RESULTS


Mechelen, Belgium, 5 September 2019 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces its business highlights and financial results for the first half of 2019, prepared in accordance with IAS 34 ‘Interim Financial Reporting’ as adopted by the European Union. Furthermore, the Company provides an updated outlook for the full year 2019.

Key messages


Updated 2019 guidance

Biocartis 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 2019 results. Click here to access the live webcast.
To participate in the questions and answers session, please dial
5-10 minutes prior to the start time the number +44 (0)8445718892 (standard international), followed by the confirmation code 9075637.
The conference call and webcast will be conducted in English.
A replay of the webcast will be available on the Biocartis investors’ website shortly thereafter.

Commenting on the H1 2019 results, Herman Verrelst, Chief Executive Officer Biocartis, said: “During H1 2019, we realized continued commercial growth in Europe and our RoW2 distributor markets and we maintain a good outlook for full year installed base growth. Despite the number of new high profile US customers that we attracted in the first half of this year, we encountered a delay in the actual US commercial cartridge volume ramp-up. While we take all actions to address this situation, our total cartridge volume growth for 2019 will be impacted. Good progress was made on other fronts. We added another CE-marked IVD test to our menu, further progressed work on US FDA filings and ventured into the immuno-oncology space, one of our strategic focus areas, with BMS and Kite as partners. Furthermore, with the closing of our commercialization deal for Japan, our commercial footprint is now covering all major markets worldwide. Finally, we significantly strengthened our financial position for the upcoming years thanks to a successful equity raise and a convertible bonds issuance. Overall, despite the delay incurred in US commercialization, we significantly strengthened our business in H1 2019 and feel confident about continuing our efforts for the remainder of the year, further supporting our ambitions towards building a leading global oncology business around the Idylla™ platform.”

Commercial highlights

Menu and partnership highlights

Organizational and operational highlights

Financial highlights

Post-period events

News flow H2 2019

Key figures for H1 2019
The tables below show an overview of the key figures and a breakdown of operating income for H1 2019. Consolidated financial statements including notes are included in Biocartis’ financial report for H1 2019 that can be downloaded from the Company’s website here.

Key figures (EUR 1,000)H1 2019H1 2018% Change
Total operating income17,29812,74136%
Cost of sales-8,742-6,89027%
Research and development expenses-20,031-16,02925%
Marketing and sales expenses-8,811-7,15223%
General and administrative expenses-6,399-3,80968%
Operating expenses-43,983-33,88030%
Operational result-26,685-21,13926%
Net financial result-2,822-691308%
Share in the result of associated companies-1810
Income tax1870-74%
Net result-29,670-21,76036%
Cash flow from operating activities-28,357-20,33539%
Cash flow from investing activities-5,267-2,301129%
Cash flow from financing activities179,4651,251na
Net cash flow1145,841-21,385na
Cash and cash equivalents2209,20091,269129%
Financial debt166,73138,145372%

1 Excludes effects of exchange rate changes on the balance of cash held in foreign currencies
2 Including EUR 1.2m of restricted cash (as a guarantee for KBC lease financing)

Operating income (EUR 1,000)H1 2019H1 2018% Change


Collaboration revenue6,8163,53593%
Idylla™ System sales2,4991,95228%
Idylla™ Cartridge sales7,4816,60313%
Product sales revenue9,9808,55517%
Service revenue35125140%
Total revenue17,14712,34139%
Grants and other income151400-62%
Total operating income17,29812,74136%


Product sales revenue (EUR 1,000) H1 2019H1 2018% Change
Commercial revenue9,5517,95020%
Research & Development revenue429605-29%
Total product sales revenue9,9808,55517%

Income statement

Collaboration revenues in H1 2019 increased year-over-year to EUR 6.8m driven by a strong growth in R&D services and license revenues, partially offset by the absence of milestone payments. R&D services, consisting of invoiced services to pharma and content partners, increased from EUR 2.6m in H1 2018 to EUR 4.4m in H1 2019 as a consequence of new partnerships closed in H2 2018 and H1 2019. License revenues increased from EUR 75k in H1 2018 to EUR 2.4m in H1 2019 and included a EUR 2m revenue recognition of a EUR 4m license payment from the China joint venture that was received in H1 2019 following the formal closing of that joint venture. No milestones revenues were recorded in H1 2019 versus EUR 0.8m of milestones in H1 2018.

Product sales revenues increased year-over-year with 17% to EUR 10.0m driven by an increase in cartridge sales and instrument revenues. Cartridge sales increased from EUR 6.6m in H1 2018 to EUR 7.5m in H1 2019, a year-over-year increase of 13%. Instrument revenues amounted to EUR 2.5m in H1 2019, a year-over-year increase of 28% as the consequence of the increase in installed base in H1 2019 and of an increased revenue contribution from instruments placed at clients under leasing contracts in previous periods. Year-over-year, commercial product revenues increased with approx. 20% whereas R&D product revenues decreased with 29%.

Service revenues increased year-over-year with 40% to EUR 0.4m. Grants and other income amounted to EUR 0.2m in H1 2019. Consequently, total operating income amounted to EUR 17.3m versus EUR 12.7m in H1 2018, a year-over-year increase of 36%.

Total operating expenses (including cost of sales) amounted to EUR 44.0m in H1 2019 versus EUR 33.9m in H1 2018, an increase of 30%. Cost of sales increased year-over-year with 27% to EUR 8.7m in H1 2019 driven by higher cartridge as well as instrument volumes. Expenses for R&D amounted to EUR 20.0m in H1 2019, a year-over-year increase of 25% that was predominantly driven by higher staffing costs and allocated depreciation expenses (see comment below on adoption IFRS 16). Expenses for sales and marketing increased year-over-year with 23% and amounted to EUR 8.8m. This increase was mainly driven by higher staffing costs, as a consequence of an expansion of Biocartis’ US sales team and higher expenses for consultancy and subcontracting. G&A expenses increased year-over-year with 68% to EUR 6.4m due to overall organizational growth as well as a general cost allocation that is shifting more towards a commercial stage organizational structure. The above resulted in an operational result for H1 2019 equal to EUR –26.7m compared to EUR -21.1m in H1 2018. Following a net financial result for the period of EUR –2.8m, of which EUR 1.1 m is related to accrued interest of the outstanding convertible bond and EUR 1.0m related to interest and repayment of the Company’s subordinated loan, the net result for H1 2019 equaled to EUR –29.7m compared to EUR -21.8m in H1 2018.

Balance sheet

As required, Biocartis has adopted the new IFRS 16 standard for lease accounting with date of initial application on 1 January 2019. This standard introduces a single lessee accounting model and requires a lessee to recognize assets and liabilities for all leases with a term of more than 12 months, eliminating the distinction between operating and finance leases. The first time adoption of IFRS 16 has an impact on the Group’s balance sheet as well as results in a reclassification of operational expenses in the Group’s income statement. Concretely, as of 1 January 2019, Biocartis also recognizes its operational leasing contracts (i.e. for buildings, company cars and office furniture) on its balance sheet in addition to the Group’s financial leasing contracts (i.e. for manufacturing equipment). This resulted in a one-off increase in property, plant and equipment and lease liabilities of EUR 14.3m on 1 January 2019. Furthermore, as property, plant and equipment is depreciated over time, the income statement recognizes deprecation charges and financing expenses for all the recognized leases versus previously the recognition of lease payments as e.g. building rent or facility & office expenses.

Property, plant and equipment increased in H1 2019 to EUR 43.7m as per end of June 2019 from EUR 30.4m at the end of 2018, an increase of EUR 13.3m. This increase was driven by a EUR 15.3m impact of IFRS 16 (as per 30 June 2019), EUR 2.8m of actual capital expenditures (mainly related to capitalization of instrumentation placed at clients under leasing or rental contracts) and a depreciation charge of around EUR 4.9m. Investments in associates and joint ventures was added to the balance sheet in H1 2019 in relation to the closing of the China joint venture and amounts to EUR 2.6m as per end of June 2019.

Inventory increased in H1 2019 to EUR 15.4m (versus EUR 11.9m per end 2018), predominantly driven by an increase in finished products of both cartridges and Idylla™ instrumentation. Trade and other receivables decreased in H1 2019 with EUR 1.14m due to lower trade receivables. On the other side of the balance sheet, trade payables decreased with EUR 2.8m to EUR 5.2m. Deferred income decreased with EUR 0.6m and accrued charges decreased with EUR 1.5m, the latter mainly driven by the first time adoption of IFRS 16.

The Group’s cash and cash equivalents end of H1 2019 amounted to EUR 209.2m compared to EUR 63.5m end of 2018. Total financial debt end of H1 2019 amounted to EUR 166.7m, representing an increase of EUR 131.4m compared to end of 2018. This was the result of the issuance of a convertible bond, an increase in lease liabilities in the context of the first time adoption of IFRS 16 and the repayment of the Company’s subordinated loan. Please note that the IFRS accounting treatment of the Company’s convertible bond has resulted in an allocation of the EUR 150m nominal amount to financial debt (EUR 134m) and equity (EUR 12m, adjusted for related transaction costs) as per the end of H1 2019.

Cash flow statement

The cash flow from operating activities in H1 2019 amounted to EUR –28.4m compared to EUR –20.3m in H1 2018. This increase is the result of a higher operating loss for the period, an increase in investments in working capital as well as higher interest and other financial expenses for H1 2019. The cash flow from investing activities in H1 2019 amounted to EUR –5.3m (compared to EUR -2.3m in H1 2018) and consisted of the initial capital contribution made to the China joint venture and capitalized Idylla™ systems. The cash flow from financing activities in H1 2019 amounted to EUR 179.5m (compared to EUR 1.3m in H1 2018) which was driven by the issuance of the convertible bonds (net proceeds of EUR 145.5m) and by the capital raise (net proceeds of EUR 53.4m), partially offset by the repayments of borrowings (predominantly the Company’s subordinated loan) of EUR 19.4m. Because of the aforementioned, the net cash flow of H1 2019 amounted to EUR 145.8m compared to EUR –21.4m in H1 2018.

Financial calendar

Webcast and presentation
Biocartis will host a conference call with live webcast, during which the H1 2019 results will be presented, followed by a Q&A session. This event will be held today, 5 September 2019 at 14:00 CEST / 13:00 BST (UK) / 08:00 EDT (USA). Access the webcast by clicking here. If you would like to participate in the Q&A, please dial
+44 (0) 8445718892 (standard international), followed by the confirmation code 9075637. A replay of the webcast will be available on the Biocartis investors’ website shortly after.

Auditor Statement
The condensed consolidated financial statements for the six-months’ period ended 30 June 2019 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 2018. 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. The statutory auditor, Deloitte Bedrijfsrevisoren/Reviseurs d’Entreprises, represented by Gert Vanhees, has performed a review, which did not reveal any significant adjustments to the condensed consolidated financial statements. The interim financial report 2019 and the review opinion of the auditor are available on www.biocartis.com.

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More information:

Renate Degrave
Head of Corporate Communications & Investor Relations
e-mail rdegrave@biocartis.com
tel +32 15 631 729
mobile +32 471 53 60 64
www.linkedin.com/Biocartis

About 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 is developing and marketing a continuously expanding test menu addressing key unmet clinical needs in oncology. This represents the fastest growing segment of the MDx market worldwide. Today, Biocartis offers tests supporting melanoma, colorectal and lung cancer. More information: www.biocartis.com. Press Photo Library available here. Follow us on Twitter: @Biocartis_.

Biocartis and Idylla™ are registered trademarks in Europe, the United States and other countries. The Biocartis and Idylla™ trademark and logo are used trademarks owned by Biocartis. This press release is not for distribution, directly or indirectly, in any jurisdiction where to do so would be unlawful. Any persons reading this press release should inform themselves of and observe any such restrictions. Biocartis takes no responsibility for any violation of any such restrictions by any person. Please refer to the product labeling for applicable intended uses for each individual Biocartis product. This press release does not constitute an offer or invitation for the sale or purchase of securities in any jurisdiction. No securities of Biocartis may be offered or sold in the United States of America absent registration with the United States Securities and Exchange Commission or an exemption from registration under the U.S. Securities Act of 1933, as amended.

Forward-looking statements

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company's or, as appropriate, the Company directors' or managements' 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. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates 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, except if specifically required to do so by law or regulation. 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.




1 An IVD companion diagnostic device is an in vitro diagnostic device that provides information that is essential for the safe and effective use of a corresponding therapeutic product. Source: US FDA, last consulted on 26 August 2019

2 RoW = Rest of World. RoW is defined as the world excluding Europe, US, China and Japan

3 Source: www.geisinger.org, last consulted on 26 August 2019

4 All Idylla™ assays sold in the US are for Research Use Only (RUO), not for use in diagnostic procedures

5 Source: ASCO guidelines, www.asco.org/endorsements/HereditaryCRC

6 Clinical Performance Study showed 99.7% concordance for MSI testing vs Promega (unpublished data); De Craene et al. (2018) Journal of Clinical Oncology 36:15 suppl, e15639; De Craene et al. (2017) Annals of Oncology 28 (suppl_5): v209-v268; Maertens et al. (2017) Annals of Oncology 28 (suppl_5): v22-v42

7 FFPE = formalin fixed, paraffin embedded

8 The Idylla™ MSI Test uses a new set of short homopolymers located in the ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A & SULF2 genes, which were exclusively licensed to Biocartis in 2013 from VIB, the life sciences research institute in Flanders (Belgium), and originated from the research of the group of Prof. Diether Lambrechts (VIB-KU Leuven, Belgium). These MSI biomarkers are tumor-specific, show a high frequency in colorectal and endometrial cancers and are stable across different ethnicities ensuring excellent specificity of the assay

9 PMA = Pre-Market Approval

10 RUO = Research Use Only, not for use in diagnostic procedures

11 Source: D. Planchard et al., ‘Metastatic non-small cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up’, published online 3 October 2018; updated 26 January 2019

12 3 mg/kg Opdivo® plus 1 mg/kg Yervoy®

13 Treatment with fluoropyrimidine, oxaliplatin and irinotecan

14 An IVD companion diagnostic device is an in vitro diagnostic device that provides information that is essential for the safe and effective use of a corresponding therapeutic product. Source: US FDA, last consulted on 16 August 2019

15 The G-BA decision will become effective following its publication by the Ministry of Health in the Federal Gazette (Bundesanzeiger). Source: Genomic Health website, https://newsroom.genomichealth.com/news-releases/news-release-details/german-federal-joint-committee-g-ba-issues-exclusive-nationwide, last consulted on 26 August 2019

16 Pauwels P. et al, ‘The Idylla™ MSI Test multi-center concordance study: microsatellite instability detection in colorectal cancer samples’, first published at ASCO Annual Meeting of the American Society of Clinical Oncology, 30 May – 4 June 2019, Chicago (IL), US

17 Polymerase Chain Reaction

18 Immunohistochemistry

19 M. Rabie Al-Turkmani et al., ‘Evaluation of a Cartridge-Based System for Rapid Detection of BRAF and NRAS Mutations in Melanoma’, Dartmouth-Hitchcock Medical Center and Geisel School of Medicine at Dartmouth, first published at the 71st AACC Annual scientific meeting & clinical lab expo, 4-8 August 2019, Anaheim (CA), US, available on https://www.abstractsonline.com/pp8/#!/6831/presentation/566

20 PMA = Pre-Market Approval

21 Research Use Only, not for use in diagnostic procedures


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